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临床试验/NCT00453570
NCT00453570已完成3 期

Immunogenicity and Safety of Pentaxim as 3 Doses Primary Vaccination Followed by a Booster Dose at 18 Months

Sanofi1 个研究点 分布在 1 个国家目标入组 792 人开始时间: 2007年3月最近更新:
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

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

发起方
Sanofi
申办方类型
Industry
责任方
Sponsor

研究点 (1)

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