At a glance
ClinicalIndex Comparison RecordStandardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Immunogenicity Study of a DTaP-Hep B-PRP-T Combined Vaccine Compared to Tritanrix-HepB/Hib™, Both Given Concomitantly With the Oral Polio Vaccine at 6, 10, and 14 Weeks of Age in Healthy Infants in the Philippines
In Brief
A Phase 3 clinical trial evaluating DTaP-HB-PRP~T vaccine + OPV, Tritanrix-HepB/Hib™ + OPV vaccine, and 1 other intervention for Diphtheria and 4 related conditions. Completed, enrolled 379 participants across 2 sites.
Detailed Summary
The purpose of this study is to support the registration of the pentavalent DTaP-HB-PRP\~T vaccine in countries that follow the World Health Organization-Expanded Program of Immunization (WHO-EPI) schedule. The primary objective is: * To demonstrate that the pentavalent DTaP-HB-PRP\~T combined vaccine does not induce a lower immune response than Tritanrix-HepB/Hib™ in terms of the seroprotection rate to hepatitis B (HB) one month after a 3-dose primary series at 6, 10, and 14 weeks of age. The secondary objectives are: * To describe in each group the immunogenicity parameters one month after the 3-dose primary series at 6, 10, and 14 weeks of age; and * To evaluate the overall safety in terms of any adverse events in the first 28 days after each injection and any serious adverse events during the entire trial.
Study Details
Timeline
Interventions
0.5 mL, Intramuscular
0.5 mL, Intramuscular
Oral co-administered with study vaccine