Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT02274285 | DTaP-IPV/Hib Vaccine Primary & Booster Vaccinations Versus Co-administration of DTaP-IPV and Hib Vaccine in Japanese Infants | PHASE3 | COMPLETED | 424 | — | — | Oct 1, 2014 | May 28, 2016 | Apr 25, 2022 | 12 | Japan |
Anti-Diphtheria antibody titers will be assayed by neutralization test on Vero cells culture in comparison to the WHO equine antitoxin standard (seroneutralization)
| Arm | Type | Description |
|---|---|---|
| Group A (SP0204) | EXPERIMENTAL | Participants will receive DTaP-IPV/Hib vaccine administered subcutaneously |
| Group B (control) | ACTIVE_COMPARATOR | Participants will be given a co-administration of DTaP-IPV vaccine and Hib vaccine subcutaneously |
| Group C | EXPERIMENTAL | Participants will receive DTaP-IPV/Hib vaccine administered intramuscularly |
| Name | Type | Description |
|---|---|---|
| DTaP-IPV/Hib Combined vaccine | BIOLOGICAL | 0.5 mL, Subcutaneously. 3 times, each given 3 to 8 weeks apart |
| DTaP-IPV vaccine and Hib vaccine | BIOLOGICAL | 0.5 mL each, Subcutaneously, 3 times, each given 3 to 8 weeks apart |
Inclusion Criteria: * Aged 2 months to 68 months inclusive (recommended 3 to 8 months for Groups A and B; 2 months for Group C) on the day of inclusion * Informed consent form signed by the parent(s) or other legal representative * Able to attend all scheduled visits and to comply with all trial pr...