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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT01062477 | A Study of DTaP//PRP-T Combined Vaccine (ACTACEL) Versus Local DTaP and Act-HIB Monovalent Vaccine in Healthy Infants | PHASE3 | COMPLETED | 1,056 | — | — | Jan 1, 2010 | Dec 1, 2011 | Dec 13, 2011 | 2 | China |
| Arm | Type | Description |
|---|---|---|
| Study Group 1 | EXPERIMENTAL | Participants will receive ACTACEL vaccine at 2, 3, and 4 months of age. |
| Study Group 2 | EXPERIMENTAL | Participants will receive ACTACEL vaccine at 3, 4, and 5 months of age. |
| Study Group 3 | ACTIVE_COMPARATOR | Participants will receive Wuhan DTaP and Act-HIB vaccines concomitantly at 3, 4 and 5 months of age. |
| Name | Type | Description |
|---|---|---|
| DTaP//PRP-T Combined Vaccine | BIOLOGICAL | 0.5 mL, Intramuscular |
| DTaP Combined Vaccine and PRP-Tetanus Conjugate Vaccine | BIOLOGICAL | 0.5 mL, Intramuscular (each vaccine) |
Inclusion Criteria : * Aged 2 months on the day of inclusion * Born at full term pregnancy (≥ 36 weeks) with a birth weight ≥ 2.5 kg * Informed consent form signed by the parent(s) or legal representative * Participant and parent/legal representative able to attend all scheduled visits and to compl...