NCT00315055

Immunogenicity of DTaP-IPV-Hep B-PRP~T Combined Vaccine Compared With PENTAXIM™ and ENGERIX B® at 2-3-4 Months Schedule

Immunogenicity of DTaP-IPV-Hep B-PRP~T Combined Vaccine Compared With PENTAXIM™ and ENGERIX B® at 2, 3, and 4 Months Primary Schedule in Healthy Turkish Infants

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 310 (actual)
• Sponsor: Sanofi Pasteur, a Sanofi Company · Industry
• Sex: All
• Age: 50 Days – 71 Days
• Healthy volunteers: Accepted

Summary

To demonstrate that the immune response to hepatitis B antigen of the DTaP-IPV-Hep B-PRP\~T is non-inferior to that of the association of PENTAXIM™ and ENGERIX B® one month after a three dose (2-3-4 month) primary series. Immunogenicity * To assess pre- and post-primary series * To assess pre- and post-booster series.

Conditions

• Hepatitis B
• Polio
• Diphtheria
• Pertussis

Interventions

Type	Name	Description
BIOLOGICAL	DTaP-IPV-HB-PRP~T vaccine	0.5 mL, Intramuscular (IM)
BIOLOGICAL	DTaP-IPV//PRP~T combined	0.5 mL, IM
BIOLOGICAL	Hepatitis B vaccine	0.5 mL, IM

Timeline

• Start date: 2006-07-01
• Primary completion: 2007-07-01
• Completion: 2008-02-01
• First posted: 2006-04-17
• Last updated: 2014-09-12
• Results posted: 2014-02-04

Locations

1 site across 1 country: Turkey (Türkiye)