NCT00453570已完成3 期
Immunogenicity and Safety of Pentaxim as 3 Doses Primary Vaccination Followed by a Booster Dose at 18 Months
适应症
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- Sanofi
- 入组人数
- 792
- 试验地点
- 1
- 主要终点
- To provide information concerning the immunogenicity of DTacP-IPV//PRP~T combined vaccine
研究概览
简要总结
As per request by the Heath Authorities, the present clinical study will assess the immunogenicity and safety of sanofi pasteur's DTacP-IPV// PRP~T combined vaccine (PENTAXIM™) as a three-dose primary vaccination at 2, 3, and 4 months of age or 3, 4 and 5 months of age followed by a booster dose at 18-20 months of age as compared to commercially available DTacP, Hib conjugate (Act-HIB™) and IPV (IMOVAX Polio™) monovalent vaccines in order to meet the requirements for registration of the product in People's Republic of China.
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
- 60 Days 至 74 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
结局指标
主要结局
To provide information concerning the immunogenicity of DTacP-IPV//PRP~T combined vaccine
时间窗: 1 Month post-dose 3
次要结局
- To provide information concerning the safety of DTacP-IPV//PRP~T combined vaccine(19 months post-dose 1)
研究者
研究点 (1)
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