At a glance
ClinicalIndex Comparison RecordStandardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Immunogenicity Study of DTaP-IPV-Hep B-PRP~T Combined Vaccine in Comparison to Infanrix®Hexa, at 2-4-6 Months of Age in Healthy Peruvian Infants
In Brief
A Phase 3 clinical trial evaluating DTaP IPV HB PRP~T vaccine and DTaP-HB-IPV and Haemophilus influenzae type b for Diphtheria and 4 related conditions. Completed, enrolled 263 participants across 1 site.
Detailed Summary
The study aims to confirm that, in Peruvian infants, the investigational DTaP-IPV Hep B-PRP\~T vaccine has immunological and safety profiles that are comparable to those of the control vaccine that is already marketed (Infanrix®Hexa) Primary Objective: To demonstrate that the hexavalent DTaP-IPV-Hep B-PRP\~T combined vaccine induces an immune response that is at least as good as the response following Infanrix®Hexa in terms of seroprotection rates to HB, one month after a three-dose primary series (2, 4 and 6 months) Secondary Objectives: * To describe in each group the immunogenicity to vaccine components (for DTaP-IPV-Hep B-PRP\~T and Infanrix®Hexa) one month after the third dose of the primary series. * To assess the overall safety in each group one month after each dose of the primary series and through the entire study.
Study Details
Timeline
Interventions
0.5 mL, Intramuscular
0.5 mL, Intramuscular