NCT00831311

Study of DTaP-IPV-Hep B-PRP~T Combined Vaccine Compared With PENTAXIM™ and ENGERIX B® PEDIATRICO in Argentinean Infants

Phase-II Immunogenicity Study of a DTaP-IPV-Hep B-PRP~T Combined Vaccine Compared With PENTAXIM™ and ENGERIX B® PEDIATRICO at 2, 4, and 6 Months of Age in Healthy Argentinean Infants

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 624 (actual)
• Sponsor: Sanofi Pasteur, a Sanofi Company · Industry
• Sex: All
• Age: 50 Days – 70 Days
• Healthy volunteers: Accepted

Summary

Primary Objective: * To demonstrate that the immune response of the DTaP-IPV-Hep B-PRP\~T is non-inferior for all valences to those of the association of PENTAXIM™ and ENGERIX B® PEDIATRICO one month after a three-dose primary series. Secondary Objectives: * To describe in each group the immunogenicity parameters one month after the three-dose primary series. * To describe safety profile after each vaccination in both groups.

Conditions

• Diphtheria
• Tetanus
• Pertussis
• Haemophilus Influenzae Type b
• Poliomyelitis

Interventions

Type	Name	Description
BIOLOGICAL	DTaP-IPV-HB-PRP~T	0.5 mL, Intramuscular
BIOLOGICAL	DTaP-IPV//PRP~T combined vaccine & Recombinant hep B vaccine	0.5 mL, Intramuscular (right and left thighs, respectively)

Timeline

• Start date: 2004-10-01
• Primary completion: 2005-11-01
• Completion: 2007-03-01
• First posted: 2009-01-28
• Last updated: 2013-12-17
• Results posted: 2013-11-21

Locations

1 site across 1 country: Argentina