Study of DTaP-IPV-Hep B-PRP~T Combined Vaccine Compared to Infanrix®Hexa in Healthy Peruvian Infants

Hepatitis B Clinical Trial

Official title: 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

Status Completed

Clinical Trial 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.

Clinical Trial Description

The present trial will involve two-month old Peruvian infants, randomly assigned to receive three doses of either the investigational or the control vaccine at 2, 4, and 6 months of age. ;

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Diphtheria
• Haemophilus Influenzae Type b
• Hepatitis B
• Pertussis
• Tetanus

• NCT number: NCT00831753
• Study type: Interventional
• Source: Sanofi
• Status: Completed
• Phase: Phase 3
• Start date: May 2008
• Completion date: November 2009