NCT01003431撤回3 期
A Randomized, Open-Label Clinical Study to Assess the Immunogenicity and Safety of Whole-Cell Pertussis Containing Vaccine When Administered Concomitantly With RotaTeq™ or Rotarix™ in Healthy Infants in South Africa
适应症
干预措施
试验速览
- 阶段
- 3 期
- 状态
- 撤回
- 主要终点
- Geometric Mean Titer (GMT) for Pertussis Toxoid
研究概览
简要总结
This study will evaluate the immunogenicity and safety of the pertussis component of DTwP (whole-cell pertussis containing vaccine) when administered concomitantly with RotaTeq™ or Rotatrix™.
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
- 6 Weeks 至 12 Weeks（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy infants
排除标准
- •History of abdominal disorders, intestinal folding, or abdominal surgery
- •Impaired immune system
- •Prior administration of any rotavirus vaccine or DTwP/DTaP
- •Fever of >= 38.1C (100.5F) at the time of vaccination
- •History of prior rotavirus infection, chronic diarrhea, or failure to thrive
- •Evidence of active gastrointestinal illness
研究组 & 干预措施
1
Experimental
RotaTeq™ + DTwP
干预措施: Rotavirus Vaccine, Live, Oral, Pentavalent (Biological)
2
Active Comparator
Rotarix™ + DTwP
干预措施: Comparator: Rotarix™ administered concomitantly with Tritanrix™ HepB (DTwP) (Biological)
3
Active Comparator
RotaTeq™ + DTaP
干预措施: Comparator: RotaTeq™ administered concomitantly with INFANRIX™ (DTaP) (Biological)
结局指标
主要结局
Geometric Mean Titer (GMT) for Pertussis Toxoid
时间窗: 1 month post dose 3
次要结局
- Geometric Mean Titer (GMT) for rotavirus serotypes G1, G2, G3, G4 and P1A(1 month post dose 3)
研究者
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