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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Enrollment
1,056
0.5 mL, Intramuscular
0.5 mL, Intramuscular
0.5 mL, Intramuscular (each vaccine)
Unnamed facility
LingChuan County, Guilin City, Guangxi, China
Unnamed facility
Lipu County, Guilin City, Guangxi, China
Immunogenicity: To provide information concerning the immunogenicity of ACTACEL vaccine after primary and booster vaccination.
Time frame: One month post-vaccination
Safety: To provide information concerning the safety after primary and booster administration of ACTACEL vaccine.
Time frame: 0-7 days post-vaccination and entire study duration
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