Lot Consistency Study of DTaP-IPV-HB-PRP~T Vaccine Administered at 2-4-6 Months of Age in Healthy Infants

Summary

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.

Timeline

Start

2006-11

Primary completion

2008-04

Completion

2008-07

Drugs

Indications