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Co-administration of Meningococcal Vaccine GSK134612 and Pneumococcal Vaccine GSK1024850A vs Individual Administration

2018年5月8日 更新者:GlaxoSmithKline

Immunogenicity & Safety Study of GSK Biologicals' Meningococcal Vaccine GSK134612 When Co-administered With GSK Biologicals' Pneumococcal Vaccine GSK1024850A in Healthy 12-23-month-old Children Previously Primed With GSK1024850A

The purpose of this study is to demonstrate, in 12-23 months old subjects, the non-inferiority of meningococcal vaccine GSK134612 and pneumococcal vaccine GSK1024850A when co-administered, compared to each vaccine administered individually.

調査の概要

詳細な説明

Multi-center study with 3 parallel groups. One group will receive 2 vaccines injections at the same visit (pneumococcal+ meningococcal), one group will receive a pneumococcal vaccine followed one month later by a meningococcal vaccine, and the last group will receive the meningococcal vaccine followed one month later by the pneumococcal vaccine.

All subjects will have one blood sample taken before vaccination and one blood sample taken one month after each vaccination (i.e. the first group will have 2 blood samples taken, and the other two groups will have 3 blood sample taken)

研究の種類

介入

入学 (実際)

363

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

      • Mexico、メキシコ、14000
        • GSK Investigational Site
      • Mexico city、メキシコ、14000
        • GSK Investigational Site
      • Taipei、台湾、100
        • GSK Investigational Site
      • Taipei、台湾、105
        • GSK Investigational Site
      • Taoyuan Hsien、台湾
        • 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

はい

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, 12 and 23 months of age at the time of the first booster vaccination, who previously participated in study 109661 conducted in Mexico or in study 109861 conducted in Taiwan and who received 3 doses of the GSK1024850A vaccine.
  • 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.

Exclusion Criteria:

  • Use of any investigational or non-registered product (drug or vaccine) other than the study vaccines within 30 days preceding the first dose of study vaccine(s), 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 30 days before the first dose of vaccine(s) and 30 days after the last dose of vaccine(s).
  • Concurrently participating in another clinical study, at any time during the study period, in which the subject has been or will be exposed to an investigational or a non-investigational product (pharmaceutical product or device).
  • Previous vaccination with a meningococcal vaccine.
  • Previous administration of a fourth dose of a pneumococcal vaccine
  • Previous vaccination with tetanus toxoid within the last month (including also tetanus toxoid given as part of Hib-TT conjugate vaccine).
  • History of meningococcal or pneumococcal invasive disease.
  • History of reactions or allergic disease likely to be exacerbated by any component of the vaccines.
  • Hypersensitivity reaction due to previous vaccination with GSK1024850A vaccine.
  • History of seizures (this criterion does not apply to subjects who have had a single, uncomplicated febrile convulsion in the past) or progressive neurological disease.
  • Any confirmed or suspected immunosuppressive or immunodeficient condition, including human immunodeficiency virus (HIV) infection, based on medical history and physical examination (no laboratory testing required).
  • A family history of congenital or hereditary immunodeficiency, unless the child has previously been documented, through laboratory testing, to have normal immune function.
  • 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 first dose of study vaccine or planned administration during the study period.

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
Meningococcal vaccine GSK134612 co-administered with pneumococcal vaccine GSK1024850A.
Single dose intramuscular injection.
Single dose intramuscular injection.
アクティブコンパレータ:Group B
Pneumococcal vaccine GSK1024850A followed one month later by meningococcal vaccine GSK134612.
Single dose intramuscular injection.
Single dose intramuscular injection.
アクティブコンパレータ:Group C
Meningococcal vaccine GSK134612 followed one month later by pneumococcal vaccine GSK1024850A.
Single dose intramuscular injection.
Single dose intramuscular injection.

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
Anti-pneumococcal Antibody Concentrations
時間枠:At Month 1
Concentrations are presented as geometric mean concentrations (GMCs), expressed in micrograms per milliliter (µg/mL). Anti-pneumococcal serotypes assessed were Anti-1, Anti-4, Anti-5, Anti-6B, Anti-7F, Anti-9V, Anti-14, Anti-18C, Anti-19F and Anti-23F via the 22F-inhibition Enzyme Linked Immunosorbent Assay (ELISA).
At Month 1
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-Men-Y) Antibody Titers Greater Than or Equal to (≥) the Cut-off Value
時間枠:At Month 1
The cut-off value for the rSBA titers was greater than or equal to (≥) 1:8.
At Month 1
rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-Men-Y Antibody Titers
時間枠:At Month 1
Antibody titers are presented as geometric mean titers (GMTs) and are measured in titers.
At Month 1

二次結果の測定

結果測定
メジャーの説明
時間枠
Anti-pneumococcal Antibody Concentrations
時間枠:Before vaccination (PRE) and at one month post dose 2 (Month 2)
Concentrations are presented as geometric mean concentrations (GMCs), expressed in micrograms per milliliter (µg/mL). The pneumococcal serotypes assessed were 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F (Anti-1, -4, -5, -6B, -7F, -9V, -14, -18C, -19F and -23F) via 22F-inhibition ELISA. GMCs post Dose 2 are not presented for Nimenrix + Synflorix Group, as they received only one study vaccination dose.
Before vaccination (PRE) and at one month post dose 2 (Month 2)
Cross-reactive Anti-pneumococcal Antibody Concentrations
時間枠:Before vaccination (PRE), at one month post dose 1 (Month 1) and at one month post dose 2 (Month 2)
Concentrations are presented as geometric mean concentrations (GMCs), expressed in µg/mL. The pneumococcal serotypes assessed were 6A and 19A (anti-6A and anti-19A) via the 22F-inhibition ELISA. GMCs post Dose 2 are not presented for Nimenrix + Synflorix Group, as they received only one study vaccination dose.
Before vaccination (PRE), at one month post dose 1 (Month 1) and at one month post dose 2 (Month 2)
Opsonophagocytic Titers Against Pneumococcal Serotypes
時間枠:Before vaccination (PRE), at one month post dose 1 (Month 1) and at one month post dose 2 (Month 2)
Opsonophagocytic titers are presented as geometric mean titers (GMTs). The pneumococcal serotypes assessed were 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F (OPSONO-1, -4, -5, -6B, -7F, -9V, -14, -18C, -19F and -23F). GMTs post Dose 2 are not presented for Nimenrix + Synflorix Group, as they received only one study vaccination dose.
Before vaccination (PRE), at one month post dose 1 (Month 1) and at one month post dose 2 (Month 2)
Opsonophagocytic Titers Against Cross-reactive Pneumococcal Serotypes
時間枠:Before vaccination (PRE), at one month post dose 1 (Month 1) and at one month post dose 2 (Month 2)
Opsonophagocytic titers are presented as geometric mean titers (GMTs). The pneumococcal serotypes assessed were 6A and 19A (OPSONO-6A and OPSONO-19A). GMTs post Dose 2 are not presented for Nimenrix + Synflorix Group, as they received only one study vaccination dose.
Before vaccination (PRE), at one month post dose 1 (Month 1) and at one month post dose 2 (Month 2)
Anti-protein D (Anti-PD) Antibody Concentrations
時間枠:Before vaccination (PRE), at one month post dose 1(Month 1) and at one month post dose 2 (Month 2)
Concentrations are presented as geometric mean concentrations (GMCs), expressed in ELISA units per milliliter (EL.U/mL). GMCs post Dose 2 are not presented for Nimenrix + Synflorix Group, as they received only one study vaccination dose.
Before vaccination (PRE), at one month post dose 1(Month 1) and at one month post dose 2 (Month 2)
rSBA-MenA, rSBA-MenC, rSBA-MenW -135 and rSBA-Men-Y Antibody Titers
時間枠:Before vaccination (PRE) and at one month post dose 2 (Month 2)
Antibody titers are presented as geometric mean titers (GMTs) and measured in titers. GMTs post Dose 2 are not presented for Nimenrix + Synflorix Group, as they received only one study vaccination dose.
Before vaccination (PRE) and at one month post dose 2 (Month 2)
Anti-meningococcal Polysaccharide (Anti-PS) Antibody Concentrations
時間枠:Before vaccination (PRE), at one month post dose 1 (Month 1) and at one month post dose 2 (Month 2)
Concentrations are presented as geometric mean concentrations (GMCs), expressed in micrograms per milliliter (µg/mL). GMCs post Dose 2 are not presented for Nimenrix + Synflorix Group, as they received only one study vaccination dose.
Before vaccination (PRE), at one month post dose 1 (Month 1) and at one month post dose 2 (Month 2)
Anti-tetanus (Anti-T) Antibody Concentrations
時間枠:Before vaccination (PRE), at one month post dose 1 (Month 1) and at one month post dose 2 (Month 2)
Concentrations are presented as geometric mean concentrations (GMCs), expressed in international units per milliliter (IU/mL). GMCs post Dose 2 are not presented for Nimenrix + Synflorix Group, as they received only one study vaccination dose.
Before vaccination (PRE), at one month post dose 1 (Month 1) and at one month post dose 2 (Month 2)
Number of Subjects With Any and Grade 3 Solicited Local Symptoms
時間枠:Within the 4-day (Days 0-3) post-vaccination period after each dose
Assessed solicited local symptoms were pain, redness and swelling. Any = occurrence of the symptom regardless of intensity grade. Grade 3 pain = cried when limb was moved/spontaneously painful. Grade 3 redness/swelling = redness/swelling spreading beyond 30 millimeters (mm) of injection site.
Within the 4-day (Days 0-3) post-vaccination period after each dose
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
時間枠:Within the 4-day (Days 0-3) post-vaccination period after each dose
Assessed solicited general symptoms were drowsiness, irritability, loss of appetite and temperature [defined as rectally temperature equal to or above (≥) 38.0 degrees Celsius (°C)]. Any = occurrence of the symptom regardless of intensity grade. Grade 3 drowsiness = drowsiness that prevented normal activities. Grade 3 irritability = crying that could not be comforted/ prevented normal activity. Grade 3 loss of appetite = not eating at all. Grade 3 fever = fever higher than (>) 40.0 °C. Related = symptom assessed by the investigator as related to the vaccination.
Within the 4-day (Days 0-3) post-vaccination period after each dose
Number of Subjects With Any Unsolicited Adverse Events (AEs)
時間枠:Within the 31-day (Day 0-30) post-vaccination period after each dose
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.
Within the 31-day (Day 0-30) post-vaccination period after each dose
Number of Subjects With Serious Adverse Events (SAEs)
時間枠:Throughout the entire study duration (Day 0-Month 7)
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.
Throughout the entire study duration (Day 0-Month 7)
Number of Subjects Reporting Rash
時間枠:Throughout the entire study duration (Day 0-Month 7)
Rash-like symptoms assessed were hives, idiopathic thrombocytopenic purpura, petechiae.
Throughout the entire study duration (Day 0-Month 7)
Number of Subjects With New Onset Chronic Illnesses (NOCIs)
時間枠:Throughout the entire study duration (Day 0-Month 7)
NOCIs include autoimmune disorders, asthma, type I diabetes, allergies.
Throughout the entire study duration (Day 0-Month 7)
Number of Subjects Reporting Adverse Events Resulting in Emergency Room (ER) Visits
時間枠:Throughout the entire study duration (Day 0-Month 7)
Among AEs prompting emergency room visits were: infections, injuries, skin diseases, gastrointestinal symptoms.
Throughout the entire study duration (Day 0-Month 7)

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

2008年10月30日

一次修了 (実際)

2009年6月2日

研究の完了 (実際)

2009年11月2日

試験登録日

最初に提出

2008年9月23日

QC基準を満たした最初の提出物

2008年9月23日

最初の投稿 (見積もり)

2008年9月25日

学習記録の更新

投稿された最後の更新 (実際)

2018年5月9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

2017年4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

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. データセット仕様
    情報識別子:111393
    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:111393
    情報コメント:For additional information about this study please refer to the GSK Clinical Study Register
  3. 注釈付き症例報告書
    情報識別子:111393
    情報コメント:For additional information about this study please refer to the GSK Clinical Study Register
  4. 統計分析計画
    情報識別子:111393
    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:111393
    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:111393
    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:111393
    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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