NCT00317122已完成3 期
Demonstrate Non-inferiority of GSK Biologicals' Tritanrix™-HepB/Hib-MenAC vs Tritanrix™-HepB/Hiberix™ With Respect to Anti-HBs Immune Response, When Given to Healthy Infants at 6,10 & 14 Weeks Age, After a Birth Dose of Hepatitis B Vaccine
适应症
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 192
- 试验地点
- 5
- 主要终点
- One month after the third dose of the primary vaccination, measurement of anti-HBs antibody concentrations.
研究概览
简要总结
This study will only include infants born to mothers who are tested as seronegative for human immunodeficiency virus (HIV) & hepatitis B surface antigen (HBsAg). The purpose of this study is to demonstrate in infants who received a birth dose of hepatitis B vaccine that Tritanrix™-HepB/Hib-MenAC vaccine is at least as good as Tritanrix™-HepB/Hiberix™ with respect to immunogenicity of the hepatitis B antigen.
详细描述
Randomized study with two groups to receive one of the following vaccination regimens:
- GSK Biologicals' Tritanrix™-HepB/Hib-MenAC
- 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
- 盲法
- None
入排标准
- 年龄范围
- 4 Days 至 10 Days（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy infants aged 7 days +/- 3 days old born to mothers who are tested as seronegative for HIV & HBsAg, written informed consent obtained from the parents, born after a gestation period of 36 to 42 weeks.
排除标准
- •Known exposure to diphtheria, tetanus, pertussis, hepatitis B, Haemophilus influenzae type b and/or meningococcal disease since birth.
- •Any confirmed or suspected immunosuppressive or immunodeficient condition, based on physical examination.
- •A family history of congenital or hereditary immunodeficiency.
- •Major congenital defects or serious illness.
- •Any neurologic disorders or seizures.
- •Acute disease at the time of enrolment.
- •Administration of immunoglobulins and/or any blood products since birth or planned administration during the study period.
- •A birth dose of hepatitis B vaccine given outside the frame of this study.
结局指标
主要结局
One month after the third dose of the primary vaccination, measurement of anti-HBs antibody concentrations.
次要结局
- Immunogenicity: One month after the third dose of the primary vaccination, antibody concentrations or titres against all other vaccine antigens.
- Reactogenicity and safety: after each dose: solicited (day 0-3, local & general) & unsolicited (day 0-30) symptoms. Over the full course of the study: serious adverse events (SAEs)"
研究者
研究点 (5)
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