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A Study of DTaP//PRP-T Combined Vaccine (ACTACEL) Versus Local DTaP and Act-HIB Monovalent Vaccine in Healthy Infants

Sanofi · 2010
ClinicalTrials.gov · Datasets · License: Public Domain · 2010
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diphtheriahaemophilus-influenzae-type-btetanus
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.
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