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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT01214889 | Study of PENTAXIM™ Vaccine Versus TETRAXIM™ Vaccine Given With ACTHIB™ Vaccine in South Korean Infants. | PHASE3 | COMPLETED | 370 | — | — | Sep 1, 2010 | Dec 1, 2011 | Apr 17, 2012 | 14 | South Korea |
| Arm | Type | Description |
|---|---|---|
| Study Group A | EXPERIMENTAL | Participants will receive a single dose of DTacP-IPV//PRP T combined vaccine (PENTAXIM™) at age 2, 4 and 6 months. |
| Study Group B | ACTIVE_COMPARATOR | Participants will receive a dose of DTacP IPV combined vaccine (TETRAXIM™) and PRP-T vaccine (ActHIB™) at 2, 4, and 6 months of age. |
| Name | Type | Description |
|---|---|---|
| PENTAXIM™: DTacP IPV//PRP~T combined vaccine | BIOLOGICAL | 0.5 mL, intramuscular |
| TETRAXIM™: DTacP IPV combined vaccine and ActHIB™: PRP tetanus conjugate vaccine | BIOLOGICAL | 0.5 mL of each vaccine; intramuscular |
Inclusion Criteria: * Aged 2 months (56 to 70 days) inclusive on the day of inclusion * Born at full term of pregnancy (≥ 37 weeks) and with a birth weight ≥ 2.5 kg * Informed consent form signed by the parent(s) or other legal representative * Able to attend all scheduled visits and to comply with...