Safety and Immunogenicity Study of GSK Biologicals' Pandemic Influenza Candidate Vaccine (H1N1) (GSK2340272A)
2017年7月31日 更新者：GlaxoSmithKline
Safety and Immunogenicity Study of GSK Biologicals' Pandemic Influenza Candidate Vaccine (GSK2340272A) in Children Aged 3 to 17 Years
This trial is designed to assess the safety and immunogenicity of a prime-boost schedule of GSK Biologicals' investigational vaccine GSK2340272A in children aged between 3 and 17 years.
調査の概要
研究の種類
介入
入学 (実際)
210
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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Bilbao、スペイン、48013
- GSK Investigational Site
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Burgos、スペイン、09005
- GSK Investigational Site
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Madrid、スペイン、28046
- GSK Investigational Site
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Móstoles/Madrid、スペイン、28935
- GSK Investigational Site
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Sevilla、スペイン、41013
- 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
3年～17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 their parent(s)/Legally Acceptable Representative(s) (LAR) can and will comply with the requirements of the protocol.
- Children, male or female, aged between 3 and 17 years at the time of the first study vaccination.
- Written informed consent obtained from the subject parent(s) or LAR(s) of the subject. Assent obtained from the subject when applicable.
- Healthy children as established by medical history and clinical examination when entering into the study.
- Parent/LAR with access to a consistent means of telephone contact, land line or mobile, but NOT a pay phone or other multiple-user.
Exclusion Criteria:
- Use of any investigational or non-registered product other than the study vaccine within 30 days preceding the first dose of the study vaccine or planned use during the study period.
- Clinically or virologically confirmed influenza infection within six months preceding the study start.
- Planned administration of any vaccine 30 days prior and 30 days after any study vaccine administration.
- Chronic administration of immunosuppressants or other immune-modifying drugs within three months prior to enrolment in this study or planned administration during the study period.
- Acute disease and/or fever at the time of enrolment
- Any confirmed or suspected immunosuppressive or immunodeficient condition based on medical history and physical examination.
- Acute or chronic, clinically-significant pulmonary, cardiovascular, hepatic or renal functional abnormality, as determined by medical history and physical examination.
- Previous administration of any H1N1 A/California-like vaccine.
- Administration of immunoglobulins and/or any blood products within the three months prior to the enrolment in this study, or planned during the study.
- If the subject is female and if she is of childbearing potential, she must practice adequate contraception for 30 days prior to vaccination, have a negative pregnancy test and continue such precautions for two months after completion of the vaccination series.
- Any known or suspected allergy to any constituent of influenza vaccines;a history of anaphylactic-type reaction to any constituent of influenza vaccines; or a history of severe adverse reaction to a previous influenza vaccine.
- Known use of an analgesic or antipyretic medication within 12 hours prior to first vaccination.
- Child in Care.
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：なし
- 介入モデル：単一グループの割り当て
- 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：グループA
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Two primary intramuscular (IM) injections and a booster IM injection
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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 Subjects With Haemagglutination-inhibition (HI) Antibody Concentrations Above the Cut-off Value
時間枠：At Day 0
|
The seropositivity cut-off value of the assay was equal to or above (≥) 1:10 in the sera of subjects seronegative before vaccination.
The flu strain assessed was A/California/7/2009 (H1N1)v-like (Flu A/CAL/7/09).
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At Day 0
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Number of Subjects With HI Antibody Concentrations Above the Cut-off Value
時間枠：At Day 42
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The seropositivity cut-off value of the assay was ≥ 1:10 in the sera of subjects seronegative before vaccination.
The flu strain assesssed was Flu A/CAL/7/09.
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At Day 42
|
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Titers for Serum HI Antibodies
時間枠：At Day 0
|
Antibody titers were presented as geometric mean titers (GMTs).
The reference seropositivity cut-off value was ≥ 1:10.
The flu strain assessed was Flu A/CAL/7/09.
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At Day 0
|
|
Titers for Serum HI Antibodies
時間枠：At Day 42
|
Antibody titers were presented as geometric mean titers (GMTs).
The reference seropositivity cut-off value was ≥ 1:10.
The flu strain assessed was Flu A/CAL/7/09.
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At Day 42
|
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Number of Seroconverted (SCR) Subjects in Terms of HI Antibodies
時間枠：At Day 42
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A seroconverted subject was defined as: For initially seronegative subjects [antibody titer below (<) 1:10 prior to vaccination], antibody titer ≥ 1:40 after vaccination; For initially seropositive subjects (antibody titer ≥ 1:10 prior to vaccination), at least a 4-fold increase in post-vaccination titer.
The flu strain assessed was Flu A/CAL/7/09.
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At Day 42
|
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Number of Seroprotected (SPR) Subjects in Terms of HI Antibodies
時間枠：At Day 42
|
Seroprotection was defined as the percentage of subjects with a serum HI titer ≥ 1:40, that usually is accepted as indicating protection.
The flu strain assessed was Flu A/CAL/7/09.
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At Day 42
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Seroconversion Factor (SCF) for HI Antibody Titers
時間枠：At Day 42
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Seroconversion factor was defined as the fold increase in serum HI GMTs post-vaccination compared to pre-vaccination.
The flu strain assessed was Flu A/CAL/7/09.
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At Day 42
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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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任意およびグレード3の要請された局所症状を有する被験者の数
時間枠：ワクチン接種後 7 日間 (0 日目から 6 日目) の各投与後および投与後の期間
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評価された求められた局所症状は、痛み、赤み、および腫れでした。
Any = 強度グレードに関係なく症状が発生。
グレード 3 の痛み = 通常の活動を妨げた痛み。
グレード 3 の発赤/腫れ = 注射部位の 50 ミリメートル (mm) を超えて広がる発赤/腫れ。
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ワクチン接種後 7 日間 (0 日目から 6 日目) の各投与後および投与後の期間
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Number of Subjects With HI Antibody Concentrations Above the Cut-off Value
時間枠：At Days 0, 21, 42 and at Month 12
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The seropositivity cut-off value of the assay was ≥ 1:10 in the sera of subjects seronegative before vaccination.
The flu strain assesssed was Flu A/CAL/7/09.
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At Days 0, 21, 42 and at Month 12
|
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Titers for Serum HI Antibodies
時間枠：At Days 0, 21, 42 and at Month 12
|
Antibody titers were presented as geometric mean titers (GMTs).
The reference seropositivity cut-off value was ≥ 1:10.
The flu strain assessed was Flu A/CAL/7/09.
|
At Days 0, 21, 42 and at Month 12
|
|
Number of Seroconverted (SCR) Subjects in Terms of HI Antibodies
時間枠：At Days 21, 42 and at Month 12
|
A seroconverted subject was defined as: For initially seronegative subjects [antibody titer below (<) 1:10 prior to vaccination], antibody titer ≥ 1:40 after vaccination; For initially seropositive subjects (antibody titer ≥ 1:10 prior to vaccination), at least a 4-fold increase in post-vaccination antibody titer.
The flu strain assessed was Flu A/CAL/7/09.
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At Days 21, 42 and at Month 12
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Number of Seroprotected Subjects in Terms of HI Antibodies
時間枠：At Days 0, 21, 42 and at Month 12
|
Seroprotection was defined as the percentage of subjects with a serum HI titer ≥ 1:40, that usually is accepted as indicating protection.
The flu strain assessed was Flu A/CAL/7/09.
|
At Days 0, 21, 42 and at Month 12
|
|
Seroconversion Factor (SCF) for HI Antibody Titers
時間枠：At Days 21, 42 and at Month 12
|
Seroconversion factor was defined as the fold increase in serum HI GMTs post-vaccination compared to pre-vaccination.
The flu strain assessed was Flu A/CAL/7/09.
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At Days 21, 42 and at Month 12
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Number of Subjects With Neutralizing Antibody Concentrations Above the Cut-off Value
時間枠：At Days 0, 21 and 42
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The seropositivity cut-off value of the assay was ≥ 1:8 in the sera of subjects seronegative before vaccination.
The flu strain assesssed was Flu A/Neth/602/09.
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At Days 0, 21 and 42
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Titers for Serum Neutralizing Antibodies
時間枠：At Days 0, 21 and 42
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Antibody titers were presented as geometric mean titers (GMTs).
The reference seropositivity cut-off value was ≥ 1:8.
The flu strain assessed was A/Netherlands/602/2009 (H1N1)v-like (Flu A/Neth/602/09).
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At Days 0, 21 and 42
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Number of Subjects With Neutralizing Antibody Concentrations Above the Cut-off Value
時間枠：At Month 12
|
The seropositivity cut-off value of the assay was ≥ 1:8 in the sera of subjects seronegative before vaccination.
The flu strain assesssed was Flu A/Neth/602/09.
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At Month 12
|
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Titers for Serum Neutralizing Antibodies
時間枠：At Month 12
|
Antibody titers were presented as geometric mean titers (GMTs).
The reference seropositivity cut-off value was ≥ 1:8.
The flu strain assessed was Flu A/Neth/602/09.
|
At Month 12
|
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Number of Seroconverted (SCR) Subjects in Terms of H1N1 Neutralizing Antibodies
時間枠：At Days 21 and 42
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A seroconverted subject was defined as: For initially seronegative subjects, antibody titer ≥ 1:32 after vaccination; For initially seropositive subjects, at least a 4-fold increase in post-vaccination titer.
The flu strain assessed was Flu A/Neth/602/09.
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At Days 21 and 42
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Number of Seroconverted (SCR) Subjects in Terms of H1N1 Neutralizing Antibodies
時間枠：At Month 12
|
A seroconverted subject was defined as: For initially seronegative subjects, antibody titer ≥ 1:32 after vaccination; For initially seropositive subjects, at least a 4-fold increase in post-vaccination titer.
The flu strain assessed was Flu A/Neth/602/09.
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At Month 12
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Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
時間枠：During the 7-day (Days 0-6) post-vaccination period following each dose and across doses
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Assessed solicited general symptoms were diarrhea, drowsiness, irritability, loss of appetite, shivering, sweating and fever [defined as axillary temperature equal to or above (≥) 37.5 degrees Celsius (°C)].
Any = occurrence of the symptom regardless of intensity grade.
Grade 3 symptom = symptom that prevented normal activity.
Grade 3 fever = fever > 39.0 °C.
Related = symptom assessed by the investigator as related to the vaccination.
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During the 7-day (Days 0-6) post-vaccination period following each 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 (Days 0-6) post-vaccination period following each dose and across doses
|
Assessed solicited general symptoms were arthralgia, fatigue, gastrointestinal, headache, myalgia, shivering and fever [defined as axillary temperature equal to or above (≥) 37.5 degrees Celsius (°C)].
Any = occurrence of the symptom regardless of intensity grade.
Grade 3 symptom = symptom that prevented normal activity.
Grade 3 fever = fever > 39.0 °C.
Related = symptom assessed by the investigator as related to the vaccination.
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During the 7-day (Days 0-6) post-vaccination period following each dose and across doses
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Number of Subjects With Any Medically-attended Events (MAEs)
時間枠：During the entire study period (from Day 0 up to Month 12)
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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.
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During the entire study period (from Day 0 up to Month 12)
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Number of Subjects With Any Adverse Events of Specific Interest (AESIs), Including Potential Immune-mediated Disease (pIMDs)
時間枠：During the entire study period (from Day 0 up to Month 12)
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An AESI was defined as an AE including autoimmune diseases and other mediated inflammatory disorders and assessed by the investigator as specific to the treatment administration.
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During the entire study period (from Day 0 up to Month 12)
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Number of Subjects With Normal or Abnormal Biochemical Levels
時間枠：At Days 0, 21 and 42
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Among biochemical parameters assessed were alanine aminotransferase [ALAT], aspartate aminotransferase [ASAT], bilirubin [BILI], creatinine [CREA] and blood urea nitrogen [BUN].
Levels of biochemical parameters assessed in terms of normal laboratory values were - unknown, below, within and above.
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At Days 0, 21 and 42
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Number of Subjects With Any, Grade 3 and Related Unsolicited Adverse Events (AEs)
時間枠：During the 21-day (Days 0-20) follow-up period after the first vaccination
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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 was defined as the occurrence of any unsolicited AE regardless of intensity grade or relation to vaccination.
Grade 3 AE = an AE which prevented normal, everyday activities.
Related = AE assessed by the investigator as related to the vaccination.
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During the 21-day (Days 0-20) follow-up period after the first vaccination
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Number of Subjects With Any, Grade 3 and Related Unsolicited Adverse Events (AEs)
時間枠：During the 83-day (Days 0-82) follow-up period after the first vaccination and the 62-day (Days 0-61) follow-up period after the second vaccination
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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 was defined as the occurrence of any unsolicited AE regardless of intensity grade or relation to vaccination.
Grade 3 AE = an AE which prevented normal, everyday activities.
Related = AE assessed by the investigator as related to the vaccination.
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During the 83-day (Days 0-82) follow-up period after the first vaccination and the 62-day (Days 0-61) follow-up period after the second vaccination
|
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Number of Subjects With Serious Adverse Events (SAEs)
時間枠：During the entire study period (from Day 0 up to Month 12)
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Serious adverse events (SAEs) assessed include 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 up to Month 12)
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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
- Garcia-Sicilia J, Aristegui J, Omenaca F, Carmona A, Tejedor JC, Merino JM, Garcia-Corbeira P, Walravens K, Bambure V, Moris P, Caplanusi A, Gillard P, Dieussaert I. Safety and persistence of the humoral and cellular immune responses induced by 2 doses of an AS03-adjuvanted A(H1N1)pdm09 pandemic influenza vaccine administered to infants, children and adolescents: Two open, uncontrolled studies. Hum Vaccin Immunother. 2015;11(10):2359-69. doi: 10.1080/21645515.2015.1063754.
- Garcia-Sicilia J, Gillard P, Carmona A, Tejedor JC, Aristegui J, Merino JM, Behre U, Caplanusi A, Vaman T, Dieussaert I. Immunogenicity and safety of AS03-adjuvanted H1N1 pandemic vaccines in children and adolescents. Vaccine. 2011 Jun 10;29(26):4353-61. doi: 10.1016/j.vaccine.2011.04.011. Epub 2011 Apr 17.
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
2009年9月10日
一次修了 (実際)
2010年11月27日
研究の完了 (実際)
2010年11月27日
試験登録日
最初に提出
2009年8月20日
QC基準を満たした最初の提出物
2009年8月20日
最初の投稿 (見積もり)
2009年8月24日
学習記録の更新
投稿された最後の更新 (実際)
2018年2月19日
QC基準を満たした最後の更新が送信されました
2017年7月31日
最終確認日
2016年10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
- 113528
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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統計分析計画
情報識別子：113528情報コメント：For additional information about this study please refer to the GSK Clinical Study Register
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注釈付き症例報告書
情報識別子：113528情報コメント：For additional information about this study please refer to the GSK Clinical Study Register
-
インフォームド コンセント フォーム
情報識別子：113528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：113528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：113528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：113528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：113528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。