NCT00348881

Study Comparing a DTaP-HB-PRP~T Combined Vaccine With Tritanrix HepB/Hib™, Concomitantly With OPV in Healthy Infants

Large Scale Safety and Immunogenicity Study of a DTaP-Hep B-PRP-T Combined Vaccine Compared to Tritanrix HepB/Hib™, Both Given Concomitantly With OPV at 6, 10, and 14 Weeks of Age in Healthy Filipino Infants

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 2,133 (actual)
• Sponsor: Sanofi Pasteur, a Sanofi Company · Industry
• Sex: All
• Age: 42 Days – 50 Days
• Healthy volunteers: Accepted

Summary

This is a study to compare the safety and immune response of a pentavalent DTaP-HB-PRP\~T combined vaccine with Tritanrix-HepB/Hib™, when both are given concomitantly with OPV at 6, 10, and 14 weeks of age.

Conditions

• Diphtheria
• Tetanus
• Pertussis
• Hepatitis B
• Influenza

Interventions

Type	Name	Description
BIOLOGICAL	DTaP-HB-PRP~T combined vaccine	0.5 mL, Intramuscular
BIOLOGICAL	Tritanrix-HepB/Hib™ vaccine	0.5 mL, Intramuscular
BIOLOGICAL	Oral poliomyelitis vaccine (OPV)	Oral co-administered with study vaccine.

Timeline

• Start date: 2006-06-01
• Primary completion: 2007-10-01
• Completion: 2008-06-01
• First posted: 2006-07-06
• Last updated: 2013-10-22
• Results posted: 2013-10-22

Locations

4 sites across 1 country: Philippines