Assess Reactogenicity and Safety of GSK Biologicals' Tritanrix™-HepB/Hib-MenAC Compared to Tritanrix™-HepB/Hiberix™ (Control) in Healthy Infants (2,4,6 Months Age), After a Hepatitis B Birth Dose
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 500
- 试验地点
- 2
- 主要终点
- Occurrence of fever > 38.5°C(axillary) during the 4-day follow-up period after dose 1
研究概览
简要总结
The purpose of this study is to compare the reactogenicity & safety of Tritanrix™-HepB/Hib-MenAC vaccine to the international standard of care, Tritanrix™-HepB/Hiberix™.
详细描述
Randomized study with four groups to receive one of the following vaccination regimens after a dose of hepatitis B vaccine given at birth:
- One of the 3 lots of GSK Biologicals' Hib-MenAC mixed with GSK Biologicals' Tritanrix™-HepB (3 different groups) - GSK Biologicals' Tritanrix™-HepB/Hiberix™
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
入排标准
- 年龄范围
- — 至 3 Days（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
Hib-MenAC Lot 1 Group
Healthy male or female subjects aged 56 to 83 days of age at the time of the first study vaccine dose, with previous hepatitis B vaccine at birth, received Tritanrix-HepB combined vaccine mixed extemporaneously with Meningitec conjugate vaccine Lot 1 at 2, 4 and 6 months of age as an intramuscular injections in the anterolateral part of the left thigh.
干预措施: Tritanrix-HepB/Meningitec conjugate vaccine (Biological)
Hib-MenAC Lot 2 Group
Healthy male or female subjects aged 56 to 83 days of age at the time of the first study vaccine dose, with previous hepatitis B vaccine at birth, received Tritanrix-HepB combined vaccine mixed extemporaneously with Meningitec conjugate vaccine Lot 2 at 2, 4 and 6 months of age as an intramuscular injections in the anterolateral part of the left thigh.
干预措施: Tritanrix-HepB/Meningitec conjugate vaccine (Biological)
Hib-MenAC Lot 3 Group
Healthy male or female subjects aged 56 to 83 days of age at the time of the first study vaccine dose, with previous hepatitis B vaccine at birth, received Tritanrix-HepB combined vaccine mixed extemporaneously with Meningitec conjugate vaccine Lot 3 at 2, 4 and 6 months of age as an intramuscular injections in the anterolateral part of the left thigh.
干预措施: Tritanrix-HepB/Meningitec conjugate vaccine (Biological)
Hiberix Group
Healthy male or female subjects aged 56 to 83 days of age at the time of the first study vaccine dose, with previous hepatitis B vaccine at birth, received Tritanrix-HepB vaccine mixed extemporaneously with conjugate vaccine Hiberix at 2, 4 and 6 months of age as intramuscular injection in the anterolateral part of the thigh.
干预措施: Tritanrix/Hiberix vaccine (Biological)
结局指标
主要结局
Occurrence of fever > 38.5°C(axillary) during the 4-day follow-up period after dose 1
时间窗: Days 0-3 post dose 1
Occurrence of fever > 38.5°C(axillary) during the 4-day follow-up period after dose 3
时间窗: Days 0-3 post dose 3
Occurrence of fever > 38.5°C(axillary) during the 4-day follow-up period after dose 2
时间窗: Days 0-3 post dose 2
次要结局
- Occurrence of unsolicited symptoms during the 31-day follow-up period after each dose(Day 0-30 after each dose)
- Occurrence of serious adverse events during the entire study period(Day 0 up to Month 5)
- Occurrence of solicited symptoms other than fever >38.5°C (axillary) during the 4-day follow-up period after each dose(Days 0-3 after each dose)