Tetanus Clinical Trial
Official title:
Immunogenicity and Safety of the Sanofi Pasteur's DTacP-IPV//PRP~T Combined Vaccine (PENTAXIM™) Versus Sanofi Pasteur's DTacP-IPV Combined Vaccine (TETRAXIM™) Given Simultaneously at Separate Sites With PRP~T Conjugate Vaccine (ACTHIB™) as a Three-dose Primary Vaccination at 2, 4 and 6 Months of Age in South Korean Infants
This study is designed to assess the immunogenicity and safety of PENTAXIM™ combined vaccine
versus TETRAXIM™ vaccine to support registration of PENTAXIM™ in South Korea.
Primary Objective:
To demonstrate the non-inferiority in terms of seroprotection rates (Diphtheria, Tetanus,
Polio types 1, 2 and 3, Polyribosyl Ribitol Phosphate [PRP]) and vaccine response rates to
acellular Pertussis antigens of sanofi pasteur's PENTAXIM™ vaccine versus sanofi pasteur's
TETRAXIM™ and Act (Haemophilus influenzae type b) HIB™ vaccines, one month after the
three-dose primary vaccination.
All participants will receive three primary doses of their assigned study the vaccine, on Days 0, 60, and 120. They will be assessed for immunogenicity on Day 0 before vaccination and Day 150 post-vaccination. Safety will be assessed for all participants throughout the study, up to Day 157. ;
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention
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