Tetanus Clinical Trial
Official title:
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
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.
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. ;
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention
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