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Non-Inferiority of Meningococcal Vaccine GSK134612 Versus Mencevax™ in 11-17 Year-Old Subjects

2018年5月8日 更新者：GlaxoSmithKline

Primary Vaccination Study in Subjects Aged 11-17 Years to Demonstrate the Non-inferiority of GSK Biologicals' Meningococcal Vaccine GSK134612 Vaccine Versus Mencevax™ ACWY

The purpose of this study is to demonstrate, in 11-17 year old subjects, the non-inferiority of meningococcal vaccine GSK134612 compared to licensed meningococcal vaccine Mencevax™.

調査の概要

状態

完了

条件

介入・治療

詳細な説明

Multicentre study with 2 treatment groups. Each subject will have 2 blood samples taken for immunogenicity analyses, one prior to vaccination and one taken 30 days later.

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

研究の種類

介入

入学 (実際)

1025

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

  • インド
      • Goa、インド、403202
        • GSK Investigational Site
      • Indore、インド、452001
        • GSK Investigational Site
      • New Delhi、インド、110002
        • GSK Investigational Site
      • Pune、インド、411 011
        • GSK Investigational Site
  • フィリピン
      • Muntinlupa、フィリピン、1781
        • GSK Investigational Site
  • 台湾
      • Taipei、台湾、100
        • GSK Investigational Site
      • Tao Yuan County、台湾、333
        • 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

11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 they and/or their parents/guardians can and will comply with the requirements of the protocol.
  • A male or female between, and including, 11 and 17 years of age at the time of the vaccination.
  • Written informed assent/consent obtained from the subject/ from the parent or guardian of the subject.
  • Healthy subjects as established by medical history and clinical examination before entering into the study.
  • Previously completed routine childhood vaccinations to the best of the subject's/the subject's parent's/guardian's knowledge.
  • If the subject is female, she must be of non-childbearing potential, or 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 vaccination.

Exclusion Criteria:

  • Use of any investigational or non-registered product (drug or vaccine) 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 (defined as more than 14 days) of immunosuppressants or other immune-modifying drugs within six months prior to the first vaccine dose.
  • Planned administration/ administration of a vaccine not foreseen by the study protocol within one month of the dose of vaccine.
  • Previous vaccination with meningococcal polysaccharide vaccine of serogroup A, C, W-135 and/or Y within the last five years.
  • Previous vaccination with meningococcal polysaccharide conjugate vaccine of serogroup A, C, W-135 and/or Y.
  • Previous vaccination with tetanus toxoid within the last month.
  • History of meningococcal disease.
  • Any confirmed or suspected immunosuppressive or immunodeficient condition (congenital or secondary), including human immunodeficiency virus (HIV) infection, based on medical history and physical examination.
  • A family history of congenital or hereditary immunodeficiency, until the immune competence of the potential vaccine recipient is demonstrated.
  • History of reactions or allergic disease likely to be exacerbated by any component of the vaccine(s).
  • Major congenital defects or serious chronic illness.
  • Acute disease at the time of enrolment.
  • Administration of immunoglobulins and/or any blood products within the three months preceding the dose of study vaccine or planned administration during the study period.
  • Pregnant or lactating female.
  • History of chronic alcohol consumption and/or drug abuse.
  • Female planning to become pregnant or planning to discontinue contraceptive precautions.

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：Group A
Subjects of 11-17 years of age who will receive GSK134612
生物学的：髄膜炎菌ワクチン GSK134612
1回の筋肉内投与
アクティブコンパレータ：Group B
Subjects of 11-17 years of age who will receive MencevaxTM ACWY
生物学的：Mencevax™ ACWY
One subcutaneous dose

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 Vaccine Response to Meningococcal Antigens
時間枠：One month post-vaccination (At Month 1)
Vaccine response induced by Neisseria meningitidis serogroups A, C, W-135 and Y (MenA, MenC, MenW-135 and menY) as measured by serum bactericidal antibodies using baby rabbit complement (rSBA), was defined as an rSBA titer of at least 1:32 in subjects initially seronegative [rSBA titer below (<) 1:8] and as a 4-fold increase in titer in subjects initially seropositive [rSBA titer greater than or equal to (≥) 1:8].
One month post-vaccination (At Month 1)
Number of Subjects With Any Grade 3 General (Solicited and Unsolicited) Symptoms
時間枠：During the 4-day (Days 0-3) period after vaccination
General symptoms assessed included fatigue, fever (defined as axillary temperature), gastrointestinal symptoms and headache. Grade 3 symptom= event that prevented normal activities. Grade 3 fever= temperature above (>) 39.5 degrees Celsius (°C).
During the 4-day (Days 0-3) period after vaccination

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-Men Antibody Titers ≥ the Cut-off Values
時間枠：Prior to (Month 0) and one month after vaccination (Month 1)
Neisseria meningitidis serogroups A, C, W-135 and Y were measured by serum bactericidal assay using baby rabbit complement (rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY). The cut-off values for the rSBA titers was greater than or equal to (≥) 1:8 and ≥ 1:128.
Prior to (Month 0) and one month after vaccination (Month 1)
Meningococcal rSBA Antibody Titers
時間枠：Prior to (Month 0) and one month after vaccination (Month 1)
rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY antibody titers are presented as geometric mean titers (GMTs).
Prior to (Month 0) and one month after vaccination (Month 1)
Number of Subjects With Anti-tetanus Toxoid (Anti-TT) Greater Than (>) the Cut-off Value
時間枠：Prior to (Month 0) and one month after vaccination (Month 1)
The cut-off value of the assay was an anti-tetanus toxoid antibody titer greater than (>) 0.1 international units per milliliter (IU/mL).
Prior to (Month 0) and one month after vaccination (Month 1)
Anti-TT Antibody Concentrations
時間枠：Prior to (Month 0) and one month after vaccination (Month 1)
Antibody concentrations are presented as geometric mean concentrations (GMCs) and expressed in international units per milliliter (IU/mL).
Prior to (Month 0) and one month after vaccination (Month 1)
Number of Subjects With Anti-meningococcal Polysaccharides (PS) Antibody Concentrations ≥ the Cut-off Values
時間枠：Prior to (Month 0) and one month after vaccination (Month 1)
The cut-off values of the assay was an anti-PS concentration greater than or equal to (≥) 0.3 micrograms per milliliter (μg/mL) and ≥ 2.0 μg/mL.
Prior to (Month 0) and one month after vaccination (Month 1)
Anti-meningococcal Polysaccharide Concentrations
時間枠：Prior to (Month 0) and one month after vaccination (Month 1)
Antibody concentrations were presented as geometric mean concentrations (GMCs) and expressed in micrograms per milliliter (μg/mL).
Prior to (Month 0) and one month after vaccination (Month 1)
Number of Subjects With Any and Grade 3 Solicited Local Symptoms
時間枠：During the 4-day (Days 0-3) period after vaccination
Solicited local symptoms assessed included pain, redness and swelling. Any= incidence of a particular symptom regardless of intensity. Grade 3 symptoms= symptoms that prevented normal activity. Grade 3 swelling= swelling spreading beyond 50 millimeters (mm).
During the 4-day (Days 0-3) period after vaccination
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
時間枠：During the 4-day (Days 0-3) period after vaccination
Solicited general symptoms assessed included fatigue, fever [defined as axillary temperature equal to or above (≥) 37.5 degrees Celsius (°C)]. Any= incidence of a particular symptom regardless of intensity or relationship to vaccination. Grade 3= event that prevented normal activities. Grade 3 fever= fever > 39.5 °C. Related= general symptom assessed by the investigator as causally related to the study vaccination.
During the 4-day (Days 0-3) period after vaccination
Number of Subjects With Any Unsolicited Adverse Events
時間枠：During the 31-day (Days 0-30) post-vaccination period
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) post-vaccination period
Number of Subjects With Any Serious Adverse Events (SAEs)
時間枠：Up to study end (Month 6)
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.
Up to study end (Month 6)
Number of Subjects With Specific Adverse Events
時間枠：Up to study end (Month 6)
These events consist of specific categories of adverse events (AEs) which included rash (e.g. hives, idiopathic thrombocytopenia purpura, petechiae), new onset of chronic illness(es) (NOCIs) (e.g. autoimmune disorders, asthma, type I diabetes and allergies), conditions prompting emergency room (ER) visits or non-routine physician office visits (i.e. office visits not related to well-being care, vaccination, injury or common acute illnesses such as upper respiratory tract infections, otitis media, pharyngitis, gastroenteritis), any events related to lack of meningococcal vaccine efficacy (i.e. meningococcal disease).
Up to study end (Month 6)

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)

2007年5月2日

一次修了 (実際)

2008年4月16日

研究の完了 (実際)

2008年9月10日

試験登録日

最初に提出

2007年4月23日

QC基準を満たした最初の提出物

2007年4月23日

最初の投稿 (見積もり)

2007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8日

QC基準を満たした最後の更新が送信されました

2018年5月8日

最終確認日

2018年3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

  • 109069

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. 統計分析計画
    情報識別子：109069
    情報コメント：For additional information about this study please refer to the GSK Clinical Study Register
  2. 注釈付き症例報告書
    情報識別子：109069
    情報コメント：For additional information about this study please refer to the GSK Clinical Study Register
  3. データセット仕様
    情報識別子：109069
    情報コメント：For additional information about this study please refer to the GSK Clinical Study Register
  4. 研究プロトコル
    情報識別子：109069
    情報コメント：For additional information about this study please refer to the GSK Clinical Study Register
  5. 臨床研究報告書
    情報識別子：109069
    情報コメント：For additional information about this study please refer to the GSK Clinical Study Register
  6. 個人参加者データセット
    情報識別子：109069
    情報コメント：For additional information about this study please refer to the GSK Clinical Study Register
  7. インフォームド コンセント フォーム
    情報識別子：109069
    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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