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Immunogenicity and Safety of Meningococcal Vaccine GSK134612 Given as 1 or 2 Doses to Healthy 9-12 Months Old Toddlers.

2019年6月11日 更新者:GlaxoSmithKline

Study to Assess Immunogenicity, Reactogenicity and Safety of Primary Vaccination With GSK Biologicals' MenACWY Vaccine (GSK134612) Given as 1 or 2 Doses to Healthy Toddlers 9-12 Months of Age

The purpose of the study is to characterize the safety and immunogenicity of 1 dose of GSK134612 vaccine at 12 months of age and of GSK134612 vaccine administered as 2 doses at 9 and 12 months of age.

調査の概要

詳細な説明

The protocol posting has been amended to reflect changes as a consequence of an amendment to the protocol and also to comply with the FDA amendment Act, Sep 2007. Sections impacted are Brief Title, Official Title of the study, Brief Summary, Key Inclusion & Exclusion criteria.

研究の種類

介入

入学 (実際)

385

段階

  • フェーズ2

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

    • Alabama
      • Birmingham、Alabama、アメリカ、35205
        • GSK Investigational Site
    • Arkansas
      • Benton、Arkansas、アメリカ、72015
        • GSK Investigational Site
      • Little Rock、Arkansas、アメリカ、72205
        • GSK Investigational Site
    • California
      • Antioch、California、アメリカ、94509
        • GSK Investigational Site
      • Fremont、California、アメリカ、94538
        • GSK Investigational Site
      • Hayward、California、アメリカ、94545
        • GSK Investigational Site
      • Madera、California、アメリカ、93637
        • GSK Investigational Site
      • Santa Rosa、California、アメリカ、95403
        • GSK Investigational Site
      • Vacaville、California、アメリカ、95688
        • GSK Investigational Site
    • Colorado
      • Lakewood、Colorado、アメリカ、80226
        • GSK Investigational Site
      • Littleton、Colorado、アメリカ、80234
        • GSK Investigational Site
      • Littleton、Colorado、アメリカ、80122
        • GSK Investigational Site
      • Westminster、Colorado、アメリカ、80234
        • GSK Investigational Site
      • Wheat Ridge、Colorado、アメリカ、80033
        • GSK Investigational Site
    • Georgia
      • Birmingham、Georgia、アメリカ、35244
        • GSK Investigational Site
    • Ohio
      • Canton、Ohio、アメリカ、44718
        • GSK Investigational Site
    • Pennsylvania
      • Erie、Pennsylvania、アメリカ、16501
        • GSK Investigational Site
      • Greenville、Pennsylvania、アメリカ、16125
        • GSK Investigational Site
    • Texas
      • Amarillo、Texas、アメリカ、79124
        • 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

9ヶ月~9ヶ月 (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 whose parents/guardians the investigator believes can and will comply with the requirements of the protocol
  • A male or female of 9 months of age (has not attained 10 months of age) at the time of enrollment.
  • Up to date on vaccinations based on ACIP recommendations and the standard practice at the investigational site.
  • Written informed consent obtained from parents/guardian of the subject.
  • Healthy subjects as established by medical history and clinical examination before entering into the study.

Exclusion Criteria:

  • Use of any investigational or non-registered product (drug or vaccine) other than the study vaccine(s) within 30 days preceding enrollment, 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 vaccine dose.
  • Planned administration/ administration of a vaccine not foreseen by the study protocol within 1 month of a dose of study vaccine(s), with the exception of influenza vaccine.
  • Planned administration of a tetanus toxoid (TT) containing vaccine throughout the active phase of the study (through one month after the last vaccination).
  • Previous vaccination with meningococcal polysaccharide or conjugate vaccine of serogroup A, C W and/or Y.
  • History of meningococcal diseases.
  • Any confirmed or suspected immunosuppressive or immunodeficient condition (congenital or secondary), including human immunodeficiency virus (HIV) infection, based on medical history and physical examination (no laboratory testing is required).
  • 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.
  • Major congenital defects or serious chronic illness.
  • History of any neurologic disorders or seizures.
  • Acute disease at the time of enrollment.
  • Administration of immunoglobulins and/or any blood products within the three months preceding the first dose of study vaccine or planned administration during the active phase of the study (through one month after the last dose of study vaccine).

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
Single dose GSK134612.
One or 2 intramuscular injections.
実験的:Group B
Two doses of GSK134612.
One or 2 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
Number of Subjects With Serum Bactericidal Assay Using Human Complement Against Neisseria Meningitides Serogroups A, C, W-135, Y (hSBA-MenA, hSBA-MenC, hSBA-MenW -135 and hSBA-Men-Y) Antibody Titers Greater Than or Equal to the Cut-off Value
時間枠:One month after the last dose (at Month 4)
The cut-off value for the hSBA titers was greater than or equal to (≥) 1:8.
One month after the last dose (at Month 4)

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 Serum Bactericidal Assay Using hSBA-MenA, hSBA-MenC, hSBA-MenW -135 and hSBA-Men-Y Antibody Titers Greater Than or Equal to the Cut-off Value
時間枠:One month after the first dose (at Month 1)
The cut-off value for the hSBA titers was greater than or equal to (≥) 1:8.
One month after the first dose (at Month 1)
Number of Subjects With Serum Bactericidal Assay Using hSBA-MenA, hSBA-MenC, hSBA-MenW -135 and hSBA-Men-Y Antibody Titers Greater Than or Equal to the Cut-off Value
時間枠:At Month 1 (for GSK 134612 2 doses Group only) and Month 4
The cut-off value for the hSBA titers was greater than or equal to (≥) 1:4.
At Month 1 (for GSK 134612 2 doses Group only) and Month 4
hSBA-MenA, hSBA-MenC, hSBA-MenW -135 and hSBA-Men-Y Antibody Titers
時間枠:At Month 1 (for GSK 134612 2 doses Group only) and Month 4
Antibody titers were presented as geometric mean titers (GMTs).
At Month 1 (for GSK 134612 2 doses Group only) and Month 4
Number of Subjects With Serum Bactericidal Assay Using Rabbit Complement Against Neisseria Meningitides Serogroups A, C, W-135, Y (rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY) Antibody Titers Greater Than or Equal to the Cut-off Value
時間枠:At Month 1 (for GSK 134612 2 doses Group only) and Month 4
The cut-off value for the rSBA titers was greater than or equal to (≥) 1:8.
At Month 1 (for GSK 134612 2 doses Group only) and Month 4
Number of Subjects With Serum Bactericidal Assay Using rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Antibody Titers Greater Than or Equal to the Cut-off Value
時間枠:At Month 1 (GSK 134612 2 doses Group only) and Month 4
The cut-off value for the rSBA titers was greater than or equal to (≥) 1:128.
At Month 1 (GSK 134612 2 doses Group only) and Month 4
rSBA-MenA, rSBA-MenC, rSBA-MenW -135 and rSBA-Men-Y Antibody Titers
時間枠:At Month 1 (GSK 134612 2 doses Group only) and Month 4
Antibody titers were presented as geometric mean titers (GMTs).
At Month 1 (GSK 134612 2 doses Group only) and Month 4
Number of Subjects With Anti-polysaccharide Meningococcal Serogroup A (Anti-PSA), Serogroup C (Anti-PSC), Serogroup W-135 (Anti-PSW-135) and Serogroup Y (Anti-PSY) Antibody Concentrations Greater Than or Equal to the Cut-off Value
時間枠:At Month 1 (GSK 134612 2 doses Group only) and Month 4
The cut-off value for the anti-polysaccharide concentrations was greater than or equal to (≥) 0.3 micrograms per milliliter (μg/mL).
At Month 1 (GSK 134612 2 doses Group only) and Month 4
Number of Subjects With Anti-PSA, Anti-PSC, Anti-PSW-135 and Anti-PSY Antibody Concentrations Greater Than or Equal to the Cut-off Value
時間枠:At Month 1 (GSK 134612 s doses Group only) and Month 4
The cut-off value for the anti-polysaccharide concentrations was greater than or equal to (≥) 2.0 micrograms per milliliter (μg/mL).
At Month 1 (GSK 134612 s doses Group only) and Month 4
Anti-PSC, Anti-PSW-135 and Anti-PSY Antibody Concentrations
時間枠:At Month 1 (GSK 134612 2 doses Group only) and Month 4
Antibody concentrations were presented as geometric mean concentrations (GMCs) and expressed in micrograms per milliliter (μg/mL).
At Month 1 (GSK 134612 2 doses Group only) and Month 4
Number of Subjects With Any and Grade 3 Solicited Local Symptoms
時間枠:During the 4-day (Days 0-3) and 8-day (Days 0-7) periods following each vaccination
Assessed solicited local symptoms were pain, redness and swelling. Any = occurrence of the symptom regardless of intensity grade. Grade 3 pain = pain that prevented normal activity. Grade 3 redness/swelling = redness/swelling spreading beyond 30 millimeters (mm) of injection site.
During the 4-day (Days 0-3) and 8-day (Days 0-7) periods following each vaccination
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
時間枠:During the 4-day (Days 0-3) and 8-day (Days 0-7) periods following each vaccination
Assessed solicited general symptoms were drowsiness, fever [defined as axillary, oral, tympanic or rectal temperature equal to or above (≥) 38 degrees Celsius (°C)], irritability and loss of appetite. Any = occurrence of the symptom regardless of intensity grade. Grade 3 symptom = symptom that prevented normal activity. Grade 3 fever = fever higher than (>) 40.0 °C. Related = symptom assessed by the investigator as related to the vaccination.
During the 4-day (Days 0-3) and 8-day (Days 0-7) periods following each vaccination
Number of Subjects With Any Unsolicited Adverse Events (AEs)
時間枠:Up to 1 month post-vaccination
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.
Up to 1 month post-vaccination
Number of Subjects With Serious Adverse Events (SAEs)
時間枠:Up to study end (Month 9)
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 9)
Number of Subjects With New Onset Chronic Ilnesses (NOCI)
時間枠:Up to study end (Month 9)
NOCIs include autoimmune disorders, asthma, type I diabetes, allergies.
Up to study end (Month 9)
Number of Subjects Reporting Rash
時間枠:Up to study end (Month 9)
Rash assessed included hives, idiopathic thrombocytopenic purpura and petechiae.
Up to study end (Month 9)
Number of Subjects Reporting Adverse Events Resulting in Emergency Room (ER) Visits
時間枠:Up to study end (Month 9)
Among AEs prompting emergency room visits were: infections, injuries, skin diseases and respiratory diseases.
Up to study end (Month 9)

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

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7月5日

一次修了 (実際)

2008年10月23日

研究の完了 (実際)

2008年11月26日

試験登録日

最初に提出

2007年5月8日

QC基準を満たした最初の提出物

2007年5月8日

最初の投稿 (見積もり)

2007年5月9日

学習記録の更新

投稿された最後の更新 (実際)

2019年6月25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

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

  1. 注釈付き症例報告書
    情報識別子:109375
    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:109375
    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:109375
    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:109375
    情報コメント:For additional information about this study please refer to the GSK Clinical Study Register
  5. インフォームド コンセント フォーム
    情報識別子:109375
    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:109375
    情報コメント:For additional information about this study please refer to the GSK Clinical Study Register
  7. 研究プロトコル
    情報識別子:109375
    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。

Meningococcal vaccine GSK134612の臨床試験

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