NCT00319852

Immunogenicity and Safety of Tetraxim Versus Local DTP + IPV

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 442 (actual)
• Sponsor: Sanofi · Industry
• Sex: All
• Age: 56 Days – 70 Days
• Healthy volunteers: Accepted

Summary

The present clinical study will assess the immunogenicity and reactogenicity of Sanofi Pasteur's DTaP-IPV combined vaccines as a three-dose primary vaccination at 2, 4 and 6 months of age compared to commercially available vaccines in order to meet the requirements for registration of the product in South Korea. Primary objective To demonstrate the non-inferiority in terms of seroprotection rates (Diphtheria, Tetanus, Polio types 1, 2 and 3) and seroconversion/vaccine response rates to Pertussis antigens (PT, FHA) of Sanofi Pasteur's DTaP-IPV combined vaccine versus commercially available Biken's DTaP (CJ purified PDT vaccine ™) and Aventis Pasteur's IPV (IMOVAX POLIO) monovalent vaccines, one month after the three-dose primary vaccination. Secondary objectives 1. Immunogenicity: To assess the non-inferiority in terms of seroprotection rates (Diphtheria, Tetanus, Polio types 1, 2 and 3) and seroconversion / vaccine response rates to Pertussis antigens (PT, FHA) of Sanofi Pasteur's DTaP-IPV combined vaccine versus historical reference (Study E2I03294 - France). To assess and describe the immunogenicity of the study vaccines in both groups. 2. Safety: To assess and describe the safety of the study vaccines after each dose.

Conditions

• Pertussis
• Diphtheria
• Poliomyelitis
• Tetanus

Interventions

Type	Name	Description
BIOLOGICAL	DTaP-IPV combined vaccine	0.5 mL, IM
BIOLOGICAL	DTaP vaccine	0.5 mL, IM

Timeline

• Start date: 2006-04-01
• Primary completion: 2008-04-01
• Completion: 2008-07-01
• First posted: 2006-04-27
• Last updated: 2012-04-16

Locations

1 site across 1 country: South Korea