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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Enrollment
370
0.5 mL, intramuscular
0.5 mL of each vaccine; intramuscular
Unnamed facility
Daejeon, South Korea
Unnamed facility
Gyeionggi Do, South Korea
Unnamed facility
Gyeonggi-do, South Korea
Unnamed facility
Gyeonggi-do, South Korea
Unnamed facility
Incheon, South Korea
Unnamed facility
Incheon, South Korea
Unnamed facility
Incheon, South Korea
Unnamed facility
Seoul, South Korea
Unnamed facility
Seoul, South Korea
Unnamed facility
Seoul, South Korea
...and 4 more locations
Non-inferiority in terms of seroprotection rates (Diphtheria, Tetanus, Polio types 1, 2 and 3, Polyribosyl Ribitol Phosphate conjugated to Tetanus protein) of PENTAXIM™ Vaccine to the Tetraxim™ and PRP~T conjugate (Act-HIB™) vaccines.
Time frame: 1 month post-dose 3 vaccination
Information regarding the safety (in terms of solicited injection site and systemic reactions) of PENTAXIM™ vaccine.
Time frame: Day 0 up to Day 157
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