Non-inferiority of GSK Biologicals' Meningococcal Vaccine GSK134612 Versus Mencevax™ in Healthy Subjects Aged 2 Through 10 Years of Age
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 1,504
- 试验地点
- 7
- 主要终点
- Number of Subjects With Vaccine Response to N. Meningitidis Serogroups A (MenA), MenC, MenY and MenW-135
研究概览
简要总结
The purpose of this study is to demonstrate, in 2-10 year old subjects, the non-inferiority of meningococcal vaccine GSK134612 compared to licensed meningococcal vaccine Mencevax™.
The Protocol Posting has been updated in order to comply with the FDA Amendment Act, Sep 2007.
详细描述
Multicentre study with 2 treatment groups. Two blood samples will be taken, prior to and one month after vaccination, from the first 75% enrolled subjects per country independent of the treatment group.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 2 Years 至 10 Years（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Subjects who the investigator believes that their parents or guardians can and will comply with the requirements of the protocol.
- •A male or female between, and including, 2 and 10 years 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.
排除标准
- •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 (for subjects below 6 years) or within the last five previous years (for subjects 6 years old or above).
- •Previous vaccination with meningococcal polysaccharide conjugate vaccine of serogroups 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..
- •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 first dose of study vaccine or planned administration during the study period.
研究组 & 干预措施
Mencevax ACWY Group
Subjects received 1 dose of Mencevax ACWY vaccine at Month 0. Mencevax ACWY vaccine was administered subcutaneously into the upper region of the non-dominant arm.
干预措施: Mencevax (Biological)
Nimenrix Group
Subjects received 1 dose of Nimenrix vaccine at Month 0. Nimenrix vaccine was administered intramuscularly into the deltoid region of the non-dominant arm.
干预措施: Nimenrix (Biological)
结局指标
主要结局
Number of Subjects With Vaccine Response to N. Meningitidis Serogroups A (MenA), MenC, MenY and MenW-135
时间窗: One month after vaccination (Post-vaccination, study Month 1)
Vaccine response was defined as an rSBA titer of at least 1:32 in subjects initially seronegative (\< 1:8) and as 4-fold increase in titer from pre- to post-vaccination in subjects initially seropositive (≥ 1:8).
Number of Subjects With Grade 3 General Symptoms (Solicited and Unsolicited)
时间窗: During the 4-day (Days 0-3) post-vaccination period
Grade 3 symptom was defined as symptom that prevented normal, everyday activities.
次要结局
- Number of Subjects With rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY) Titers Greater Than or Equal (≥) to the Cut-off Values(Pre vaccination (Month 0) and post vaccination (Month 1))
- rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Antibody Titers(Pre vaccination (Month 0) and post vaccination (Month 1))
- Number of Subjects With Anti-tetanus Toxoid (Anti-TT) Concentrations Greater Than or Equal to (≥) the Cut-off Values(Pre vaccination (Month 0) and post vaccination (Month 1))
- Anti-tetanus Toxoid (Anti-TT) Antibody Concentrations(Pre vaccination (Month 0) and post vaccination (Month 1))
- Number of Subjects With Anti-polysaccharide (Anti-PS) Concentrations Greater Than or Equal to (≥) the Cut-off Values(Pre vaccination (Month 0) and post vaccination, (Month 1))
- Anti-polysaccharide (Anti-PS) Antibody Concentrations(Pre vaccination (Month 0) and post vaccination (Month 1))
- Number of Subjects Less Than (<) 6 Years of Age With Solicited Local Symptoms(During the 4-day (Days 0-3) follow-up period after vaccination)
- Number of Subjects < 6 Years of Age With Solicited General Symptoms(During the 4-day (Days 0-3) follow-up period after vaccination)
- Number of Subjects ≥ 6 Years of Age With Solicited Local Symptoms(During the 4-day (Days 0-3) follow-up period after vaccination)
- Number of Subjects Reporting Specific Adverse Events (AEs)(From Day 0 up to 6 months after vaccination)
- Number of Subjects ≥ 6 Years of Age With Solicited General Symptoms(During the 4-day (Days 0-3) follow-up period after vaccination)
- Number of Subjects Reporting Any Unsolicited Symptoms(Up to one month (Day 0-Day 30) after vaccination)
- Number of Subjects Reporting Any Serious Adverse Events (SAEs)(From Day 0 up to 6 months after vaccination)