Safety and Immunogenicity of the Sanofi Pasteur's DTaP//PRP-T Combined Vaccine (ACTACEL) Versus Local DTaP and Hib Conjugate (Act-HIB) Monovalent Vaccine as a Three-dose Primary and Booster Vaccination in Healthy Infants in China
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- Sanofi
- 入组人数
- 1,056
- 试验地点
- 2
- 主要终点
- Immunogenicity: To provide information concerning the immunogenicity of ACTACEL vaccine after primary and booster vaccination.
研究概览
简要总结
The purpose of this study is to assess the immunogenicity and safety of ACTACEL combined vaccine in support of registration of this product in China
Primary Objectives:
- To demonstrate that ACTACEL vaccine administered at 2, 3 and 4 months of age or at 3, 4 and 5 months of age is not inferior, in terms of seroprotection, to Wuhan's Diphtheria, Tetanus, acellular Pertussis (DTaP) and Haemophilus influenzae type b (Act-HIB) vaccine given concomitantly, for diphtheria, tetanus, and Polyribosyl Ribitol Phosphate (PRP) antigens, one month after the three-dose primary vaccination.
- To demonstrate the superiority, in terms of seroconversion, of ACTACEL vaccine administered at 2, 3 and 4 months of age or at 3, 4 and 5 months of age for Pertussis Toxoid (PT), Fimbriae types 2 and 3 (FIM2) and (FIM3) pertussis antigens, compared with Wuhan's DTaP and Act-HIB vaccines given concomitantly, one month after the three-dose primary vaccination.
Secondary Objectives:
- To describe the safety after administration of the study vaccines.
- To describe in each group the immunogenicity of the study vaccines one month after the primary vaccination and before and one month after the booster vaccination.
详细描述
Participants will receive a primary vaccination consisting of three doses of ACTACEL at either 2, 3, and 4 months of age or at 3, 4, and 5 months of age; or Wuhan DTaP and Act-HIB vaccines at 3, 4, and 5 months of age. All participants will receive a single booster dose at 18-20 months of age and will be followed up for one month after the last dose of study vaccine.
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 89 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
研究组 & 干预措施
Study Group 1
Participants will receive ACTACEL vaccine at 2, 3, and 4 months of age.
干预措施: DTaP//PRP-T Combined Vaccine (Biological)
Study Group 2
Participants will receive ACTACEL vaccine at 3, 4, and 5 months of age.
干预措施: DTaP//PRP-T Combined Vaccine (Biological)
Study Group 3
Participants will receive Wuhan DTaP and Act-HIB vaccines concomitantly at 3, 4 and 5 months of age.
干预措施: DTaP Combined Vaccine and PRP-Tetanus Conjugate Vaccine (Biological)
结局指标
主要结局
Immunogenicity: To provide information concerning the immunogenicity of ACTACEL vaccine after primary and booster vaccination.
时间窗: One month post-vaccination
次要结局
- Safety: To provide information concerning the safety after primary and booster administration of ACTACEL vaccine.(0-7 days post-vaccination and entire study duration)