NCT00343889

Comparison of DTaP-HB-PRP~T Combined Vaccine to Tritanrix-HepB/Hib™, Both Given Concomitantly With Oral Polio Vaccine

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

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 379 (actual)
• Sponsor: Sanofi Pasteur, a Sanofi Company · Industry
• Sex: All
• Age: 42 Days – 50 Days
• Healthy volunteers: Accepted

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.

Conditions

• Diphtheria
• Tetanus
• Pertussis
• Hepatitis B
• Haemophilus Infections

Interventions

Type	Name	Description
BIOLOGICAL	DTaP-HB-PRP~T vaccine + OPV	0.5 mL, Intramuscular
BIOLOGICAL	Tritanrix-HepB/Hib™ + OPV vaccine	0.5 mL, Intramuscular
BIOLOGICAL	Oral Polio Vaccine	Oral co-administered with study vaccine

Timeline

• Start date: 2006-08-01
• Primary completion: 2007-11-01
• Completion: 2008-04-01
• First posted: 2006-06-23
• Last updated: 2013-12-10
• Results posted: 2013-12-10

Locations

2 sites across 1 country: Philippines