NCT00544271终止4 期
Phase IIIb Study to Evaluate Immunogenicity, Antibody Persistency and Reactogenicity of DTPa - INFANRIX and dTpa - BOOSTRIX Vaccines Administered to Healthy Children Previously Primed With 3 Doses of DTPa Vaccine Compared to Placebo (HAVRIX®JUNIOR)
适应症
试验速览
- 阶段
- 4 期
- 状态
- 终止
- 入组人数
- 720
- 试验地点
- 2
- 主要终点
- Anti-diphtheria and anti-tetanus antibody concentration (1M, 15-18M & 27-29M after vacc)
研究概览
简要总结
To evaluate the immunogenicity, persistence of antibodies and reactogenicity of GSK Biologicals' DTPa (INFANRIX) and dTpa (BOOSTRIX), when administered to subjects 18-20 months old, compared with not giving a booster DTP vaccine at 18-20 months. Study double blinded for the two DTP vaccines and single blinded for the control arm.
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
- Single
入排标准
- 年龄范围
- 18 Months 至 20 Months（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Male or female children between and including 18 -20 months of age at the time of the vaccination.
- •Completed a primary vaccination course with DTPa (INFANRIX) vaccine at 2, 4, and 6 months.
- •Written informed consent obtained before study entry from the parents or guardians of the subject.
- •Free of obvious health problems as established by medical history and clinical examination before entering into the study.
排除标准
- •Use of any investigational or non-registered drug or vaccine other than the study vaccine(s) within 30 days preceding the administration of the study vaccine dose, or planned use during the study period.
- •Evidence of previous or intercurrent diphtheria, tetanus, or pertussis disease, or of vaccination against any of these diseases since completion of the primary course of DTPa (INFANRIX) vaccine.
结局指标
主要结局
Anti-diphtheria and anti-tetanus antibody concentration (1M, 15-18M & 27-29M after vacc)
Occurrence of local injection site reactions (1M after vacc).
次要结局
- Antibody concentration to all vaccine antigens (1M, 15-18M & 27-29M after vacc),
- Solicited (Day 0-14) & Unsolicited symptoms (Day 0-30),
- SAEs (full study).
研究者
研究点 (2)
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