NCT00362336

Comparison of DTaP-IPV-Hep B-PRP~T Combined Vaccine to CombAct-HIB® Concomitantly Given With Engerix B® Paediatric and OPV

Immunogenicity Study of a DTaP-IPV-Hep B-PRP~T Combined Vaccine in Comparison to CombAct-HIB® Concomitantly Administered With Engerix B® Paediatric and OPV at 6, 10, and 14 Weeks of Age in South African Infants

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 622 (actual)
• Sponsor: Sanofi Pasteur, a Sanofi Company · Industry
• Sex: All
• Age: 3 Days
• Healthy volunteers: Accepted

Summary

The purpose of this study is to document the immunological response to the investigational hexavalent vaccine at the 6, 10, and 14 weeks schedule The primary objective is to demonstrate that the hexavalent DTaP-IPV-HB-PRP\~T combined vaccine does not induce lower immune responses than CombAct-HIB® with Engerix B® Paediatric and OPV in terms of seroprotection rates to Diphtheria (D), Tetanus (T), polio, Hepatitis B (HB), and Polyribosyl ribitol phosphate (PRP), one month after a 3-dose primary series (6, 10, and 14 weeks) with no HB vaccination at birth. The secondary Objectives are: To describe the safety in terms of any adverse events in the first 28 days after each injection and any serious adverse events during the entire trial. To describe Immunogenicity after the primary series and prior to and after a booster vaccination.

Conditions

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

Interventions

Type	Name	Description
BIOLOGICAL	DTaP-IPV-HB-PRP~T	0.5 mL, Intramuscular (IM)
BIOLOGICAL	CombAct-HIB®	0.5 mL, IM
BIOLOGICAL	Engerix B® Pediatric	0.5 mL, IM

Timeline

• Start date: 2006-08-01
• Primary completion: 2008-05-01
• Completion: 2009-08-01
• First posted: 2006-08-10
• Last updated: 2014-05-02
• Results posted: 2014-05-02

Locations

2 sites across 1 country: South Africa