Evaluation of Immunogenicity and Safety of Two 2-dose Human Papillomavirus (HPV) Vaccine Schedules in 9-14 Year Old Girls
2020年5月19日 更新者：GlaxoSmithKline
Immunogenicity and Safety Study of GlaxoSmithKline Biologicals' HPV-16/18 L1 AS04 Vaccine When Administered According to Alternative 2-dose Schedules in 9 - 14 Year Old Females
This study has been designed to evaluate the immunogenicity and safety of GSK Biologicals' HPV-16/18 vaccine when administered according to alternative 2-dose schedules (0,6 months and 0,12 months) in healthy 9-14 year old females as compared to the standard 3-dose schedule (0,1,6 months) in 15-25 year old females.
調査の概要
研究の種類
介入
入学 (実際)
1447
段階
- フェーズ 3
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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Liguria
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Genova、Liguria、イタリア、16132
- GSK Investigational Site
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Lombardia
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Milano、Lombardia、イタリア、20122
- GSK Investigational Site
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Piemonte
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Cuneo、Piemonte、イタリア、12100
- GSK Investigational Site
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Sardegna
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Cagliari、Sardegna、イタリア、09127
- GSK Investigational Site
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Sicilia
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Ragusa、Sicilia、イタリア、97100
- GSK Investigational Site
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Veneto
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Padova、Veneto、イタリア、35128
- GSK Investigational Site
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British Columbia
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Coquitlam、British Columbia、カナダ、V3K 3P4
- GSK Investigational Site
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Nova Scotia
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Halifax、Nova Scotia、カナダ、B3K 6R8
- GSK Investigational Site
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Ontario
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Sudbury、Ontario、カナダ、P3E 1H5
- GSK Investigational Site
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Toronto、Ontario、カナダ、M9W 4L6
- GSK Investigational Site
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Woodstock、Ontario、カナダ、N4S 5P5
- GSK Investigational Site
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Quebec
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Sherbrooke、Quebec、カナダ、J1H 2G2
- GSK Investigational Site
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Bangkok、タイ、10330
- GSK Investigational Site
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Chiangmai、タイ、50200
- GSK Investigational Site
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Berlin、ドイツ、13055
- GSK Investigational Site
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Hamburg、ドイツ、22159
- GSK Investigational Site
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Baden-Wuerttemberg
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Freiburg、Baden-Wuerttemberg、ドイツ、79106
- GSK Investigational Site
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Kehl、Baden-Wuerttemberg、ドイツ、77694
- GSK Investigational Site
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Bayern
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Schoenau Am Koenigssee、Bayern、ドイツ、83471
- GSK Investigational Site
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Wuerzburg、Bayern、ドイツ、97070
- GSK Investigational Site
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Niedersachsen
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Hannover、Niedersachsen、ドイツ、30625
- GSK Investigational Site
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Hannover、Niedersachsen、ドイツ、30657
- GSK Investigational Site
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Wolfenbuettel、Niedersachsen、ドイツ、38302
- GSK Investigational Site
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Wolfsburg、Niedersachsen、ドイツ、38440
- GSK Investigational Site
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Nordrhein-Westfalen
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Kleve-Materborn、Nordrhein-Westfalen、ドイツ、47533
- GSK Investigational Site
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Rheinland-Pfalz
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Mainz、Rheinland-Pfalz、ドイツ、55116
- GSK Investigational Site
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Mainz、Rheinland-Pfalz、ドイツ、55131
- GSK Investigational Site
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Trier、Rheinland-Pfalz、ドイツ、54290
- GSK Investigational Site
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Schleswig-Holstein
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Flensburg、Schleswig-Holstein、ドイツ、24937
- GSK Investigational Site
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Thueringen
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Weimar、Thueringen、ドイツ、99423
- GSK Investigational Site
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Taipei、台湾、100
- GSK Investigational Site
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Taipei、台湾
- GSK Investigational Site
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Taoyuan、台湾、333
- 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
9年～25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
女性
説明
Inclusion Criteria:
- Subjects who the investigator believes can and will comply with the requirements of the protocol or/ and subjects who the investigator believes their parent(s)/Legally Acceptable Representative(s) [LAR(s)] can and will comply with the requirements of the protocol
- A female between, and including, 9 and 25 years of age at the time of the first vaccination
- Written informed consent obtained from the subject/from the parent(s)/LAR(s) of the subject prior to enrolment in the study. In addition, subjects below the legal age of consent should sign and personally date a written informed assent form
- Healthy subjects
- Female subjects of non-childbearing potential may be enrolled in the study
Female subjects of childbearing potential may be enrolled in the study, if the subject:
- has practiced adequate contraception for 30 days prior to vaccination, and
- has a negative pregnancy test on the day of vaccination, and
- has agreed to continue adequate contraception during the entire vaccination period and up to two months after the last study vaccine dose
Exclusion Criteria:
- Pregnant or breastfeeding
- A female planning to become pregnant, likely to become pregnant or planning to discontinue contraceptive precautions during the entire vaccination period and up to two months after the last study vaccine dose
- Previous vaccination against HPV or planned administration of another HPV vaccine during the study
- Child in care. A child in care is a child who has been placed under the control or protection of an agency, organisation, institution or entity by the courts, the government or a government body, acting in accordance with powers conferred on them by law or regulation. The definition of a child in care does not include a child who is adopted or has an appointed legal guardian.
- Use of any investigational or non-registered product other than the study vaccine 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. History of allergic disease, suspected allergy or reactions likely to be exacerbated by any component of the study vaccines
- Cancer or autoimmune disease under treatment
- Planned administration/administration of a vaccine/product not foreseen by the study protocol within 30 days before each dose of vaccine. Administration of routine meningococcal, hepatitis B, hepatitis A, inactivated influenza, diphtheria/tetanus and/or diphtheria/tetanus-containing vaccine up to 8 days before each dose of study vaccine is allowed. Enrolment will be deferred until the subject is outside of specified window
- Concurrently participating in another clinical study, at any time during the study period, in which the subject has been or will be exposed to an investigational or a non-investigational product
- Previous administration of MPL or AS04 adjuvant.
- Administration of immunoglobulins and/or any blood products within the 3 months preceding the first dose of study vaccine or planned administration during the study period
- Any confirmed or suspected immunosuppressive or immunodeficient condition
- Family history of congenital or hereditary immunodeficiency
- Major congenital defects or serious chronic illness
- Acute or chronic, clinically significant pulmonary, cardiovascular, hepatic or renal functional abnormality, as determined by physical examination or laboratory screening tests, which in the opinion of the investigator precludes administration of the study vaccine
- Acute disease and/or fever at the time of enrolment
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：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：Cervarix 1 Group
Female subjects aged 9 to 14 years at the time of the first vaccination, who received 2 doses of the Cervarix vaccine at Day 0 and at Month 6, respectively.
The vaccine was administered intramuscularly into the deltoid muscle of the non-dominant arm.
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Subjects received 2 or 3 doses of HPV vaccine administered intramuscularly.
他の名前：
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アクティブコンパレータ：Cervarix 2 Group
Female subjects aged 15 to 25 years at the time of the first vaccination, who received 3 doses of the Cervarix vaccine at Day 0, at Month 1 and at Month 6, respectively.
The vaccine was administered intramuscularly into the deltoid muscle of the non-dominant arm.
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Subjects received 2 or 3 doses of HPV vaccine administered intramuscularly.
他の名前：
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実験的：Cervarix 3 Group
Female subjects aged 9 to 14 years at the time of the first vaccination, who received 2 doses of the Cervarix vaccine at Day 0 and at Month 12, respectively.
The vaccine was administered intramuscularly into the deltoid muscle of the non-dominant arm.
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Subjects received 2 or 3 doses of HPV vaccine administered intramuscularly.
他の名前：
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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 for Anti-human Papilloma Virus 16 (Anti-HPV-16) and Anti-human Papilloma Virus 18 (Anti-HPV-18) Antibodies in Cervarix 1 Group and Cervarix 2 Group at Month 7
時間枠：At Month 7 (i.e. one month after the last dose of study vaccine)
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Seroconversion was defined as the appearance of antibodies (anti-HPV-16 concentrations greater than or equal to (≥) 8 enzyme-linked immunosorbent assay (ELISA) units per milliliter (EL.U/mL) and anti-HPV-18 concentrations ≥ 7 EL.U/mL) in the serum of subjects seronegative before vaccination.
A seronegative subject was a subject with anti-HPV-16/18 antibody concentration lower than (<) 8/7 EL.U/mL, respectively.
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At Month 7 (i.e. one month after the last dose of study vaccine)
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Anti-HPV-16 and Anti-HPV-18 Antibody Concentrations (by ELISA) in Cervarix 1 Group and Cervarix 2 Group at Month 7
時間枠：At Month 7 (i.e. one month after the last dose of study vaccine)
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Antibody concentrations were assessed by ELISA and expressed as geometric mean concentrations (GMCs) in EL.U/mL.
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At Month 7 (i.e. one month after the last dose of study vaccine)
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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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Number of Seroconverted Subjects for Anti-HPV-16 and Anti-HPV-18 Antibodies in Cervarix 1 Group and Cervarix 2 Group at Day 0 and at Months 7, 12, 18, 24 and 36
時間枠：At Day 0 and at Months 7, 12, 18, 24 and 36
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Seroconversion was defined as the appearance of antibodies (anti-HPV-16 concentrations ≥ 8 EL.U/mL and anti-HPV-18 concentrations ≥ 7 EL.U/mL [applicable for Day 0, Month 7 and Month 12 time points] and anti-HPV-16 concentrations ≥ 19 EL.U/mL and anti-HPV-18 concentrations ≥ 18 EL.U/mL [applicable for Month 18, Month 24 and Month 36 time points]) in the serum of subjects seronegative before vaccination. A seronegative subject was a subject with an anti-HPV-16/18 antibody concentration below (<) the aforementioned cut-offs. Note: In order to increase the ELISA precision, the assay cut-off value was changed from 8 EL.U/mL to 19 EL.U/mL for HPV-16 and from 7 EL.U/mL to 18 EL.U/mL for HPV-18 from Month 18 onwards. |
At Day 0 and at Months 7, 12, 18, 24 and 36
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Anti-HPV-16 and Anti-HPV-18 Antibody Concentrations (by ELISA) in Cervarix 1 Group and Cervarix 2 Group at Day 0 and at Months 7, 12, 18, 24 and 36
時間枠：At Day 0 and at Months 7, 12, 18, 24 and 36
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Antibody concentrations were assessed by ELISA and expressed as geometric mean concentrations (GMCs) in EL.U/mL.
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At Day 0 and at Months 7, 12, 18, 24 and 36
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Number of Seroconverted Subjects for Anti-HPV-16 and Anti-HPV-18 Antibodies in Cervarix 3 Group
時間枠：At Day 0 and at Months 13, 18, 24 and 36
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Seroconversion was defined as the appearance of antibodies (anti-HPV-16 concentrations ≥ 8 EL.U/mL and anti-HPV-18 concentrations ≥ 7 EL.U/mL [applicable for Day 0 and Month 13 time points] and anti-HPV-16 concentrations ≥ 19 EL.U/mL and anti-HPV-18 concentrations ≥ 18 EL.U/mL [applicable for Month 18, Month 24 and Month 36 time points]) in the serum of subjects seronegative before vaccination. A seronegative subject was a subject with an anti-HPV-16/18 antibody concentration below (<) the aforementioned cut-offs. Note: In order to increase the ELISA precision, the assay cut-off value was changed from 8 EL.U/mL to 19 EL.U/mL for HPV-16 and from 7 EL.U/mL to 18 EL.U/mL for HPV-18 from Month 18 onwards. |
At Day 0 and at Months 13, 18, 24 and 36
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Anti-HPV-16 and Anti-HPV-18 Antibody Concentrations (by ELISA) in Cervarix 3 Group
時間枠：At Day 0 and at Months 13, 18, 24 and 36
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Antibody concentrations were assessed by ELISA and expressed as geometric mean concentrations (GMCs) in EL.U/mL.
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At Day 0 and at Months 13, 18, 24 and 36
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Anti-HPV-16 and Anti-HPV-18 Antibody Titers [by Pseudovirion-Based Neutralisation Assay (PBNA)] in a Subset of Subjects From Cervarix 3 Group
時間枠：At Day 0 and at Months 13, 18, 24 and 36
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Antibody titers were expressed as geometric mean titers (GMTs).
The cut-off of the assay was 40 ED50 for both anti-HPV-16 and anti-HPV-18.
The assay was performed on a subset of 100 subjects from Cervarix 3 Group.
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At Day 0 and at Months 13, 18, 24 and 36
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Anti-HPV-16 and Anti-HPV-18 Antibody Titers (by PBNA) in a Subset of Subjects From Cervarix 1 Group and Cervarix 2 Group
時間枠：At Day 0 and at Months 7, 12, 18, 24 and 36
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Antibody titers were expressed as GMTs.
The cut-off of the assay was 40 ED50 for both anti-HPV-16 and anti-HPV-18.
The assay was performed on a subset of 100 subjects per study group.
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At Day 0 and at Months 7, 12, 18, 24 and 36
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Cell-mediated Immunogenicity Related to Anti-HPV-16 Specific T Cell-mediated Immune Response (CMI) for Cervarix 1 Group and Cervarix 2 Group in a Sub-cohort of Subjects
時間枠：At Day 0 and at Months 7, 12, 24 and 36
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The CMI response represents the measure of the cytokines production [i.e.
interleukin-2 (IL-2), interferon gamma (IFN-γ), tumor necrosis factor alpha (TNF-α) and the cluster of differentiation 40 Ligand (CD40L)] by HPV-antigen specific T lymphocytes and measured by intracellular cytokine staining (ICS) assay for HPV-16.
The frequency was presented as number of cytokine-positive cluster of differentiation (CD)4 i.e.
CD4+/CD8+ cells per million CD4+/CD8+ cells.
All doubles = T cell expressing at least 2 cytokines.
Results were tabulated by the pre-vaccination status of the subjects, where S- = seronegative subjects (antibody concentration < cut-off value) prior to vaccination.
S+ = seropositive subjects (antibody concentration ≥ cut-off value) prior to vaccination.
The assay was performed on a subset of 100 subjects per study group.
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At Day 0 and at Months 7, 12, 24 and 36
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Cell-mediated Immunogenicity Related to Anti-HPV-18 Specific T CMI Response for Cervarix 1 Group and Cervarix 2 Group in a Sub-cohort of Subjects
時間枠：At Day 0 and at Months 7, 12, 24 and 36
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The CMI response represents the measure of the cytokines production [IL-2, IFN-γ, TNF-α, and CD40L] by HPV-antigen specific T lymphocytes and measured by ICS assay for HPV-18.
The frequency was presented as a number of cytokine-producing CD4+/CD8+ cells per million CD4+/CD8+ cells.
All doubles = T cell expressing at least 2 cytokines.
Results were tabulated by the pre-vaccination status of the subjects, where S- = seronegative subjects (antibody concentration < the cut-off value) prior to vaccination.
S+ = seropositive subjects (antibody concentration ≥ cut-off value) prior to vaccination.
The assay was performed on a subset of 100 subjects per study group.
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At Day 0 and at Months 7, 12, 24 and 36
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Cell-mediated Immunogenicity Related to Anti-HPV-16 Specific T CMI Response for Cervarix 3 Group in a Sub-cohort of Subjects
時間枠：At Day 0 and at Months 13, 18 and 36
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The CMI response represents the measure of the cytokines production (IL-2, IFN-γ, TNF-α, and CD40L) by HPV-antigen specific T lymphocytes and measured by ICS assay for HPV-16.
The frequency was presented as a number of cytokine-positive cluster of differentiation (CD)4 i.e.CD4+/CD8+ cells per million CD4+/CD8+ cells.
All doubles= T cell expressing at least 2 cytokines.
Results were tabulated by the pre-vaccination status of the subjects, where S- = seronegative subjects (antibody concentration < cut-off value) prior to vaccination.
S+ = seropositive subjects (antibody concentration ≥ cut-off value) prior to vaccination.
The assay was performed on a subset of 100 subjects from Cervarix 3 Group.
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At Day 0 and at Months 13, 18 and 36
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Cell-mediated Immunogenicity Related to Anti-HPV-18 Specific T CMI Response for Cervarix 3 Group in a Sub-cohort of Subjects
時間枠：At Day 0 and at Months 13, 18 and 36
|
The CMI response represents the measure of the cytokines production (i.e.
IL-2, IFN-γ, TNF-α, and CD40L) by HPV-antigen specific T lymphocytes and measured by ICS assay for HPV-18.
The frequency was presented as a number of cytokine-producing CD4+/CD8+ cells per million CD4+/CD8+ cells.
All doubles = T cell expressing at least 2 cytokines.
Results were tabulated by the pre-vaccination status of the subjects, where S- = seronegative subjects (antibody concentration < cut-off value) prior to vaccination.
S+ = seropositive subjects (antibody concentration ≥ cut-off value) prior to vaccination.
The assay was performed on a subset of 100 subjects from Cervarix 3 Group.
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At Day 0 and at Months 13, 18 and 36
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Cell-mediated Immunogenicity Related to Anti-HPV-16 Specific B CMI Response for Cervarix 1 Group and Cervarix 2 Group in a Sub-cohort of Subjects
時間枠：At Day 0 and at Months 7, 12, 24 and 36
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The CMI response was assessed as being the frequency of B-cell memory of HPV-16 antigen-specific memory B-cells per million memory B-cells in subjects with detectable B-cells.
The results are presented by pre-vaccination status, where S- = seronegative subjects (antibody concentration < cut-off value) prior to vaccination and S+ = seropositive subjects (antibody concentration ≥ cut-off value) prior to vaccination.
The assay was performed on a subset of 100 subjects per study group.
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At Day 0 and at Months 7, 12, 24 and 36
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Cell-mediated Immunogenicity Related to Anti-HPV-18 Specific B CMI Response for Cervarix 1 Group and Cervarix 2 Group in a Sub-cohort of Subjects
時間枠：At Day 0 and at Months 7, 12, 24 and 36
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The cell-mediated immune response was assessed as being the frequency of B-cell memory of HPV-18 antigen-specific memory B-cells per million memory B-cells in subjects with detectable B-cells.
The results are presented by pre-vaccination status, where S- = seronegative subjects (antibody concentration < cut-off value) prior to vaccination and S+ = seropositive subjects (antibody concentration ≥ cut-off value) prior to vaccination.
The assay was performed on a subset of 100 subjects per study group.
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At Day 0 and at Months 7, 12, 24 and 36
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Cell-mediated Immunogenicity Related to Anti-HPV-16 Specific B CMI Response for Cervarix 3 Group in a Sub-cohort of Subjects
時間枠：At Day 0 and at Months 13, 18 and 36
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The cell-mediated immune response was assessed as being the frequency of B-cell memory of HPV-16 antigen-specific memory B-cells per million memory B-cells in subjects with detectable B-cells.
The results are presented by pre-vaccination status, where S- = seronegative subjects (antibody concentration < cut-off value) prior to vaccination and S+ = seropositive subjects (antibody concentration ≥ cut-off value) prior to vaccination.
The assay was performed on a subset of 100 subjects from Cervarix 3 Group.
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At Day 0 and at Months 13, 18 and 36
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Cell-mediated Immunogenicity Related to Anti-HPV-18 Specific B CMI Response for Cervarix 3 Group in a Sub-cohort of Subjects
時間枠：At Day 0 and at Months 13, 18 and 36
|
The cell-mediated immune response was assessed as being the frequency of B-cell memory of HPV-18 antigen-specific memory B-cells per million memory B-cells in subjects with detectable B-cells.
The results are presented by pre-vaccination status, where S- = seronegative subjects (antibody concentration < cut-off value) prior to vaccination and S+ = seropositive subjects (antibody concentration ≥ cut off value) prior to vaccination.
The assay was performed on a subset of 100 subjects from Cervarix 3 Group.
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At Day 0 and at Months 13, 18 and 36
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Number of Subjects With Any and Grade 3 Solicited Local Symptoms
時間枠：During the 7-day period (Days 0-6) after each vaccine dose and across doses
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Assessed solicited local symptoms were pain, redness and swelling.
Any = occurrence of any solicited local symptom regardless of their intensity grade.
Grade 3 pain = significant pain at rest, that prevented normal every day activity.
Grade 3 redness/swelling = redness/swelling above 50 millimeters (mm).
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During the 7-day period (Days 0-6) after each vaccine dose and across doses
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Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
時間枠：During the 7-day period (Days 0-6) after each vaccine dose and across doses
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Assessed solicited general symptoms were arthralgia, fatigue, gastrointestinal symptoms, headache, myalgia, rash, fever and urticaria.
Any = occurrence of any solicited general symptom regardless of intensity grade or relationship to vaccination.
Any fever = axillary temperature ≥ 37.5 degrees Celsius (°C).
Grade 3 symptom = symptom that prevented normal activity.
Grade 3 fever = fever greater than (>) 39.0 °C.
Related = general symptom assessed by the investigator as causally related to the vaccination.
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During the 7-day period (Days 0-6) after each vaccine dose and across doses
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Number of Subjects With Any, Grade 3 and Related Unsolicited Adverse Events (AEs)
時間枠：During the 30 day (Days 0-29) post-vaccination period
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An unsolicited AE covers 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 and reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms.
Any = any unsolicited AE regardless of intensity grade or relation to vaccination.
Grade 3 = unsolicited AE preventing normal activity.
Related = unsolicited AE assessed by the investigator as causally related to the study vaccination.
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During the 30 day (Days 0-29) post-vaccination period
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Number of Subjects With Any Potential Immune-Mediated Diseases (pIMDs)
時間枠：From Day 0 up to Month 13 (for Cervarix 1 Group and Cervarix 2 Group) and from Day 0 up to Month 18 (for Cervarix 3 Group)
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pIMDs are a subset of AEs that include both clearly autoimmune diseases and also other inflammatory and/or neurologic disorders which may or may not have an autoimmune etiology.
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From Day 0 up to Month 13 (for Cervarix 1 Group and Cervarix 2 Group) and from Day 0 up to Month 18 (for Cervarix 3 Group)
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Number of Subjects With Medically Significant Conditions (MSCs)
時間枠：From Day 0 up to Month 36 (throughout the study period)
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MSCs include AEs prompting emergency room or physician visits that are not related to common diseases or routine visits for physical examination or vaccination, or serious adverse events (SAEs) that are not related to common diseases.
Common diseases include upper respiratory infections, sinusitis, pharyngitis, gastroenteritis, urinary tract infections, cervico-vaginal yeast infections, menstrual cycle abnormalities and injury.
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From Day 0 up to Month 36 (throughout the study period)
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Number of Subjects With Any, Related and Fatal Serious Adverse Events (SAEs)
時間枠：From Day 0 up to Month 36 (throughout the study period)
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SAEs assessed include medical occurrences that resulted in death, were life-threatening, required hospitalization or prolongation of hospitalization or resulted in disability/incapacity or were a congenital anomaly/birth defect in the offspring of a study subject. Any = any SAE regardless of intensity grade or relation to vaccination. Related = SAE assessed by the investigator as causally related to the study vaccination. |
From Day 0 up to Month 36 (throughout the study period)
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Number of Subjects Reporting Pregnancies and Outcomes of Reported Pregnancies
時間枠：From Day 0 up to Month 36 (throughout the study period)
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Outcomes of reported pregnancies were: Ectopic pregnancy, Elective termination NO apparent congenital anomaly (ACA), Live Infant NO ACA, Stillbirth NO ACA.
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From Day 0 up to Month 36 (throughout the study period)
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Number of Subjects Completing the Vaccination Course
時間枠：From Day 0 up to Month 13
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The number of subjects completing the vaccination course was assessed as the number of subjects with at least one dose received during the study.
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From Day 0 up to Month 13
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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。
一般刊行物
- Huang LM, Puthanakit T, Cheng-Hsun C, Ren-Bin T, Schwarz T, Pellegrino A, Esposito S, Frenette L, McNeil S, Durando P, Rheault P, Giaquinto C, Horn M, Petry KU, Peters K, Azhar T, Hillemanns P, De Simoni S, Friel D, Pemmaraju S, Hezareh M, Thomas F, Descamps D, Folschweiller N, Struyf F. Sustained Immunogenicity of 2-dose Human Papillomavirus 16/18 AS04-adjuvanted Vaccine Schedules in Girls Aged 9-14 Years: A Randomized Trial. J Infect Dis. 2017 Jun 1;215(11):1711-1719. doi: 10.1093/infdis/jix154.
- Puthanakit T, Huang LM, Chiu CH, Tang RB, Schwarz TF, Esposito S, Frenette L, Giaquinto C, McNeil S, Rheault P, Durando P, Horn M, Klar M, Poncelet S, De Simoni S, Friel D, De Muynck B, Suryakiran PV, Hezareh M, Descamps D, Thomas F, Struyf F. Randomized Open Trial Comparing 2-Dose Regimens of the Human Papillomavirus 16/18 AS04-Adjuvanted Vaccine in Girls Aged 9-14 Years Versus a 3-Dose Regimen in Women Aged 15-25 Years. J Infect Dis. 2016 Aug 15;214(4):525-36. doi: 10.1093/infdis/jiw036. Epub 2016 Feb 3.
- Stevenson L, Huang LM, Berlaimont V, Folschweiller N. Reply to Poddighe. J Infect Dis. 2017 Sep 15;216(6):783-785. doi: 10.1093/infdis/jix365. No abstract available.
- Folschweiller N, Behre U, Dionne M, Durando P, Esposito S, Ferguson L, Ferguson M, Hillemanns P, McNeil SA, Peters K, Ramjattan B, Schwarz TF, Supparatpinyo K, Suryakirian PV, Janssens M, Moris P, Decreux A, Poncelet S, Struyf F. Long-term Cross-reactivity Against Nonvaccine Human Papillomavirus Types 31 and 45 After 2- or 3-Dose Schedules of the AS04-Adjuvanted Human HPV-16/18 Vaccine. J Infect Dis. 2019 May 5;219(11):1799-1803. doi: 10.1093/infdis/jiy743.
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6月29日
一次修了 (実際)
2012年6月28日
研究の完了 (実際)
2014年11月13日
試験登録日
最初に提出
2011年6月17日
QC基準を満たした最初の提出物
2011年6月23日
最初の投稿 (見積もり)
2011年6月27日
学習記録の更新
投稿された最後の更新 (実際)
2020年6月9日
QC基準を満たした最後の更新が送信されました
2020年5月19日
最終確認日
2020年5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
- 114700
- 2011-000757-22 (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
IPD for this study will be made available via the Clinical Study Data Request site.
IPD 共有時間枠
IPD is available via the Clinical Study Data Request site (click on the link provided below)
IPD 共有アクセス基準
Access is provided after a research proposal is submitted and has received approval from the Independent Review Panel and after a Data Sharing Agreement is in place.
Access is provided for an initial period of 12 months but an extension can be granted, when justified, for up to another 12 months.
IPD 共有サポート情報タイプ
- STUDY_PROTOCOL
- SAP
- ICF
- CSR
試験データ・資料
-
インフォームド コンセント フォーム
情報識別子：114700情報コメント：For additional information about this study please refer to the GSK Clinical Study Register
-
研究プロトコル
情報識別子：114700情報コメント：For additional information about this study please refer to the GSK Clinical Study Register
-
臨床研究報告書
情報識別子：114700情報コメント：For additional information about this study please refer to the GSK Clinical Study Register
-
統計分析計画
情報識別子：114700情報コメント：For additional information about this study please refer to the GSK Clinical Study Register
-
個人参加者データセット
情報識別子：114700情報コメント：For additional information about this study please refer to the GSK Clinical Study Register
-
データセット仕様
情報識別子：114700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。