At a glance
ClinicalIndex Comparison RecordStandardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
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
In Brief
A Phase 3 clinical trial evaluating DTaP-IPV-HB-PRP~T vaccine and DTaP-HBV-IPV vaccine for Diphtheria and 4 related conditions. Completed, enrolled 1,189 participants across 6 sites.
Detailed 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.
Study Details
Timeline
Interventions
0.5 mL, intramuscular (IM)
0.5 mL, IM
0.5 mL, IM
0.5 mL, IM