Partially Blinded Study to Assess Reactogenicity & Safety of GSK Biologicals' Tritanrix™-HepB/Hib-MenAC vs Tritanrix™-HepB/Hiberix™ in Healthy Infants 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
- 1
- 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
- 56 Days 至 83 Days（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy infants 56-83 days of age at the time of the first vaccine dose, written informed consent obtained from the parents, born after a gestation period of 36 to 42 weeks & has received a birth dose of hepatitis B vaccine within the first 3 days of life.
排除标准
- •Any confirmed immunodeficient condition, based on medical history and physical examination.
- •Planned administration/administration of a vaccine not foreseen by the study protocol within 30 days before the first dose of study vaccine, or planned administration during the study period with the exception of oral polio vaccine (OPV).
- •Use of any investigational or non-registered 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 since birth.
- •Bacille Calmette-Guérin (BCG) vaccine received after the first 2 weeks of life.
- •Previous vaccination against diphtheria, tetanus, pertussis, Haemophilus influenzae type b, and/or meningococcal disease.
- •History of diphtheria, tetanus, pertussis, hepatitis B, Haemophilus influenzae type b and/or meningococcal disease or known exposure to these diseases since birth.
- •Administration of immunoglobulins and/or any blood products since birth or planned administration during the study period.
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 serious adverse events during the entire study period(Day 0 up to Month 5)
- Occurrence of unsolicited symptoms during the 31-day follow-up period after each dose(Day 0-30 after each dose)
- 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)