Primary objective: * To demonstrate the non-inferiority in terms of seroprotection rates (Hib antigen (PRP), Diphtheria, Tetanus, and Pertussis antigens (PT and FHA), and polio types 1, 2 and 3 antigens) of investigational arm (Group A: DTaP-IPV/Hib) versus control arm (Group B: DTaP-IPV and Hib vaccines administered at separate sites), one month after the primary vaccination (all antigens). Secondary objectives: * To describe immune responses against all vaccine antigens with no pre-specified hypothesis, and at all time points (pre-dose 1, post-dose 3, pre-dose 4 and post-dose 4) in the two study groups (Group A and Group B). * To describe the safety after each dose of each vaccine in the two study groups (Group A and Group B). * To describe immune responses against all vaccine antigens with no pre-specified hypothesis, and at all time points (pre-dose 1, post-dose 3, pre-dose 4 and post-dose 4 (Group C)
Participants will be enrolled in two steps (Cohort 1 and Cohort 2). Step one will enroll Cohort 1 made of 40 participants randomized in two groups with a 1:1 ratio. After review of the local and systemic adverse events occurring during the 7 Days following the first dose administered in these subjects, 2nd vaccination of Cohort 1 participants will resume and enrollment of the participants of Cohort number 2 will start. Step two will enroll Cohort 2 made of subjects randomized in two groups with a 1:1 ratio. A sub-study Group C will be enrolled and will receive the vaccine by intramuscular route.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
TRIPLE
Enrollment
424
0.5 mL, Subcutaneously. 3 times, each given 3 to 8 weeks apart
0.5 mL each, Subcutaneously, 3 times, each given 3 to 8 weeks apart
0.5 mL, Intramuscularly. 3 times, each given 4 to 8 weeks apart
Unnamed facility
Aichi, Japan
Unnamed facility
Chiba, Japan
Unnamed facility
Fukui, Japan
Unnamed facility
Fukuoka, Japan
Unnamed facility
Gunma, Japan
Unnamed facility
Hokkaido, Japan
Unnamed facility
Miyagi, Japan
Unnamed facility
Nagano, Japan
Unnamed facility
Osaka, Japan
Unnamed facility
Shizuoka, Japan
...and 2 more locations
Percentage of participants with anti-Diphtheria level ≥ 0.1 IU/mL post-dose 3
Anti-Diphtheria antibody titers will be assayed by neutralization test on Vero cells culture in comparison to the WHO equine antitoxin standard (seroneutralization)
Time frame: 21 Days post-dose 3
Percentage of participants with Seroprotection to vaccine antigens following vaccination
Seroprotection is defined as: percentage of participants with anti-Diphtheria and anti Tetanus antibody levels ≥0.01, ≥0.1 and ≥1.0 IU/mL
Time frame: Day 0 (pre-vaccination ) and 21 Days post-dose 3
Geometric Mean Titer (GMT) of antibodies to vaccine antigens following vaccination
Anti-Diphtheria antibody titers will be assayed by neutralization test on Vero cells culture in comparison to the WHO equine antitoxin standard (seroneutralization)
Time frame: 21 Days post-dose 3
Information concerning the safety in terms of solicited injection site and systemic reactions, unsolicited adverse events, and serious adverse events post vaccination with DTaP IPV/Hib vaccine.
Solicited injection site reactions: Tenderness, Erythema, Swelling and Induration; Solicited Systemic Reactions: Fever (Temperature), Vomiting, Crying abnormal, Drowsiness, Appetite lost and Irritability.
Time frame: Day 0 (post-vaccination) up to 21 days post each vaccination
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