Study to Evaluate the Immunogenicity and Safety of an Investigational Pandemic Influenza Vaccine in Children
2019年4月24日 更新者：GlaxoSmithKline
Safety and Immunogenicity of GSK Biologicals' (Pre-) Pandemic Influenza Candidate Vaccine (GSK1562902A) in Children Aged 6 to 35 Months
The objective of the study is to evaluate the immunogenicity and safety of prime-boost vaccination schedule of GSK Biologicals' investigational vaccine GSK1562902A.
調査の概要
詳細な説明
This protocol posting was modified according to the protocol amendment 2 (dated 16-June-2011).
The impacted section is eligibility criteria.
研究の種類
介入
入学 (実際)
113
段階
- フェーズ2
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
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Australian Capital Territory
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Garran、Australian Capital Territory、オーストラリア、2606
- GSK Investigational Site
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New South Wales
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Westmead、New South Wales、オーストラリア、2145
- GSK Investigational Site
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South Australia
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North Adelaide、South Australia、オーストラリア、5006
- GSK Investigational Site
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Victoria
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Carlton、Victoria、オーストラリア、3053
- GSK Investigational Site
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Singapore、シンガポール、119074
- GSK Investigational Site
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Singapore、シンガポール、228510
- GSK Investigational Site
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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～2年 (子)
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
説明
Inclusion Criteria:
- Subjects who the investigator believes that parents/Legally Acceptable Representatives (LARs) can and will comply with the requirements of the protocol.
- Children, male or female between, and including, 6 and 35 months of age at the time of first study vaccination.
- Written informed consent obtained from the parent(s)/LAR(s) of the subject.
- Healthy children as established by medical history and clinical examination before entering the study.
- Parent/LAR access to a consistent means of telephone contact, land line or mobile, but NOT a pay phone or other multiple-user device.
- Subjects who are likely to reside in the vicinity of the study centre for the duration of the study. In studies using the home-based model for vaccination and follow-up, subjects who are likely to remain in the vicinity of the area where they were recruited.
Exclusion Criteria:
- Use of any investigational or non-registered product other than the study vaccine(s) within 30 days preceding the first dose of study vaccine, or planned use during the study period.
- Chronic administration of immunosuppressants or other immune-modifying drugs within six months prior to the first vaccine dose.
- Planned administration of any vaccine 30 days prior and 21 days after any study vaccine administration.
- History of any reaction or hypersensitivity likely to be exacerbated by any component of the vaccines such as egg protein or thiomersal.
- Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination.
- History of any neurological disorders or seizures.
- Acute disease at the time of enrolment.
- Acute or chronic, clinically significant pulmonary, cardiovascular, hepatic or renal functional abnormality, as determined by physical examination or laboratory tests.
- Administration of immunoglobulins and/or any blood products within the three months prior to the enrolment in this study, or planned administration during the study period.
- Any condition which, in the opinion of the investigator, renders the subject unfit for participation in the study.
- Child in care.
- Previous vaccination at any time with an H5N1 vaccine.
- Medical history of physician-confirmed infection with a H5N1 virus.
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
- 主な目的：防止
- 割り当て：非ランダム化
- 介入モデル：並列代入
- マスキング：なし（オープンラベル）
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
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実験的：GSK1562902A 6 to 12 M Group
Subjects between 6 and 12 months of age (6 to 12 M), who received 2 primary doses of A/Indonesia/05/2005 GSK1562902A vaccine on Days 0 and 21 and 1 booster dose of the A/turkey/Turkey/1/2005 GSK1562902A vaccine on Day 182.
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Three intramuscular injections
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実験的：GSK1562902A 12 to 24 M Group
Subjects between 12 and 24 months of age (12 to 24 M), who received 2 primary doses of A/Indonesia/05/2005 GSK1562902A vaccine on Days 0 and 21 and 1 booster dose of the A/turkey/Turkey/1/2005 GSK1562902A vaccine on Day 182.
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Three intramuscular injections
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実験的：GSK1562902A 24 to 36 M Group
Subjects between 24 and 36 months of age (24 to 36 M), who received 2 primary doses of A/Indonesia/05/2005 GSK1562902A vaccine on Days 0 and 21 and 1 booster dose of the A/turkey/Turkey/1/2005 GSK1562902A vaccine on Day 182.
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Three intramuscular injections
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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 |
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Number of Seroconverted Subjects in Terms of H5N1 Hemagglutination Inhibition (HI) Antibodies Against A/Turkey/Turkey/1/2005 H5N1 Virus Strain
時間枠：At Day 192
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A seroconverted subject is defined as a subject that had either a pre-vaccination (Day 0) titer < 1:10 and a post-vaccination titer ≥ 1:40 or a pre-vaccination titer ≥ 1:10 and at least a 4-fold increase in post-vaccination titer on Day 192.
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At Day 192
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Mean Geometric Change in Terms of H5N1 HI Antibodies Against A/Turkey/Turkey/01/2005 H5N1 Virus Strain
時間枠：At Day 192
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Mean Geometric Change is defined as the geometric mean of the within-subject ratios of the post vaccination (Day 192) reciprocal HI titer to the pre-vaccination (Day 0) reciprocal HI titer (i.e.
post-vaccination divided by pre-vaccination titer).
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At Day 192
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Number of Seroprotected Subjects in Terms of H5N1 HI Antibodies Against A/Turkey/Turkey/01/2005 H5N1 Virus Strain
時間枠：At Day 192
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A seroprotected subject is defined as a subject with a serum H5N1 HI antibody titer ≥1:40.
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At Day 192
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二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Hemagglutination Inhibition (HI) Antibody Titers Against the A/Indonesia/05/2005 H5N1 Virus Strain
時間枠：At Day 0, Day 42, Day 182, Day 192 and Day 364
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Titers were presented as geometric mean titers (GMTs).
Analyses were done by age stratum and overall.
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At Day 0, Day 42, Day 182, Day 192 and Day 364
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Hemagglutination Inhibition (HI) Antibody Titers Against the A/Turkey/Turkey/01/2005 H5N1 Virus Strain
時間枠：At Day 0, Day 182, Day 192 and Day 364
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Titers were presented as geometric mean titers (GMTs).
Analyses were done by age stratum and overall.
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At Day 0, Day 182, Day 192 and Day 364
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Number of Seropositive Subjects in Terms of H5N1 HI Antibodies Against A/Indonesia/05/2005
時間枠：At Day 0, Day 42, Day 182, Day 192 and Day 364
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A seropositive subject is defined as a subject with a serum H5N1 HI antibody titer ≥ 1:10.
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At Day 0, Day 42, Day 182, Day 192 and Day 364
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Number of Seropositive Subjects in Terms of H5N1 HI Antibodies Against A/Turkey/Turkey/1/2005 H5N1 Virus Strain
時間枠：At Day 0, Day 182, Day 192 and Day 364
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A seropositive subject is defined as a subject with a serum H5N1 HI antibody titer ≥ 1:10.
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At Day 0, Day 182, Day 192 and Day 364
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Number of Seroconverted Subjects in Terms of H5N1 HI Antibodies Against A/Indonesia/05/2005 H5N1 Virus Strain
時間枠：At Day 42, Day 182, Day 192 and Day 364
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A seroconverted subjects is defined as a subject who had either a pre vaccination (Day 0) titer <1:10 and a post-vaccination titer ≥1:40, or a pre-vaccination titer ≥1:10 and at least a 4-fold increase in post-vaccination titer.
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At Day 42, Day 182, Day 192 and Day 364
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Number of Seroconverted Subjects in Terms of H5N1 HI Antibodies Against A/Turkey/Turkey/1/2005 H5N1 Virus Strain
時間枠：At Day 182 and Day 364
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A seroconverted subjects is defined as a subject who had either a pre vaccination (Day 0) titer <1:10 and a post-vaccination titer ≥1:40, or a pre-vaccination titer ≥1:10 and at least a 4-fold increase in post-vaccination titer.
Data for Day 192 are presented under Primary Outcome Measures.
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At Day 182 and Day 364
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Number of Seroprotected Subjects in Terms of H5N1 HI Antibodies Against A/Indonesia/05/2005 Virus Strain
時間枠：At Day 0, Day 42, Day 182, Day 192 and Day 364
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A seroprotected subject is defined as a subject with a serum H5N1 HI antibody titer ≥1:40.
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At Day 0, Day 42, Day 182, Day 192 and Day 364
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Number of Seroprotected Subjects in Terms of H5N1 HI Antibodies Against A/Turkey/Turkey/1/2005 H5N1 Virus Strain
時間枠：Day 0, Day 182 and Day 364
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A seroprotected subject is defined as a subject with a serum H5N1 HI antibody titer ≥1:40.
Data for Day 192 are presented under Primary Outcome Measures.
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Day 0, Day 182 and Day 364
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Mean Geometric Change in Terms of H5N1 HI Antibodies Against A/Indonesia/05/2005 H5N1 Virus Strain
時間枠：At Day 42, Day 182, Day 192 and Day 364
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Mean Geometric Change is defined as the geometric mean of the within-subject ratios of the post-vaccination reciprocal HI titer to the pre-vaccination (Day 0) reciprocal HI titer (i.e.
post-vaccination divided by pre-vaccination titer).
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At Day 42, Day 182, Day 192 and Day 364
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Mean Geometric Change in Terms of H5N1 HI Antibodies Against A/Turkey/Turkey/01/2005 H5N1 Virus Strain
時間枠：Day 182 and Day 364
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Mean Geometric Change is defined as the geometric mean of the within-subject ratios of the post vaccination reciprocal HI titer to the pre-vaccination (Day 0) reciprocal HI titer (i.e.
post-vaccination divided by pre-vaccination titer).
Data for Day 192 are presented under Primary Outcome Measures.
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Day 182 and Day 364
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Number of Booster Seroconverted Subjects in Terms of H5N1 HI Antibodies Against A/Turkey/Turkey/1/2005 H5N1 Virus Strain
時間枠：At Day 192 and Day 364
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Booster seroconversion is defined as follows: For seronegative subjects at pre-booster (Day 182), antibody titer ≥1:40 at post-booster time point(s).
For seropositive subjects at pre-booster (Day 182), antibody titer at post-booster time point(s) ≥4-fold the pre-booster antibody titer.
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At Day 192 and Day 364
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Booster Factor in Terms of Neutralizing Antibodies Against A/Turkey/Turkey/1/2005 H5N1 Virus Strain
時間枠：At Day 192 and Day 364
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Booster Factor was defined as the geometric mean of the within-subject ratios of the post-booster vaccination reciprocal HI titer to the pre-booster (Day 182) reciprocal titer.
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At Day 192 and Day 364
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Number of Seropositive Subjects in Terms of Serum Neutralizing Antibodies Against A/Indonesia/05/2005 H5N1 Virus Strain
時間枠：Day 0, Day 42, Day 182, Day 192 and Day 364
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A seropositive subject is defined as a subject with serum neutralizing antibody titers ≥ 1:28
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Day 0, Day 42, Day 182, Day 192 and Day 364
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Number of Seropositive Subjects in Terms of Serum Neutralizing Antibodies Against A/Turkey/Turkey/1/2005 H5N1 Virus Strain
時間枠：Day 0, Day 182, Day 192 and Day 364
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A seropositive subject is defined as a subject with serum neutralizing antibody titers ≥ 1:28.
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Day 0, Day 182, Day 192 and Day 364
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Serum Neutralizing Antibody Titers in Terms of Neutralizing Antibodies Against A/Indonesia/05/2005 H5N1 Virus Strain
時間枠：Day 0, Day 42, Day 182, Day 192 and Day 364
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Titers were presented as geometric mean titers (GMTs).
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Day 0, Day 42, Day 182, Day 192 and Day 364
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Serum Neutralizing Antibody Titers in Terms of Neutralizing Antibodies Against A/Turkey/Turkey/1/2005 H5N1 Virus Strain
時間枠：Day 0, Day 182, Day 192 and Day 364
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Titers were presented as geometric mean titers (GMTs).
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Day 0, Day 182, Day 192 and Day 364
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Number of Subjects With a Vaccine Response in Terms of Serum Neutralizing Antibodies Against A/Indonesia/05/2005 H5N1 Virus Strain
時間枠：At Day 42, Day 182, Day 192 and Day 364
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Vaccine response is defined as: For initially seronegative subjects, neutralizing antibody titer ≥ 1:56 at the considered time point after vaccination For initially seropositive subjects, neutralizing antibody titer ≥ 4 fold from pre-vaccination (Day 0)
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At Day 42, Day 182, Day 192 and Day 364
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Number of Subjects With a Vaccine Response in Terms of Serum Neutralizing Antibodies Against A/Turkey/Turkey/1/2005 H5N1 Virus Strain
時間枠：At Day 182, Day 192 and Day 364
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Vaccine response is defined as: For initially seronegative subjects, neutralizing antibody titer ≥ 1:56 at the considered time point after vaccination For initially seropositive subjects, neutralizing antibody titer ≥ 4 fold from pre-vaccination (Day 0)
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At Day 182, Day 192 and Day 364
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Number of Subjects With a Booster Vaccine Response in Terms of Serum Neutralizing Antibodies Against A/Turkey/Turkey/1/2005 H5N1 Virus Strain
時間枠：At Day 192 and Day 364
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Booster vaccine response is defined as: For seronegative subjects at Day 182, neutralizing antibody titers ≥ 1:56 at the considered time point after vaccination For seropositive subjects at Day 182, neutralizing antibody titers ≥ 4 fold from pre-vaccination (Day 182)
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At Day 192 and Day 364
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Number of Subjects With Any and Grade 3 Solicited Local Symptoms
時間枠：During the 7-day post-vaccination period following each dose and across doses (Day 0 - Day 7, Day 21 - Day 28, Day 182 - Day 189)
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Solicited local symptoms assigned were pain, swelling and redness.
Any was defined as occurrence of any local symptom regardless of intensity grade; Grade 3 pain was defined as cried when limb was moved spontaneously painful.
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During the 7-day post-vaccination period following each dose and across doses (Day 0 - Day 7, Day 21 - Day 28, Day 182 - Day 189)
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Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
時間枠：During the 7-day post-vaccination period following each dose and across doses (Day 0 - Day 7, Day 21 - Day 28, Day 182 - Day 189)
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Solicited general symptoms assessed were diarrhoea/ vomiting, drowsiness, irritability/ fussiness, loss of appetite, fever (axillary).
Any= occurrence of any general symptom regardless of intensity grade and relationship to the vaccine.
Irritability/ fussiness grade 3=crying that could not be comforted/ prevented normal activity; Drowsiness grade 3= drowsiness that prevented normal activity; Loss of appetite grade 3= did not eat at all; Diarrhoea/ vomiting grade 3= diarrhoea/ vomiting that prevented normal activity; Related= general symptom assessed by the investigator as causally related to the study vaccination.
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During the 7-day post-vaccination period following each dose and across doses (Day 0 - Day 7, Day 21 - Day 28, Day 182 - Day 189)
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Number of Subjects With Medically-attended Events (MAEs)
時間枠：During the entire study period (from Day 0 to Day 364)
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MAEs were defined as events for which the subject received medical attention defined as hospitalization, an emergency room visit, or a visit to or from medical personnel (medical doctor) for any reason.
Any MAE(s) = Occurrence of any MAE(s) regardless of intensity grade or relation to vaccination.
Analysis of intensity and relationship to vaccination of MAEs was not performed.
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During the entire study period (from Day 0 to Day 364)
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Number of Subjects With Potential Immune-mediated Disease (pIMDs)
時間枠：During the entire study period (from day 0 to Day 364)
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Potential immune-mediated diseases (pIMDs) are a subset of AEs that include autoimmune diseases and other inflammatory and/or neurologic disorders of interest which may or may not have an autoimmune aetiology.
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During the entire study period (from day 0 to Day 364)
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Number of Subjects With Unsolicited Adverse Events (AEs)
時間枠：During a 21 day follow-up period after each vaccination (Day 0 - Day 21, Day 21 - Day 42, Day 182 - Day 203)
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An AE is any untoward medical occurrence in a clinical investigation subject, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
"Any" was defined as an incidence of an unsolicited AE regardless of intensity or relationship to study vaccination.
"Grade 3" was defined as an AE which prevented normal, everyday activities.
"Related" was defined as an AE assessed by the investigator as causally related to the study vaccination.
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During a 21 day follow-up period after each vaccination (Day 0 - Day 21, Day 21 - Day 42, Day 182 - Day 203)
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Number of Subjects With Unsolicited Adverse Events (AEs)
時間枠：During an 84 day follow-up period after each vaccination (Day 0 - Day 84, Day 21 - Day 105, Day 182 - Day 266)
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An AE is any untoward medical occurrence in a clinical investigation subject, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
"Any" was defined as an incidence of an unsolicited AE regardless of intensity or relationship to study vaccination.
"Grade 3" was defined as an AE which prevented normal, everyday activities.
"Related" was defined as an AE assessed by the investigator as causally related to the study vaccination.
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During an 84 day follow-up period after each vaccination (Day 0 - Day 84, Day 21 - Day 105, Day 182 - Day 266)
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Number of Subjects With Serious Adverse Events (SAEs)
時間枠：During the entire study period (from Day 0 to 364)
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Serious adverse events (SAEs) assessed included medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization or result in disability/ incapacity.
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During the entire study period (from Day 0 to 364)
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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。
スポンサー
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)
2011年4月18日
一次修了 (実際)
2012年6月22日
研究の完了 (実際)
2012年11月2日
試験登録日
最初に提出
2011年3月24日
QC基準を満たした最初の提出物
2011年3月24日
最初の投稿 (見積もり)
2011年3月28日
学習記録の更新
投稿された最後の更新 (実際)
2019年5月7日
QC基準を満たした最後の更新が送信されました
2019年4月24日
最終確認日
2019年4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
- 109825
- 2011-004734-33 (EudraCT番号)
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?
はい
IPD プランの説明
Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.
試験データ・資料
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注釈付き症例報告書
情報識別子：109825情報コメント：For additional information about this study please refer to the GSK Clinical Study Register
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臨床研究報告書
情報識別子：109825情報コメント：For additional information about this study please refer to the GSK Clinical Study Register
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個人参加者データセット
情報識別子：109825情報コメント：For additional information about this study please refer to the GSK Clinical Study Register
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研究プロトコル
情報識別子：109825情報コメント：For additional information about this study please refer to the GSK Clinical Study Register
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統計分析計画
情報識別子：109825情報コメント：For additional information about this study please refer to the GSK Clinical Study Register
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インフォームド コンセント フォーム
情報識別子：109825情報コメント：For additional information about this study please refer to the GSK Clinical Study Register
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データセット仕様
情報識別子：109825情報コメント：For additional information about this study please refer to the GSK Clinical Study Register
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。
GSK Biologicals' investigational vaccine GSK1562902Aの臨床試験
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GlaxoSmithKline完了
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GlaxoSmithKline完了
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GlaxoSmithKline完了
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GlaxoSmithKlineAeras完了
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GlaxoSmithKline完了