NCT00401531

Comparison of a DTaP-IPV-HB-PRP~T Combined Vaccine to Infanrix™-Hexa, When Administered With Prevnar® in Thai Infants

Immunogenicity Study of a DTaP IPV Hep B PRP T Combined Vaccine in Comparison to Infanrix Hexa™, Both Concomitantly Administered With Prevnar™ at 2, 4, and 6 Months of Age in Thai Infants

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 412 (actual)
• Sponsor: Sanofi Pasteur, a Sanofi Company · Industry
• Sex: All
• Age: 50 Days – 71 Days
• Healthy volunteers: Accepted

Summary

The purpose of the study is to provide immunogenicity and safety data of the investigational hexavalent vaccine when it is given concomitantly (the same day at separate injection sites) with Prevnar, according to the 2-4-6 month immunization schedule, following one dose of HB vaccine at birth. Primary Objective: To demonstrate that the hexavalent DTaP-IPV-HB-PRP\~T combined vaccine induces an immune response that is at least as good as the response following Infanrix™-Hexa in terms of seroprotection rates to HB and PRP, one month after a 3 dose primary series (2, 4, and 6 months), when co-administered with Prevnar® Secondary Objectives: Immunogenicity: To describe in each group the immunogenicity parameters to each vaccine component (for DTaP-IPV-HB-PRP\~T and Infanrix™-Hexa) one month after the third dose of the primary series. Safety: To describe the overall safety after each injection.

Conditions

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

Interventions

Type	Name	Description
BIOLOGICAL	DTaP-IPV-HB-PRP~T and Pneumococcal polysaccharide vaccines	0.5 mL, IM
BIOLOGICAL	DTaP-HB-IPV and Pneumococcal polysaccharide vaccines	0.5 mL, IM

Timeline

• Start date: 2006-10-01
• Primary completion: 2007-11-01
• Completion: 2008-08-01
• First posted: 2006-11-20
• Last updated: 2014-04-01
• Results posted: 2014-04-01

Locations

2 sites across 1 country: Thailand