NCT00831753

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

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
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 263 (actual)
• Sponsor: Sanofi Pasteur, a Sanofi Company · Industry
• Sex: All
• Age: 50 Days – 71 Days
• Healthy volunteers: Accepted

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.

Detailed 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.

Conditions

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

Interventions

Type	Name	Description
BIOLOGICAL	DTaP IPV HB PRP~T vaccine	0.5 mL, Intramuscular
BIOLOGICAL	DTaP-HB-IPV and Haemophilus influenzae type b	0.5 mL, Intramuscular

Timeline

• Start date: 2008-05-01
• Primary completion: 2009-05-01
• Completion: 2009-11-01
• First posted: 2009-01-29
• Last updated: 2016-05-13
• Results posted: 2014-04-02

Locations

1 site across 1 country: Peru