Immunogenicity & Safety Study of GSK Biologicals' Meningococcal Vaccine GSK134612 When Co-Administered With GSK Biologicals' MMRV Vaccine (Priorix-Tetra™) in Healthy 12 to 23-Month-Old Children
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 1,000
- 试验地点
- 15
- 主要终点
- Number of Subjects With Anti-mumps Antibody Concentrations ≥ the Cut-off Values
研究概览
简要总结
The purpose of this study is to demonstrate, in 12-23 month old children, the non-inferiority of the meningococcal vaccine 134612 given with Priorix-Tetra.
The Protocol Posting has been updated in order to comply with the FDA Amendment Act, Sep 2007.
详细描述
Open multicentre study with 4 treatment groups. Two groups will receive the 134612 vaccine with Priorix-Tetra either at the same or different visits followed by a second Priorix-Tetra vaccination at 84 days.
Two control groups will receive Priorix-Tetra and Meningitec at different visits followed by a second Priorix-Tetra vaccination at 84 days.
For all subjects, two blood samples will be taken: prior to and 42 days after the first vaccination. In a subset (30% of subjects in Groups A en C) from selected study centres: additional sample 42 days after second Priorix-Tetra dose.
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
- 12 Months 至 23 Months（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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 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 parents' or legal 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 vaccine dose.
- •Planned administration/ administration of a vaccine not foreseen by the study protocol within one month before and 42 days after the first dose of vaccine(s).
- •Previous vaccination with meningococcal vaccine of serogroup A, C W and/or Y.
- •History of meningococcal disease.
- •Previous vaccination against measles, mumps, rubella, and/or varicella.
- •History of measles, mumps, rubella and/or varicella.
- •Known exposure to measles, mumps, rubella, varicella or zoster within 30 days prior to vaccination.
- •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 allergic disease or reactions likely to be exacerbated by any component of the vaccine, including neomycin.
- •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.
结局指标
主要结局
Number of Subjects With Anti-mumps Antibody Concentrations ≥ the Cut-off Values
时间窗: 42 days after the first vaccine dose (Day 42)
The cut-off values for anti-mumps antibody concentrations were ≥ 231 units per milliliter (U/mL).
Number of Subjects With rSBA-MenC, rSBA-MenA, rSBA-MenW-135, rSBA-MenY Titers Greater Than or Equal to (≥) the Cut-off Values
时间窗: 42 days after the first vaccine dose (Day 42)
The cut-off values for the rSBA titers were ≥ 1:8. The analysis was performed only on subjects receiving meningitis vaccination (Nimenrix) at Day 0.
Number of Subjects With Anti-measles Antibody Concentrations ≥ the Cut-off Values
时间窗: 42 days after the first vaccine dose (Day 42)
The cut-off values for anti-measles antibody concentrations were ≥ 150 milli-international units per milliliter (mIU/mL).
Number of Subjects With Anti-varicella Antibody Concentrations ≥ the Cut-off Values
时间窗: 42 days after the first vaccine dose (Day 42)
The cut-off values for anti-varicella antibody concentrations were ≥ 1:4.
Number of Subjects With Anti-rubella Antibody Concentrations ≥ the Cut-off Values.
时间窗: 42 days after the first vaccine dose (Day 42)
The cut-off values for anti-rubella antibody concentrations were ≥ 4 international units per milliliter (IU/mL).
次要结局
- Anti-PSA (Anti-polysaccharide A), Anti-PSC, Anti-PSW-135 and Anti-PSY Antibodies Concentrations ≥ the Cut-off Values(Prior to the first vaccine dose (Day 0) and 42 days after the first vaccine dose (Day 42))
- Number of Subjects Reporting Solicited Local Symptoms After Nimenrix or Meningitec Vaccination at Day 0(During the 4-day (Days 0-3) after vaccination with Nimenrix or Meningitec at Day 0)
- Number of Subjects Reporting Specific Adverse Events (AEs)(From Day 0 up to Month 6 after first vaccine dose)
- Number of Subjects With rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Titers ≥ the Cut-off Values(Prior to vaccination (Day 0) and after the first vaccination dose (Day 42))
- rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Antibody Titers(Prior to first vaccine dose (Day 0) and 42 days after the first vaccine dose (Day 42))
- Number of Subjects With Anti-PSA, Anti-PSC, Anti-PSW-135 and Anti-PSY Antibodies Concentrations ≥ the Cut-off Values(Prior to first vaccine dose (Day 0) and 42 days after the first vaccine dose (Day 42))
- Number of Subjects With hSBA-MenA (Meningococcal Polysaccharide A Serum Bactericidal Antibodies Using Human Complement), hSBA-MenC, hSBA-MenW-135 and hSBA-MenY Titers ≥ the Cut-off Values(Prior to first vaccine dose (Day 0) and 42 days after the first vaccine dose (Day 42))
- Anti-mumps Antibody Concentrations(42 days after the second Priorix-Tetra vaccine dose (Day 126))
- Anti-rubella Antibody Concentrations(42 days after the second Priorix-Tetra vaccine dose (Day 126))
- Anti-varicella Antibody Titers(42 days after the second Priorix-Tetra vaccine dose (Day 126))
- Number of Subjects Reporting Unsolicited Symptoms(During the 43-day (Days 0-42) follow-up period after each vaccination)
- Number of Subjects Reporting Serious Adverse Events (SAEs)(From Day 0 up to Month 6 after vaccination)
- hSBA-MenA, hSBA-MenC, hSBA-MenW-135 and hSBA-MenY Antibody Titers(Prior to first vaccine dose (Day 0) and 42 days after the first vaccine dose (Day 42))
- Number of Subjects Reporting Solicited Local Symptoms Specific for Priorix-Tetra Vaccination(During the 4-day (Days 0-3) after vaccination with first dose of Priorix-Tetra vaccine at Day 0)
- Number of Subjects Reporting Solicited General Symptoms(During the 4-day (Days 0-3) follow-up period after first vaccination dose in all groups)
- Number of Subjects With Priorix-Tetra - Specific Solicited General Symptoms(During the 43-day (Days 0-42) after first vaccination dose)
- Anti-measles Antibody Concentrations(42 days after the second Priorix-Tetra vaccine dose (Day 126))