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Study in Toddlers to Demonstrate Non-inferiority of GSK Biologicals' Hib-MenC & to Evaluate Persistence up to 5 Years.

2018年7月26日 更新者:GlaxoSmithKline

Study to Demonstrate Non-inferiority of GSK Biologicals' Hib-MenC With Priorix™, Versus MenC-CRM197 Vaccine With Hiberix™ & Priorix™ in Toddlers Primed With Hib But Not MenC & to Evaluate Persistence up to 5 Years After Vaccination.

The purpose of the primary phase of the study is to demonstrate the non-inferiority of a single dose of GSK Biologicals' Haemophilus influenzae type b and meningococcal C (Hib-MenC) conjugate vaccine when given in the second year of life to subjects primed in infancy with a Hib vaccine, but not with a meningococcal serogroup C vaccine, versus commercially available Hib and MenC vaccines.

In the extension phase, at Years 1, 2, 3, 4 & 5, one blood sample is taken at each year to follow the antibody persistence up to 5 years after vaccination. No additional vaccine is administered during the extension phase. The Protocol Posting has been updated in order to comply with the FDA Amendment Act, Sep 2007.

研究概览

详细说明

This multicenter study is open and has 2 treatment groups with Hiberix™ + a commercially available MenC vaccine as active controls. Priorix™ is given concomitantly in both groups. In the primary phase, two blood samples are taken from all subjects for immunogenicity analyses: before and one month after vaccination. In the extension phase, at Year 1, 2, 3, 4 & 5, one blood sample is taken at each year to follow the antibody persistence up to 5 years after vaccination. No additional vaccine is administered during the extension phase.

研究类型

介入性

注册 (实际的)

433

阶段

  • 第三阶段

联系人和位置

本节提供了进行研究的人员的详细联系信息,以及有关进行该研究的地点的信息。

学习地点

    • Australian Capital Territory
      • Garran、Australian Capital Territory、澳大利亚、2606
        • GSK Investigational Site
    • New South Wales
      • Randwick、New South Wales、澳大利亚、2031
        • GSK Investigational Site
      • Westmead、New South Wales、澳大利亚、2145
        • GSK Investigational Site
    • Queensland
      • Herston、Queensland、澳大利亚、4029
        • GSK Investigational Site
    • South Australia
      • North Adelaide、South Australia、澳大利亚、5006
        • GSK Investigational Site
    • Victoria
      • Carlton、Victoria、澳大利亚、3053
        • GSK Investigational Site
    • Western Australia
      • Perth、Western Australia、澳大利亚
        • GSK Investigational Site

参与标准

研究人员寻找符合特定描述的人,称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

1年 至 1年 (孩子)

接受健康志愿者

是的

有资格学习的性别

全部

描述

Inclusion Criteria:

Primary phase:

  • Subjects whom 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 18 months of age at the time of vaccination.
  • Written informed consent obtained from the parent or guardian of the subject.
  • Free of obvious health problems as established by medical history and clinical examination before entering into the study.
  • Previously completed routine childhood vaccinations to the best of his/her parents'/guardians knowledge.
  • Having completed primary vaccination with two doses of Haemophilus influenzae type b outer membrane protein (Hib-OMP) containing vaccine OR three doses of diphtheria, tetanus, acellular pertussis and Haemophilus influenzae type b (DTPa/Hib) containing vaccine at least 6 months before the study start.

Long-term persistence phase:

- Having participated in the vaccination study 106445

Exclusion Criteria:

For the primary vaccination phase:

  • 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) or planned administration of immuno-suppressants or other immune-modifying drugs within six months prior to vaccination.
  • Planned administration/administration of a vaccine not foreseen by the protocol during the period starting from 30 days before vaccination and ending 30 days after vaccination.
  • Administration of a meningococcal vaccine not foreseen by the study protocol during the period starting at birth and ending at first dose.
  • Previous administration of a booster dose of Hib vaccine.
  • Previous vaccination against measles, mumps, rubella.
  • History of H. influenzae type b, meningococcal serogroup C and/or confirmed measles, mumps or rubella diseases.
  • Known exposure to measles, mumps or rubella within 30 days prior to the start of the study.
  • Any confirmed or suspected immunosuppressive or immunodeficient condition, including human immunodeficiency virus infection.
  • A family history of congenital or hereditary immunodeficiency.
  • History of allergic disease or reactions likely to be exacerbated by any component of the vaccine.
  • Major congenital defects or serious chronic illness.
  • History of neurological disorders or more than one episode of febrile convulsion.
  • Acute disease at the time of enrolment.
  • Administration of immunoglobulins and/or any blood products since birth or planned administration during the study period.

Additional exclusion criteria for the long-term persistence phase: to be checked each year.

  • Previous administration of a booster dose of Hib, meningococcal serogroup C vaccines.
  • History of H. influenzae type b, meningococcal serogroup C diseases.

学习计划

本节提供研究计划的详细信息,包括研究的设计方式和研究的衡量标准。

研究是如何设计的?

设计细节

  • 主要用途:预防
  • 分配:随机化
  • 介入模型:并行分配
  • 屏蔽:无(打开标签)

武器和干预

参与者组/臂
干预/治疗
有源比较器:Meningitec + Hiberix Group
Subjects received a single dose of Meningitec™ vaccine co-administered with Hiberix™ and Priorix™ vaccines. The Meningitec vaccine was administered intramuscularly in the left deltoid region, the Hiberix vaccine was administered intramuscularly in the left thigh region and the Priorix vaccine was administered subcutaneously in the right upper arm.
One subcutaneous dose at 12-18 months of age
One intramuscular dose at 12-18 months of age.
One intramuscular dose at 12-18 months of age
实验性的:Menitorix Group
Subjects received a single dose of Menitorix™ vaccine co-administered with Priorix™ vaccine. Menitorix vaccine was administered intramuscularly in the left deltoid region and the Priorix vaccine was administered subcutaneously in the right upper arm.
One subcutaneous dose at 12-18 months of age
One intramuscular dose at 12-18 months of age
其他名称:
  • Hib-MenC
  • Menitorix™

研究衡量的是什么?

主要结果指标

结果测量
措施说明
大体时间
Number of Subjects With Anti-polyribosylribitol Phosphate (Anti-PRP) Antibody Concentration Greater Than or Equal to 0.15 Micrograms Per Milliliter (µg/mL)
大体时间:1 month after vaccination
Anti-PRP antibody concentration greater than or equal to 0.15 µg/mL is indicative of short-term protection.
1 month after vaccination
Number of Subjects With Meningococcal Serogroup C Serum Bactericidal Assay Using Rabbit Complement (rSBA-MenC) Titers Greater Than or Equal to 1:8 Titer
大体时间:1 month after vaccination
rSBA-MenC titers greater than or equal to 1:8 titer are indicative of seroprotection.
1 month after vaccination

次要结果测量

结果测量
措施说明
大体时间
Number of Subjects With Meningococcal Serogroup C Serum Bactericidal Assay Using Rabbit Complement (rSBA-MenC) Titers Above the Cut-off Values
大体时间:Prior to, 1 month, 1 year, 2 years, 3 years and 4 years after vaccination

rSBA-MenC titers cut-off values assessed were greater than or equal to (≥) 1:8 (indicative of seroprotection) and ≥ 1:128 titers.

Functional anti-meningococcal serogroup C activity (SBA-MenC) was determined by a serum bactericidal test using rabbit complement. For SBA testing at a GlaxoSmithKline (GSK) laboratory up to Year 3 after vaccination, titres were expressed as the reciprocal of the dilution resulting in 50% inhibition. For SBA testing at the Public Health England (PHE), formerly known as Health Protection Agency (HPA), at Year 4, titres were expressed as the reciprocal of the last dilution resulting in at least 50% inhibition.

Prior to, 1 month, 1 year, 2 years, 3 years and 4 years after vaccination
Number of Subjects With Meningococcal Serogroup C Serum Bactericidal Assay Using Rabbit Complement (rSBA-MenC) Titers Above the Cut-off Values
大体时间:5 years after vaccination
rSBA-MenC titers cut-off values assessed were greater than or equal to (≥)1:8 (indicative of seroprotection) and 1:128 titers. For SBA testing at the PHE at Year 5, titres were expressed as the reciprocal of the last dilution resulting in at least 50% inhibition.
5 years after vaccination
Meningococcal Serogroup C Serum Bactericidal Assay Using Rabbit Complement (rSBA-MenC) Titers
大体时间:Prior to, 1 month, 1 year, 2 years, 3 years and 4 years after vaccination.
Titers are given as Geometric Mean Titers (GMTs). Functional anti-meningococcal serogroup C activity (SBA-MenC) was determined by a serum bactericidal test using rabbit complement. For SBA testing at a GlaxoSmithKline (GSK) laboratory up to Year 3 after vaccination, titres were expressed as the reciprocal of the dilution resulting in 50% inhibition. For SBA testing at the PHE at year 4 after vaccination, titres were expressed as the reciprocal of the last dilution resulting in at least 50% inhibition.
Prior to, 1 month, 1 year, 2 years, 3 years and 4 years after vaccination.
Meningococcal Serogroup C Serum Bactericidal Assay Using Rabbit Complement (rSBA-MenC) Titers
大体时间:5 years after vaccination
Titers are given as Geometric Mean Titers (GMTs). Functional anti-meningococcal serogroup C activity (SBA-MenC) was determined by a serum bactericidal test using rabbit complement. For SBA testing at the PHE at Year 5, titres were expressed as the reciprocal of the last dilution resulting in at least 50% inhibition.
5 years after vaccination
Number of Subjects With Anti-polyribosylribitol Phosphate (Anti-PRP) Antibody Concentration Above Cut-off Values
大体时间:Prior to, 1 month, 1 year, 2 years, 3 years and 4 years after vaccination
Anti-PRP antibody concentration cut-off values assessed include 0.15 µg/mL (indicative of short-term protection) and 1.0 µg/mL (indicative of long-term protection).
Prior to, 1 month, 1 year, 2 years, 3 years and 4 years after vaccination
Number of Subjects With Anti-polyribosylribitol Phosphate (Anti-PRP) Antibody Concentration Above Cut-off Values
大体时间:5 years after vaccination
Anti-PRP antibody concentration cut-off values assessed include 0.15 µg/mL (indicative of short-term protection) and 1.0 µg/mL (indicative of long-term protection).
5 years after vaccination
Anti-polyribosylribitol Phosphate (Anti-PRP) Antibody Concentrations
大体时间:Prior to, 1 month , 1 year, 2 years, 3 years and 4 years after vaccination
Concentrations are given as Geometric Mean Concentrations (GMCs).
Prior to, 1 month , 1 year, 2 years, 3 years and 4 years after vaccination
Anti-polyribosylribitol Phosphate (Anti-PRP) Antibody Concentrations
大体时间:5 years after vaccination
Concentrations are given as Geometric Mean Concentrations (GMCs).
5 years after vaccination
Number of Subjects With Anti-polysaccharide C (Anti-PSC) Antibody Concentration Above the Cut-off Values
大体时间:Prior to, 1 month, 1 year, 2 years and 3 years after vaccination
Anti-PSC antibody concentration cut-off values assessed include greater than or equal to (≥) 0.30 µg/mL and ≥ 2.0 µg/mL.
Prior to, 1 month, 1 year, 2 years and 3 years after vaccination
Anti-polysaccharide C (Anti-PSC) Antibody Concentrations
大体时间:Prior to, 1 month, 1 year, 2 years and 3 years after vaccination
Concentrations given as Geometric Mean Concentrations (GMCs).
Prior to, 1 month, 1 year, 2 years and 3 years after vaccination
Number of Subjects Reporting Solicited Local and General Symptoms
大体时间:Within 4 days (Day 0 -Day 3) after vaccination

Solicited local symptoms assessed include pain, redness and swelling at the injection site.

Solicited general symptoms assessed include drowsiness, fever (≥ 38°C), irritability and loss of appetite.

Within 4 days (Day 0 -Day 3) after vaccination
Number of Subjects Reporting Unsolicited Symptoms
大体时间:Within 31 days (Day 0 - Day 30) after vaccination
Unsolicited symptom: Any adverse event (AE) reported in addition to those solicited during the clinical study. Also any solicited symptom with onset outside the specified period of follow-up for solicited symptoms will be reported as an unsolicited adverse event.
Within 31 days (Day 0 - Day 30) after vaccination
Number of Subjects Reporting Serious Adverse Events (SAEs)
大体时间:Throughout the entire study period (up to year 5)

A serious adverse event (SAE) is any untoward medical occurrence that results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, or is a congenital anomaly/birth defect in the offspring of a study subject.

For the long-term persistence phase (Years 1 through 5), only those SAEs that are determined by the investigator to have a causal relationship to the vaccination will be described individually.

Throughout the entire study period (up to year 5)

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

出版物和有用的链接

负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。

一般刊物

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查,以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始

2006年6月1日

初级完成 (实际的)

2007年11月1日

研究完成 (实际的)

2007年11月6日

研究注册日期

首次提交

2006年5月12日

首先提交符合 QC 标准的

2006年5月12日

首次发布 (估计)

2006年5月16日

研究记录更新

最后更新发布 (实际的)

2018年8月24日

上次提交的符合 QC 标准的更新

2018年7月26日

最后验证

2016年9月1日

更多信息

与本研究相关的术语

其他研究编号

  • 106445
  • 106446 (其他标识符:GSK)
  • 106449 (其他标识符:GSK)
  • 106450 (其他标识符:GSK)
  • 106452 (其他标识符:GSK)
  • 106454 (其他标识符:GSK)

计划个人参与者数据 (IPD)

计划共享个人参与者数据 (IPD)?

是的

IPD 计划说明

Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.

研究数据/文件

  1. 统计分析计划
    信息标识符:106445
    信息评论:For additional information about this study please refer to the GSK Clinical Study Register
  2. 知情同意书
    信息标识符:106445
    信息评论:For additional information about this study please refer to the GSK Clinical Study Register
  3. 研究协议
    信息标识符:106445
    信息评论:For additional information about this study please refer to the GSK Clinical Study Register
  4. 数据集规范
    信息标识符:106445
    信息评论:For additional information about this study please refer to the GSK Clinical Study Register
  5. 个人参与者数据集
    信息标识符:106445
    信息评论:For additional information about this study please refer to the GSK Clinical Study Register
  6. 临床研究报告
    信息标识符:106445
    信息评论:For additional information about this study please refer to the GSK Clinical Study Register

此信息直接从 clinicaltrials.gov 网站检索,没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求,请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改,我们的网站上也会自动更新.

Priorix™的临床试验

3
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