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Study to Evaluate the Immunogenicity and Safety of an Investigational Influenza Vaccine (H1N1) in Children

2019年6月11日 更新者：GlaxoSmithKline

Safety and Immunogenicity Study of GSK Biologicals' Pandemic Influenza Candidate Vaccine (GSK2340272A) in Children Aged 3 to 17 Years

The objective of this study is to evaluate the immunogenicity and safety of GSK Biologicals' investigational vaccine GSK2340272A in children aged between 3 and 17 years.

調査の概要

状態

完了

条件

介入・治療

詳細な説明

This Protocol Posting has been updated following Protocol amendment 1, October 2009. The impacted section are the study design section, the outcomes measures section and the intervention section.

研究の種類

介入

入学 (実際)

245

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

  • ドイツ
    • Baden-Wuerttemberg
      • Kehl、Baden-Wuerttemberg、ドイツ、77694
        • GSK Investigational Site
      • Schwaebisch-Hall、Baden-Wuerttemberg、ドイツ、74523
        • GSK Investigational Site
      • Stuttgart、Baden-Wuerttemberg、ドイツ、70469
        • GSK Investigational Site
    • Bayern
      • Bindlach、Bayern、ドイツ、95463
        • GSK Investigational Site
      • Muenchen、Bayern、ドイツ、81241
        • GSK Investigational Site
      • Noerdlingen、Bayern、ドイツ、86720
        • GSK Investigational Site
    • Rheinland-Pfalz
      • Frankenthal、Rheinland-Pfalz、ドイツ、67227
        • GSK Investigational Site
      • Worms、Rheinland-Pfalz、ドイツ、67547
        • 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

3年～17年 (子)

健康ボランティアの受け入れ

いいえ

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 device.

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
実験的：Group A
Subjects receiving alternative dose of GSK23440272A vaccine
生物学的：GSK investigational vaccine GSK2340272A
Three intramuscular injections

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
Humoral Immune Response in Terms of Haemagglutination Inhibition (HI) Antibody Titers Against the Flu A/California/7/2009 (H1N1) Vaccine Strain
時間枠：At Day 0, Day 21 and Day 42
Antibody titers were expressed as Geometric mean titers (GMTs).
At Day 0, Day 21 and Day 42
Number of Seroconverted Subjects for HI Antibodies Against the Flu A/California/7/2009 (H1N1) Virus Strain
時間枠：At Day 42
A seroconverted subject was defined as a vaccinated subject with either a pre-vaccination titre less than (<) 1:10 and a post-vaccination titre greater than or equal to (≥) 1:40 or a pre-vaccination titre ≥ 1:10 and at least a 4-fold increase in post-vaccination titre. The Committee for Medicinal Products for Human Use (CHMP) criterion was fulfilled if the point estimate for SCR was greater than (>) 40% in children aged 3 to 17 years.
At Day 42
Number of Subjects Who Were Seroprotected for HI Antibodies Against the Flu A/California/7/2009 (H1N1) Virus Strain
時間枠：At Day 42
A seroprotected subject was defined as a vaccinated subject with a serum HI titre greater than or equal to (≥) 1:40, that usually is accepted as indicating protection. The Committee for Medicinal Products for Human Use (CHMP) criterion was fulfilled if the post-vaccination time point estimate for SPR the point estimate for SPR was greater than (>) 70% in children aged 3 to 17 years.
At Day 42
HI Antibody Geometric Mean Fold Rise (GMFR) Against the Flu A/California/7/2009 (H1N1) Virus Strain
時間枠：At Day 42
GMFR, also called seroconversion factor (SCF), was defined as the fold increase in serum HI GMTs post-vaccination compared to pre-vaccination. The CHMP criterion was fulfilled if the point estimate for GMFR was greater than (>) 2.5 in children aged 3 to 17 years
At Day 42

二次結果の測定

結果測定
メジャーの説明
時間枠
Humoral Immune Response in Terms of Haemagglutination Inhibition (HI) Antibody Titers Against the Flu A/California/7/2009 (H1N1) Vaccine Strain
時間枠：At Month 6
Antibody titers were expressed as geometric mean titers (GMTs)
At Month 6
Humoral Immune Response in Terms of Haemagglutination Inhibition (HI) Antibody Titers Against the Flu A/California/7/2009 (H1N1) Vaccine Strain
時間枠：At Month 12
Antibody titers were expressed as geometric mean titers (GMTs)
At Month 12
Number of Seroconverted Subjects for HI Antibodies Against the Flu A/California/7/2009 (H1N1) Virus Strain
時間枠：At Month 6
A seroconverted subject was defined as a vaccinated subject with either a pre-vaccination titre less than (<) 1:10 and a post-vaccination titre greater than or equal to (≥) 1:40 or a pre-vaccination titre ≥ 1:10 and at least a 4-fold increase in post-vaccination titre. The Committee for Medicinal Products for Human Use (CHMP) criterion was fulfilled if the point estimate for SCR was greater than (>) 40% in children aged 3 to 17 years.
At Month 6
Number of Subjects Who Were Seroprotected for HI Antibodies Against the Flu A/California/7/2009 (H1N1) Virus Strain
時間枠：At Month 6
A seroprotected subject was defined as a vaccinated subject with a serum HI titre greater than or equal to (≥) 1:40, that usually is accepted as indicating protection. The Committee for Medicinal Products for Human Use (CHMP) criterion was fulfilled if the post-vaccination time point estimate for SPR the point estimate for SPR was greater than (>) 70% in children aged 3 to 17 years.
At Month 6
Number of Subjects Who Were Seroprotected for HI Antibodies Against the Flu A/California/7/2009 (H1N1) Virus Strain
時間枠：At Month 12
A seroprotected subject was defined as a vaccinated subject with a serum HI titre greater than or equal to (≥) 1:40, that usually is accepted as indicating protection. The Committee for Medicinal Products for Human Use (CHMP) criterion was fulfilled if the post-vaccination time point estimate for SPR the point estimate for SPR was greater than (>) 70% in children aged 3 to 17 years.
At Month 12
HI Antibody Geometric Mean Fold Rise (GMFR) Against the Flu A/California/7/2009 (H1N1) Virus Strain
時間枠：At Month 6
GMFR, also called seroconversion factor (SCF), was defined as the fold increase in serum HI GMTs post-vaccination compared to pre-vaccination. The CHMP criterion was fulfilled if the point estimate for GMFR was greater than (>) 2.5 in children aged 3 to 17 years
At Month 6
Humoral Immune Response in Terms of Neutralising Antibodies Against the Flu A/Netherlands/602/2009 (H1N1) Vaccine Strain
時間枠：At Day 0, Day 21, Day 42 and Month 6
Antibody titers were expressed as Geometric mean titers (GMTs).
At Day 0, Day 21, Day 42 and Month 6
Humoral Immune Response in Terms of Neutralising Antibodies Against the Flu A/Netherlands/602/2009 (H1N1) Vaccine Strain
時間枠：At Month 12
Antibody titers were expressed as Geometric mean titers (GMTs).
At Month 12
Number of Seroconverted Subjects for Neutralising Antibodies Against the Flu A/Netherlands/602/2009 (H1N1) Virus Strain
時間枠：At Day 21 and Day 42
A seroconverted subject was defined as a vaccinated subject with either a pre-vaccination titre less than (<) 1:10 and a post-vaccination titre greater than or equal to (≥) 1:40 or a pre-vaccination titre ≥ 1:10 and at least a 4-fold increase in post-vaccination titre. The Committee for Medicinal Products for Human Use (CHMP) criterion was fulfilled if the point estimate for SCR was greater than (>) 40% in children aged 3 to 17 years.
At Day 21 and Day 42
Number of Seroconverted Subjects for Neutralising Antibodies Against the Flu A/Netherlands/602/2009 (H1N1) Virus Strain
時間枠：At Month 6
A seroconverted subject was defined as a vaccinated subject with either a pre-vaccination titre less than (<) 1:10 and a post-vaccination titre greater than or equal to (≥) 1:40 or a pre-vaccination titre ≥ 1:10 and at least a 4-fold increase in post-vaccination titre. The Committee for Medicinal Products for Human Use (CHMP) criterion was fulfilled if the point estimate for SCR was greater than (>) 40% in children aged 3 to 17 years.
At Month 6
Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms
時間枠：During the 7-day (Days 0-6) post-vaccination period
Solicited local symptoms assessed were pain, redness and swelling. Any was defined as any solicited local symptom reported irrespective of intensity. Grade 3 pain was defined as significant pain at rest that prevented normal everyday activities as assessed by inability to attend/do work or school or cried when limb was moved/spontaneously painful. Grade 3 redness and swelling was greater than 50 millimeters (mm) i.e. > 50mm.
During the 7-day (Days 0-6) post-vaccination period
Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms
時間枠：During the 7-day (Days 0-6) post-vaccination period
Solicited general symptoms assessed were arthralgia, diarrhoea, drowsiness, fatigue, gastro-intestinal symptoms, headache, irritability, loss of appetite, myalgia, shivering, sweating and fever [axillary temperature above 37.5 degrees Celsius (°C)]. Any = any solicited general symptom reported irrespective of intensity and relationship to vaccination. Related = symptoms considered by the investigator to have a causal relationship to vaccination. Grade 3 symptoms = symptoms that prevented normal activity. Grade 3 fever = axillary temperature above 39.0°C.
During the 7-day (Days 0-6) post-vaccination period
Number of Subjects Reporting Any Medically Attended Adverse Events (MAEs)
時間枠：During the entire study period (Day 0 to Month 12)
MAEs were defined as adverse events with medically-attended visits that were not routine visits for physical examination or vaccination.
During the entire study period (Day 0 to Month 12)
Number of Subjects Reporting Any Adverse Events of Specific Interest (AESI)/Potential Immune-mediated Diseases (pIMDs)
時間枠：During the entire study period (Day 0 to Month 12)
Potential immune-mediated diseases (pIMDs) were defined as a subset of adverse events that included both clearly autoimmune diseases and also other inflammatory and/or neurologic disorders which might or might not have an autoimmune etiology. "Any pIMD" was defined as at least one pIMD experienced by the study subject.
During the entire study period (Day 0 to Month 12)
Number of Subjects Reporting Any, Grade 3 and Related Unsolicited Adverse Events (AEs).
時間枠：Within the 84-day after the first vaccination or from 63-day follow-up period after the second vaccination
An unsolicited AE was defined as any AE (i.e. any untoward medical occurrence in a patient or clinical investigation subject, temporally associated with use of a medicinal product, whether or not considered related to the medicinal product) 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 occurrence of any unsolicited symptom regardless of intensity grade or relation to vaccination.
Within the 84-day after the first vaccination or from 63-day follow-up period after the second vaccination
Number of Subjects Reporting Any and Related Serious Adverse Events (SAEs)
時間枠：During the entire study period (Day 0 to Month 12)
A serious adverse event was any untoward medical occurrence that: resulted in death, was life threatening, required hospitalization or prolongation of hospitalization, resulted in disability/incapacity or was a congenital anomaly/birth defect in the offspring of a study subject. Any was defined as occurrence of any symptom regardless of intensity grade or relation to vaccination and related was an event assessed by the investigator as causally related to the study vaccination.
During the entire study period (Day 0 to Month 12)
Number of Subjects With Normal and Abnormal Haematological and Biochemistry Parameters With Respect to Alanine Aminotransferase (ALAT), Aspartate Aminotransferase (ASAT), Total Bilirubin, Bilirubin Conjugated/ Direct,Creatine and Blood Urea Nitrogen(BUN)
時間枠：At Day 0, Day 21, Day 42 and Month 6 (M6)
Subjects were categorized by age and according to their results at pre-vaccination (Day 0), Day 21, Day 42 and Month 6 which were below, within and above the normal ranges or unknown as measured by validated assay according to international standards.
At Day 0, Day 21, Day 42 and Month 6 (M6)

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

GlaxoSmithKline

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

便利なリンク

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)

2009年9月29日

一次修了 (実際)

2010年11月22日

研究の完了 (実際)

2010年11月22日

試験登録日

最初に提出

2009年9月3日

QC基準を満たした最初の提出物

2009年9月4日

最初の投稿 (見積もり)

2009年9月7日

学習記録の更新

投稿された最後の更新 (実際)

2019年6月26日

QC基準を満たした最後の更新が送信されました

2019年6月11日

最終確認日

2019年6月1日

詳しくは

本研究に関する用語

キーワード

追加の関連 MeSH 用語

その他の研究ID番号

  • 113638
  • 2009-015011-41 (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

  • 研究プロトコル
  • 統計分析計画 (SAP)
  • インフォームド コンセント フォーム (ICF)
  • 臨床試験報告書（CSR）

試験データ・資料

  1. インフォームド コンセント フォーム
    情報識別子：113638
    情報コメント：For additional information about this study please refer to the GSK Clinical Study Register
  2. 臨床研究報告書
    情報識別子：113638
    情報コメント：For additional information about this study please refer to the GSK Clinical Study Register
  3. 研究プロトコル
    情報識別子：113638
    情報コメント：For additional information about this study please refer to the GSK Clinical Study Register
  4. 個人参加者データセット
    情報識別子：113638
    情報コメント：For additional information about this study please refer to the GSK Clinical Study Register
  5. データセット仕様
    情報識別子：113638
    情報コメント：For additional information about this study please refer to the GSK Clinical Study Register
  6. 統計分析計画
    情報識別子：113638
    情報コメント：For additional information about this study please refer to the GSK Clinical Study Register
  7. 注釈付き症例報告書
    情報識別子：113638
    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 investigational vaccine GSK2340272Aの臨床試験

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スポンサーと協力者

医学的状態

薬物療法

CROs by country

CROs in Mongolia

条件

まれな病気

薬物療法

ダイエットサプリメント

スポンサー/協力者

場所

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