A Laboratory Evaluation of the Humoral Immune Response in Adults and Children to the H1 Hemagglutinin (HA) Stalk Domain and Other Influenza A Virus Protein Epitopes, After Administration of GlaxoSmithKline (GSK) Biologicals' Pandemic Influenza Vaccines
2019年7月12日 更新者：GlaxoSmithKline
An Exploratory, Retrospective Laboratory Evaluation of the Humoral Immune Response in Adults and Children to the H1 HA Stalk Domain and Other Influenza A Virus Protein Epitopes, After Administration of GSK Biologicals' Pandemic Influenza Vaccines
The purpose of this exploratory, retrospective laboratory study is to assess the humoral immune response to H1 hemagglutinin stalk domain and other influenza A virus protein epitopes following administration, in adults and children, of GSK Biologicals' adjuvanted and unadjuvanted pandemic influenza vaccines, using archived serum samples from previously completed clinical trials.
調査の概要
研究の種類
観察的
入学 (実際)
414
連絡先と場所
このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。
研究場所
-
-
New York
-
New York、New York、アメリカ、10029
- GSK Investigational Site
-
-
参加基準
研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。
適格基準
就学可能な年齢
6ヶ月～64年 (子、大人)
健康ボランティアの受け入れ
はい
受講資格のある性別
全て
サンプリング方法
非確率サンプル
調査対象母集団
Archived serum samples to be evaluated in this study were collected from adults 18-64 years of age and children 6-35 months of age.
説明
Inclusion Criteria:
Not applicable since no subjects will be actively enrolled in this study; only the sera samples of the subjects who were a part of previously conducted primary trials will be used for testing. However, the archived serum samples of only those subjects who satisfy the following criteria will be included in this study:
- Subjects who received two doses of influenza vaccine 21 days apart and were included in the ATP cohort for immunogenicity and Persistence cohort (depending on the study) in the primary studies listed.
- Subjects who had agreed that their blood samples could be used for further research while giving informed consent for any of the primary studies listed.
- Subjects who have sufficient residual sample volume (i.e., ≥0.5 mL) of serum at all time points.
- Subjects with vaccine homologous neutralizing antibody result available at Day 0 and at 21 (25 samples available per group in Study H9N2-001)
Exclusion Criteria:
- Not applicable since no subjects will be actively enrolled in this study; only the serum samples of the subjects who were a part of previously conducted trials will be used for testing.
研究計画
このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。
研究はどのように設計されていますか？
デザインの詳細
コホートと介入
グループ/コホート |
介入・治療 |
|---|---|
|
H1N1_AS Group
Subjects 19-40 years of age (in H1N1 cohort of primary completed study Q-PAN H1N1-019 (113536) (A/California/07/2009)) who were administered adjuvanted (AS03A) pandemic vaccine with 3.75 µg HA (hemagglutinin) at Days 0 and 21 and TIV at Day 42.
|
The archived sera samples collected in previously completed pandemic influenza vaccine clinical trials (H1N1, H5N1, and H9N2 pandemic vaccines in adult trials and H5N1 pandemic vaccine in a pediatric trial) will be tested in this study.
|
|
H1N1_NAS Group
Subjects 19-40 years of age (in H1N1 cohort of primary completed study -Q-PAN H1N1-019 (113536) (A/California/07/2009)) who were administered unadjuvanted pandemic vaccine with 15 µg HA (hemagglutinin) at Days 0 and 21 and TIV at Day 42
|
The archived sera samples collected in previously completed pandemic influenza vaccine clinical trials (H1N1, H5N1, and H9N2 pandemic vaccines in adult trials and H5N1 pandemic vaccine in a pediatric trial) will be tested in this study.
|
|
H5N1_AS Group
Subjects 18-49 years of age (in H5N1 cohort of primary completed study CC-PAN H5N1-001 (114371)(A/Indonesia/5/2005 RG)) who were administered adjuvanted (AS03A) pandemic vaccine with 3.75 µg HA (hemagglutinin) at Days 0 and 21
|
The archived sera samples collected in previously completed pandemic influenza vaccine clinical trials (H1N1, H5N1, and H9N2 pandemic vaccines in adult trials and H5N1 pandemic vaccine in a pediatric trial) will be tested in this study.
|
|
H5N1_NAS Group
Subjects 18-49 years of age (in H5N1 cohort of primary completed study CC-PAN H5N1-001 (114371)(A/Indonesia/5/2005 RG)) who were administered unadjuvanted pandemic vaccine with 15 µg HA (hemagglutinin) at Days 0 and 21.
|
The archived sera samples collected in previously completed pandemic influenza vaccine clinical trials (H1N1, H5N1, and H9N2 pandemic vaccines in adult trials and H5N1 pandemic vaccine in a pediatric trial) will be tested in this study.
|
|
H9N2_AS Group
Subjects 18-64 years of age (in H9N2 cohort of primary completed study Q-PAN H9N2-001 (116358) (A/chicken/Hong Kong/G9/1997 NIBRG-91)) who were administered adjuvanted (AS03A) pandemic vaccine with 3.75 µg HA (hemagglutinin) at Days 0 and 21 and saline placebo at Day 182.
|
The archived sera samples collected in previously completed pandemic influenza vaccine clinical trials (H1N1, H5N1, and H9N2 pandemic vaccines in adult trials and H5N1 pandemic vaccine in a pediatric trial) will be tested in this study.
|
|
H9N2_NAS Group
Subjects 18-64 years of age (in H9N2 cohort of primary completed studyQ-PAN H9N2-001 (116358)(A/chicken/Hong Kong/G9/1997 NIBRG-91)) who were administered unadjuvanted pandemic vaccine with 15 µg HA (hemagglutinin) at Days 0 and 21 and with saline placebo at Day 182.
|
The archived sera samples collected in previously completed pandemic influenza vaccine clinical trials (H1N1, H5N1, and H9N2 pandemic vaccines in adult trials and H5N1 pandemic vaccine in a pediatric trial) will be tested in this study.
|
|
DQIV_NAS Group
Subjects 18-≤39 years of age (in D-QIV cohort of primary completed study FLU D-QIV-015 (201251) (A/Christchurch/16/2010 (H1N1)pdm09, A/Texas/50/2012 (H3N2), B/Massachusetts/02/2012, B/Brisbane/60/2008)) who were administered 15 µg HA (no AS) of each of 4 strains (total 60 µg HA) at Day 0.
|
The archived sera samples collected in previously completed pandemic influenza vaccine clinical trials (H1N1, H5N1, and H9N2 pandemic vaccines in adult trials and H5N1 pandemic vaccine in a pediatric trial) will be tested in this study.
|
|
QPAN_C Group
Subjects 18-40 years of age (in Q-PAN cohort of primary completed study Q-PAN-005 (110624)) who were administered 3.8 µg A/Indonesia/5/05 (H5N1) with AS03A on Day 0; phosphate buffer saline (PBS) preserved with 20 ppm thimerosal on Day 182; 3.8 µg A/turkey/Turkey/1/05 (H5N1) with AS03A on Day 549.
|
The archived sera samples collected in previously completed pandemic influenza vaccine clinical trials (H1N1, H5N1, and H9N2 pandemic vaccines in adult trials and H5N1 pandemic vaccine in a pediatric trial) will be tested in this study.
|
|
QPAN5_G Group
Subjects 18-40 years of age (in Q-PAN cohort of primary completed study Q-PAN-005 (110624)) who were administered PBS preserved with 20 ppm thimerosal on Day 0; 3.8 µg A/turkey/Turkey/1/05 (H5N1) with AS03A on Days 182 and 549.
|
The archived sera samples collected in previously completed pandemic influenza vaccine clinical trials (H1N1, H5N1, and H9N2 pandemic vaccines in adult trials and H5N1 pandemic vaccine in a pediatric trial) will be tested in this study.
|
|
H5N1_VT Group
Subjects 18-60 years of age (in H5N1 cohort of primary completed study H5N1-012 (107495) A/Vietnam/1194/2004-like or A/Indonesia/05/2005-like) who received two administrations of the adjuvanted (AS03A) pandemic influenza vaccine (3.8 µg) containing the Vietnam (VT) strain at Day 0 and Month 12.
|
The archived sera samples collected in previously completed pandemic influenza vaccine clinical trials (H1N1, H5N1, and H9N2 pandemic vaccines in adult trials and H5N1 pandemic vaccine in a pediatric trial) will be tested in this study.
|
|
H5N1_IN Group
Subjects 18-60 years of age (in H5N1 cohort of primary completed studyH5N1-012 (107495) A/Vietnam/1194/2004-like or A/Indonesia/05/2005-like) who received one administration(3.8
µg) of the adjuvanted (AS03A) pandemic influenza vaccine containing the Vietnam (VT) strain at Day 0 and one administration(3.8
µg) of the adjuvanted (AS03A) pandemic vaccine containing the Indonesia (IN) strain at Month 12.
|
The archived sera samples collected in previously completed pandemic influenza vaccine clinical trials (H1N1, H5N1, and H9N2 pandemic vaccines in adult trials and H5N1 pandemic vaccine in a pediatric trial) will be tested in this study.
|
|
H5N1_PAS Group
Subjects 6-35 months of age (in H5N1 cohort of primary completed study Q-PAN H5N1-AS03-021 (114464)(A/Indonesia/5/2005 RG)) who were administered adjuvanted (AS03B) pandemic vaccine with 1.9 µg HA (hemagglutinin) at Days 0 and 21.
|
The archived sera samples collected in previously completed pandemic influenza vaccine clinical trials (H1N1, H5N1, and H9N2 pandemic vaccines in adult trials and H5N1 pandemic vaccine in a pediatric trial) will be tested in this study.
|
|
H5N1_PCN Group
Subjects 6-35 months of age (in H5N1 cohort of primary completed study Q-PAN H5N1-AS03-021 (114464)(A/Indonesia/5/2005 RG)) who were administered placebo at Days 0 and 21.
|
The archived sera samples collected in previously completed pandemic influenza vaccine clinical trials (H1N1, H5N1, and H9N2 pandemic vaccines in adult trials and H5N1 pandemic vaccine in a pediatric trial) will be tested in this study.
|
この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Percentage of Subjects With Anti-H1 Stalk Enzyme-linked Immunosorbent Assay (ELISA) Antibody Concentration Equal or Above the Cut-off of 66 EU/mL - Adult Q-PAN H1N1-019, CC-PAN H5N1-001, Q-PAN H9N2-001 Cohorts
時間枠：At Day 0 (Pre-vaccination), Day 21 (Post-vaccination 1), Day 42 (Post-vaccination 2), Day 182 (post-vaccination 2) and Day 385 (Post-vaccination 2 -for H5N1 cohorts only)
|
With respect to samples from Hemagglutinin (HA) Group 1-related studies (i.e., with H1N1, H5N1,and H9N2 pandemic, and quadrivalent inactivated seasonal, influenza vaccines, analysis was performed for measuring levels of anti-H1 stalk antibody by ELISA for all subjects in each study cohort, aggregate variables were calculated with 95% CI for each treatment group within each study cohort.
Seropositivity rate was defined as the percentage of subjects with concentrations greater or equal than 66 Elisa Unit per milliliter (EU/mL).
|
At Day 0 (Pre-vaccination), Day 21 (Post-vaccination 1), Day 42 (Post-vaccination 2), Day 182 (post-vaccination 2) and Day 385 (Post-vaccination 2 -for H5N1 cohorts only)
|
|
Anti-H1 Stalk Enzyme-linked Immunosorbent Assay (ELISA) Antibody Concentrations - Adult Q-PAN H1N1-019, CC-PAN H5N1-001, Q-PAN H9N2-001 Cohorts
時間枠：At Day 0 (Pre-vaccination), Day 21 (Post-vaccination 1), Day 42 (Post-vaccination 2), Day 182 (post-vaccination 2) and Day 385 (Post-vaccination 2 -for H5N1 cohorts only)
|
With respect to samples from HA Group 1-related studies (i.e., with H1N1, H5N1,and H9N2 pandemic, and quadrivalent inactivated seasonal, influenza vaccines, analysis was performed for measuring levels of anti-H1 stalk antibody by ELISA for all subjects in each study cohort, aggregate variables were calculated with 95% CI for each treatment group within each study cohort.
Geometric mean concentrations (GMCs) were expressed in Elisa Unit per milliliter (EU/mL)
|
At Day 0 (Pre-vaccination), Day 21 (Post-vaccination 1), Day 42 (Post-vaccination 2), Day 182 (post-vaccination 2) and Day 385 (Post-vaccination 2 -for H5N1 cohorts only)
|
|
Percentage of Subjects With a ≥4-fold Rise for Anti-H1 Stalk ELISA Antibody Concentration - Adult Q-PAN H1N1-019, CC-PAN H5N1-001, Q-PAN H9N2-001 Cohorts
時間枠：At Day 21 (post-vaccination 1 compared to pre-vaccination), Day 42 (post-vaccination 2 compared to pre-vaccination)
|
With respect to samples from HA Group 1-related studies (i.e., with H1N1, H5N1,and H9N2 pandemic, and quadrivalent inactivated seasonal, influenza vaccines, analysis was performed for measuring levels of anti-H1 stalk antibody by ELISA for all subjects in each study cohort, aggregate variables were calculated with 95% CI for each treatment group within each study cohort.
Seronegative subjects = concentration < 66 EU/mL for anti-H1 stalk ELISA prior to vaccination.
Seropositive subjects = concentration ≥ 66 EU/mL for anti-H1 stalk ELISA prior to vaccination.
4-fold increase defined as: For initially seronegative subjects, antibody concentration ≥ 132 EU/mL at post-vaccination.
For initially seropositive subjects, antibody concentration at post-vaccination ≥ 4-fold the pre-vaccination antibody concentration.
|
At Day 21 (post-vaccination 1 compared to pre-vaccination), Day 42 (post-vaccination 2 compared to pre-vaccination)
|
|
Percentage of Subjects With a ≥10-fold Rise for Anti-H1 Stalk ELISA Antibody Concentration - Adult Q-PAN H1N1-019, CC-PAN H5N1-001, Q-PAN H9N2-001 Cohorts
時間枠：At Day 21 (post-vaccination1 compared to pre-vaccination), Day 42 (post-vaccination2 compared to pre-vaccination)
|
With respect to samples from HA Group 1-related studies (i.e., with H1N1, H5N1,and H9N2 pandemic, and quadrivalent inactivated seasonal, influenza vaccines, analysis was performed for measuring levels of anti-H1 stalk antibody by ELISA for all subjects in each study cohort, aggregate variables were calculated with 95% CI for each treatment group within each study cohort.
seronegative subjects = concentration < 66 EU/mL for anti-H1 stalk ELISA prior to vaccination.
seropositive subjects = concentration ≥ 66 EU/mL for anti-H1 stalk ELISA prior to vaccination 10-fold increase defined as: For initially seronegative subjects, antibody concentration ≥ 330 EU/mL at post-vaccination, For initially seropositive subjects, antibody concentration at post-vaccination ≥ 10-fold the pre-vaccination antibody concentration.
|
At Day 21 (post-vaccination1 compared to pre-vaccination), Day 42 (post-vaccination2 compared to pre-vaccination)
|
|
Mean Geometric Increase (MGI) for Anti-H1 Stalk ELISA Antibody Post-vaccination Concentration Compared to Pre-vaccination - Adult Q-PAN H1N1-019, CC-PAN H5N1-001, Q-PAN H9N2-001 Cohorts
時間枠：At Day 21 (post-vaccination1/ pre-vaccination), Day 42 (post-vaccination2/ pre-vaccination), Day 182 (post-vaccination2/ pre-vaccination) and Day 385(post-vaccination2/ pre-vaccination - for H5N1 cohorts only )
|
With respect to samples from HA Group 1-related studies (i.e., with H1N1, H5N1,and H9N2 pandemic, and quadrivalent inactivated seasonal, influenza vaccines, analysis was performed for measuring levels of anti-H1 stalk antibody by ELISA for all subjects in each study cohort, aggregate variables were calculated with 95% CI for each treatment group within each study cohort.
Mean Geometric Increase (MGI) = post-vaccination GMC over pre-vaccination GMC.
|
At Day 21 (post-vaccination1/ pre-vaccination), Day 42 (post-vaccination2/ pre-vaccination), Day 182 (post-vaccination2/ pre-vaccination) and Day 385(post-vaccination2/ pre-vaccination - for H5N1 cohorts only )
|
|
Percentage of Subjects With Anti-H1 Stalk Enzyme-linked Immunosorbent Assay (ELISA) Antibody Concentration Equal or Above the Cut-off of 66 EU/mL - Pediatric Q-PAN H5N1-AS03-021 Cohort
時間枠：At Day 0 (Pre-vaccination), Day 21 (Post-vaccination 1), Day 42 (Post-vaccination 2) and Day 385 (Post-vaccination 2)
|
With respect to samples from HA Group 1-related studies (i.e., with H1N1, H5N1,and H9N2 pandemic, and quadrivalent inactivated seasonal, influenza vaccines, analysis was performed for measuring levels of anti-H1 stalk antibody by ELISA for all subjects in each study cohort, aggregate variables were calculated with 95% CI for each treatment group within each study cohort.
Seropositivity rate was defined as the percentage of subjects with concentrations greater or equal than 66 Elisa Unit per milliliter (EU/mL)
|
At Day 0 (Pre-vaccination), Day 21 (Post-vaccination 1), Day 42 (Post-vaccination 2) and Day 385 (Post-vaccination 2)
|
|
Anti-H1 Stalk Enzyme-linked Immunosorbent Assay (ELISA) Antibody Concentrations -Pediatric Q-PAN H5N1-AS03-021 Cohort
時間枠：At Day 0 (Pre-vaccination), Day 21 (Post-vaccination 1), Day 42 (Post-vaccination 2) and Day 385 (Post-vaccination 2)
|
With respect to samples from HA Group 1-related studies (i.e., with H1N1, H5N1,and H9N2 pandemic, and quadrivalent inactivated seasonal, influenza vaccines, analysis was performed for measuring levels of anti-H1 stalk antibody by ELISA for all subjects in each study cohort, aggregate variables were calculated with 95% CI for each treatment group within each study cohort.
Geometric mean concentrations (GMCs) were expressed in Elisa Unit per milliliter (EU/mL).
|
At Day 0 (Pre-vaccination), Day 21 (Post-vaccination 1), Day 42 (Post-vaccination 2) and Day 385 (Post-vaccination 2)
|
|
Percentage of Subjects With a ≥4-fold Rise for Anti-H1 Stalk ELISA Antibody Concentration - Pediatric Q-PAN H5N1-AS03-021 Cohort
時間枠：At Day 21 (post-vaccination1 compared to pre-vaccination), Day 42 (post-vaccination2 compared to pre-vaccination)
|
With respect to samples from HA Group 1-related studies (i.e., with H1N1, H5N1,and H9N2 pandemic, and quadrivalent inactivated seasonal, influenza vaccines, analysis was performed for measuring levels of anti-H1 stalk antibody by ELISA for all subjects in each study cohort, aggregate variables were calculated with 95% CI for each treatment group within each study cohort.
seronegative subjects = concentration < 66 EU/mL for anti-H1 stalk ELISA prior to vaccination.
seropositive subjects = concentration ≥ 66 EU/mL for anti-H1 stalk ELISA prior to vaccination.
4-fold increase defined as: For initially seronegative subjects, antibody concentration ≥ 132 EU/mL at post-vaccination.
For initially seropositive subjects, antibody concentration at post-vaccination ≥ 4-fold the pre-vaccination antibody concentration.
|
At Day 21 (post-vaccination1 compared to pre-vaccination), Day 42 (post-vaccination2 compared to pre-vaccination)
|
|
Percentage of Subjects With a ≥10-fold Rise for Anti-H1 Stalk ELISA Antibody Concentration - Pediatric Q-PAN H5N1-AS03-021 Cohort
時間枠：At Day 21 (post-vaccination1 compared to pre-vaccination), Day 42 (post-vaccination2 compared to pre-vaccination)
|
With respect to samples from HA Group 1-related studies (i.e., with H1N1, H5N1,and H9N2 pandemic, and quadrivalent inactivated seasonal, influenza vaccines, analysis was performed for measuring levels of anti-H1 stalk antibody by ELISA for all subjects in each study cohort, aggregate variables were calculated with 95% CI for each treatment group within each study cohort.
seronegative subjects = concentration < 66 EU/mL for anti-H1 stalk ELISA prior to vaccination.
seropositive subjects = concentration ≥ 66 EU/mL for anti-H1 stalk ELISA prior to vaccination 10-fold increase defined as: For initially seronegative subjects, antibody concentration ≥ 330 EU/mL at post-vaccination, For initially seropositive subjects, antibody concentration at post-vaccination ≥ 10-fold the pre-vaccination antibody concentration.
|
At Day 21 (post-vaccination1 compared to pre-vaccination), Day 42 (post-vaccination2 compared to pre-vaccination)
|
|
Mean Geometric Increase (MGI) for Anti-H1 Stalk ELISA Antibody Post-vaccination Concentration Compared to Pre-vaccination -Pediatric Q-PAN H5N1-AS03-021 Cohort
時間枠：At Day 21 (post-vaccination1/ pre-vaccination), Day 42 (post-vaccination2/ pre-vaccination) and Day 385(post-vaccination2/ pre-vaccination)
|
With respect to samples from HA Group 1-related studies (i.e., with H1N1, H5N1,and H9N2 pandemic, and quadrivalent inactivated seasonal, influenza vaccines, analysis was performed for measuring levels of anti-H1 stalk antibody by ELISA for all subjects in each study cohort, aggregate variables were calculated with 95% CI for each treatment group within each study cohort.
Mean Geometric Increase (MGI) = post-vaccination GMC over pre-vaccination GMC.
|
At Day 21 (post-vaccination1/ pre-vaccination), Day 42 (post-vaccination2/ pre-vaccination) and Day 385(post-vaccination2/ pre-vaccination)
|
|
Percentage of Subjects With Anti-H1 Stalk Enzyme-linked Immunosorbent Assay (ELISA) Antibody Concentration Equal or Above the Cut-off of 66 EU/mL - Adult Q-PAN-005 Cohort
時間枠：At Day 0 (Pre-vaccination), Day 42 (Post-vaccination 1), Day 182 (post-vaccination 1), Day 224 (Post-vaccination 2), Day 549 (post-vaccination 2), Day 591 (Post-vaccination 3) and Day 729 (Post-vaccination 3)
|
With respect to samples from HA Group 1-related studies (i.e., with H1N1, H5N1,and H9N2 pandemic, and quadrivalent inactivated seasonal, influenza vaccines, analysis was performed for measuring levels of anti-H1 stalk antibody by ELISA for all subjects in each study cohort, aggregate variables were calculated with 95% CI for each treatment group within each study cohort.
Seropositivity rate was defined as the percentage of subjects with concentrations greater or equal than 66 Elisa Unit per milliliter (EU/mL).
|
At Day 0 (Pre-vaccination), Day 42 (Post-vaccination 1), Day 182 (post-vaccination 1), Day 224 (Post-vaccination 2), Day 549 (post-vaccination 2), Day 591 (Post-vaccination 3) and Day 729 (Post-vaccination 3)
|
|
Anti-H1 Stalk Enzyme-linked Immunosorbent Assay (ELISA) Antibody Concentrations - Adult Q-PAN-005 Cohort
時間枠：At Day 0 (Pre-vaccination), Day 42 (Post-vaccination 1), Day 182 (post-vaccination 1), Day 224 (Post-vaccination 2), Day 549 (post-vaccination 2), Day 591 (Post-vaccination 3) and Day 729 (Post-vaccination 3)
|
With respect to samples from HA Group 1-related studies (i.e., with H1N1, H5N1,and H9N2 pandemic, and quadrivalent inactivated seasonal, influenza vaccines, analysis was performed for measuring levels of anti-H1 stalk antibody by ELISA for all subjects in each study cohort, aggregate variables were calculated with 95% CI for each treatment group within each study cohort.
Geometric mean concentrations (GMCs) were expressed in Elisa Unit per milliliter (EU/mL).
|
At Day 0 (Pre-vaccination), Day 42 (Post-vaccination 1), Day 182 (post-vaccination 1), Day 224 (Post-vaccination 2), Day 549 (post-vaccination 2), Day 591 (Post-vaccination 3) and Day 729 (Post-vaccination 3)
|
|
Percentage of Subjects With a ≥4-fold Rise for Anti-H1 Stalk ELISA Antibody Concentration - Adult Q-PAN-005 Cohort
時間枠：For group C: At Day 42 (post-dose1 compared to [/]Day 0), Day 224 (post-dose 2/Day 0), Day 591 (post-dose3 / Day 0) - For group G: At Day 224 (post-dose2 / Day 182); at Day 591 (post-dose3 / Day 182)
|
With respect to samples from HA Group 1-related studies (i.e., with H1N1, H5N1,and H9N2 pandemic, and quadrivalent inactivated seasonal, influenza vaccines, analysis was performed for measuring levels of anti-H1 stalk antibody by ELISA for all subjects in each study cohort, aggregate variables were calculated with 95% CI for each treatment group within each study cohort.
seronegative subjects = concentration < 66 EU/mL for anti-H1 stalk ELISA prior to vaccination.
seropositive subjects = concentration ≥ 66 EU/mL for anti-H1 stalk ELISA prior to vaccination.
4-fold increase defined as: For initially seronegative subjects, antibody concentration ≥ 132 EU/mL at post-vaccination.
For initially seropositive subjects, antibody concentration at post-vaccination ≥ 4-fold the pre-vaccination antibody concentration.
The ≥4-fold increases were only calculated relative to baseline.
|
For group C: At Day 42 (post-dose1 compared to [/]Day 0), Day 224 (post-dose 2/Day 0), Day 591 (post-dose3 / Day 0) - For group G: At Day 224 (post-dose2 / Day 182); at Day 591 (post-dose3 / Day 182)
|
|
Percentage of Subjects With a ≥10-fold Rise for Anti-H1 Stalk ELISA Antibody Concentration - Adult Q-PAN-005 Cohort
時間枠：For group C: At Day 42 (post-dose1 compared to [/]Day 0), Day 224 (post-dose 2/Day 0), Day 591 (post-dose3 / Day 0) - For group G: At Day 224 (post-dose2 / Day 182), at Day 591 (post-dose3 / Day 182)
|
With respect to samples from HA Group 1-related studies (i.e., with H1N1, H5N1,and H9N2 pandemic, and quadrivalent inactivated seasonal, influenza vaccines, analysis was performed for measuring levels of anti-H1 stalk antibody by ELISA for all subjects in each study cohort, aggregate variables were calculated with 95% CI for each treatment group within each study cohort.
seronegative subjects = concentration < 66 EU/mL for anti-H1 stalk ELISA prior to vaccination.
seropositive subjects = concentration ≥ 66 EU/mL for anti-H1 stalk ELISA prior to vaccination 10-fold increase defined as: For initially seronegative subjects, antibody concentration ≥ 330 EU/mL at post-vaccination, For initially seropositive subjects, antibody concentration at post-vaccination ≥ 10-fold the pre-vaccination antibody concentration.
The ≥10-fold increases were only calculated relative to baseline.
|
For group C: At Day 42 (post-dose1 compared to [/]Day 0), Day 224 (post-dose 2/Day 0), Day 591 (post-dose3 / Day 0) - For group G: At Day 224 (post-dose2 / Day 182), at Day 591 (post-dose3 / Day 182)
|
|
Mean Geometric Increase (MGI) for Anti-H1 Stalk ELISA Antibody Post-vaccination Concentration Compared to Pre-vaccination - Adult Q-PAN-005 Cohort
時間枠：At Day[D] 42 (post-dose[ps-d]1), D182 (ps-d1), D224 (ps-d2), D549 (ps-d2), D591 (ps-d3) and D729(ps-d3) compared to D0 for Group C and at D224 (ps-d2), D549 (ps-d2), D591 (ps-d3) and D729(ps-d3) compared to D182 for Group G
|
With respect to samples from HA Group 1-related studies (i.e., with H1N1, H5N1,and H9N2 pandemic, and quadrivalent inactivated seasonal, influenza vaccines, analysis was performed for measuring levels of anti-H1 stalk antibody by ELISA for all subjects in each study cohort, aggregate variables were calculated with 95% CI for each treatment group within each study cohort.
Mean Geometric Increase (MGI) = post-vaccination GMC over pre-vaccination GMC.
|
At Day[D] 42 (post-dose[ps-d]1), D182 (ps-d1), D224 (ps-d2), D549 (ps-d2), D591 (ps-d3) and D729(ps-d3) compared to D0 for Group C and at D224 (ps-d2), D549 (ps-d2), D591 (ps-d3) and D729(ps-d3) compared to D182 for Group G
|
|
Percentage of Subjects With Anti-H1 Stalk Enzyme-linked Immunosorbent Assay (ELISA) Antibody Concentration Equal or Above the Cut-off of 66 EU/mL - Adult H5N1-012 Cohort
時間枠：At D0 (Pre), D21 (Post-dose 1), Month (M)6 (post-dose 1), M12 (Post-dose1), M12+21days (post-dose2), M18 (Post-dose2)
|
With respect to samples from HA Group 1-related studies (i.e., with H1N1, H5N1,and H9N2 pandemic, and quadrivalent inactivated seasonal, influenza vaccines, analysis was performed for measuring levels of anti-H1 stalk antibody by ELISA for all subjects in each study cohort, aggregate variables were calculated with 95% CI for each treatment group within each study cohort.
Seropositivity rate was defined as the percentage of subjects with concentrations greater or equal than 66 Elisa Unit per milliliter (EU/mL)
|
At D0 (Pre), D21 (Post-dose 1), Month (M)6 (post-dose 1), M12 (Post-dose1), M12+21days (post-dose2), M18 (Post-dose2)
|
|
Anti-H1 Stalk Enzyme-linked Immunosorbent Assay (ELISA) Antibody Concentrations - Adult H5N1-012 Cohort
時間枠：At D0 (Pre), D21 (Post-dose 1), Month (M)6 (post-dose 1), M12 (Post-dose1), M12+21days (post-dose2), M18 (Post-dose2)
|
With respect to samples from HA Group 1-related studies (i.e., with H1N1, H5N1,and H9N2 pandemic, and quadrivalent inactivated seasonal, influenza vaccines, analysis was performed for measuring levels of anti-H1 stalk antibody by ELISA for all subjects in each study cohort, aggregate variables were calculated with 95% CI for each treatment group within each study cohort.
Geometric mean concentrations (GMCs) were expressed in Elisa Unit per milliliter (EU/mL)
|
At D0 (Pre), D21 (Post-dose 1), Month (M)6 (post-dose 1), M12 (Post-dose1), M12+21days (post-dose2), M18 (Post-dose2)
|
|
Percentage of Subjects With a ≥4-fold Rise for Anti-H1 Stalk ELISA Antibody Concentration - Adult H5N1-012 Cohort
時間枠：At D21 (post-dose1 compared to [/]D0), at M12+21days (post-dose2 /D0)
|
With respect to samples from HA Group 1-related studies (i.e., with H1N1, H5N1,and H9N2 pandemic, and quadrivalent inactivated seasonal, influenza vaccines, analysis was performed for measuring levels of anti-H1 stalk antibody by ELISA for all subjects in each study cohort, aggregate variables were calculated with 95% CI for each treatment group within each study cohort.
seronegative subjects = concentration < 66 EU/mL for anti-H1 stalk ELISA prior to vaccination.
seropositive subjects = concentration ≥ 66 EU/mL for anti-H1 stalk ELISA prior to vaccination.
4-fold increase defined as: For initially seronegative subjects, antibody concentration ≥ 132 EU/mL at post-vaccination.
For initially seropositive subjects, antibody concentration at post-vaccination ≥ 4-fold the pre-vaccination antibody concentration.
The ≥4-fold increases were only calculated relative to baseline.
|
At D21 (post-dose1 compared to [/]D0), at M12+21days (post-dose2 /D0)
|
|
Percentage of Subjects With a ≥10-fold Rise for Anti-H1 Stalk ELISA Antibody Concentration - Adult H5N1-012 Cohort
時間枠：At D21 (post-dose1 compared to [/]D0), at M12+21days (post-dose2 /D0)
|
With respect to samples from HA Group 1-related studies (i.e., with H1N1, H5N1,and H9N2 pandemic, and quadrivalent inactivated seasonal, influenza vaccines, analysis was performed for measuring levels of anti-H1 stalk antibody by ELISA for all subjects in each study cohort, aggregate variables were calculated with 95% CI for each treatment group within each study cohort.
seronegative subjects = concentration < 66 EU/mL for anti-H1 stalk ELISA prior to vaccination.
seropositive subjects = concentration ≥ 66 EU/mL for anti-H1 stalk ELISA prior to vaccination 10-fold increase defined as: For initially seronegative subjects, antibody concentration ≥ 330 EU/mL at post-vaccination, For initially seropositive subjects, antibody concentration at post-vaccination ≥ 10-fold the pre-vaccination antibody concentration.
The ≥10-fold increases were only calculated relative to baseline.
|
At D21 (post-dose1 compared to [/]D0), at M12+21days (post-dose2 /D0)
|
|
Mean Geometric Increase (MGI) for Anti-H1 Stalk ELISA Antibody Post-vaccination Concentration Compared to Pre-vaccination - Adult H5N1-012 Cohort
時間枠：At D21 (post-dose[ps-d]1), M6 (ps-d1), M12 (ps-d1), M12+21days (ps-d2) and M18 compared to D0
|
With respect to samples from HA Group 1-related studies (i.e., with H1N1, H5N1,and H9N2 pandemic, and quadrivalent inactivated seasonal, influenza vaccines, analysis was performed for measuring levels of anti-H1 stalk antibody by ELISA for all subjects in each study cohort, aggregate variables were calculated with 95% CI for each treatment group within each study cohort.
Mean Geometric Increase (MGI) = post-vaccination GMC over pre-vaccination GMC.
|
At D21 (post-dose[ps-d]1), M6 (ps-d1), M12 (ps-d1), M12+21days (ps-d2) and M18 compared to D0
|
|
Percentage of Subjects With Anti-H1 Stalk Enzyme-linked Immunosorbent Assay (ELISA) Antibody Concentration Equal or Above the Cut-off of 66 EU/mL - Adult FLU D-QIV-015 Cohort
時間枠：At D0 (Pre), D21 (Post-dose 1)
|
With respect to samples from HA Group 1-related studies (i.e., with H1N1, H5N1,and H9N2 pandemic, and quadrivalent inactivated seasonal, influenza vaccines, analysis was performed for measuring levels of anti-H1 stalk antibody by ELISA for all subjects in each study cohort, aggregate variables were calculated with 95% CI for each treatment group within each study cohort.
Seropositivity rate was defined as the percentage of subjects with concentrations greater or equal than 66 Elisa Unit per milliliter (EU/mL)
|
At D0 (Pre), D21 (Post-dose 1)
|
|
Anti-H1 Stalk Enzyme-linked Immunosorbent Assay (ELISA) Antibody Concentrations - Adult FLU D-QIV-015 Cohort
時間枠：At D0 (Pre), D21 (Post-dose 1)
|
With respect to samples from HA Group 1-related studies (i.e., with H1N1, H5N1,and H9N2 pandemic, and quadrivalent inactivated seasonal, influenza vaccines, analysis was performed for measuring levels of anti-H1 stalk antibody by ELISA for all subjects in each study cohort, aggregate variables were calculated with 95% CI for each treatment group within each study cohort.
Geometric mean concentrations (GMCs) were expressed in Elisa Unit per milliliter (EU/mL)
|
At D0 (Pre), D21 (Post-dose 1)
|
|
Percentage of Subjects With a ≥4-fold Rise for Anti-H1 Stalk ELISA Antibody Concentration - Adult FLU D-QIV-015 Cohort
時間枠：At D21 (post-dose1 compared to [/]D0)
|
With respect to samples from HA Group 1-related studies (i.e., with H1N1, H5N1,and H9N2 pandemic, and quadrivalent inactivated seasonal, influenza vaccines, analysis was performed for measuring levels of anti-H1 stalk antibody by ELISA for all subjects in each study cohort, aggregate variables were calculated with 95% CI for each treatment group within each study cohort.
seronegative subjects = concentration < 66 EU/mL for anti-H1 stalk ELISA prior to vaccination.
seropositive subjects = concentration ≥ 66 EU/mL for anti-H1 stalk ELISA prior to vaccination.
4-fold increase defined as: For initially seronegative subjects, antibody concentration ≥ 132 EU/mL at post-vaccination.
For initially seropositive subjects, antibody concentration at post-vaccination ≥ 4-fold the pre-vaccination antibody concentration.
|
At D21 (post-dose1 compared to [/]D0)
|
|
Percentage of Subjects With a ≥10-fold Rise for Anti-H1 Stalk ELISA Antibody Concentration - Adult FLU D-QIV-015 Cohort
時間枠：At D21 (post-dose1 compared to [/]D0)
|
With respect to samples from HA Group 1-related studies (i.e., with H1N1, H5N1,and H9N2 pandemic, and quadrivalent inactivated seasonal, influenza vaccines, analysis was performed for measuring levels of anti-H1 stalk antibody by ELISA for all subjects in each study cohort, aggregate variables were calculated with 95% CI for each treatment group within each study cohort.
seronegative subjects = concentration < 66 EU/mL for anti-H1 stalk ELISA prior to vaccination.
seropositive subjects = concentration ≥ 66 EU/mL for anti-H1 stalk ELISA prior to vaccination 10-fold increase defined as: For initially seronegative subjects, antibody concentration ≥ 330 EU/mL at post-vaccination, For initially seropositive subjects, antibody concentration at post-vaccination ≥ 10-fold the pre-vaccination antibody concentration.
|
At D21 (post-dose1 compared to [/]D0)
|
|
Mean Geometric Increase (MGI) for Anti-H1 Stalk ELISA Antibody Post-vaccination Concentration Compared to Pre-vaccination - Adult FLU D-QIV-015 Cohort
時間枠：At D21 (post-dose1) compared to D0
|
With respect to samples from HA Group 1-related studies (i.e., with H1N1, H5N1,and H9N2 pandemic, and quadrivalent inactivated seasonal, influenza vaccines, analysis was performed for measuring levels of anti-H1 stalk antibody by ELISA for all subjects in each study cohort, aggregate variables were calculated with 95% CI for each treatment group within each study cohort.
Mean Geometric Increase (MGI) = post-vaccination GMC over pre-vaccination GMC.
|
At D21 (post-dose1) compared to D0
|
|
Percentage of Subjects With Anti-H1 Stalk Antibody Titer (by MN) Equal or Above the Cut-off of 10 1/DIL - Adult Q-PAN H1N1-019, CC-PAN H5N1-001, Q-PAN H9N2-001 Cohorts (Only AS Vaccines)
時間枠：At Day 0 (Pre-vaccination), Day 21 (Post-vaccination 1), Day 42 (Post-vaccination 2), Day 182 (post-vaccination 2) and Day 385 (Post-vaccination 2 -for H5N1 cohorts only)
|
With respect to samples from HA Group 1-related studies (i.e., with H1N1, H5N1,and H9N2 pandemic, and quadrivalent inactivated seasonal, influenza vaccines, analysis was performed for measuring levels of anti-H1 stalk antibody by microneutralization (MN) for all subjects who received an adjuvant system (AS) vaccine in each study cohort, aggregate variables were calculated with 95% CI for each treatment group within each study cohort.
Seropositivity rate was defined as the percentage of subjects with titers greater or equal than 10 1/Dilution (1/DIL).
|
At Day 0 (Pre-vaccination), Day 21 (Post-vaccination 1), Day 42 (Post-vaccination 2), Day 182 (post-vaccination 2) and Day 385 (Post-vaccination 2 -for H5N1 cohorts only)
|
|
Anti-H1 Stalk Antibody Titers (by MN) - Adult Q-PAN H1N1-019, CC-PAN H5N1-001, Q-PAN H9N2-001 Cohorts (Only AS Vaccines)
時間枠：At Day 0 (Pre-vaccination), Day 21 (Post-vaccination 1), Day 42 (Post-vaccination 2), Day 182 (post-vaccination 2) and Day 385 (Post-vaccination 2 -for H5N1 cohorts only)
|
With respect to samples from HA Group 1-related studies (i.e., with H1N1, H5N1,and H9N2 pandemic, and quadrivalent inactivated seasonal, influenza vaccines, analysis was performed for measuring levels of anti-H1 stalk antibody by MN for all subjects who received an AS vaccine in each study cohort, Geometric mean titers (GMTs) were calculated with 95% CI for each treatment group within each study cohort.
|
At Day 0 (Pre-vaccination), Day 21 (Post-vaccination 1), Day 42 (Post-vaccination 2), Day 182 (post-vaccination 2) and Day 385 (Post-vaccination 2 -for H5N1 cohorts only)
|
|
Percentage of Subjects With a ≥4-fold Rise for Anti-H1 Stalk Antibody Titer by MN - Adult Q-PAN H1N1-019, CC-PAN H5N1-001, Q-PAN H9N2-001 Cohorts (Only AS Vaccines)
時間枠：At Day 21 (post-vaccination1 compared to pre-vaccination), Day 42 (post-vaccination2 compared to pre-vaccination)
|
With respect to samples from HA Group 1-related studies (i.e., with H1N1, H5N1,and H9N2 pandemic, and quadrivalent inactivated seasonal, influenza vaccines, analysis was performed for measuring levels of anti-H1 stalk antibody by MN for all subjects who received an AS vaccine in each study cohort, aggregate variables were calculated with 95% CI for each treatment group within each study cohort.
seronegative subjects = titer < 10 1/DIL for anti-H1 stalk MN prior to vaccination seropositive subjects = titer ≥ 10 1/DIL for anti-H1 stalk MN prior to vaccination.
4-fold increase defined as: For initially seronegative subjects, antibody titer ≥ 20 1/DIL at post-vaccination; For initially seropositive subjects, antibody titer at post-vaccination ≥ 4-fold the pre-vaccination antibody titer.
|
At Day 21 (post-vaccination1 compared to pre-vaccination), Day 42 (post-vaccination2 compared to pre-vaccination)
|
|
Percentage of Subjects With a ≥10-fold Rise for Anti-H1 Stalk Antibody Titer (by MN) - Adult Q-PAN H1N1-019, CC-PAN H5N1-001, Q-PAN H9N2-001 Cohorts (Only AS Vaccines)
時間枠：At Day 21 (post-vaccination1 compared to pre-vaccination), Day 42 (post-vaccination2 compared to pre-vaccination)
|
With respect to samples from HA Group 1-related studies (i.e., with H1N1, H5N1,and H9N2 pandemic, and quadrivalent inactivated seasonal, influenza vaccines, analysis was performed for measuring levels of anti-H1 stalk antibody by MN for all subjects who received an AS vaccine in each study cohort, aggregate variables were calculated with 95% CI for each treatment group within each study cohort.
seronegative subjects = titer < 10 1/DIL for anti-H1 stalk MN prior to vaccination seropositive subjects = titer ≥ 10 1/DIL for anti-H1 stalk MN prior to vaccination.
10-fold increase defined as: For initially seronegative subjects, antibody titer ≥ 50 1/DIL at post-vaccination; For initially seropositive subjects, antibody titer at post-vaccination ≥ 10-fold the pre-vaccination antibody titer.
|
At Day 21 (post-vaccination1 compared to pre-vaccination), Day 42 (post-vaccination2 compared to pre-vaccination)
|
|
Mean Geometric Increase (MGI) for Anti-H1 Stalk Antibody Post-vaccination Concentration Compared to Pre-vaccination, by MN - Adult Q-PAN H1N1-019, CC-PAN H5N1-001, Q-PAN H9N2-001 Cohorts (Only AS Vaccines)
時間枠：At Day 21 (post-vaccination1/ pre-vaccination), Day 42 (post-vaccination2/ pre-vaccination), Day 182 (post-vaccination2/ pre-vaccination) and Day 385(post-vaccination2/ pre-vaccination - for H5N1 cohorts only )
|
With respect to samples from HA Group 1-related studies (i.e., with H1N1, H5N1,and H9N2 pandemic, and quadrivalent inactivated seasonal, influenza vaccines, analysis was performed for measuring levels of anti-H1 stalk antibody by MN for all subjects who received an AS vaccine in each study cohort, aggregate variables were calculated with 95% CI for each treatment group within each study cohort.
Mean Geometric Increase (MGI) = post-vaccination GMT over pre-vaccination GMT.
|
At Day 21 (post-vaccination1/ pre-vaccination), Day 42 (post-vaccination2/ pre-vaccination), Day 182 (post-vaccination2/ pre-vaccination) and Day 385(post-vaccination2/ pre-vaccination - for H5N1 cohorts only )
|
|
Percentage of Subjects With Anti-H1 Stalk Antibody Titer (by MN) Equal or Above the Cut-off of 10 1/DIL - Pediatric Q-PAN H5N1-AS03-021 Cohort (Only AS Vaccines)
時間枠：At Day 0 (Pre-vaccination), Day 21 (Post-vaccination 1), Day 42 (Post-vaccination 2) and Day 385 (Post-vaccination 2)
|
With respect to samples from HA Group 1-related studies (i.e., with H1N1, H5N1,and H9N2 pandemic, and quadrivalent inactivated seasonal, influenza vaccines, analysis was performed for measuring levels of anti-H1 stalk antibody by MN for all subjects who received an AS vaccine in each study cohort, aggregate variables were calculated with 95% CI for each treatment group within each study cohort.
Seropositivity rate was defined as the percentage of subjects with titerss greater or equal than 10 1/DIL.
|
At Day 0 (Pre-vaccination), Day 21 (Post-vaccination 1), Day 42 (Post-vaccination 2) and Day 385 (Post-vaccination 2)
|
|
Anti-H1 Stalk Antibody Titers (by MN) -Pediatric Q-PAN H5N1-AS03-021 Cohort (Only AS Vaccines)
時間枠：At Day 0 (Pre-vaccination), Day 21 (Post-vaccination 1), Day 42 (Post-vaccination 2) and Day 385 (Post-vaccination 2)
|
With respect to samples from HA Group 1-related studies (i.e., with H1N1, H5N1,and H9N2 pandemic, and quadrivalent inactivated seasonal, influenza vaccines, analysis was performed for measuring levels of anti-H1 stalk antibody by MN for all subjects who received an AS vaccine in each study cohort, Geometric mean titers (GMTs) were calculated with 95% CI for each treatment group within each study cohort.
|
At Day 0 (Pre-vaccination), Day 21 (Post-vaccination 1), Day 42 (Post-vaccination 2) and Day 385 (Post-vaccination 2)
|
|
Percentage of Subjects With a ≥4-fold Rise for Anti-H1 Stalk Antibody Titer by MN - Pediatric Q-PAN H5N1-AS03-021 Cohort (Only AS Vaccines)
時間枠：At Day 21 (post-vaccination1 compared to pre-vaccination), Day 42 (post-vaccination2 compared to pre-vaccination)
|
With respect to samples from HA Group 1-related studies (i.e., with H1N1, H5N1,and H9N2 pandemic, and quadrivalent inactivated seasonal, influenza vaccines, analysis was performed for measuring levels of anti-H1 stalk antibody by MN for all subjects who received an AS vaccine in each study cohort, aggregate variables were calculated with 95% CI for each treatment group within each study cohort.
seronegative subjects = titer < 10 1/DIL for anti-H1 stalk MN prior to vaccination seropositive subjects = titer ≥ 10 1/DIL for anti-H1 stalk MN prior to vaccination.
4-fold increase defined as: For initially seronegative subjects, antibody titer ≥ 20 1/DIL at post-vaccination; For initially seropositive subjects, antibody titer at post-vaccination ≥ 4-fold the pre-vaccination antibody titer.
|
At Day 21 (post-vaccination1 compared to pre-vaccination), Day 42 (post-vaccination2 compared to pre-vaccination)
|
|
Percentage of Subjects With a ≥10-fold Rise for Anti-H1 Stalk Antibody Titer by MN - Pediatric Q-PAN H5N1-AS03-021 Cohort (Only AS Vaccines)
時間枠：At Day 21 (post-vaccination1 compared to pre-vaccination), Day 42 (post-vaccination2 compared to pre-vaccination)
|
With respect to samples from HA Group 1-related studies (i.e., with H1N1, H5N1,and H9N2 pandemic, and quadrivalent inactivated seasonal, influenza vaccines, analysis was performed for measuring levels of anti-H1 stalk antibody by MN for all subjects who received an AS vaccine in each study cohort, aggregate variables were calculated with 95% CI for each treatment group within each study cohort.
seronegative subjects = titer < 10 1/DIL for anti-H1 stalk MN prior to vaccination seropositive subjects = titer ≥ 10 1/DIL for anti-H1 stalk MN prior to vaccination.
10-fold increase defined as: For initially seronegative subjects, antibody titer ≥ 50 1/DIL at post-vaccination; For initially seropositive subjects, antibody titer at post-vaccination ≥ 10-fold the pre-vaccination antibody titer.
|
At Day 21 (post-vaccination1 compared to pre-vaccination), Day 42 (post-vaccination2 compared to pre-vaccination)
|
|
Mean Geometric Increase (MGI) for Anti-H1 Stalk Antibody Post-vaccination Concentration Compared to Pre-vaccination, by MN -Pediatric Q-PAN H5N1-AS03-021 Cohort (Only AS Vaccines
時間枠：At Day 21 (post-vaccination1/ pre-vaccination), Day 42 (post-vaccination2/ pre-vaccination) and Day 385(post-vaccination2/ pre-vaccination)
|
With respect to samples from HA Group 1-related studies (i.e., with H1N1, H5N1,and H9N2 pandemic, and quadrivalent inactivated seasonal, influenza vaccines, analysis was performed for measuring levels of anti-H1 stalk antibody by MN for all subjects who received an AS vaccine in each study cohort, aggregate variables were calculated with 95% CI for each treatment group within each study cohort.
Mean Geometric Increase (MGI) = post-vaccination GMT over pre-vaccination GMT.
|
At Day 21 (post-vaccination1/ pre-vaccination), Day 42 (post-vaccination2/ pre-vaccination) and Day 385(post-vaccination2/ pre-vaccination)
|
|
Percentage of Subjects With Anti-H1 Stalk Antibody Titer (by MN) Equal or Above the Cut-off of 10 1/DIL - Adult Q-PAN-005 Cohort
時間枠：Group C: At D0 (Pre), D42 (Post-dose 1), D182 (post-dose 1), D549 (post-dose 2), D591 (Post-dose 3) and D729 (Post-dose 3); Group G: At D182 (Post-dose 1), D224 (Post-dose 2), D549 (post-dose 2), D591 (Post-dose 3) and D729 (Post-dose 3)
|
With respect to samples from HA Group 1-related studies (i.e., with H1N1, H5N1,and H9N2 pandemic, and quadrivalent inactivated seasonal, influenza vaccines, analysis was performed for measuring levels of anti-H1 stalk antibody by MN for all subjects who received an AS vaccine in each study cohort, aggregate variables were calculated with 95% CI for each treatment group within each study cohort.
Seropositivity rate was defined as the percentage of subjects with titers greater or equal than 10 1/DIL
|
Group C: At D0 (Pre), D42 (Post-dose 1), D182 (post-dose 1), D549 (post-dose 2), D591 (Post-dose 3) and D729 (Post-dose 3); Group G: At D182 (Post-dose 1), D224 (Post-dose 2), D549 (post-dose 2), D591 (Post-dose 3) and D729 (Post-dose 3)
|
|
Anti-H1 Stalk Enzyme-linked Immunosorbent Assay (ELISA) Antibody Titers - Adult Q-PAN-005 Cohort
時間枠：Group C: At D0 (Pre), D42 (Post-dose 1), D182 (post-dose 1), D549 (post-dose 2), D591 (Post-dose 3) and D729 (Post-dose 3); Group G: At D182 (Post-dose 1), D224 (Post-dose 2), D549 (post-dose 2), D591 (Post-dose 3) and D729 (Post-dose 3)
|
With respect to samples from HA Group 1-related studies (i.e., with H1N1, H5N1,and H9N2 pandemic, and quadrivalent inactivated seasonal, influenza vaccines, analysis was performed for measuring levels of anti-H1 stalk antibody by MN for all subjects who received an AS vaccine in each study cohort, Geometric mean titers (GMTs) were calculated with 95% CI for each treatment group within each study cohort.
|
Group C: At D0 (Pre), D42 (Post-dose 1), D182 (post-dose 1), D549 (post-dose 2), D591 (Post-dose 3) and D729 (Post-dose 3); Group G: At D182 (Post-dose 1), D224 (Post-dose 2), D549 (post-dose 2), D591 (Post-dose 3) and D729 (Post-dose 3)
|
|
Percentage of Subjects With a ≥4-fold Rise for Anti-H1 Stalk Antibody Titer by MN - Adult Q-PAN-005 Cohort
時間枠：For group C: At Day 42 (post-dose1 compared to [/]Day 0), at Day 591 (post-dose3 / Day 0) - For group G: At Day 224 (post-dose2 / Day 182), at Day 591 (post-dose3 / Day 182)
|
With respect to samples from HA Group 1-related studies (i.e., with H1N1, H5N1,and H9N2 pandemic, and quadrivalent inactivated seasonal, influenza vaccines, analysis was performed for measuring levels of anti-H1 stalk antibody by MN for all subjects who received an AS vaccine in each study cohort, aggregate variables were calculated with 95% CI for each treatment group within each study cohort.
seronegative subjects = titer < 10 1/DIL for anti-H1 stalk MN prior to vaccination seropositive subjects = titer ≥ 10 1/DIL for anti-H1 stalk MN prior to vaccination.
4-fold increase defined as: For initially seronegative subjects, antibody titer ≥ 20 1/DIL at post-vaccination; For initially seropositive subjects, antibody titer at post-vaccination ≥ 4-fold the pre-vaccination antibody titer.
The ≥4-fold increases were only calculated relative to baseline.
|
For group C: At Day 42 (post-dose1 compared to [/]Day 0), at Day 591 (post-dose3 / Day 0) - For group G: At Day 224 (post-dose2 / Day 182), at Day 591 (post-dose3 / Day 182)
|
|
Percentage of Subjects With a ≥10-fold Rise for Anti-H1 Stalk Antibody Titer by MN - Adult Q-PAN-005 Cohort
時間枠：For group C: At Day 42 (post-dose1 compared to [/]Day 0), at Day 591 (post-dose3 / Day 0) - For group G: At Day 224 (post-dose2 / Day 182), at Day 591 (post-dose3 / Day 182)
|
With respect to samples from HA Group 1-related studies (i.e., with H1N1, H5N1,and H9N2 pandemic, and quadrivalent inactivated seasonal, influenza vaccines, analysis was performed for measuring levels of anti-H1 stalk antibody by MN for all subjects who received an AS vaccine in each study cohort, aggregate variables were calculated with 95% CI for each treatment group within each study cohort.
seronegative subjects = titer < 10 1/DIL for anti-H1 stalk MN prior to vaccination seropositive subjects = titer ≥ 10 1/DIL for anti-H1 stalk MN prior to vaccination.
10-fold increase defined as: For initially seronegative subjects, antibody titer ≥ 50 1/DIL at post-vaccination; For initially seropositive subjects, antibody titer at post-vaccination ≥ 10-fold the pre-vaccination antibody titer.
The ≥10-fold increases were only calculated relative to baseline.
|
For group C: At Day 42 (post-dose1 compared to [/]Day 0), at Day 591 (post-dose3 / Day 0) - For group G: At Day 224 (post-dose2 / Day 182), at Day 591 (post-dose3 / Day 182)
|
|
Mean Geometric Increase (MGI) for Anti-H1 Stalk Antibody Post-vaccination Concentration Compared to Pre-vaccination - Adult Q-PAN-005 Cohort
時間枠：At Day[D] 42 (post-dose[ps-d]1), D182 (ps-d1), D549 (ps-d2), D591 (ps-d3) and D729(ps-d3) compared to D0 for Group C and at D224 (ps-d2), D549 (ps-d2), D591 (ps-d3) and D729(ps-d3) compared to D182 for Group G
|
With respect to samples from HA Group 1-related studies (i.e., with H1N1, H5N1,and H9N2 pandemic, and quadrivalent inactivated seasonal, influenza vaccines, analysis was performed for measuring levels of anti-H1 stalk antibody by MN for all subjects who received an AS vaccine in each study cohort, aggregate variables were calculated with 95% CI for each treatment group within each study cohort.
Mean Geometric Increase (MGI) = post-vaccination GMT over pre-vaccination GMT.
|
At Day[D] 42 (post-dose[ps-d]1), D182 (ps-d1), D549 (ps-d2), D591 (ps-d3) and D729(ps-d3) compared to D0 for Group C and at D224 (ps-d2), D549 (ps-d2), D591 (ps-d3) and D729(ps-d3) compared to D182 for Group G
|
|
Percentage of Subjects With Anti-H1 Stalk Antibody Titer (by MN) Equal or Above the Cut-off of 10 1/DIL - Adult H5N1-012 Cohort
時間枠：At D0 (Pre), D21 (Post-dose 1), Month (M)6 (post-dose 1), M12 (Post-dose1), M12+21days (post-dose2), M18 (Post-dose2)
|
With respect to samples from HA Group 1-related studies (i.e., with H1N1, H5N1,and H9N2 pandemic, and quadrivalent inactivated seasonal, influenza vaccines, analysis was performed for measuring levels of anti-H1 stalk antibody by MN for all subjects who received an AS vaccine in each study cohort, aggregate variables were calculated with 95% CI for each treatment group within each study cohort.
Seropositivity rate was defined as the percentage of subjects with titers greater or equal than 10 1/DIL
|
At D0 (Pre), D21 (Post-dose 1), Month (M)6 (post-dose 1), M12 (Post-dose1), M12+21days (post-dose2), M18 (Post-dose2)
|
|
Anti-H1 Stalk Antibody Titers (by MN) - Adult H5N1-012 Cohort
時間枠：At D0 (Pre), D21 (Post-dose 1), Month (M)6 (post-dose 1), M12 (Post-dose1), M12+21days (post-dose2), M18 (Post-dose2)
|
With respect to samples from HA Group 1-related studies (i.e., with H1N1, H5N1,and H9N2 pandemic, and quadrivalent inactivated seasonal, influenza vaccines, analysis was performed for measuring levels of anti-H1 stalk antibody by MN for all subjects who received an AS vaccine in each study cohort, Geometric mean titers (GMTs) were calculated with 95% CI for each treatment group within each study cohort.
|
At D0 (Pre), D21 (Post-dose 1), Month (M)6 (post-dose 1), M12 (Post-dose1), M12+21days (post-dose2), M18 (Post-dose2)
|
|
Percentage of Subjects With a ≥4-fold Rise for Anti-H1 Stalk Antibody Titer by MN - Adult H5N1-012 Cohort
時間枠：At D21 (post-dose1 compared to [/]D0), at M12+21days (post-dose2 /D0)
|
With respect to samples from HA Group 1-related studies (i.e., with H1N1, H5N1,and H9N2 pandemic, and quadrivalent inactivated seasonal, influenza vaccines, analysis was performed for measuring levels of anti-H1 stalk antibody by MN for all subjects who received an AS vaccine in each study cohort, aggregate variables were calculated with 95% CI for each treatment group within each study cohort.
seronegative subjects = titer < 10 1/DIL for anti-H1 stalk MN prior to vaccination seropositive subjects = titer ≥ 10 1/DIL for anti-H1 stalk MN prior to vaccination.
4-fold increase defined as: For initially seronegative subjects, antibody titer ≥ 20 1/DIL at post-vaccination; For initially seropositive subjects, antibody titer at post-vaccination ≥ 4-fold the pre-vaccination antibody titer.
The ≥4-fold increases were only calculated relative to baseline.
|
At D21 (post-dose1 compared to [/]D0), at M12+21days (post-dose2 /D0)
|
|
Percentage of Subjects With a ≥10-fold Rise for Anti-H1 Stalk Antibody Titer - Adult H5N1-012 Cohort
時間枠：At D21 (post-dose1 compared to [/]D0), at M12+21days (post-dose2 /D0)
|
With respect to samples from HA Group 1-related studies (i.e., with H1N1, H5N1,and H9N2 pandemic, and quadrivalent inactivated seasonal, influenza vaccines, analysis was performed for measuring levels of anti-H1 stalk antibody by MN for all subjects who received an AS vaccine in each study cohort, aggregate variables were calculated with 95% CI for each treatment group within each study cohort.
seronegative subjects = titer < 10 1/DIL for anti-H1 stalk MN prior to vaccination seropositive subjects = titer ≥ 10 1/DIL for anti-H1 stalk MN prior to vaccination.
10-fold increase defined as: For initially seronegative subjects, antibody titer ≥ 50 1/DIL at post-vaccination; For initially seropositive subjects, antibody titer at post-vaccination ≥ 10-fold the pre-vaccination antibody titer.
The ≥4-fold increases were only calculated relative to baseline.
|
At D21 (post-dose1 compared to [/]D0), at M12+21days (post-dose2 /D0)
|
|
Mean Geometric Increase (MGI) for Anti-H1 Stalk Antibody Post-vaccination Concentration Compared to Pre-vaccination, by MN - Adult H5N1-012 Cohort
時間枠：At D21 (post-dose[ps-d]1), M6 (ps-d1), M12 (ps-d1), M12+21days (ps-d2) and M18 compared to D0
|
With respect to samples from HA Group 1-related studies (i.e., with H1N1, H5N1,and H9N2 pandemic, and quadrivalent inactivated seasonal, influenza vaccines, analysis was performed for measuring levels of anti-H1 stalk antibody by MN for all subjects who received an AS vaccine in each study cohort, aggregate variables were calculated with 95% CI for each treatment group within each study cohort.
Mean Geometric Increase (MGI) = post-vaccination GMT over pre-vaccination GMT.
|
At D21 (post-dose[ps-d]1), M6 (ps-d1), M12 (ps-d1), M12+21days (ps-d2) and M18 compared to D0
|
|
Percentage of Subjects With Anti-H1 Stalk Antibody Titer (by MN) Equal or Above the Cut-off of 10 1/DIL - Adult FLU D-QIV-015 Cohort
時間枠：At D0 (Pre), D21 (Post-dose 1)
|
With respect to samples from HA Group 1-related studies (i.e., with H1N1, H5N1,and H9N2 pandemic, and quadrivalent inactivated seasonal, influenza vaccines, analysis was performed for measuring levels of anti-H1 stalk antibody by MN for all subjects who received an AS vaccine in each study cohort, aggregate variables were calculated with 95% CI for each treatment group within each study cohort.
Seropositivity rate was defined as the percentage of subjects with titers greater or equal than 10 1/DIL
|
At D0 (Pre), D21 (Post-dose 1)
|
|
Anti-H1 Stalk Antibody Titers (by MN) - Adult FLU D-QIV-015 Cohort
時間枠：At D0 (Pre), D21 (Post-dose 1)
|
With respect to samples from HA Group 1-related studies (i.e., with H1N1, H5N1,and H9N2 pandemic, and quadrivalent inactivated seasonal, influenza vaccines, analysis was performed for measuring levels of anti-H1 stalk antibody by MN for all subjects who received an AS vaccine in each study cohort, Geometric mean titers (GMTs) were calculated with 95% CI for each treatment group within each study cohort.
|
At D0 (Pre), D21 (Post-dose 1)
|
|
Percentage of Subjects With a ≥4-fold Rise for Anti-H1 Stalk Antibody Titer by MN - Adult FLU D-QIV-015 Cohort
時間枠：At D21 (post-dose1 compared to [/]D0)
|
With respect to samples from HA Group 1-related studies (i.e., with H1N1, H5N1,and H9N2 pandemic, and quadrivalent inactivated seasonal, influenza vaccines, analysis was performed for measuring levels of anti-H1 stalk antibody by MN for all subjects who received an AS vaccine in each study cohort, aggregate variables were calculated with 95% CI for each treatment group within each study cohort.
seronegative subjects = titer < 10 1/DIL for anti-H1 stalk MN prior to vaccination seropositive subjects = titer ≥ 10 1/DIL for anti-H1 stalk MN prior to vaccination.
4-fold increase defined as: For initially seronegative subjects, antibody titer ≥ 20 1/DIL at post-vaccination; For initially seropositive subjects, antibody titer at post-vaccination ≥ 4-fold the pre-vaccination antibody titer.
|
At D21 (post-dose1 compared to [/]D0)
|
|
Percentage of Subjects With a ≥10-fold Rise for Anti-H1 Stalk Antibody Titer - Adult FLU D-QIV-015 Cohort
時間枠：At D21 (post-dose1 compared to [/]D0)
|
With respect to samples from HA Group 1-related studies (i.e., with H1N1, H5N1,and H9N2 pandemic, and quadrivalent inactivated seasonal, influenza vaccines, analysis was performed for measuring levels of anti-H1 stalk antibody by MN for all subjects who received an AS vaccine in each study cohort, aggregate variables were calculated with 95% CI for each treatment group within each study cohort.
seronegative subjects = titer < 10 1/DIL for anti-H1 stalk MN prior to vaccination seropositive subjects = titer ≥ 10 1/DIL for anti-H1 stalk MN prior to vaccination.
10-fold increase defined as: For initially seronegative subjects, antibody titer ≥ 50 1/DIL at post-vaccination; For initially seropositive subjects, antibody titer at post-vaccination ≥ 10-fold the pre-vaccination antibody titer.
|
At D21 (post-dose1 compared to [/]D0)
|
|
Mean Geometric Increase (MGI) for Anti-H1 Stalk Antibody Post-vaccination Concentration Compared to Pre-vaccination, by MN - Adult FLU D-QIV-015 Cohort
時間枠：At D21 (post-dose1) compared to D0
|
With respect to samples from HA Group 1-related studies (i.e., with H1N1, H5N1,and H9N2 pandemic, and quadrivalent inactivated seasonal, influenza vaccines, analysis was performed for measuring levels of anti-H1 stalk antibody by MN for all subjects who received an AS vaccine in each study cohort, aggregate variables were calculated with 95% CI for each treatment group within each study cohort.
Mean Geometric Increase (MGI) = post-vaccination GMT over pre-vaccination GMT.
|
At D21 (post-dose1) compared to D0
|
|
Percentage of Subjects With Anti-H2 Full Length HA ELISA Antibody Concentration Equal or Above the Cut-off of 50 EU/mL - Adult Q-PAN H1N1-019, CC-PAN H5N1-001, Q-PAN H9N2-001 Cohorts
時間枠：At Day 42 (Post-vaccination 2), and final timepoint (for persistence) (i.e., Day 182 for the Q-Pan-H1N1-019, Q-PAN-H9N2-001 and Day 385 for the CC-Pan-H5N1 study cohorts)
|
With respect to samples from HA Group 1-related studies (i.e., with H1N1, H5N1,and H9N2 pandemic, and quadrivalent inactivated seasonal, influenza vaccines, analysis was performed for measuring levels of anti-H2 antibody by ELISA for the subjects who received an AS vaccine in each study cohort and for the subjects in the FLU D-QIV-015 study cohort, aggregate variables were calculated with 95% CI for each treatment group within each study cohort.
Seropositivity rate was defined as the percentage of subjects with concentrations greater or equal than 50 Elisa Unit per milliliter (EU/mL)
|
At Day 42 (Post-vaccination 2), and final timepoint (for persistence) (i.e., Day 182 for the Q-Pan-H1N1-019, Q-PAN-H9N2-001 and Day 385 for the CC-Pan-H5N1 study cohorts)
|
|
Anti-H2 Full Length HA ELISA Antibody Concentrations - Adult Q-PAN H1N1-019, CC-PAN H5N1-001, Q-PAN H9N2-001 Cohorts
時間枠：At Day 42 (Post-vaccination 2), and final timepoint (for persistence) (i.e., Day 182 for the Q-Pan-H1N1-019, Q-PAN-H9N2-001 and Day 385 for the CC-Pan-H5N1 study cohorts)
|
With respect to samples from HA Group 1-related studies (i.e., with H1N1, H5N1,and H9N2 pandemic, and quadrivalent inactivated seasonal, influenza vaccines, analysis was performed for measuring levels of anti-H2 antibody by ELISA for the subjects who received an AS vaccine in each study cohort and for the subjects in the FLU D-QIV-015 study cohort, aggregate variables were calculated with 95% CI for each treatment group within each study cohort.
Geometric mean concentrations (GMCs) were expressed in Elisa Unit per milliliter (EU/mL)
|
At Day 42 (Post-vaccination 2), and final timepoint (for persistence) (i.e., Day 182 for the Q-Pan-H1N1-019, Q-PAN-H9N2-001 and Day 385 for the CC-Pan-H5N1 study cohorts)
|
|
Percentage of Subjects With a ≥4-fold Rise for Anti-H2 Full Length HA ELISA Antibody Concentration - Adult Q-PAN H1N1-019, CC-PAN H5N1-001, Q-PAN H9N2-001 Cohorts
時間枠：At Day 42 (post-vaccination2 compared to pre-vaccination)
|
With respect to samples from HA Group 1-related studies (i.e., with H1N1, H5N1,and H9N2 pandemic, and quadrivalent inactivated seasonal, influenza vaccines, analysis was performed for measuring levels of anti-H2 antibody by ELISA for the subjects who received an AS vaccine in each study cohort and for the subjects in the FLU D-QIV-015 study cohort, aggregate variables were calculated with 95% CI for each treatment group within each study cohort.
seronegative subjects = concentration < 50 EU/mL for anti-H2 HA (full length) antibody prior to vaccination.
seropositive subjects = concentration ≥ 50 EU/mL for anti-H2 HA (full length) antibody prior to vaccination.
4-fold increase defined as: For initially seronegative subjects, antibody concentration ≥ 100 EU/mL at post-vaccination; For initially seropositive subjects, antibody concentration at post-vaccination ≥ 4-fold the pre-vaccination antibody concentration.
|
At Day 42 (post-vaccination2 compared to pre-vaccination)
|
|
Mean Geometric Increase (MGI) for Anti-H2 Full Length HA ELISA Antibody Post-vaccination Concentration Compared to Pre-vaccination - Adult Q-PAN H1N1-019, CC-PAN H5N1-001, Q-PAN H9N2-001 Cohorts
時間枠：At Day 42 (post-vaccination2/ Day 0), and final timepoint (for persistence) compared to Day 0 (i.e., Day 182 for the Q-Pan-H1N1-019, Q-PAN-H9N2-001 and Day 385 for the CC-Pan-H5N1 study cohorts)
|
With respect to samples from HA Group 1-related studies (i.e., with H1N1, H5N1,and H9N2 pandemic, and quadrivalent inactivated seasonal, influenza vaccines, analysis was performed for measuring levels of anti-H2 antibody by ELISA for the subjects who received an AS vaccine in each study cohort and for the subjects in the FLU D-QIV-015 study cohort, aggregate variables were calculated with 95% CI for each treatment group within each study cohort.
Mean Geometric Increase (MGI) = post-vaccination GMC over pre-vaccination GMC.
|
At Day 42 (post-vaccination2/ Day 0), and final timepoint (for persistence) compared to Day 0 (i.e., Day 182 for the Q-Pan-H1N1-019, Q-PAN-H9N2-001 and Day 385 for the CC-Pan-H5N1 study cohorts)
|
|
Percentage of Subjects With Anti-H2 Full Length HA ELISA Antibody Concentration Equal or Above the Cut-off of 50 EU/mL - Pediatric Q-PAN H5N1-AS03-021 Cohort
時間枠：At Day 42 (Post-vaccination 2) and final timepoint (for persistence) (i.e., Day 385)
|
With respect to samples from HA Group 1-related studies (i.e., with H1N1, H5N1,and H9N2 pandemic, and quadrivalent inactivated seasonal, influenza vaccines, analysis was performed for measuring levels of anti-H2 antibody by ELISA for the subjects who received an AS vaccine in each study cohort and for the subjects in the FLU D-QIV-015 study cohort, aggregate variables were calculated with 95% CI for each treatment group within each study cohort.
Seropositivity rate was defined as the percentage of subjects with concentrations greater or equal than 50 Elisa Unit per milliliter (EU/mL)
|
At Day 42 (Post-vaccination 2) and final timepoint (for persistence) (i.e., Day 385)
|
|
Anti-H2 Full Length HA ELISA Antibody Concentrations -Pediatric Q-PAN H5N1-AS03-021 Cohort
時間枠：At Day 42 (Post-vaccination 2) and final timepoint (for persistence) (i.e., Day 385)
|
With respect to samples from HA Group 1-related studies (i.e., with H1N1, H5N1,and H9N2 pandemic, and quadrivalent inactivated seasonal, influenza vaccines, analysis was performed for measuring levels of anti-H2 antibody by ELISA for the subjects who received an AS vaccine in each study cohort and for the subjects in the FLU D-QIV-015 study cohort, aggregate variables were calculated with 95% CI for each treatment group within each study cohort.
Geometric mean concentrations (GMCs) were expressed in Elisa Unit per milliliter (EU/mL)
|
At Day 42 (Post-vaccination 2) and final timepoint (for persistence) (i.e., Day 385)
|
|
Percentage of Subjects With a ≥4-fold Rise for Anti-H2 Full Length HA ELISA Antibody Concentration - Pediatric Q-PAN H5N1-AS03-021 Cohort
時間枠：At Day 42 (post-vaccination2 compared to Day 0)
|
With respect to samples from HA Group 1-related studies (i.e., with H1N1, H5N1,and H9N2 pandemic, and quadrivalent inactivated seasonal, influenza vaccines, analysis was performed for measuring levels of anti-H2 antibody by ELISA for the subjects who received an AS vaccine in each study cohortand for the subjects in the FLU D-QIV-015 study cohort, aggregate variables were calculated with 95% CI for each treatment group within each study cohort.
seronegative subjects = concentration < 50 EU/mL for anti-H2 HA (full length) antibody prior to vaccination.
seropositive subjects = concentration ≥ 50 EU/mL for anti-H2 HA (full length) antibody prior to vaccination.
4-fold increase defined as: For initially seronegative subjects, antibody concentration ≥ 100 EU/mL at post-vaccination; For initially seropositive subjects, antibody concentration at post-vaccination ≥ 4-fold the pre-vaccination antibody concentration.
|
At Day 42 (post-vaccination2 compared to Day 0)
|
|
Mean Geometric Increase (MGI) for Anti-H2 Full Length HA ELISA Antibody Post-vaccination Concentration Compared to Pre-vaccination -Pediatric Q-PAN H5N1-AS03-021 Cohort
時間枠：At Day 42 (post-vaccination2/ Day 0) and final time point (for persistence)(i.e., Day 385[post-vaccination2]/ Day 0)
|
With respect to samples from HA Group 1-related studies (i.e., with H1N1, H5N1,and H9N2 pandemic, and quadrivalent inactivated seasonal, influenza vaccines, analysis was performed for measuring levels of anti-H2 antibody by ELISA for the subjects who received an AS vaccine in each study cohort and for the subjects in the FLU D-QIV-015 study cohort, aggregate variables were calculated with 95% CI for each treatment group within each study cohort.
Mean Geometric Increase (MGI) = post-vaccination GMC over pre-vaccination GMC.
|
At Day 42 (post-vaccination2/ Day 0) and final time point (for persistence)(i.e., Day 385[post-vaccination2]/ Day 0)
|
|
Percentage of Subjects With Anti-H2 Full Length HA ELISA Antibody Concentration Equal or Above the Cut-off of 50 EU/mL - Adult Q-PAN-005 Cohort
時間枠：At D0(Pre), D42(Post-dose [Pst-d]1), D182(Pst-d1), D549(Pst-d2), D591(Pst-d3) and D729(Pst-d3) for group C, and D182(Pst-d1), D224(Pst-d2), D549(Pst-d2), D591(Pst-d3) and D729(Pst-d3) for group G
|
With respect to samples from HA Group 1-related studies (i.e., with H1N1, H5N1,and H9N2 pandemic, and quadrivalent inactivated seasonal, influenza vaccines, analysis was performed for measuring levels of anti-H2 antibody by ELISA for the subjects who received an AS vaccine in each study cohort and for the subjects in the FLU D-QIV-015 study cohort, aggregate variables were calculated with 95% CI for each treatment group within each study cohort.
Seropositivity rate was defined as the percentage of subjects with concentrations greater or equal than 50 Elisa Unit per milliliter (EU/mL)
|
At D0(Pre), D42(Post-dose [Pst-d]1), D182(Pst-d1), D549(Pst-d2), D591(Pst-d3) and D729(Pst-d3) for group C, and D182(Pst-d1), D224(Pst-d2), D549(Pst-d2), D591(Pst-d3) and D729(Pst-d3) for group G
|
|
Anti-H2 Full Length HA ELISA Antibody Concentrations - Adult Q-PAN-005 Cohort
時間枠：At D0(Pre), D42(Post-dose [Pst-d]1), D182(Pst-d1), D549(Pst-d2), D591(Pst-d3) and D729(Pst-d3) for group C, and D182(Pst-d1), D224(Pst-d2), D549(Pst-d2), D591(Pst-d3) and D729(Pst-d3) for group G
|
With respect to samples from HA Group 1-related studies (i.e., with H1N1, H5N1,and H9N2 pandemic, and quadrivalent inactivated seasonal, influenza vaccines, analysis was performed for measuring levels of anti-H2 antibody by ELISA for the subjects who received an AS vaccine in each study cohort and for the subjects in the FLU D-QIV-015 study cohort, aggregate variables were calculated with 95% CI for each treatment group within each study cohort.
Geometric mean concentrations (GMCs) were expressed in Elisa Unit per milliliter (EU/mL)
|
At D0(Pre), D42(Post-dose [Pst-d]1), D182(Pst-d1), D549(Pst-d2), D591(Pst-d3) and D729(Pst-d3) for group C, and D182(Pst-d1), D224(Pst-d2), D549(Pst-d2), D591(Pst-d3) and D729(Pst-d3) for group G
|
|
Percentage of Subjects With a ≥4-fold Rise for Anti-H2 Full Length HA ELISA Antibody Concentration - Adult Q-PAN-005 Cohort
時間枠：For group C: At Day 42 (post-dose1 compared to [/]Day 0), at Day 591 (post-dose3 / Day 0) - For group G: At Day 224 (post-dose2 / Day 182), at Day 591 (post-dose3 / Day 182)
|
With respect to samples from HA Group 1-related studies (i.e., with H1N1, H5N1,and H9N2 pandemic, and quadrivalent inactivated seasonal, influenza vaccines, analysis was performed for measuring levels of anti-H2 antibody by ELISA for the subjects who received an AS vaccine in each study cohort and for the subjects in the FLU D-QIV-015 study cohort, aggregate variables were calculated with 95% CI for each treatment group within each study cohort.
seronegative subjects = concentration < 50 EU/mL for anti-H2 HA (full length) antibody prior to vaccination.
seropositive subjects = concentration ≥ 50 EU/mL for anti-H2 HA (full length) antibody prior to vaccination.
4-fold increase defined as: For initially seronegative subjects, antibody concentration ≥ 100 EU/mL at post-vaccination; For initially seropositive subjects, antibody concentration at post-vaccination ≥ 4-fold the pre-vaccination antibody concentration.
The ≥4-fold increases were only calculated relative to baseline.
|
For group C: At Day 42 (post-dose1 compared to [/]Day 0), at Day 591 (post-dose3 / Day 0) - For group G: At Day 224 (post-dose2 / Day 182), at Day 591 (post-dose3 / Day 182)
|
|
Mean Geometric Increase (MGI) for Anti-H2 Full Length HA ELISA Antibody Post-vaccination Concentration Compared to Pre-vaccination - Adult Q-PAN-005 Cohort
時間枠：At Day[D] 42 (post-dose[ps-d]1), D549 (ps-d2), D591 (ps-d3) and D729(ps-d3) compared to D0 for Group C and at D224 (ps-d2), D549 (ps-d2), D591 (ps-d3) and D729(ps-d3) compared to D182 for Group G
|
With respect to samples from HA Group 1-related studies (i.e., with H1N1, H5N1,and H9N2 pandemic, and quadrivalent inactivated seasonal, influenza vaccines, analysis was performed for measuring levels of anti-H2 antibody by ELISA for the subjects who received an AS vaccine in each study cohort and for the subjects in the FLU D-QIV-015 study cohort, aggregate variables were calculated with 95% CI for each treatment group within each study cohort.
Mean Geometric Increase (MGI) = post-vaccination GMC over pre-vaccination GMC.
|
At Day[D] 42 (post-dose[ps-d]1), D549 (ps-d2), D591 (ps-d3) and D729(ps-d3) compared to D0 for Group C and at D224 (ps-d2), D549 (ps-d2), D591 (ps-d3) and D729(ps-d3) compared to D182 for Group G
|
|
Percentage of Subjects With Anti-H2 Full Length HA ELISA Antibody Concentration Equal or Above the Cut-off of 50 EU/mL - Adult H5N1-012 Cohort
時間枠：At D0 (Pre), D21 (Post-dose 1), M12 (Post-dose1), M12+21days (post-dose2), M18 (Post-dose2)
|
With respect to samples from HA Group 1-related studies (i.e., with H1N1, H5N1,and H9N2 pandemic, and quadrivalent inactivated seasonal, influenza vaccines, analysis was performed for measuring levels of anti-H2 antibody by ELISA for the subjects who received an AS vaccine in each study cohort and for the subjects in the FLU D-QIV-015 study cohort, aggregate variables were calculated with 95% CI for each treatment group within each study cohort.
Seropositivity rate was defined as the percentage of subjects with concentrations greater or equal than 50 Elisa Unit per milliliter (EU/mL)
|
At D0 (Pre), D21 (Post-dose 1), M12 (Post-dose1), M12+21days (post-dose2), M18 (Post-dose2)
|
|
Anti-H2 Full Length HA ELISA Antibody Concentrations - Adult H5N1-012 Cohort
時間枠：At D0 (Pre), D21 (Post-dose 1), M12 (Post-dose1), M12+21days (post-dose2), M18 (Post-dose2)
|
With respect to samples from HA Group 1-related studies (i.e., with H1N1, H5N1,and H9N2 pandemic, and quadrivalent inactivated seasonal, influenza vaccines, analysis was performed for measuring levels of anti-H2 antibody by ELISA for the subjects who received an AS vaccine in each study cohort and for the subjects in the FLU D-QIV-015 study cohort, aggregate variables were calculated with 95% CI for each treatment group within each study cohort.
Geometric mean concentrations (GMCs) were expressed in Elisa Unit per milliliter (EU/mL)
|
At D0 (Pre), D21 (Post-dose 1), M12 (Post-dose1), M12+21days (post-dose2), M18 (Post-dose2)
|
|
Percentage of Subjects With a ≥4-fold Rise for Anti-H2 Full Length HA ELISA Antibody Concentration - Adult H5N1-012 Cohort
時間枠：At D21 (post-dose1 compared to [/]D0), at M12+21days (post-dose2 /D0)
|
With respect to samples from HA Group 1-related studies (i.e., with H1N1, H5N1,and H9N2 pandemic, and quadrivalent inactivated seasonal, influenza vaccines, analysis was performed for measuring levels of anti-H2 antibody by ELISA for the subjects who received an AS vaccine in each study cohort and for the subjects in the FLU D-QIV-015 study cohort, aggregate variables were calculated with 95% CI for each treatment group within each study cohort.
seronegative subjects = concentration < 50 EU/mL for anti-H2 HA (full length) antibody prior to vaccination.
seropositive subjects = concentration ≥ 50 EU/mL for anti-H2 HA (full length) antibody prior to vaccination.
4-fold increase defined as: For initially seronegative subjects, antibody concentration ≥ 100 EU/mL at post-vaccination; For initially seropositive subjects, antibody concentration at post-vaccination ≥ 4-fold the pre-vaccination antibody concentration.
The ≥4-fold increases were only calculated relative to baseline.
|
At D21 (post-dose1 compared to [/]D0), at M12+21days (post-dose2 /D0)
|
|
Mean Geometric Increase (MGI) for Anti-H2 Full Length HA ELISA Antibody Post-vaccination Concentration Compared to Pre-vaccination - Adult H5N1-012 Cohort
時間枠：At D21 (post-dose[ps-d]1), M12 (ps-d1), M12+21days (ps-d2) and M18 compared to D0
|
With respect to samples from HA Group 1-related studies (i.e., with H1N1, H5N1,and H9N2 pandemic, and quadrivalent inactivated seasonal, influenza vaccines, analysis was performed for measuring levels of anti-H2 antibody by ELISA for the subjects who received an AS vaccine in each study cohort and for the subjects in the FLU D-QIV-015 study cohort, aggregate variables were calculated with 95% CI for each treatment group within each study cohort.
Mean Geometric Increase (MGI) = post-vaccination GMC over pre-vaccination GMC.
|
At D21 (post-dose[ps-d]1), M12 (ps-d1), M12+21days (ps-d2) and M18 compared to D0
|
|
Percentage of Subjects With Anti-H2 Full Length HA ELISA Antibody Concentration Equal or Above the Cut-off of 50 EU/mL - Adult FLU D-QIV-015 Cohort
時間枠：At D0 (Pre), D21 (Post-dose 1)
|
With respect to samples from HA Group 1-related studies (i.e., with H1N1, H5N1,and H9N2 pandemic, and quadrivalent inactivated seasonal, influenza vaccines, analysis was performed for measuring levels of anti-H2 antibody by ELISA for the subjects who received an AS vaccine in each study cohort and for the subjects in the FLU D-QIV-015 study cohort, aggregate variables were calculated with 95% CI for each treatment group within each study cohort.
Seropositivity rate was defined as the percentage of subjects with concentrations greater or equal than 50 Elisa Unit per milliliter (EU/mL)
|
At D0 (Pre), D21 (Post-dose 1)
|
|
Anti-H2 Full Length HA ELISA Antibody Concentrations - Adult FLU D-QIV-015 Cohort
時間枠：At D0 (Pre), D21 (Post-dose 1)
|
With respect to samples from HA Group 1-related studies (i.e., with H1N1, H5N1,and H9N2 pandemic, and quadrivalent inactivated seasonal, influenza vaccines, analysis was performed for measuring levels of anti-H2 antibody by ELISA for the subjects who received an AS vaccine in each study cohort and for the subjects in the FLU D-QIV-015 study cohort, aggregate variables were calculated with 95% CI for each treatment group within each study cohort.
Geometric mean concentrations (GMCs) were expressed in Elisa Unit per milliliter (EU/mL)
|
At D0 (Pre), D21 (Post-dose 1)
|
|
Percentage of Subjects With a ≥4-fold Rise for Anti-H2 Full Length HA ELISA Antibody Concentration - Adult FLU D-QIV-015 Cohort
時間枠：At D21 (post-dose1 compared to [/]D0)
|
With respect to samples from HA Group 1-related studies (i.e., with H1N1, H5N1,and H9N2 pandemic, and quadrivalent inactivated seasonal, influenza vaccines, analysis was performed for measuring levels of anti-H2 antibody by ELISA for the subjects who received an AS vaccine in each study cohort and for the subjects in the FLU D-QIV-015 study cohort, aggregate variables were calculated with 95% CI for each treatment group within each study cohort.
seronegative subjects = concentration < 50 EU/mL for anti-H2 HA (full length) antibody prior to vaccination.
seropositive subjects = concentration ≥ 50 EU/mL for anti-H2 HA (full length) antibody prior to vaccination.
4-fold increase defined as: For initially seronegative subjects, antibody concentration ≥ 100 EU/mL at post-vaccination; For initially seropositive subjects, antibody concentration at post-vaccination ≥ 4-fold the pre-vaccination antibody concentration.
|
At D21 (post-dose1 compared to [/]D0)
|
|
Mean Geometric Increase (MGI) for Anti-H2 Full Length HA ELISA Antibody Post-vaccination Concentration Compared to Pre-vaccination - Adult FLU D-QIV-015 Cohort
時間枠：At D21 (post-dose1) compared to D0
|
With respect to samples from HA Group 1-related studies (i.e., with H1N1, H5N1,and H9N2 pandemic, and quadrivalent inactivated seasonal, influenza vaccines, analysis was performed for measuring levels of anti-H2 antibody by ELISA for the subjects who received an AS vaccine in each study cohort and for the subjects in the FLU D-QIV-015 study cohort, aggregate variables were calculated with 95% CI for each treatment group within each study cohort.
Mean Geometric Increase (MGI) = post-vaccination GMC over pre-vaccination GMC.
|
At D21 (post-dose1) compared to D0
|
|
Percentage of Subjects With Anti-H18 Full Length HA ELISA Antibody Concentration Equal or Above the Cut-off of 50 EU/mL - Adult Q-PAN H1N1-019, CC-PAN H5N1-001, Q-PAN H9N2-001 Cohorts
時間枠：At Day 42 (Post-vaccination 2), and final timepoint (for persistence) (i.e., Day 182 for the Q-Pan-H1N1-019, Q-PAN-H9N2-001 and Day 385 for the CC-Pan-H5N1 study cohorts)
|
With respect to samples from HA Group 1-related studies (i.e., with H1N1, H5N1,and H9N2 pandemic, and quadrivalent inactivated seasonal, influenza vaccines, analysis was performed for measuring levels of anti-H18 antibody by ELISA for the subjects who received an AS vaccine in each study cohort and for the subjects in the FLU D-QIV-015 study cohort, aggregate variables were calculated with 95% CI for each treatment group within each study cohort.
Seropositivity rate was defined as the percentage of subjects with concentrations greater or equal than 50 Elisa Unit per milliliter (EU/mL)
|
At Day 42 (Post-vaccination 2), and final timepoint (for persistence) (i.e., Day 182 for the Q-Pan-H1N1-019, Q-PAN-H9N2-001 and Day 385 for the CC-Pan-H5N1 study cohorts)
|
|
Anti-H18 Full Length HA ELISA Antibody Concentrations - Adult Q-PAN H1N1-019, CC-PAN H5N1-001, Q-PAN H9N2-001 Cohorts
時間枠：At Day 42 (Post-vaccination 2), and final timepoint (for persistence) (i.e., Day 182 for the Q-Pan-H1N1-019, Q-PAN-H9N2-001 and Day 385 for the CC-Pan-H5N1 study cohorts)
|
With respect to samples from HA Group 1-related studies (i.e., with H1N1, H5N1,and H9N2 pandemic, and quadrivalent inactivated seasonal, influenza vaccines, analysis was performed for measuring levels of anti-H18 antibody by ELISA for the subjects who received an AS vaccine in each study cohort and for the subjects in the FLU D-QIV-015 study cohort, aggregate variables were calculated with 95% CI for each treatment group within each study cohort.
Geometric mean concentrations (GMCs) were expressed in Elisa Unit per milliliter (EU/mL)
|
At Day 42 (Post-vaccination 2), and final timepoint (for persistence) (i.e., Day 182 for the Q-Pan-H1N1-019, Q-PAN-H9N2-001 and Day 385 for the CC-Pan-H5N1 study cohorts)
|
|
Percentage of Subjects With a ≥4-fold Rise for Anti-H18 Full Length HA ELISA Antibody Concentration - Adult Q-PAN H1N1-019, CC-PAN H5N1-001, Q-PAN H9N2-001 Cohorts
時間枠：At Day 42 (post-vaccination2 compared to pre-vaccination)
|
With respect to samples from HA Group 1-related studies (i.e., with H1N1, H5N1,and H9N2 pandemic, and quadrivalent inactivated seasonal, influenza vaccines, analysis was performed for measuring levels of anti-H18 antibody by ELISA for the subjects who received an AS vaccine in each study cohort and for the subjects in the FLU D-QIV-015 study cohort, aggregate variables were calculated with 95% CI for each treatment group within each study cohort.
seronegative subjects = concentration < 50 EU/mL for anti-H18 HA (full length) antibody prior to vaccination.
seropositive subjects = concentration ≥ 50 EU/mL for anti-H18 HA (full length) antibody prior to vaccination.
4-fold increase defined as: For initially seronegative subjects, antibody concentration ≥ 100 EU/mL at post-vaccination; For initially seropositive subjects, antibody concentration at post-vaccination ≥ 4-fold the pre-vaccination antibody concentration.
|
At Day 42 (post-vaccination2 compared to pre-vaccination)
|
|
Mean Geometric Increase (MGI) for Anti-H18 Full Length HA ELISA Antibody Post-vaccination Concentration Compared to Pre-vaccination - Adult Q-PAN H1N1-019, CC-PAN H5N1-001, Q-PAN H9N2-001 Cohorts
時間枠：At Day 42 (post-vaccination2/ Day 0), and final timepoint (for persistence) compared to Day 0 (i.e., Day 182 for the Q-Pan-H1N1-019, Q-PAN-H9N2-001 and Day 385 for the CC-Pan-H5N1 study cohorts)
|
With respect to samples from HA Group 1-related studies (i.e., with H1N1, H5N1,and H9N2 pandemic, and quadrivalent inactivated seasonal, influenza vaccines, analysis was performed for measuring levels of anti-H18 antibody by ELISA for the subjects who received an AS vaccine in each study cohort and for the subjects in the FLU D-QIV-015 study cohort, aggregate variables were calculated with 95% CI for each treatment group within each study cohort.
Mean Geometric Increase (MGI) = post-vaccination GMC over pre-vaccination GMC.
|
At Day 42 (post-vaccination2/ Day 0), and final timepoint (for persistence) compared to Day 0 (i.e., Day 182 for the Q-Pan-H1N1-019, Q-PAN-H9N2-001 and Day 385 for the CC-Pan-H5N1 study cohorts)
|
|
Percentage of Subjects With Anti-H18 Full Length HA ELISA Antibody Concentration Equal or Above the Cut-off of 50 EU/mL - Pediatric Q-PAN H5N1-AS03-021 Cohort
時間枠：At Day 42 (Post-vaccination 2) and final timepoint (for persistence) (i.e., Day 385)
|
With respect to samples from HA Group 1-related studies (i.e., with H1N1, H5N1,and H9N2 pandemic, and quadrivalent inactivated seasonal, influenza vaccines, analysis was performed for measuring levels of anti-H18 antibody by ELISA for the subjects who received an AS vaccine in each study cohort and for the subjects in the FLU D-QIV-015 study cohort, aggregate variables were calculated with 95% CI for each treatment group within each study cohort.
Seropositivity rate was defined as the percentage of subjects with concentrations greater or equal than 50 Elisa Unit per milliliter (EU/mL)
|
At Day 42 (Post-vaccination 2) and final timepoint (for persistence) (i.e., Day 385)
|
|
Anti-H18 Full Length HA ELISA Antibody Concentrations -Pediatric Q-PAN H5N1-AS03-021 Cohort
時間枠：At Day 42 (Post-vaccination 2) and final timepoint (for persistence) (i.e., Day 385)
|
With respect to samples from HA Group 1-related studies (i.e., with H1N1, H5N1,and H9N2 pandemic, and quadrivalent inactivated seasonal, influenza vaccines, analysis was performed for measuring levels of anti-H18 antibody by ELISA for the subjects who received an AS vaccine in each study cohort and for the subjects in the FLU D-QIV-015 study cohort, aggregate variables were calculated with 95% CI for each treatment group within each study cohort.
Geometric mean concentrations (GMCs) were expressed in Elisa Unit per milliliter (EU/mL)
|
At Day 42 (Post-vaccination 2) and final timepoint (for persistence) (i.e., Day 385)
|
|
Percentage of Subjects With a ≥4-fold Rise for Anti-H18 Full Length HA ELISA Antibody Concentration - Pediatric Q-PAN H5N1-AS03-021 Cohort
時間枠：At Day 42 (post-vaccination2 compared to Day 0)
|
With respect to samples from HA Group 1-related studies (i.e., with H1N1, H5N1,and H9N2 pandemic, and quadrivalent inactivated seasonal, influenza vaccines, analysis was performed for measuring levels of anti-H18 antibody by ELISA for the subjects who received an AS vaccine in each study cohortand for the subjects in the FLU D-QIV-015 study cohort, aggregate variables were calculated with 95% CI for each treatment group within each study cohort.
seronegative subjects = concentration < 50 EU/mL for anti-H18 HA (full length) antibody prior to vaccination.
seropositive subjects = concentration ≥ 50 EU/mL for anti-H18 HA (full length) antibody prior to vaccination.
4-fold increase defined as: For initially seronegative subjects, antibody concentration ≥ 100 EU/mL at post-vaccination; For initially seropositive subjects, antibody concentration at post-vaccination ≥ 4-fold the pre-vaccination antibody concentration.
|
At Day 42 (post-vaccination2 compared to Day 0)
|
|
Mean Geometric Increase (MGI) for Anti-H18 Full Length HA ELISA Antibody Post-vaccination Concentration Compared to Pre-vaccination -Pediatric Q-PAN H5N1-AS03-021 Cohort
時間枠：At Day 42 (post-vaccination2/ Day 0) and final time point (for persistence)(i.e., Day 385(post-vaccination2/ Day 0)
|
With respect to samples from HA Group 1-related studies (i.e., with H1N1, H5N1,and H9N2 pandemic, and quadrivalent inactivated seasonal, influenza vaccines, analysis was performed for measuring levels of anti-H18 antibody by ELISA for the subjects who received an AS vaccine in each study cohort and for the subjects in the FLU D-QIV-015 study cohort, aggregate variables were calculated with 95% CI for each treatment group within each study cohort.
Mean Geometric Increase (MGI) = post-vaccination GMC over pre-vaccination GMC.
|
At Day 42 (post-vaccination2/ Day 0) and final time point (for persistence)(i.e., Day 385(post-vaccination2/ Day 0)
|
|
Percentage of Subjects With Anti-H18 Full Length HA ELISA Antibody Concentration Equal or Above the Cut-off of 50 EU/mL - Adult Q-PAN-005 Cohort
時間枠：At D0(Pre), D42 (Post-dose[Pst-d]1), D182(Pst-d1), D549(Pst-d2), D591(Pst-d3) and D729(Pst-d3) for group C, and D182(Pst-d1), D224(Pst-d2), D549(Pst-d2), D591(Pst-d3) and D729(Pst-d3) for group G
|
With respect to samples from HA Group 1-related studies (i.e., with H1N1, H5N1,and H9N2 pandemic, and quadrivalent inactivated seasonal, influenza vaccines, analysis was performed for measuring levels of anti-H18 antibody by ELISA for the subjects who received an AS vaccine in each study cohort and for the subjects in the FLU D-QIV-015 study cohort, aggregate variables were calculated with 95% CI for each treatment group within each study cohort.
Seropositivity rate was defined as the percentage of subjects with concentrations greater or equal than 50 Elisa Unit per milliliter (EU/mL)
|
At D0(Pre), D42 (Post-dose[Pst-d]1), D182(Pst-d1), D549(Pst-d2), D591(Pst-d3) and D729(Pst-d3) for group C, and D182(Pst-d1), D224(Pst-d2), D549(Pst-d2), D591(Pst-d3) and D729(Pst-d3) for group G
|
|
Anti-H18 Full Length HA ELISA Antibody Concentrations - Adult Q-PAN-005 Cohort
時間枠：At D0(Pre), D42 (Post-dose[Pst-d]1), D182(Pst-d1), D549(Pst-d2), D591(Pst-d3) and D729(Pst-d3) for group C, and D182(Pst-d1), D224(Pst-d2), D549(Pst-d2), D591(Pst-d3) and D729(Pst-d3) for group G
|
With respect to samples from HA Group 1-related studies (i.e., with H1N1, H5N1,and H9N2 pandemic, and quadrivalent inactivated seasonal, influenza vaccines, analysis was performed for measuring levels of anti-H18 antibody by ELISA for the subjects who received an AS vaccine in each study cohort and for the subjects in the FLU D-QIV-015 study cohort, aggregate variables were calculated with 95% CI for each treatment group within each study cohort.
Geometric mean concentrations (GMCs) were expressed in Elisa Unit per milliliter (EU/mL)
|
At D0(Pre), D42 (Post-dose[Pst-d]1), D182(Pst-d1), D549(Pst-d2), D591(Pst-d3) and D729(Pst-d3) for group C, and D182(Pst-d1), D224(Pst-d2), D549(Pst-d2), D591(Pst-d3) and D729(Pst-d3) for group G
|
|
Percentage of Subjects With a ≥4-fold Rise for Anti-H18 Full Length HA ELISA Antibody Concentration - Adult Q-PAN-005 Cohort
時間枠：For group C: At Day 42 (post-dose1 compared to [/]Day 0), at Day 591 (post-dose3 / Day 0) - For group G: At Day 224 (post-dose2 / Day 182), at Day 591 (post-dose3 / Day 182)
|
With respect to samples from HA Group 1-related studies (i.e., with H1N1, H5N1,and H9N2 pandemic, and quadrivalent inactivated seasonal, influenza vaccines, analysis was performed for measuring levels of anti-H18 antibody by ELISA for the subjects who received an AS vaccine in each study cohort and for the subjects in the FLU D-QIV-015 study cohort, aggregate variables were calculated with 95% CI for each treatment group within each study cohort.
seronegative subjects = concentration < 50 EU/mL for anti-H18 HA (full length) antibody prior to vaccination.
seropositive subjects = concentration ≥ 50 EU/mL for anti-H18 HA (full length) antibody prior to vaccination.
4-fold increase defined as: For initially seronegative subjects, antibody concentration ≥ 100 EU/mL at post-vaccination; For initially seropositive subjects, antibody concentration at post-vaccination ≥ 4-fold the pre-vaccination antibody concentration.
The ≥4-fold increases were only calculated relative to baseline.
|
For group C: At Day 42 (post-dose1 compared to [/]Day 0), at Day 591 (post-dose3 / Day 0) - For group G: At Day 224 (post-dose2 / Day 182), at Day 591 (post-dose3 / Day 182)
|
|
Mean Geometric Increase (MGI) for Anti-H18 Full Length HA ELISA Antibody Post-vaccination Concentration Compared to Pre-vaccination - Adult Q-PAN-005 Cohort
時間枠：At Day[D] 42 (post-dose[ps-d]1), D549 (ps-d2), D591 (ps-d3) and D729(ps-d3) compared to D0 for Group C and at D224 (ps-d2), D549 (ps-d2), D591 (ps-d3) and D729(ps-d3) compared to D182 for Group G
|
With respect to samples from HA Group 1-related studies (i.e., with H1N1, H5N1,and H9N2 pandemic, and quadrivalent inactivated seasonal, influenza vaccines, analysis was performed for measuring levels of anti-H18 antibody by ELISA for the subjects who received an AS vaccine in each study cohort and for the subjects in the FLU D-QIV-015 study cohort, aggregate variables were calculated with 95% CI for each treatment group within each study cohort.
Mean Geometric Increase (MGI) = post-vaccination GMC over pre-vaccination GMC.
|
At Day[D] 42 (post-dose[ps-d]1), D549 (ps-d2), D591 (ps-d3) and D729(ps-d3) compared to D0 for Group C and at D224 (ps-d2), D549 (ps-d2), D591 (ps-d3) and D729(ps-d3) compared to D182 for Group G
|
|
Percentage of Subjects With Anti-H18 Full Length HA ELISA Antibody Concentration Equal or Above the Cut-off of 50 EU/mL - Adult H5N1-012 Cohort
時間枠：At D0 (Pre), D21 (Post-dose 1), M12 (Post-dose1), M12+21days (post-dose2), M18 (Post-dose2)
|
With respect to samples from HA Group 1-related studies (i.e., with H1N1, H5N1,and H9N2 pandemic, and quadrivalent inactivated seasonal, influenza vaccines, analysis was performed for measuring levels of anti-H18 antibody by ELISA for the subjects who received an AS vaccine in each study cohort and for the subjects in the FLU D-QIV-015 study cohort, aggregate variables were calculated with 95% CI for each treatment group within each study cohort.
Seropositivity rate was defined as the percentage of subjects with concentrations greater or equal than 50 Elisa Unit per milliliter (EU/mL)
|
At D0 (Pre), D21 (Post-dose 1), M12 (Post-dose1), M12+21days (post-dose2), M18 (Post-dose2)
|
|
Anti-H18 Full Length HA ELISA Antibody Concentrations - Adult H5N1-012 Cohort
時間枠：At D0 (Pre), D21 (Post-dose 1), M12 (Post-dose1), M12+21days (post-dose2), M18 (Post-dose2)
|
With respect to samples from HA Group 1-related studies (i.e., with H1N1, H5N1,and H9N2 pandemic, and quadrivalent inactivated seasonal, influenza vaccines, analysis was performed for measuring levels of anti-H18 antibody by ELISA for the subjects who received an AS vaccine in each study cohort and for the subjects in the FLU D-QIV-015 study cohort, aggregate variables were calculated with 95% CI for each treatment group within each study cohort.
Geometric mean concentrations (GMCs) were expressed in Elisa Unit per milliliter (EU/mL)
|
At D0 (Pre), D21 (Post-dose 1), M12 (Post-dose1), M12+21days (post-dose2), M18 (Post-dose2)
|
|
Percentage of Subjects With a ≥4-fold Rise for Anti-H18 Full Length HA ELISA Antibody Concentration - Adult H5N1-012 Cohort
時間枠：At D21 (post-dose1 compared to [/]D0), at M12+21days (post-dose2 /D0)
|
With respect to samples from HA Group 1-related studies (i.e., with H1N1, H5N1,and H9N2 pandemic, and quadrivalent inactivated seasonal, influenza vaccines, analysis was performed for measuring levels of anti-H18 antibody by ELISA for the subjects who received an AS vaccine in each study cohort and for the subjects in the FLU D-QIV-015 study cohort, aggregate variables were calculated with 95% CI for each treatment group within each study cohort.
seronegative subjects = concentration < 50 EU/mL for anti-H18 HA (full length) antibody prior to vaccination.
seropositive subjects = concentration ≥ 50 EU/mL for anti-H18 HA (full length) antibody prior to vaccination.
4-fold increase defined as: For initially seronegative subjects, antibody concentration ≥ 100 EU/mL at post-vaccination; For initially seropositive subjects, antibody concentration at post-vaccination ≥ 4-fold the pre-vaccination antibody concentration.
The ≥4-fold increases were only calculated relative to baseline.
|
At D21 (post-dose1 compared to [/]D0), at M12+21days (post-dose2 /D0)
|
|
Mean Geometric Increase (MGI) for Anti-H18 Full Length HA ELISA Antibody Post-vaccination Concentration Compared to Pre-vaccination - Adult H5N1-012 Cohort
時間枠：At D21 (post-dose[ps-d]1), M12 (ps-d1), M12+21days (ps-d2) and M18 compared to D0
|
With respect to samples from HA Group 1-related studies (i.e., with H1N1, H5N1,and H9N2 pandemic, and quadrivalent inactivated seasonal, influenza vaccines, analysis was performed for measuring levels of anti-H18 antibody by ELISA for the subjects who received an AS vaccine in each study cohort and for the subjects in the FLU D-QIV-015 study cohort, aggregate variables were calculated with 95% CI for each treatment group within each study cohort.
Mean Geometric Increase (MGI) = post-vaccination GMC over pre-vaccination GMC.
|
At D21 (post-dose[ps-d]1), M12 (ps-d1), M12+21days (ps-d2) and M18 compared to D0
|
|
Percentage of Subjects With Anti-H18 Full Length HA ELISA Antibody Concentration Equal or Above the Cut-off of 50 EU/mL - Adult FLU D-QIV-015 Cohort
時間枠：At D0 (Pre), D21 (Post-dose 1)
|
With respect to samples from HA Group 1-related studies (i.e., with H1N1, H5N1,and H9N2 pandemic, and quadrivalent inactivated seasonal, influenza vaccines, analysis was performed for measuring levels of anti-H18 antibody by ELISA for the subjects who received an AS vaccine in each study cohort and for the subjects in the FLU D-QIV-015 study cohort, aggregate variables were calculated with 95% CI for each treatment group within each study cohort.
Seropositivity rate was defined as the percentage of subjects with concentrations greater or equal than 50 Elisa Unit per milliliter (EU/mL)
|
At D0 (Pre), D21 (Post-dose 1)
|
|
Anti-H18 Full Length HA ELISA Antibody Concentrations - Adult FLU D-QIV-015 Cohort
時間枠：At D0 (Pre), D21 (Post-dose 1)
|
With respect to samples from HA Group 1-related studies (i.e., with H1N1, H5N1,and H9N2 pandemic, and quadrivalent inactivated seasonal, influenza vaccines, analysis was performed for measuring levels of anti-H18 antibody by ELISA for the subjects who received an AS vaccine in each study cohort and for the subjects in the FLU D-QIV-015 study cohort, aggregate variables were calculated with 95% CI for each treatment group within each study cohort.
Geometric mean concentrations (GMCs) were expressed in Elisa Unit per milliliter (EU/mL)
|
At D0 (Pre), D21 (Post-dose 1)
|
|
Percentage of Subjects With a ≥4-fold Rise for Anti-H18 Full Length HA ELISA Antibody Concentration - Adult FLU D-QIV-015 Cohort
時間枠：At D21 (post-dose1 compared to [/]D0)
|
With respect to samples from HA Group 1-related studies (i.e., with H1N1, H5N1,and H9N2 pandemic, and quadrivalent inactivated seasonal, influenza vaccines, analysis was performed for measuring levels of anti-H18 antibody by ELISA for the subjects who received an AS vaccine in each study cohort and for the subjects in the FLU D-QIV-015 study cohort, aggregate variables were calculated with 95% CI for each treatment group within each study cohort.
seronegative subjects = concentration < 50 EU/mL for anti-H18 HA (full length) antibody prior to vaccination.
seropositive subjects = concentration ≥ 50 EU/mL for anti-H18 HA (full length) antibody prior to vaccination.
4-fold increase defined as: For initially seronegative subjects, antibody concentration ≥ 100 EU/mL at post-vaccination; For initially seropositive subjects, antibody concentration at post-vaccination ≥ 4-fold the pre-vaccination antibody concentration.
|
At D21 (post-dose1 compared to [/]D0)
|
|
Mean Geometric Increase (MGI) for Anti-H18 Full Length HA ELISA Antibody Post-vaccination Concentration Compared to Pre-vaccination - Adult FLU D-QIV-015 Cohort
時間枠：At D21 (post-dose1) compared to D0
|
With respect to samples from HA Group 1-related studies (i.e., with H1N1, H5N1,and H9N2 pandemic, and quadrivalent inactivated seasonal, influenza vaccines, analysis was performed for measuring levels of anti-H18 antibody by ELISA for the subjects who received an AS vaccine in each study cohort and for the subjects in the FLU D-QIV-015 study cohort, aggregate variables were calculated with 95% CI for each treatment group within each study cohort.
Mean Geometric Increase (MGI) = post-vaccination GMC over pre-vaccination GMC.
|
At D21 (post-dose1) compared to D0
|
|
Percentage of Subjects With RG Reassortant Virus (H5N8) Antibody Titer (by MN) Equal or Above the Cut-off of 10 1/DIL - Adult Q-PAN H1N1-019, CC-PAN H5N1-001, Q-PAN H9N2-001 Cohorts (Only AS Vaccines)
時間枠：At Day 0 (Pre-vaccination), Day 42 (Post-vaccination 2)
|
With respect to samples from HA Group 1-related studies (i.e., with H1N1, H5N1,and H9N2 pandemic, and quadrivalent inactivated seasonal, influenza vaccines, analysis was performed for measuring levels of RG reassortant virus (H5N8) antibody by MN for all subjects who received an AS vaccine in each study cohort, aggregate variables were calculated with 95% CI for each treatment group within each study cohort.
Seropositivity rate was defined as the percentage of subjects with titers greater or equal than 10 1/Dilution )
|
At Day 0 (Pre-vaccination), Day 42 (Post-vaccination 2)
|
|
RG Reassortant Virus (H5N8) Antibody Titers (by MN) - Adult Q-PAN H1N1-019, CC-PAN H5N1-001, Q-PAN H9N2-001 Cohorts (Only AS Vaccines)
時間枠：At Day 0 (Pre-vaccination), Day 42 (Post-vaccination 2)
|
With respect to samples from HA Group 1-related studies (i.e., with H1N1, H5N1,and H9N2 pandemic, and quadrivalent inactivated seasonal, influenza vaccines, analysis was performed for measuring levels of RG reassortant virus (H5N8) antibody by MN for all subjects who received an AS vaccine in each study cohort, Geometric mean titers (GMTs) were calculated with 95% CI for each treatment group within each study cohort.
|
At Day 0 (Pre-vaccination), Day 42 (Post-vaccination 2)
|
|
Percentage of Subjects With a ≥4-fold Rise for RG Reassortant Virus (H5N8) Antibody Titer by MN - Adult Q-PAN H1N1-019, CC-PAN H5N1-001, Q-PAN H9N2-001 Cohorts (Only AS Vaccines)
時間枠：At Day 42 (post-vaccination2 compared to pre-vaccination)
|
With respect to samples from HA Group 1-related studies (i.e., with H1N1, H5N1,and H9N2 pandemic, and quadrivalent inactivated seasonal, influenza vaccines, analysis was performed for measuring levels of RG reassortant virus (H5N8) antibody by MN for all subjects who received an AS vaccine in each study cohort, aggregate variables were calculated with 95% CI for each treatment group within each study cohort.
seronegative subjects = titer < 10 1/DIL for RG reassortant virus (H5N8) MN prior to vaccination.
seropositive subjects = titer ≥ 10 1/DIL for RG reassortant virus (H5N8) MN prior to vaccination.
4-fold increase defined as: For initially seronegative subjects, antibody titer ≥ 20 1/DIL at post-vaccination; For initially seropositive subjects, antibody titer at post-vaccination ≥ 4-fold the pre-vaccination antibody titer.
|
At Day 42 (post-vaccination2 compared to pre-vaccination)
|
|
Mean Geometric Increase (MGI) for RG Reassortant Virus (H5N8) Antibody Post-vaccination Concentration Compared to Pre-vaccination, by MN - Adult Q-PAN H1N1-019, CC-PAN H5N1-001, Q-PAN H9N2-001 Cohorts (Only AS Vaccines)
時間枠：At Day 42 (post-vaccination2/ pre-vaccination)
|
With respect to samples from HA Group 1-related studies (i.e., with H1N1, H5N1,and H9N2 pandemic, and quadrivalent inactivated seasonal, influenza vaccines, analysis was performed for measuring levels of RG reassortant virus (H5N8) antibody by MN for all subjects who received an AS vaccine in each study cohort, aggregate variables were calculated with 95% CI for each treatment group within each study cohort.
Mean Geometric Increase (MGI) = post-vaccination GMT over pre-vaccination GMT.
|
At Day 42 (post-vaccination2/ pre-vaccination)
|
|
Percentage of Subjects With RG Reassortant Virus (H5N8) Antibody Titer (by MN) Equal or Above the Cut-off of 10 1/DIL - Pediatric Q-PAN H5N1-AS03-021 Cohort (Only AS Vaccines)
時間枠：At Day 0 (Pre-vaccination), Day 42 (Post-vaccination 2)
|
With respect to samples from HA Group 1-related studies (i.e., with H1N1, H5N1,and H9N2 pandemic, and quadrivalent inactivated seasonal, influenza vaccines, analysis was performed for measuring levels of RG reassortant virus (H5N8) antibody by MN for all subjects who received an AS vaccine in each study cohort, aggregate variables were calculated with 95% CI for each treatment group within each study cohort.
Seropositivity rate was defined as the percentage of subjects with titerss greater or equal than 10 1/DIL.
|
At Day 0 (Pre-vaccination), Day 42 (Post-vaccination 2)
|
|
RG Reassortant Virus (H5N8) Antibody Titers (by MN) -Pediatric Q-PAN H5N1-AS03-021 Cohort (Only AS Vaccines)
時間枠：At Day 0 (Pre-vaccination), Day 42 (Post-vaccination 2)
|
With respect to samples from HA Group 1-related studies (i.e., with H1N1, H5N1,and H9N2 pandemic, and quadrivalent inactivated seasonal, influenza vaccines, analysis was performed for measuring levels of RG reassortant virus (H5N8) antibody by MN for all subjects who received an AS vaccine in each study cohort, Geometric mean titers (GMTs) were calculated with 95% CI for each treatment group within each study cohort.
|
At Day 0 (Pre-vaccination), Day 42 (Post-vaccination 2)
|
|
Percentage of Subjects With a ≥4-fold Rise for RG Reassortant Virus (H5N8) Antibody Titer by MN - Pediatric Q-PAN H5N1-AS03-021 Cohort (Only AS Vaccines)
時間枠：At Day 42 (post-vaccination2 compared to pre-vaccination)
|
With respect to samples from HA Group 1-related studies (i.e., with H1N1, H5N1,and H9N2 pandemic, and quadrivalent inactivated seasonal, influenza vaccines, analysis was performed for measuring levels of RG reassortant virus (H5N8) antibody by MN for all subjects who received an AS vaccine in each study cohort, aggregate variables were calculated with 95% CI for each treatment group within each study cohort.
seronegative subjects = titer < 10 1/DIL for RG reassortant virus (H5N8) MN prior to vaccination seropositive subjects = titer ≥ 10 1/DIL for RG reassortant virus (H5N8) MN prior to vaccination.
4-fold increase defined as: For initially seronegative subjects, antibody titer ≥ 20 1/DIL at post-vaccination; For initially seropositive subjects, antibody titer at post-vaccination ≥ 4-fold the pre-vaccination antibody titer.
|
At Day 42 (post-vaccination2 compared to pre-vaccination)
|
|
Mean Geometric Increase (MGI) for RG Reassortant Virus (H5N8) Antibody Post-vaccination Concentration Compared to Pre-vaccination, by MN -Pediatric Q-PAN H5N1-AS03-021 Cohort (Only AS Vaccines)
時間枠：At Day 42 (post-vaccination2/ pre-vaccination)
|
With respect to samples from HA Group 1-related studies (i.e., with H1N1, H5N1,and H9N2 pandemic, and quadrivalent inactivated seasonal, influenza vaccines, analysis was performed for measuring levels of RG reassortant virus (H5N8) antibody by MN for all subjects who received an AS vaccine in each study cohort, aggregate variables were calculated with 95% CI for each treatment group within each study cohort.
Mean Geometric Increase (MGI) = post-vaccination GMT over pre-vaccination GMT.
|
At Day 42 (post-vaccination2/ pre-vaccination)
|
|
Percentage of Subjects With RG Reassortant Virus (H5N8) Antibody Titer (by MN) Equal or Above the Cut-off of 10 1/DIL - Adult Q-PAN-005 Cohort
時間枠：Group C: At D0 (Pre), D42 (Post-dose 1), D549 (post-dose 2) and D591 (Post-dose 3); Group G: At D182 (Post-dose 1), D224 (Post-dose 2), D549 (post-dose 2) and D591 (Post-dose 3)
|
With respect to samples from HA Group 1-related studies (i.e., with H1N1, H5N1,and H9N2 pandemic, and quadrivalent inactivated seasonal, influenza vaccines, analysis was performed for measuring levels of RG reassortant virus (H5N8) antibody by MN for all subjects who received an AS vaccine in each study cohort, aggregate variables were calculated with 95% CI for each treatment group within each study cohort.
Seropositivity rate was defined as the percentage of subjects with titers greater or equal than 10 1/DIL
|
Group C: At D0 (Pre), D42 (Post-dose 1), D549 (post-dose 2) and D591 (Post-dose 3); Group G: At D182 (Post-dose 1), D224 (Post-dose 2), D549 (post-dose 2) and D591 (Post-dose 3)
|
|
RG Reassortant Virus (H5N8) Enzyme-linked Immunosorbent Assay (ELISA) Antibody Titers - Adult Q-PAN-005 Cohort
時間枠：Group C: At D0 (Pre), D42 (Post-dose 1), D549 (post-dose 2) and D591 (Post-dose 3); Group G: At D182 (Post-dose 1), D224 (Post-dose 2), D549 (post-dose 2) and D591 (Post-dose 3)
|
With respect to samples from HA Group 1-related studies (i.e., with H1N1, H5N1,and H9N2 pandemic, and quadrivalent inactivated seasonal, influenza vaccines, analysis was performed for measuring levels of RG reassortant virus (H5N8) antibody by MN for all subjects who received an AS vaccine in each study cohort, Geometric mean titers (GMTs) were calculated with 95% CI for each treatment group within each study cohort.
|
Group C: At D0 (Pre), D42 (Post-dose 1), D549 (post-dose 2) and D591 (Post-dose 3); Group G: At D182 (Post-dose 1), D224 (Post-dose 2), D549 (post-dose 2) and D591 (Post-dose 3)
|
|
Percentage of Subjects With a ≥4-fold Rise for RG Reassortant Virus (H5N8) Antibody Titer by MN - Adult Q-PAN-005 Cohort
時間枠：For group C: At Day 42 (post-dose1 compared to [/]Day 0), at Day 591 (post-dose3 / Day 0) - For group G: At Day 224 (post-dose2 / Day 182), at Day 591 (post-dose3 / Day 182)
|
With respect to samples from HA Group 1-related studies (i.e., with H1N1, H5N1,and H9N2 pandemic, and quadrivalent inactivated seasonal, influenza vaccines, analysis was performed for measuring levels of RG reassortant virus (H5N8) antibody by MN for all subjects who received an AS vaccine in each study cohort, aggregate variables were calculated with 95% CI for each treatment group within each study cohort.
seronegative subjects = titer < 10 1/DIL for RG reassortant virus (H5N8) MN prior to vaccination.
seropositive subjects = titer ≥ 10 1/DIL for RG reassortant virus (H5N8) MN prior to vaccination.
4-fold increase defined as: For initially seronegative subjects, antibody titer ≥ 20 1/DIL at post-vaccination; For initially seropositive subjects, antibody titer at post-vaccination ≥ 4-fold the pre-vaccination antibody titer.
The ≥4-fold increases were only calculated relative to baseline.
|
For group C: At Day 42 (post-dose1 compared to [/]Day 0), at Day 591 (post-dose3 / Day 0) - For group G: At Day 224 (post-dose2 / Day 182), at Day 591 (post-dose3 / Day 182)
|
|
Mean Geometric Increase (MGI) for RG Reassortant Virus (H5N8) Antibody Post-vaccination Concentration Compared to Pre-vaccination - Adult Q-PAN-005 Cohort
時間枠：At Day[D] 42 (post-dose[ps-d]1), D549 (ps-d2) and D591 (ps-d3) compared to D0 for Group C and at D224 (ps-d2), D549 (ps-d2) and D591 (ps-d3) compared to D182 for Group G
|
With respect to samples from HA Group 1-related studies (i.e., with H1N1, H5N1,and H9N2 pandemic, and quadrivalent inactivated seasonal, influenza vaccines, analysis was performed for measuring levels of RG reassortant virus (H5N8) antibody by MN for all subjects who received an AS vaccine in each study cohort, aggregate variables were calculated with 95% CI for each treatment group within each study cohort.
Mean Geometric Increase (MGI) = post-vaccination GMT over pre-vaccination GMT.
|
At Day[D] 42 (post-dose[ps-d]1), D549 (ps-d2) and D591 (ps-d3) compared to D0 for Group C and at D224 (ps-d2), D549 (ps-d2) and D591 (ps-d3) compared to D182 for Group G
|
|
Percentage of Subjects With RG Reassortant Virus (H5N8) Antibody Titer (by MN) Equal or Above the Cut-off of 10 1/DIL - Adult H5N1-012 Cohort
時間枠：At D0 (Pre), D21 (Post-dose 1) and M12+21days (post-dose2)
|
With respect to samples from HA Group 1-related studies (i.e., with H1N1, H5N1,and H9N2 pandemic, and quadrivalent inactivated seasonal, influenza vaccines, analysis was performed for measuring levels of RG reassortant virus (H5N8) antibody by MN for all subjects who received an AS vaccine in each study cohort, aggregate variables were calculated with 95% CI for each treatment group within each study cohort.
Seropositivity rate was defined as the percentage of subjects with titers greater or equal than 10 1/DIL
|
At D0 (Pre), D21 (Post-dose 1) and M12+21days (post-dose2)
|
|
RG Reassortant Virus (H5N8) Antibody Titers (by MN) - Adult H5N1-012 Cohort
時間枠：At D0 (Pre), D21 (Post-dose 1) and M12+21days (post-dose2)
|
With respect to samples from HA Group 1-related studies (i.e., with H1N1, H5N1,and H9N2 pandemic, and quadrivalent inactivated seasonal, influenza vaccines, analysis was performed for measuring levels of RG reassortant virus (H5N8) antibody by MN for all subjects who received an AS vaccine in each study cohort, Geometric mean titers (GMTs) were calculated with 95% CI for each treatment group within each study cohort.
|
At D0 (Pre), D21 (Post-dose 1) and M12+21days (post-dose2)
|
|
Percentage of Subjects With a ≥4-fold Rise for RG Reassortant Virus (H5N8) Antibody Titer by MN - Adult H5N1-012 Cohort
時間枠：At D21 (post-dose1 compared to [/]D0), at M12+21days (post-dose2 /D0)
|
With respect to samples from HA Group 1-related studies (i.e., with H1N1, H5N1,and H9N2 pandemic, and quadrivalent inactivated seasonal, influenza vaccines, analysis was performed for measuring levels of RG reassortant virus (H5N8) antibody by MN for all subjects who received an AS vaccine in each study cohort, aggregate variables were calculated with 95% CI for each treatment group within each study cohort.
seronegative subjects = titer < 10 1/DIL for RG reassortant virus (H5N8) MN prior to vaccination.
seropositive subjects = titer ≥ 10 1/DIL for RG reassortant virus (H5N8) MN prior to vaccination.
4-fold increase defined as: For initially seronegative subjects, antibody titer ≥ 20 1/DIL at post-vaccination; For initially seropositive subjects, antibody titer at post-vaccination ≥ 4-fold the pre-vaccination antibody titer.
The ≥4-fold increases were only calculated relative to baseline.
|
At D21 (post-dose1 compared to [/]D0), at M12+21days (post-dose2 /D0)
|
|
Mean Geometric Increase (MGI) for RG Reassortant Virus (H5N8) Antibody Post-vaccination Concentration Compared to Pre-vaccination, by MN - Adult H5N1-012 Cohort
時間枠：At D21 (post-dose[ps-d]1), M12 (ps-d1) and M12+21days (ps-d2) compared to D0
|
With respect to samples from HA Group 1-related studies (i.e., with H1N1, H5N1,and H9N2 pandemic, and quadrivalent inactivated seasonal, influenza vaccines, analysis was performed for measuring levels of RG reassortant virus (H5N8) antibody by MN for all subjects who received an AS vaccine in each study cohort, aggregate variables were calculated with 95% CI for each treatment group within each study cohort.
Mean Geometric Increase (MGI) = post-vaccination GMT over pre-vaccination GMT.
|
At D21 (post-dose[ps-d]1), M12 (ps-d1) and M12+21days (ps-d2) compared to D0
|
|
Percentage of Subjects With RG Reassortant Virus (H5N8) Antibody Titer (by MN) Equal or Above the Cut-off of 10 1/DIL - Adult FLU D-QIV-015 Cohort
時間枠：At D0 (Pre), D21 (Post-dose 1)
|
With respect to samples from HA Group 1-related studies (i.e., with H1N1, H5N1,and H9N2 pandemic, and quadrivalent inactivated seasonal, influenza vaccines, analysis was performed for measuring levels of RG reassortant virus (H5N8) antibody by MN for all subjects who received an AS vaccine in each study cohort, aggregate variables were calculated with 95% CI for each treatment group within each study cohort.
Seropositivity rate was defined as the percentage of subjects with titers greater or equal than 10 1/DIL.
|
At D0 (Pre), D21 (Post-dose 1)
|
|
RG Reassortant Virus (H5N8) Antibody Titers (by MN) - Adult FLU D-QIV-015 Cohort
時間枠：At D0 (Pre), D21 (Post-dose 1)
|
With respect to samples from HA Group 1-related studies (i.e., with H1N1, H5N1,and H9N2 pandemic, and quadrivalent inactivated seasonal, influenza vaccines, analysis was performed for measuring levels of RG reassortant virus (H5N8) antibody by MN for all subjects who received an AS vaccine in each study cohort, Geometric mean titers (GMTs) were calculated with 95% CI for each treatment group within each study cohort.
|
At D0 (Pre), D21 (Post-dose 1)
|
|
Percentage of Subjects With a ≥4-fold Rise for RG Reassortant Virus (H5N8) Antibody Titer by MN - Adult FLU D-QIV-015 Cohort
時間枠：At D21 (post-dose1 compared to [/]D0)
|
With respect to samples from HA Group 1-related studies (i.e., with H1N1, H5N1,and H9N2 pandemic, and quadrivalent inactivated seasonal, influenza vaccines, analysis was performed for measuring levels of RG reassortant virus (H5N8) antibody by MN for all subjects who received an AS vaccine in each study cohort, aggregate variables were calculated with 95% CI for each treatment group within each study cohort.
seronegative subjects = titer < 10 1/DIL for RG reassortant virus (H5N8) MN prior to vaccination seropositive subjects = titer ≥ 10 1/DIL for RG reassortant virus (H5N8) MN prior to vaccination.
4-fold increase defined as: For initially seronegative subjects, antibody titer ≥ 20 1/DIL at post-vaccination; For initially seropositive subjects, antibody titer at post-vaccination ≥ 4-fold the pre-vaccination antibody titer.
|
At D21 (post-dose1 compared to [/]D0)
|
|
Mean Geometric Increase (MGI) for RG Reassortant Virus (H5N8) Antibody Post-vaccination Concentration Compared to Pre-vaccination, by MN - Adult FLU D-QIV-015 Cohort
時間枠：At D21 (post-dose1 compared to D0)
|
With respect to samples from HA Group 1-related studies (i.e., with H1N1, H5N1,and H9N2 pandemic, and quadrivalent inactivated seasonal, influenza vaccines, analysis was performed for measuring levels of RG reassortant virus (H5N8) antibody by MN for all subjects who received an AS vaccine in each study cohort, aggregate variables were calculated with 95% CI for each treatment group within each study cohort.
Mean Geometric Increase (MGI) = post-vaccination GMT over pre-vaccination GMT.
|
At D21 (post-dose1 compared to D0)
|
|
Percentage of Subjects With H1N1 Swine Flu Virus Antibody Titer (by MN) Equal or Above the Cut-off of 10 1/DIL - Adult Q-PAN H1N1-019, CC-PAN H5N1-001, Q-PAN H9N2-001 Cohorts (Only AS Vaccines)
時間枠：At Day 0 (Pre-vaccination), Day 42 (Post-vaccination 2)
|
With respect to samples from HA Group 1-related studies (i.e., with H1N1, H5N1,and H9N2 pandemic, and quadrivalent inactivated seasonal, influenza vaccines, analysis was performed for measuring levels of H1N1 swine Flu virus antibody by MN for all subjects who received an AS vaccine in each study cohort, aggregate variables were calculated with 95% CI for each treatment group within each study cohort.
Seropositivity rate was defined as the percentage of subjects with titers greater or equal than 10 1/Dilution ).
|
At Day 0 (Pre-vaccination), Day 42 (Post-vaccination 2)
|
|
H1N1 Swine Flu Virus Antibody Titers (by MN) - Adult Q-PAN H1N1-019, CC-PAN H5N1-001, Q-PAN H9N2-001 Cohorts (Only AS Vaccines)
時間枠：At Day 0 (Pre-vaccination), Day 42 (Post-vaccination 2)
|
With respect to samples from HA Group 1-related studies (i.e., with H1N1, H5N1,and H9N2 pandemic, and quadrivalent inactivated seasonal, influenza vaccines, analysis was performed for measuring levels of H1N1 swine Flu virus antibody by MN for all subjects who received an AS vaccine in each study cohort, Geometric mean titers (GMTs) were calculated with 95% CI for each treatment group within each study cohort.
|
At Day 0 (Pre-vaccination), Day 42 (Post-vaccination 2)
|
|
Percentage of Subjects With a ≥4-fold Rise for H1N1 Swine Flu Virus Antibody Titer by MN - Adult Q-PAN H1N1-019, CC-PAN H5N1-001, Q-PAN H9N2-001 Cohorts (Only AS Vaccines)
時間枠：At Day 42 (post-vaccination2 compared to pre-vaccination)
|
With respect to samples from HA Group 1-related studies (i.e., with H1N1, H5N1,and H9N2 pandemic, and quadrivalent inactivated seasonal, influenza vaccines, analysis was performed for measuring levels of H1N1 swine Flu virus antibody by MN for all subjects who received an AS vaccine in each study cohort, aggregate variables were calculated with 95% CI for each treatment group within each study cohort.
seronegative subjects = titer < 10 1/DIL for H1N1 swine Flu virus MN prior to vaccination.
seropositive subjects = titer ≥ 10 1/DIL for H1N1 swine Flu virus MN prior to vaccination.
4-fold increase defined as: For initially seronegative subjects, antibody titer ≥ 20 1/DIL at post-vaccination; For initially seropositive subjects, antibody titer at post-vaccination ≥ 4-fold the pre-vaccination antibody titer.
|
At Day 42 (post-vaccination2 compared to pre-vaccination)
|
|
Mean Geometric Increase (MGI) for H1N1 Swine Flu Virus Antibody Post-vaccination Concentration Compared to Pre-vaccination, by MN - Adult Q-PAN H1N1-019, CC-PAN H5N1-001, Q-PAN H9N2-001 Cohorts (Only AS Vaccines)
時間枠：At Day 42 (post-vaccination2/ pre-vaccination)
|
With respect to samples from HA Group 1-related studies (i.e., with H1N1, H5N1,and H9N2 pandemic, and quadrivalent inactivated seasonal, influenza vaccines, analysis was performed for measuring levels of H1N1 swine Flu virus antibody by MN for all subjects who received an AS vaccine in each study cohort, aggregate variables were calculated with 95% CI for each treatment group within each study cohort.
Mean Geometric Increase (MGI) = post-vaccination GMT over pre-vaccination GMT.
|
At Day 42 (post-vaccination2/ pre-vaccination)
|
|
Percentage of Subjects With H1N1 Swine Flu Virus Antibody Titer (by MN) Equal or Above the Cut-off of 10 1/DIL - Pediatric Q-PAN H5N1-AS03-021 Cohort (Only AS Vaccines)
時間枠：At Day 0 (Pre-vaccination), Day 42 (Post-vaccination 2)
|
With respect to samples from HA Group 1-related studies (i.e., with H1N1, H5N1,and H9N2 pandemic, and quadrivalent inactivated seasonal, influenza vaccines, analysis was performed for measuring levels of H1N1 swine Flu virus antibody by MN for all subjects who received an AS vaccine in each study cohort, aggregate variables were calculated with 95% CI for each treatment group within each study cohort.
Seropositivity rate was defined as the percentage of subjects with titerss greater or equal than 10 1/DIL.
|
At Day 0 (Pre-vaccination), Day 42 (Post-vaccination 2)
|
|
H1N1 Swine Flu Virus Antibody Titers (by MN) -Pediatric Q-PAN H5N1-AS03-021 Cohort (Only AS Vaccines)
時間枠：At Day 0 (Pre-vaccination), Day 42 (Post-vaccination 2)
|
With respect to samples from HA Group 1-related studies (i.e., with H1N1, H5N1,and H9N2 pandemic, and quadrivalent inactivated seasonal, influenza vaccines, analysis was performed for measuring levels of H1N1 swine Flu virus antibody by MN for all subjects who received an AS vaccine in each study cohort, Geometric mean titers (GMTs) were calculated with 95% CI for each treatment group within each study cohort.
|
At Day 0 (Pre-vaccination), Day 42 (Post-vaccination 2)
|
|
Percentage of Subjects With a ≥4-fold Rise for H1N1 Swine Flu Virus Antibody Titer by MN - Pediatric Q-PAN H5N1-AS03-021 Cohort (Only AS Vaccines)
時間枠：At Day 42 (post-vaccination2 compared to pre-vaccination)
|
With respect to samples from HA Group 1-related studies (i.e., with H1N1, H5N1,and H9N2 pandemic, and quadrivalent inactivated seasonal, influenza vaccines, analysis was performed for measuring levels of H1N1 swine Flu virus antibody by MN for all subjects who received an AS vaccine in each study cohort, aggregate variables were calculated with 95% CI for each treatment group within each study cohort.
seronegative subjects = titer < 10 1/DIL for H1N1 swine Flu virus MN prior to vaccination seropositive subjects = titer ≥ 10 1/DIL for H1N1 swine Flu virus MN prior to vaccination.
4-fold increase defined as: For initially seronegative subjects, antibody titer ≥ 20 1/DIL at post-vaccination; For initially seropositive subjects, antibody titer at post-vaccination ≥ 4-fold the pre-vaccination antibody titer
|
At Day 42 (post-vaccination2 compared to pre-vaccination)
|
|
Mean Geometric Increase (MGI) for H1N1 Swine Flu Virus Antibody Post-vaccination Concentration Compared to Pre-vaccination, by MN -Pediatric Q-PAN H5N1-AS03-021 Cohort (Only AS Vaccines
時間枠：At Day 42 (post-vaccination2/ pre-vaccination)
|
With respect to samples from HA Group 1-related studies (i.e., with H1N1, H5N1,and H9N2 pandemic, and quadrivalent inactivated seasonal, influenza vaccines, analysis was performed for measuring levels of H1N1 swine Flu virus antibody by MN for all subjects who received an AS vaccine in each study cohort, aggregate variables were calculated with 95% CI for each treatment group within each study cohort.
Mean Geometric Increase (MGI) = post-vaccination GMT over pre-vaccination GMT.
|
At Day 42 (post-vaccination2/ pre-vaccination)
|
|
Percentage of Subjects With H1N1 Swine Flu Virus Antibody Titer (by MN) Equal or Above the Cut-off of 10 1/DIL - Adult Q-PAN-005 Cohort
時間枠：Group C: At D0 (Pre), D42 (Post-dose 1), D549 (post-dose 2) and D591 (Post-dose 3); Group G: At D182 (Post-dose 1), D224 (Post-dose 2), D549 (post-dose 2) and D591 (Post-dose 3)
|
With respect to samples from HA Group 1-related studies (i.e., with H1N1, H5N1,and H9N2 pandemic, and quadrivalent inactivated seasonal, influenza vaccines, analysis was performed for measuring levels of H1N1 swine Flu virus antibody by MN for all subjects who received an AS vaccine in each study cohort, aggregate variables were calculated with 95% CI for each treatment group within each study cohort.
Seropositivity rate was defined as the percentage of subjects with titers greater or equal than 10 1/DIL.
|
Group C: At D0 (Pre), D42 (Post-dose 1), D549 (post-dose 2) and D591 (Post-dose 3); Group G: At D182 (Post-dose 1), D224 (Post-dose 2), D549 (post-dose 2) and D591 (Post-dose 3)
|
|
H1N1 Swine Flu Virus Enzyme-linked Immunosorbent Assay (ELISA) Antibody Titers - Adult Q-PAN-005 Cohort
時間枠：Group C: At D0 (Pre), D42 (Post-dose 1), D549 (post-dose 2) and D591 (Post-dose 3); Group G: At D182 (Post-dose 1), D224 (Post-dose 2), D549 (post-dose 2) and D591 (Post-dose 3)
|
With respect to samples from HA Group 1-related studies (i.e., with H1N1, H5N1,and H9N2 pandemic, and quadrivalent inactivated seasonal, influenza vaccines, analysis was performed for measuring levels of H1N1 swine Flu virus antibody by MN for all subjects who received an AS vaccine in each study cohort, Geometric mean titers (GMTs) were calculated with 95% CI for each treatment group within each study cohort.
|
Group C: At D0 (Pre), D42 (Post-dose 1), D549 (post-dose 2) and D591 (Post-dose 3); Group G: At D182 (Post-dose 1), D224 (Post-dose 2), D549 (post-dose 2) and D591 (Post-dose 3)
|
|
Percentage of Subjects With a ≥4-fold Rise for H1N1 Swine Flu Virus Antibody Titer by MN - Adult Q-PAN-005 Cohort
時間枠：For group C: At Day 42 (post-dose1 compared to [/]Day 0), at Day 591 (post-dose3 / Day 0) - For group G: At Day 224 (post-dose2 / Day 182), at Day 591 (post-dose3 / Day 182)
|
With respect to samples from HA Group 1-related studies (i.e., with H1N1, H5N1,and H9N2 pandemic, and quadrivalent inactivated seasonal, influenza vaccines, analysis was performed for measuring levels of H1N1 swine Flu virus antibody by MN for all subjects who received an AS vaccine in each study cohort, aggregate variables were calculated with 95% CI for each treatment group within each study cohort.
seronegative subjects = titer < 10 1/DIL for H1N1 swine Flu virus MN prior to vaccination.
seropositive subjects = titer ≥ 10 1/DIL for H1N1 swine Flu virus MN prior to vaccination.
4-fold increase defined as: For initially seronegative subjects, antibody titer ≥ 20 1/DIL at post-vaccination; For initially seropositive subjects, antibody titer at post-vaccination ≥ 4-fold the pre-vaccination antibody titer.
The ≥4-fold increases were only calculated relative to baseline.
|
For group C: At Day 42 (post-dose1 compared to [/]Day 0), at Day 591 (post-dose3 / Day 0) - For group G: At Day 224 (post-dose2 / Day 182), at Day 591 (post-dose3 / Day 182)
|
|
Mean Geometric Increase (MGI) for H1N1 Swine Flu Virus Antibody Post-vaccination Concentration Compared to Pre-vaccination - Adult Q-PAN-005 Cohort
時間枠：At Day[D] 42 (post-dose[ps-d]1), D549 (ps-d2) and D591 (ps-d3) compared to D0 for Group C and at D224 (ps-d2), D549 (ps-d2) and D591 (ps-d3) compared to D182 for Group G
|
With respect to samples from HA Group 1-related studies (i.e., with H1N1, H5N1,and H9N2 pandemic, and quadrivalent inactivated seasonal, influenza vaccines, analysis was performed for measuring levels of H1N1 swine Flu virus antibody by MN for all subjects who received an AS vaccine in each study cohort, aggregate variables were calculated with 95% CI for each treatment group within each study cohort.
Mean Geometric Increase (MGI) = post-vaccination GMT over pre-vaccination GMT.
|
At Day[D] 42 (post-dose[ps-d]1), D549 (ps-d2) and D591 (ps-d3) compared to D0 for Group C and at D224 (ps-d2), D549 (ps-d2) and D591 (ps-d3) compared to D182 for Group G
|
|
Percentage of Subjects With H1N1 Swine Flu Virus Antibody Titer (by MN) Equal or Above the Cut-off of 10 1/DIL - Adult H5N1-012 Cohort
時間枠：At D0 (Pre), D21 (Post-dose 1) and M12+21days (post-dose2)
|
With respect to samples from HA Group 1-related studies (i.e., with H1N1, H5N1,and H9N2 pandemic, and quadrivalent inactivated seasonal, influenza vaccines, analysis was performed for measuring levels of H1N1 swine Flu virus antibody by MN for all subjects who received an AS vaccine in each study cohort, aggregate variables were calculated with 95% CI for each treatment group within each study cohort.
Seropositivity rate was defined as the percentage of subjects with titers greater or equal than 10 1/DIL.
|
At D0 (Pre), D21 (Post-dose 1) and M12+21days (post-dose2)
|
|
H1N1 Swine Flu Virus Antibody Titers (by MN) - Adult H5N1-012 Cohort
時間枠：At D0 (Pre), D21 (Post-dose 1) and M12+21days (post-dose2)
|
With respect to samples from HA Group 1-related studies (i.e., with H1N1, H5N1,and H9N2 pandemic, and quadrivalent inactivated seasonal, influenza vaccines, analysis was performed for measuring levels of H1N1 swine Flu virus antibody by MN for all subjects who received an AS vaccine in each study cohort, Geometric mean titers (GMTs) were calculated with 95% CI for each treatment group within each study cohort.
|
At D0 (Pre), D21 (Post-dose 1) and M12+21days (post-dose2)
|
|
Percentage of Subjects With a ≥4-fold Rise for H1N1 Swine Flu Virus Antibody Titer by MN - Adult H5N1-012 Cohort
時間枠：At D21 (post-dose1 compared to [/]D0), at M12+21days (post-dose2 /D0)
|
With respect to samples from HA Group 1-related studies (i.e., with H1N1, H5N1,and H9N2 pandemic, and quadrivalent inactivated seasonal, influenza vaccines, analysis was performed for measuring levels of H1N1 swine Flu virus antibody by MN for all subjects who received an AS vaccine in each study cohort, aggregate variables were calculated with 95% CI for each treatment group within each study cohort.
seronegative subjects = titer < 10 1/DIL for H1N1 swine Flu virus MN prior to vaccination.
seropositive subjects = titer ≥ 10 1/DIL for H1N1 swine Flu virus MN prior to vaccination.
4-fold increase defined as: For initially seronegative subjects, antibody titer ≥ 20 1/DIL at post-vaccination; For initially seropositive subjects, antibody titer at post-vaccination ≥ 4-fold the pre-vaccination antibody titer.
The ≥4-fold increases were only calculated relative to baseline.
|
At D21 (post-dose1 compared to [/]D0), at M12+21days (post-dose2 /D0)
|
|
Mean Geometric Increase (MGI) for H1N1 Swine Flu Virus Antibody Post-vaccination Concentration Compared to Pre-vaccination, by MN - Adult H5N1-012 Cohort
時間枠：At D21 (post-dose[ps-d]1), M12 (ps-d1) and M12+21days (ps-d2) compared to D0
|
With respect to samples from HA Group 1-related studies (i.e., with H1N1, H5N1,and H9N2 pandemic, and quadrivalent inactivated seasonal, influenza vaccines, analysis was performed for measuring levels of H1N1 swine Flu virus antibody by MN for all subjects who received an AS vaccine in each study cohort, aggregate variables were calculated with 95% CI for each treatment group within each study cohort.
Mean Geometric Increase (MGI) = post-vaccination GMT over pre-vaccination GMT.
|
At D21 (post-dose[ps-d]1), M12 (ps-d1) and M12+21days (ps-d2) compared to D0
|
|
Percentage of Subjects With H1N1 Swine Flu Virus Antibody Titer (by MN) Equal or Above the Cut-off of 10 1/DIL - Adult FLU D-QIV-015 Cohort
時間枠：At D0 (Pre), D21 (Post-dose 1)
|
With respect to samples from HA Group 1-related studies (i.e., with H1N1, H5N1,and H9N2 pandemic, and quadrivalent inactivated seasonal, influenza vaccines, analysis was performed for measuring levels of H1N1 swine Flu virus antibody by MN for all subjects who received an AS vaccine in each study cohort, aggregate variables were calculated with 95% CI for each treatment group within each study cohort.
Seropositivity rate was defined as the percentage of subjects with titers greater or equal than 10 1/DIL.
|
At D0 (Pre), D21 (Post-dose 1)
|
|
H1N1 Swine Flu Virus Antibody Titers (by MN) - Adult FLU D-QIV-015 Cohort
時間枠：At D0 (Pre), D21 (Post-dose 1)
|
With respect to samples from HA Group 1-related studies (i.e., with H1N1, H5N1,and H9N2 pandemic, and quadrivalent inactivated seasonal, influenza vaccines, analysis was performed for measuring levels of H1N1 swine Flu virus antibody by MN for all subjects who received an AS vaccine in each study cohort, Geometric mean titers (GMTs) were calculated with 95% CI for each treatment group within each study cohort.
|
At D0 (Pre), D21 (Post-dose 1)
|
|
Percentage of Subjects With a ≥4-fold Rise for H1N1 Swine Flu Virus Antibody Titer by MN - Adult FLU D-QIV-015 Cohort
時間枠：At D21 (post-dose1 compared to [/]D0)
|
With respect to samples from HA Group 1-related studies (i.e., with H1N1, H5N1,and H9N2 pandemic, and quadrivalent inactivated seasonal, influenza vaccines, analysis was performed for measuring levels of H1N1 swine Flu virus antibody by MN for all subjects who received an AS vaccine in each study cohort, aggregate variables were calculated with 95% CI for each treatment group within each study cohort.
seronegative subjects = titer < 10 1/DIL for H1N1 swine Flu virus MN prior to vaccination seropositive subjects = titer ≥ 10 1/DIL for H1N1 swine Flu virus MN prior to vaccination.
4-fold increase defined as: For initially seronegative subjects, antibody titer ≥ 20 1/DIL at post-vaccination; For initially seropositive subjects, antibody titer at post-vaccination ≥ 4-fold the pre-vaccination antibody titer.
|
At D21 (post-dose1 compared to [/]D0)
|
|
Mean Geometric Increase (MGI) for H1N1 Swine Flu Virus Antibody Post-vaccination Concentration Compared to Pre-vaccination, by MN - Adult FLU D-QIV-015 Cohort
時間枠：At D21 (post-dose1) compared to D0
|
With respect to samples from HA Group 1-related studies (i.e., with H1N1, H5N1,and H9N2 pandemic, and quadrivalent inactivated seasonal, influenza vaccines, analysis was performed for measuring levels of H1N1 swine Flu virus antibody by MN for all subjects who received an AS vaccine in each study cohort, aggregate variables were calculated with 95% CI for each treatment group within each study cohort.
Mean Geometric Increase (MGI) = post-vaccination GMT over pre-vaccination GMT.
|
At D21 (post-dose1) compared to D0
|
|
Percentage of Subjects With H1N1pdm09-like Flu Virus Antibody Titer (by MN) Equal or Above the Cut-off of 10 1/DIL - Adult Q-PAN H1N1-019, CC-PAN H5N1-001, Q-PAN H9N2-001 Cohorts (Only AS Vaccines)
時間枠：At Day 0 (Pre-vaccination), Day 42 (Post-vaccination 2)
|
With respect to samples from HA Group 1-related studies (i.e., with H1N1, H5N1,and H9N2 pandemic, and quadrivalent inactivated seasonal, influenza vaccines, analysis was performed for measuring levels of H1N1pdm09-like Flu virus antibody by MN for all subjects who received an AS vaccine in each study cohort, aggregate variables were calculated with 95% CI for each treatment group within each study cohort.
Seropositivity rate was defined as the percentage of subjects with titers greater or equal than 10 1/Dilution).
|
At Day 0 (Pre-vaccination), Day 42 (Post-vaccination 2)
|
|
H1N1pdm09-like Flu Virus Antibody Titers (by MN) - Adult Q-PAN H1N1-019, CC-PAN H5N1-001, Q-PAN H9N2-001 Cohorts (Only AS Vaccines)
時間枠：At Day 0 (Pre-vaccination), Day 42 (Post-vaccination 2)
|
With respect to samples from HA Group 1-related studies (i.e., with H1N1, H5N1,and H9N2 pandemic, and quadrivalent inactivated seasonal, influenza vaccines, analysis was performed for measuring levels of H1N1pdm09-like Flu virus antibody by MN for all subjects who received an AS vaccine in each study cohort, Geometric mean titers (GMTs) were calculated with 95% CI for each treatment group within each study cohort.
|
At Day 0 (Pre-vaccination), Day 42 (Post-vaccination 2)
|
|
Percentage of Subjects With a ≥4-fold Rise for H1N1pdm09-like Flu Virus Antibody Titer by MN - Adult Q-PAN H1N1-019, CC-PAN H5N1-001, Q-PAN H9N2-001 Cohorts (Only AS Vaccines)
時間枠：At Day 42 (post-vaccination2 compared to pre-vaccination)
|
With respect to samples from HA Group 1-related studies (i.e., with H1N1, H5N1,and H9N2 pandemic, and quadrivalent inactivated seasonal, influenza vaccines, analysis was performed for measuring levels of H1N1pdm09-like Flu virus antibody by MN for all subjects who received an AS vaccine in each study cohort, aggregate variables were calculated with 95% CI for each treatment group within each study cohort.
seronegative subjects = titer < 10 1/DIL for H1N1pdm09-like Flu virus MN prior to vaccination.
seropositive subjects = titer ≥ 10 1/DIL for H1N1pdm09-like Flu virus MN prior to vaccination.
4-fold increase defined as: For initially seronegative subjects, antibody titer ≥ 20 1/DIL at post-vaccination; For initially seropositive subjects, antibody titer at post-vaccination ≥ 4-fold the pre-vaccination antibody titer.
|
At Day 42 (post-vaccination2 compared to pre-vaccination)
|
|
Mean Geometric Increase (MGI) for H1N1pdm09-like Flu Virus Antibody Post-vaccination Concentration Compared to Pre-vaccination, by MN - Adult Q-PAN H1N1-019, CC-PAN H5N1-001, Q-PAN H9N2-001 Cohorts (Only AS Vaccines)
時間枠：At Day 42 (post-vaccination2/ pre-vaccination)
|
With respect to samples from HA Group 1-related studies (i.e., with H1N1, H5N1,and H9N2 pandemic, and quadrivalent inactivated seasonal, influenza vaccines, analysis was performed for measuring levels of H1N1pdm09-like Flu virus antibody by MN for all subjects who received an AS vaccine in each study cohort, aggregate variables were calculated with 95% CI for each treatment group within each study cohort.
Mean Geometric Increase (MGI) = post-vaccination GMT over pre-vaccination GMT.
|
At Day 42 (post-vaccination2/ pre-vaccination)
|
|
Percentage of Subjects With H1N1pdm09-like Flu Virus Antibody Titer (by MN) Equal or Above the Cut-off of 10 1/DIL - Pediatric Q-PAN H5N1-AS03-021 Cohort (Only AS Vaccines)
時間枠：At Day 0 (Pre-vaccination), Day 42 (Post-vaccination 2)
|
With respect to samples from HA Group 1-related studies (i.e., with H1N1, H5N1,and H9N2 pandemic, and quadrivalent inactivated seasonal, influenza vaccines, analysis was performed for measuring levels of H1N1pdm09-like Flu virus antibody by MN for all subjects who received an AS vaccine in each study cohort, aggregate variables were calculated with 95% CI for each treatment group within each study cohort.
Seropositivity rate was defined as the percentage of subjects with titerss greater or equal than 10 1/DIL.
|
At Day 0 (Pre-vaccination), Day 42 (Post-vaccination 2)
|
|
H1N1pdm09-like Flu Virus Antibody Titers (by MN) -Pediatric Q-PAN H5N1-AS03-021 Cohort (Only AS Vaccines)
時間枠：At Day 0 (Pre-vaccination), Day 42 (Post-vaccination 2)
|
With respect to samples from HA Group 1-related studies (i.e., with H1N1, H5N1,and H9N2 pandemic, and quadrivalent inactivated seasonal, influenza vaccines, analysis was performed for measuring levels of H1N1pdm09-like Flu virus antibody by MN for all subjects who received an AS vaccine in each study cohort, Geometric mean titers (GMTs) were calculated with 95% CI for each treatment group within each study cohort.
|
At Day 0 (Pre-vaccination), Day 42 (Post-vaccination 2)
|
|
Percentage of Subjects With a ≥4-fold Rise for H1N1pdm09-like Flu Virus Antibody Titer by MN - Pediatric Q-PAN H5N1-AS03-021 Cohort (Only AS Vaccines)
時間枠：At Day 42 (post-vaccination2 compared to pre-vaccination)
|
With respect to samples from HA Group 1-related studies (i.e., with H1N1, H5N1,and H9N2 pandemic, and quadrivalent inactivated seasonal, influenza vaccines, analysis was performed for measuring levels of H1N1pdm09-like Flu virus antibody by MN for all subjects who received an AS vaccine in each study cohort, aggregate variables were calculated with 95% CI for each treatment group within each study cohort.
seronegative subjects = titer < 10 1/DIL for H1N1pdm09-like Flu virus MN prior to vaccination seropositive subjects = titer ≥ 10 1/DIL for H1N1pdm09-like Flu virus MN prior to vaccination.
4-fold increase defined as: For initially seronegative subjects, antibody titer ≥ 20 1/DIL at post-vaccination; For initially seropositive subjects, antibody titer at post-vaccination ≥ 4-fold the pre-vaccination antibody titer.
|
At Day 42 (post-vaccination2 compared to pre-vaccination)
|
|
Mean Geometric Increase (MGI) for H1N1pdm09-like Flu Virus Antibody Post-vaccination Concentration Compared to Pre-vaccination, by MN -Pediatric Q-PAN H5N1-AS03-021 Cohort (Only AS Vaccines)
時間枠：At Day 42 (post-vaccination2/ pre-vaccination)
|
With respect to samples from HA Group 1-related studies (i.e., with H1N1, H5N1,and H9N2 pandemic, and quadrivalent inactivated seasonal, influenza vaccines, analysis was performed for measuring levels of H1N1pdm09-like Flu virus antibody by MN for all subjects who received an AS vaccine in each study cohort, aggregate variables were calculated with 95% CI for each treatment group within each study cohort.
Mean Geometric Increase (MGI) = post-vaccination GMT over pre-vaccination GMT.
|
At Day 42 (post-vaccination2/ pre-vaccination)
|
|
Percentage of Subjects With H1N1pdm09-like Flu Virus Antibody Titer (by MN) Equal or Above the Cut-off of 10 1/DIL - Adult Q-PAN-005 Cohort
時間枠：Group C: At D0 (Pre), D42 (Post-dose 1), D549 (post-dose 2) and D591 (Post-dose 3); Group G: At D182 (Post-dose 1), D224 (Post-dose 2), D549 (post-dose 2) and D591 (Post-dose 3)
|
With respect to samples from HA Group 1-related studies (i.e., with H1N1, H5N1,and H9N2 pandemic, and quadrivalent inactivated seasonal, influenza vaccines, analysis was performed for measuring levels of H1N1pdm09-like Flu virus antibody by MN for all subjects who received an AS vaccine in each study cohort, aggregate variables were calculated with 95% CI for each treatment group within each study cohort.
Seropositivity rate was defined as the percentage of subjects with titers greater or equal than 10 1/DIL.
|
Group C: At D0 (Pre), D42 (Post-dose 1), D549 (post-dose 2) and D591 (Post-dose 3); Group G: At D182 (Post-dose 1), D224 (Post-dose 2), D549 (post-dose 2) and D591 (Post-dose 3)
|
|
H1N1pdm09-like Flu Virus Enzyme-linked Immunosorbent Assay (ELISA) Antibody Titers - Adult Q-PAN-005 Cohort
時間枠：Group C: At D0 (Pre), D42 (Post-dose 1), D549 (post-dose 2) and D591 (Post-dose 3); Group G: At D182 (Post-dose 1), D224 (Post-dose 2), D549 (post-dose 2) and D591 (Post-dose 3)
|
With respect to samples from HA Group 1-related studies (i.e., with H1N1, H5N1,and H9N2 pandemic, and quadrivalent inactivated seasonal, influenza vaccines, analysis was performed for measuring levels of H1N1pdm09-like Flu virus antibody by MN for all subjects who received an AS vaccine in each study cohort, Geometric mean titers (GMTs) were calculated with 95% CI for each treatment group within each study cohort.
|
Group C: At D0 (Pre), D42 (Post-dose 1), D549 (post-dose 2) and D591 (Post-dose 3); Group G: At D182 (Post-dose 1), D224 (Post-dose 2), D549 (post-dose 2) and D591 (Post-dose 3)
|
|
Percentage of Subjects With a ≥4-fold Rise for H1N1pdm09-like Flu Virus Antibody Titer by MN - Adult Q-PAN-005 Cohort
時間枠：For group C: At Day 42 (post-dose1 compared to [/]Day 0), at Day 591 (post-dose3 / Day 0) - For group G: At Day 224 (post-dose2 / Day 182), at Day 591 (post-dose3 / Day 182)
|
With respect to samples from HA Group 1-related studies (i.e., with H1N1, H5N1,and H9N2 pandemic, and quadrivalent inactivated seasonal, influenza vaccines, analysis was performed for measuring levels of H1N1pdm09-like Flu virus antibody by MN for all subjects who received an AS vaccine in each study cohort, aggregate variables were calculated with 95% CI for each treatment group within each study cohort.
seronegative subjects = titer < 10 1/DIL for H1N1pdm09-like Flu virus MN prior to vaccination seropositive subjects = titer ≥ 10 1/DIL for H1N1pdm09-like Flu virus MN prior to vaccination.
4-fold increase defined as: For initially seronegative subjects, antibody titer ≥ 20 1/DIL at post-vaccination; For initially seropositive subjects, antibody titer at post-vaccination ≥ 4-fold the pre-vaccination antibody titer.
The ≥4-fold increases were only calculated relative to baseline.
|
For group C: At Day 42 (post-dose1 compared to [/]Day 0), at Day 591 (post-dose3 / Day 0) - For group G: At Day 224 (post-dose2 / Day 182), at Day 591 (post-dose3 / Day 182)
|
|
Mean Geometric Increase (MGI) for H1N1pdm09-like Flu Virus Antibody Post-vaccination Concentration Compared to Pre-vaccination - Adult Q-PAN-005 Cohort
時間枠：At Day[D] 42 (post-dose[ps-d]1), D549 (ps-d2) and D591 (ps-d3) compared to D0 for Group C and at D224 (ps-d2), D549 (ps-d2) and D591 (ps-d3) compared to D182 for Group G
|
With respect to samples from HA Group 1-related studies (i.e., with H1N1, H5N1,and H9N2 pandemic, and quadrivalent inactivated seasonal, influenza vaccines, analysis was performed for measuring levels of H1N1pdm09-like Flu virus antibody by MN for all subjects who received an AS vaccine in each study cohort, aggregate variables were calculated with 95% CI for each treatment group within each study cohort.
Mean Geometric Increase (MGI) = post-vaccination GMT over pre-vaccination GMT.
|
At Day[D] 42 (post-dose[ps-d]1), D549 (ps-d2) and D591 (ps-d3) compared to D0 for Group C and at D224 (ps-d2), D549 (ps-d2) and D591 (ps-d3) compared to D182 for Group G
|
|
Percentage of Subjects With H1N1pdm09-like Flu Virus Antibody Titer (by MN) Equal or Above the Cut-off of 10 1/DIL - Adult H5N1-012 Cohort
時間枠：At D0 (Pre), D21 (Post-dose 1) and M12+21days (post-dose2)
|
With respect to samples from HA Group 1-related studies (i.e., with H1N1, H5N1,and H9N2 pandemic, and quadrivalent inactivated seasonal, influenza vaccines, analysis was performed for measuring levels of H1N1pdm09-like Flu virus antibody by MN for all subjects who received an AS vaccine in each study cohort, aggregate variables were calculated with 95% CI for each treatment group within each study cohort.
Seropositivity rate was defined as the percentage of subjects with titers greater or equal than 10 1/DIL
|
At D0 (Pre), D21 (Post-dose 1) and M12+21days (post-dose2)
|
|
H1N1pdm09-like Flu Virus Antibody Titers (by MN) - Adult H5N1-012 Cohort
時間枠：At D0 (Pre), D21 (Post-dose 1) and M12+21days (post-dose2)
|
With respect to samples from HA Group 1-related studies (i.e., with H1N1, H5N1,and H9N2 pandemic, and quadrivalent inactivated seasonal, influenza vaccines, analysis was performed for measuring levels of H1N1pdm09-like Flu virus antibody by MN for all subjects who received an AS vaccine in each study cohort, Geometric mean titers (GMTs) were calculated with 95% CI for each treatment group within each study cohort.
|
At D0 (Pre), D21 (Post-dose 1) and M12+21days (post-dose2)
|
|
Percentage of Subjects With a ≥4-fold Rise for H1N1pdm09-like Flu Virus Antibody Titer by MN - Adult H5N1-012 Cohort
時間枠：At D21 (post-dose1 compared to [/]D0), at M12+21days (post-dose2 /D0)
|
With respect to samples from HA Group 1-related studies (i.e., with H1N1, H5N1,and H9N2 pandemic, and quadrivalent inactivated seasonal, influenza vaccines, analysis was performed for measuring levels of H1N1pdm09-like Flu virus antibody by MN for all subjects who received an AS vaccine in each study cohort, aggregate variables were calculated with 95% CI for each treatment group within each study cohort.
seronegative subjects = titer < 10 1/DIL for H1N1pdm09-like Flu virus MN prior to vaccination seropositive subjects = titer ≥ 10 1/DIL for H1N1pdm09-like Flu virus MN prior to vaccination.
4-fold increase defined as: For initially seronegative subjects, antibody titer ≥ 20 1/DIL at post-vaccination; For initially seropositive subjects, antibody titer at post-vaccination ≥ 4-fold the pre-vaccination antibody titer.
The ≥4-fold increases were only calculated relative to baseline.
|
At D21 (post-dose1 compared to [/]D0), at M12+21days (post-dose2 /D0)
|
|
Mean Geometric Increase (MGI) for H1N1pdm09-like Flu Virus Antibody Post-vaccination Concentration Compared to Pre-vaccination, by MN - Adult H5N1-012 Cohort
時間枠：At D21 (post-dose[ps-d]1), M12 (ps-d1) and M12+21days (ps-d2) compared to D0
|
With respect to samples from HA Group 1-related studies (i.e., with H1N1, H5N1,and H9N2 pandemic, and quadrivalent inactivated seasonal, influenza vaccines, analysis was performed for measuring levels of H1N1pdm09-like Flu virus antibody by MN for all subjects who received an AS vaccine in each study cohort, aggregate variables were calculated with 95% CI for each treatment group within each study cohort.
Mean Geometric Increase (MGI) = post-vaccination GMT over pre-vaccination GMT.
|
At D21 (post-dose[ps-d]1), M12 (ps-d1) and M12+21days (ps-d2) compared to D0
|
|
Percentage of Subjects With H1N1pdm09-like Flu Virus Antibody Titer (by MN) Equal or Above the Cut-off of 10 1/DIL - Adult FLU D-QIV-015 Cohort
時間枠：At D0 (Pre), D21 (Post-dose 1)
|
With respect to samples from HA Group 1-related studies (i.e., with H1N1, H5N1,and H9N2 pandemic, and quadrivalent inactivated seasonal, influenza vaccines, analysis was performed for measuring levels of H1N1pdm09-like Flu virus antibody by MN for all subjects who received an AS vaccine in each study cohort, aggregate variables were calculated with 95% CI for each treatment group within each study cohort.
Seropositivity rate was defined as the percentage of subjects with titers greater or equal than 10 1/DIL
|
At D0 (Pre), D21 (Post-dose 1)
|
|
H1N1pdm09-like Flu Virus Antibody Titers (by MN) - Adult FLU D-QIV-015 Cohort
時間枠：At D0 (Pre), D21 (Post-dose 1)
|
With respect to samples from HA Group 1-related studies (i.e., with H1N1, H5N1,and H9N2 pandemic, and quadrivalent inactivated seasonal, influenza vaccines, analysis was performed for measuring levels of H1N1pdm09-like Flu virus antibody by MN for all subjects who received an AS vaccine in each study cohort, Geometric mean titers (GMTs) were calculated with 95% CI for each treatment group within each study cohort.
|
At D0 (Pre), D21 (Post-dose 1)
|
|
Percentage of Subjects With a ≥4-fold Rise for H1N1pdm09-like Flu Virus Antibody Titer by MN - Adult FLU D-QIV-015 Cohort
時間枠：At D21 (post-dose1 compared to [/]D0)
|
With respect to samples from HA Group 1-related studies (i.e., with H1N1, H5N1,and H9N2 pandemic, and quadrivalent inactivated seasonal, influenza vaccines, analysis was performed for measuring levels of H1N1pdm09-like Flu virus antibody by MN for all subjects who received an AS vaccine in each study cohort, aggregate variables were calculated with 95% CI for each treatment group within each study cohort.
seronegative subjects = titer < 10 1/DIL for H1N1pdm09-like Flu virus MN prior to vaccination seropositive subjects = titer ≥ 10 1/DIL for H1N1pdm09-like Flu virus MN prior to vaccination.
4-fold increase defined as: For initially seronegative subjects, antibody titer ≥ 20 1/DIL at post-vaccination; For initially seropositive subjects, antibody titer at post-vaccination ≥ 4-fold the pre-vaccination antibody titer.
|
At D21 (post-dose1 compared to [/]D0)
|
|
Mean Geometric Increase (MGI) for H1N1pdm09-like Flu Virus Antibody Post-vaccination Concentration Compared to Pre-vaccination, by MN - Adult FLU D-QIV-015 Cohort
時間枠：At D21 (post-dose1) compared to D0
|
With respect to samples from HA Group 1-related studies (i.e., with H1N1, H5N1,and H9N2 pandemic, and quadrivalent inactivated seasonal, influenza vaccines, analysis was performed for measuring levels of H1N1pdm09-like Flu virus antibody by MN for all subjects who received an AS vaccine in each study cohort, aggregate variables were calculated with 95% CI for each treatment group within each study cohort.
Mean Geometric Increase (MGI) = post-vaccination GMT over pre-vaccination GMT.
|
At D21 (post-dose1) compared to D0
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
GMCs of Anti-H1 HA Stalk ELISA Antibody - Adult Q-PAN H1N1-019 Cohort
時間枠：At D21, D42, and D182
|
With respect to samples from the HA Group 1-related studies (i.e., with H1N1, H5N1,and H9N2 pandemic, and IIV4 seasonal, influenza vaccines), analysis was performed for measuring levels of anti-H1 stalk antibody by ELISA for all the subjects in the adult CCPan H5N1-001, the Q-Pan H1N1-019 and the Q-Pan H9N2-001 study cohorts.
Geometric mean concentration (AS Group and no AS group within each study) was calculated with 95% CI at each specified time point and expressed in Elisa Unit per milliliter (EU/mL).
|
At D21, D42, and D182
|
|
GMCs of Anti-H1 HA Stalk ELISA Antibody - Adult CC-PAN H5N1-001 Cohort
時間枠：At D21, D42, D182 and Day 385
|
With respect to samples from the HA Group 1-related studies (i.e., with H1N1, H5N1,and H9N2 pandemic, and IIV4 seasonal, influenza vaccines), analysis was performed for measuring levels of anti-H1 stalk antibody by ELISA for all the subjects in the adult CCPan H5N1-001, the Q-Pan H1N1-019 and the Q-Pan H9N2-001 study cohorts.
Geometric mean concentration (AS Group and no AS group within each study) was calculated with 95% CI at each specified time point and expressed in Elisa Unit per milliliter (EU/mL).
|
At D21, D42, D182 and Day 385
|
|
GMCs of Anti-H1 HA Stalk ELISA Antibody - Adult Q-PAN H9N2-001 Cohort
時間枠：At D21, D42 and D182
|
With respect to samples from the HA Group 1-related studies (i.e., with H1N1, H5N1,and H9N2 pandemic, and IIV4 seasonal, influenza vaccines), analysis was performed for measuring levels of anti-H1 stalk antibody by ELISA for all the subjects in the adult CCPan H5N1-001, the Q-Pan H1N1-019 and the Q-Pan H9N2-001 study cohorts.
Geometric mean concentration (AS Group and no AS group within each study) was calculated with 95% CI at each specified time point and expressed in Elisa Unit per milliliter (EU/mL).
|
At D21, D42 and D182
|
|
Percentage of Subjects With at Least 4-fold Increase of Anti-H1 Stalk ELISA - Adult Q-PAN H1N1-019 Cohort
時間枠：At D21, D42, and D182 (compared to Day 0)
|
With respect to samples from the HA Group 1-related studies (i.e., with H1N1, H5N1,and H9N2 pandemic, and IIV4 seasonal, influenza vaccines), analysis was performed for measuring levels of anti-H1 stalk antibody by ELISA for all the subjects in the adult CCPan H5N1-001, the Q-Pan H1N1-019 and the Q-Pan H9N2-001 study cohorts.
Percentage of subjects with at least 4-fold increase to anti-H1 stalk ELISA was calculated with 95% CI at each specified time point.
seronegative subjects = concentration < 66 EU/mL for anti-H1 stalk ELISA prior to vaccination.
seropositive subjects = concentration ≥ 66 EU/mL for anti-H1 stalk ELISA prior to vaccination.
4-fold increase defined as: For initially seronegative subjects, antibody concentration ≥ 132 EU/mL at post-vaccination.
For initially seropositive subjects, antibody concentration at post-vaccination ≥ 4-fold the pre-vaccination antibody concentration.
|
At D21, D42, and D182 (compared to Day 0)
|
|
Percentage of Subjects With at Least 4-fold Increase of Anti-H1 Stalk ELISA - Adult CC-PAN H5N1-001 Cohort
時間枠：At D21, D42, D182 and Day 385 (compared to Day 0)
|
With respect to samples from the HA Group 1-related studies (i.e., with H1N1, H5N1,and H9N2 pandemic, and IIV4 seasonal, influenza vaccines), analysis was performed for measuring levels of anti-H1 stalk antibody by ELISA for all the subjects in the adult CCPan H5N1-001, the Q-Pan H1N1-019 and the Q-Pan H9N2-001 study cohorts.
Percentage of subjects with at least 4-fold increase to anti-H1 stalk ELISA was calculated with 95% CI at each specified time point.
seronegative subjects = concentration < 66 EU/mL for anti-H1 stalk ELISA prior to vaccination.
seropositive subjects = concentration ≥ 66 EU/mL for anti-H1 stalk ELISA prior to vaccination.
4-fold increase defined as: For initially seronegative subjects, antibody concentration ≥ 132 EU/mL at post-vaccination.
For initially seropositive subjects, antibody concentration at post-vaccination ≥ 4-fold the pre-vaccination antibody concentration.
|
At D21, D42, D182 and Day 385 (compared to Day 0)
|
|
Percentage of Subjects With at Least 4-fold Increase of Anti-H1 Stalk ELISA - Adult Q-PAN H9N2-001 Cohort
時間枠：At D21, D42 and D182 (compared to Day 0)
|
With respect to samples from the HA Group 1-related studies (i.e., with H1N1, H5N1,and H9N2 pandemic, and IIV4 seasonal, influenza vaccines), analysis was performed for measuring levels of anti-H1 stalk antibody by ELISA for all the subjects in the adult CCPan H5N1-001, the Q-Pan H1N1-019 and the Q-Pan H9N2-001 study cohorts.
Percentage of subjects with at least 4-fold increase to anti-H1 stalk ELISA was calculated with 95% CI at each specified time point.
seronegative subjects = concentration < 66 EU/mL for anti-H1 stalk ELISA prior to vaccination.
seropositive subjects = concentration ≥ 66 EU/mL for anti-H1 stalk ELISA prior to vaccination.
4-fold increase defined as: For initially seronegative subjects, antibody concentration ≥ 132 EU/mL at post-vaccination.
For initially seropositive subjects, antibody concentration at post-vaccination ≥ 4-fold the pre-vaccination antibody concentration.
|
At D21, D42 and D182 (compared to Day 0)
|
|
Number of Subjects With Seropositivity Status at Baseline (Day 0) for the HI Assay Against the Pandemic Vaccine Homologous Virus - Adult Q-PAN H1N1-019, CC-PAN H5N1-001, Q-PAN H9N2-001 Cohorts
時間枠：At Day 0
|
With respect to samples from the HA Group 1-related studies (i.e., with H1N1, H5N1, and H9N2 pandemic, and IIV4 seasonal, influenza vaccines), analysis was performed for measuring the number of subjects with seropositivity status at baseline (Day 0) for the HI assay against the pandemic vaccine homologous virus - Adult Q-PAN H1N1-019, CC-PAN H5N1-001, Q-PAN H9N2-001 cohorts.
Seronegative subjects = Subjects with antibody titer < 10 1/DIL for Pandemic vaccine homologous virus and Seropositive subjects = Subjects with antibody titer ≥ 10 1/DIL for Pandemic vaccine homologous virus (i.e., A/California/7/2009 for subjects from the Q-PAN H1N1-019 study, A/Indonesia/5/2005 for subjects from CC-PAN H5N1-001 study, A/chicken/Hong Kong/G9/1997 for subjects from Q-PAN H9N2-001 study).
|
At Day 0
|
|
Number of Subjects With Seropositivity Status at Pre-vaccination (Baseline) for the HI Assay Against the Pandemic Vaccine Homologous Virus - Adult FLU D-QIV-015, Q-PAN-005, H5N1-012 Cohorts
時間枠：At Day 0, (except for group G of Q-PAN-005, at Day182)
|
With respect to samples from the HA Group 1-related studies (i.e., with H1N1, H5N1, and H9N2 pandemic, and IIV4 seasonal, influenza vaccines), analysis was performed for measuring the number of subjects with seropositivity status at baseline (at Day 0 in all subjects except for group G of Q-PAN-005 [i.e, at Day182]) for the HI assay against the pandemic vaccine homologous virus - Adult FLU D-QIV-015, Q-PAN-005, H5N1-012 cohorts .
Seronegative subjects = Subjects with antibody titer < 10 1/DIL for Pandemic vaccine homologous virus and Seropositive subjects = Subjects with antibody titer ≥ 10 1/DIL for Pandemic vaccine homologous virus (i.e., for FLU D-QIV-015: A/Christchurch/16/2010 at Day 0, for Q-PAN-005 study, group C: A/Turkey/01/2005 and A/Indonesia/5/2005 at Day 0 and for group G, A/Turkey/01/2005 at Day 182, for H5N1-012 study, for group VT/VT/12M : A/Vietnam/1194/2004 at Day 0, for group VT/IN/12M, A/Indonesia/5/2005 and A/Vietnam/1194/2004-like at Day 0).
|
At Day 0, (except for group G of Q-PAN-005, at Day182)
|
|
Number of Subjects With Seropositivity Status at Pre-vaccination (Baseline) for the HI Assay Against A/California/7/09 Virus (or Like Virus) - Adult Q-PAN H1N1-019, CC-PAN H5N1-001, Q-PAN H9N2-001, Q-PAN-005, H5N1-012 Cohorts
時間枠：At Day 0
|
With respect to samples from the HA Group 1-related studies (i.e., with H1N1, H5N1, and H9N2 pandemic, and IIV4 seasonal, influenza vaccines), analysis was performed for measuring the number of subjects with seropositivity status at pre-vaccination (Baseline) for the HI assay against A/California/7/09 virus (or like virus) - Adult Q-PAN H1N1-019, CC-PAN H5N1-001, Q-PAN H9N2-001, Q-PAN-005, H5N1-012 cohorts.
Seronegative subjects = Subjects with antibody titer < 10 1/DIL for A/California/7/09 virus (or like virus) and Seropositive subjects = Subjects with antibody titer ≥ 10 1/DIL for A/California/7/09 virus (or like virus).
|
At Day 0
|
|
Number of Subjects With Seropositivity Status Against Flu A/Indonesia/05/2005 (H5N1) HI Antibodies - Pediatric H5N1 Cohort
時間枠：At Day 0
|
With respect to samples from the HA Group 1-related studies (i.e., with H1N1, H5N1, and H9N2 pandemic, and IIV4 seasonal, influenza vaccines), analysis was performed for measuring the number of subjects with seropositivity status against Flu A/Indonesia/05/2005 (H5N1) HI antibodies - Pediatric H5N1 cohort.
Seronegative subjects = Subjects with antibody titer < 10 1/DIL for Flu A/Ind/05/05 (H5N1).HA HI prior to vaccination and Seropositive subjects = Subjects with antibody titer ≥ 10 1/DIL for Flu A/Ind/05/05 (H5N1).HA HI prior to vaccination.
|
At Day 0
|
協力者と研究者
ここでは、この調査に関係する人々や組織を見つけることができます。
出版物と役立つリンク
研究に関する情報を入力する責任者は、自発的にこれらの出版物を提供します。これらは、研究に関連するあらゆるものに関するものである可能性があります。
研究記録日
これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。
主要日程の研究
研究開始 (実際)
2015年10月26日
一次修了 (実際)
2018年2月16日
研究の完了 (実際)
2018年2月16日
試験登録日
最初に提出
2015年3月26日
QC基準を満たした最初の提出物
2015年4月9日
最初の投稿 (見積もり)
2015年4月14日
学習記録の更新
投稿された最後の更新 (実際)
2019年7月23日
QC基準を満たした最後の更新が送信されました
2019年7月12日
最終確認日
2019年7月1日
詳しくは
本研究に関する用語
追加の関連 MeSH 用語
その他の研究ID番号
- 201598
個々の参加者データ (IPD) の計画
個々の参加者データ (IPD) を共有する予定はありますか?
いいえ
この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。
Serum samplesの臨床試験
-
Harvard University Faculty of MedicineNational Institute of Allergy and Infectious Diseases (NIAID); Brigham and Women's Hospital; Harvard... と他の協力者わからない
-
Bandim Health ProjectStatens Serum Institut完了
-
Bandim Health ProjectResearch Center for Vitamins and Vaccines, Statens Serum Institute終了しました
-
TASK Applied Science完了
-
Institute of Dermatology, ThailandMEDEZE Cosmeceutical Company Limited募集
-
Radboud University Medical Center積極的、募集していない