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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT02094833 | DTaP-IPV-Hep B-PRP~T Combined Vaccine Versus DTaP-IPV//PRP~T Combined Vaccine + Hep B Vaccine in Hep B Primed Infants | PHASE3 | COMPLETED | 310 | — | — | Mar 1, 2014 | Nov 1, 2016 | Apr 26, 2017 | 16 | South Korea |
Anti-Diphtheria antibodies will be measured by a toxin neutralization test
Anti-Tetanus antibodies will be measured by enzyme-linked immunosorbent assay (ELISA).
Anti-PT and anti-FHA antibodies will be measured by enzyme-linked immunosorbent assay (ELISA).
| Arm | Type | Description |
|---|---|---|
| Group A | EXPERIMENTAL | Participants will receive 3 injections of the study vaccine (DTaP-IPV-Hep B-PRP\~T combined vaccine) at 2, 4, and 6 months of age |
| Group B | ACTIVE_COMPARATOR | Participants will receive 2 injections of monovalent Hep B vaccine (Euvax B®) at age 1 and 6 months and 3 injections of DTaP IPV//PRP\~T vaccine (Pentaxim™) at age 2, 4, and 6 months |
| Name | Type | Description |
|---|---|---|
| DTaP-IPV-Hep B-PRP~T combined vaccine | BIOLOGICAL | 0.5 mL, Intramuscular |
| DTaP-IPV//PRP~T and Hepatitis B vaccine | BIOLOGICAL | 0.5 mL, Intramuscular |
Inclusion Criteria: * Aged 30 to 40 days on the day of the first study visit * Born at full term of pregnancy (≥ 37 weeks) and with a birth weight ≥ 2.5 kg * Informed consent form has been signed and dated by the parent(s) or other legally acceptable representative * Participant and parent/legally ...