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Study to Asses DTPw-HBV/Hib at 15-18 Months (m) and Mencevax™ ACW at 24 to 30 m in Primed Subjects

2018年4月26日 更新者：GlaxoSmithKline

Booster Vaccination Study to Assess Safety & Reactogenicity of a Dose of DTPw-HBV/Hib Vaccine and to Assess the Immunogenicity, Safety & Reactogenicity of a Dose of Mencevax™ ACW in Subjects Primed in Study 759346/007

The purpose of this study is to assess the safety and reactogenicity of a booster dose of diphtheria-tetanus-whole cell pertussis-hepatitis B virus/Haemophilus influenzae type b vaccine (DTPw-HBV/Hib) at 15-18 m and to assess the immunogenicity, safety, and reactogenicity of a dose of Mencevax™ Group A, C and W135 polysaccharide meningococcal vaccine (ACW) at 24 to 30 m in primed subjects.

The Protocol Posting has been updated in order to comply with the FDA Amendment Act, Sep 2007.

調査の概要

状態

完了

条件

介入・治療

詳細な説明

This open study will have two parallel groups based on the vaccination received in the primary study: AC primed Group: primed with Tritanrix™-HepB/Hib-MenAC vaccine and AC unprimed Group (control): primed with Tritanrix™-HepB/Hiberix™ vaccine. All subjects will receive a booster dose of Tritanrix™-HepB/Hiberix™ vaccine at 15 to 18 months of age with GSK Biological's OPV vaccine given concomitantly and a dose of Mencevax™ ACW vaccine at 24 to 30 months of age. Blood sampling will be done prior to (pre) and one month after (post) the Mencevax™ ACW vaccine administration for immunogenicity analyses. The study will last minimum 7 to maximum 16 months per subject.

Mencevax™ ACWY was changed to Mencevax™ ACW throughout the posting to correct an inconsistency in the earlier version of the protocol posting and to reflect the actual situation.

研究の種類

介入

入学 (実際)

168

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

  • 南アフリカ
      • Brits、南アフリカ、0250
        • GSK Investigational Site
      • Ga-Rankuwa、南アフリカ、0208
        • GSK Investigational Site
      • Rooihuiskraal、南アフリカ、0145
        • 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

1年～1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 parents/guardians can and will comply with the requirements of the protocol.
  • A male or female between, and including, 15 and 18 months of age at the time of vaccination.
  • Written informed consent obtained from the parent or guardian of the subject.
  • Healthy subjects as established by medical history and clinical examination before entering into the study.
  • Having participated in the primary vaccination study (CPMS N° 759346/007).

Exclusion criteria:

  • Use of any investigational or non-registered product (drug or vaccine) other than the study vaccine within 30 days preceding the vaccination, or planned use during the study period.
  • Chronic administration (defined as more than 14 days) of immunosuppressants or other immune-modifying drugs within six months prior to vaccination.
  • Planned administration/ administration of a vaccine not foreseen by the study protocol within 30 days of vaccination.
  • Booster vaccination against diphtheria, tetanus, pertussis, hepatitis B, Haemophilus influenzae type b (Hib) and/or meningococcal serogroups A, C or W disease, after the date of the study conclusion visit of the primary vaccination study (CPMS N° 759346/007).
  • History of diphtheria, tetanus, pertussis, hepatitis B, Hib and/or meningococcal serogroup A, C or W disease.
  • Known exposure to diphtheria, tetanus, pertussis, hepatitis B, Hib and/or meningococcal serogroup A, C or W disease.
  • Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination.
  • A family history of congenital or hereditary immunodeficiency.
  • History of allergic disease or reactions likely to be exacerbated by any component of the vaccines administered in the study.
  • Major congenital defects or serious chronic illness.
  • History of any neurologic disorders or seizures including febrile seizures in infancy.
  • Acute disease at the time of enrolment.
  • Axillary temperature ≥ 37.5°C at the time of vaccination.
  • Administration of immunoglobulins and/or any blood products within the three months preceding the vaccination or planned administration during the study period.
  • Anaphylactic reaction following the administration of vaccine in the primary vaccination study.
  • Known hypersensitivity to any component of the vaccine, or subjects having shown signs of hypersensitivity after previous administration of diphtheria, tetanus, pertussis, hepatitis B, Hib or meningococcal vaccines.

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
実験的：AC primed Group
生物学的：Tritanrix™- HepB
One intramuscular dose during the booster vaccination study in subjects aged 15 to 18 months
生物学的：Hiberix™
One intramuscular dose during the booster vaccination study in subjects aged 15 to 18 months
生物学的：Mencevax™ ACW
One subcutaneous dose during the booster vaccination study in subjects aged 24 to 30 months
アクティブコンパレータ：AC unprimed Group
生物学的：Tritanrix™- HepB
One intramuscular dose during the booster vaccination study in subjects aged 15 to 18 months
生物学的：Hiberix™
One intramuscular dose during the booster vaccination study in subjects aged 15 to 18 months
生物学的：Mencevax™ ACW
One subcutaneous dose during the booster vaccination study in subjects aged 24 to 30 months

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
Number of Subjects With Serum Bactericidal Assay Against N. Meningitidis Serogroups A, C Using Rabbit Complement (rSBA-MenA,C) Antibodies
時間枠：At one month post vaccination with Mencevax™ ACW vaccine (Month 25-31)
Pre-defined assay cut-off values for assessed titers were greater than or equal to (≥) 1:128.
At one month post vaccination with Mencevax™ ACW vaccine (Month 25-31)

二次結果の測定

結果測定
メジャーの説明
時間枠
Number of Subjects With rSBA-MenA,C, W-135 Antibody Titers ≥ Predefined Cut-offs
時間枠：Prior to (Months 24-30) & one month after the administration of the Mencevax™ ACW vaccine (Months 25-31)
Antibody titer cut-offs were ≥ 1:8 and ≥ 1:128.
Prior to (Months 24-30) & one month after the administration of the Mencevax™ ACW vaccine (Months 25-31)
Anti-rSBA-MenA, C, W-135 Antibody Titers
時間枠：Prior to (Months 24-30) & one month after the administration of the Mencevax™ ACW vaccine (Months 25-31)
Antibody titers were expressed as geometric mean titers (GMTs).
Prior to (Months 24-30) & one month after the administration of the Mencevax™ ACW vaccine (Months 25-31)
Number of Subjects With Anti-polysaccharide A (Anti-PSA) and C (Anti-PSC) Antibody Concentrations Above Predefined Cut-off Values
時間枠：Prior to (Months 24-30) & one month after the administration of the Mencevax™ ACW vaccine (Months 25-31)
Antibody concentrations cut-off were ≥ 0.3 and ≥2 micrograms per millilitre (µg/mL).
Prior to (Months 24-30) & one month after the administration of the Mencevax™ ACW vaccine (Months 25-31)
Anti-PSA and Anti-PSC Antibody Concentrations
時間枠：Prior to (Months 24-30) & one month after the administration of the Mencevax™ ACW vaccine (Months 25-31
Antibody concentrations were expressed as Geometric Mean Concentrations (GMCs).
Prior to (Months 24-30) & one month after the administration of the Mencevax™ ACW vaccine (Months 25-31
Number of Subjects With Anti- Polysaccharide W (Anti-PSW) Antibody Concentrations ≥ Predefined Cut-off Values
時間枠：Prior to (Months 24-30) & one month after the administration of the Mencevax™ ACW vaccine (Months 25-31)
Antibody concentrations were ≥ 0.3 µg/mL.
Prior to (Months 24-30) & one month after the administration of the Mencevax™ ACW vaccine (Months 25-31)
Anti-PSW Antibody Concentrations
時間枠：Prior to (Months 24-30) & one month after the administration of the Mencevax™ ACW vaccine (Months 25-31)
Antibody concentrations were expressed as Geometric Mean Concentrations (GMCs).
Prior to (Months 24-30) & one month after the administration of the Mencevax™ ACW vaccine (Months 25-31)
Number of Subjects With Anti-hepatitis B (Anti-HBs) Antibody Concentrations ≥ Predefined Cut-off Values
時間枠：Prior to (Months 24-30) the administration of the Mencevax™ ACW vaccine
Antibody concentrations cut-off were ≥ 10 milli international units per milliliter (mIU/mL).
Prior to (Months 24-30) the administration of the Mencevax™ ACW vaccine
Anti-HBs Antibody Concentrations
時間枠：Prior to (Months 24-30) the administration of the Mencevax™ ACW vaccine
Antibody concentrations were expressed as Geometric Mean Concentrations (GMCs).
Prior to (Months 24-30) the administration of the Mencevax™ ACW vaccine
Number of Subjects With Vaccine Response for rSBA-Men A, C and W-135
時間枠：At one month after the administration of the Mencevax™ ACW vaccine (Months 25-31)
Vaccine response was defined as follows: for initially seronegative subjects (i.e. with rSBA titre < 1:8 pre-vaccination), rSBA titre ≥ 1:32 post-vaccination (seroconversion), and for initially seropositive subjects (i.e. with rSBA titre ≥ 1:8 pre-vaccination), at least a 4-fold increase in rSBA titre from pre to post-vaccination.
At one month after the administration of the Mencevax™ ACW vaccine (Months 25-31)
Number of Subjects With Fever
時間枠：During the 4-day (Days 0-3) after the administration of the Tritanrix™-HepB/Hiberix™ vaccine
Any Fever (measured rectally) = subjects with symptom, regardless of the intensity grade.
During the 4-day (Days 0-3) after the administration of the Tritanrix™-HepB/Hiberix™ vaccine
Number of Subjects With Solicited Local Symtoms
時間枠：During the 4-Day (Days 0-3) after the administration of the Mencevax™ ACW vaccine
Assessed solicited local symptoms were: pain, redness and swelling at the injection site. Any = subjects with symptom, regardless of the intensity grade.
During the 4-Day (Days 0-3) after the administration of the Mencevax™ ACW vaccine
Number of Subjects With Solicited General Symptoms
時間枠：During the 4-Day (Days 0-3) after the administration of the Mencevax™ ACW vaccine
Assessed solicited general symptoms were: drowsiness, fever, irritability and loss of appetite. Any = subjects with symptoms, regardless of intensity grade and casual relationship to study vaccination.
During the 4-Day (Days 0-3) after the administration of the Mencevax™ ACW vaccine
Number of Subjects With Unsolicited Adverse Events (AEs)
時間枠：During the 31-Day (Days 0-30) after the administration of the Mencevax™ ACW vaccine
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.
During the 31-Day (Days 0-30) after the administration of the Mencevax™ ACW vaccine
Number of Subjects With Serious Adverse Events (SAEs)
時間枠：From Months 15-18 and up to Months 25-31 post vaccination
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.
From Months 15-18 and up to Months 25-31 post vaccination

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。

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

2006年4月19日

一次修了 (実際)

2007年5月1日

研究の完了 (実際)

2007年5月17日

試験登録日

最初に提出

2006年2月3日

QC基準を満たした最初の提出物

2006年4月20日

最初の投稿 (見積もり)

2006年4月24日

学習記録の更新

投稿された最後の更新 (実際)

2018年6月6日

QC基準を満たした最後の更新が送信されました

2018年4月26日

最終確認日

2017年1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

  • 104756

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

  1. 研究プロトコル
    情報識別子：104756
    情報コメント：For additional information about this study please refer to the GSK Clinical Study Register
  2. データセット仕様
    情報識別子：104756
    情報コメント：For additional information about this study please refer to the GSK Clinical Study Register
  3. 統計分析計画
    情報識別子：104756
    情報コメント：For additional information about this study please refer to the GSK Clinical Study Register
  4. インフォームド コンセント フォーム
    情報識別子：104756
    情報コメント：For additional information about this study please refer to the GSK Clinical Study Register
  5. 個人参加者データセット
    情報識別子：104756
    情報コメント：For additional information about this study please refer to the GSK Clinical Study Register
  6. 臨床研究報告書
    情報識別子：104756
    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。

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