Tetanus Clinical Trial
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versus historical reference (Study E2I03294 - France).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.
n/a
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention
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