Hepatitis B Clinical Trial
Official title:
Lot to Lot Consistency Study of DTaP-IPV-Hep B-PRP~T Vaccine Administered at 2-4-6 Months of Age in Healthy Mexican Infants
The purpose of this trial is to clinically confirm that the manufacturing process of the
final bulk products of the investigational DTaP-IPV-HB-PRP~T vaccine is consistent.
The primary objective is to demonstrate the equivalence of three batches of
DTaP-IPV-HB-PRP~T vaccine, in terms of seroprotection and seroconversion rates for the
vaccine antigens after the three-dose primary series.
The secondary objectives are:
- To describe in each group, the immunogenicity parameters for all antigens one month
after the third dose of the primary series
- To assess the overall safety in each group one month after the third dose of the
primary series.
n/a
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Prevention
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