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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT01379846 | Study of TAK-816 in Healthy Infants | PHASE3 | COMPLETED | 416 | — | — | Jun 1, 2011 | Feb 1, 2013 | Mar 5, 2013 | 22 | Japan |
| Arm | Type | Description |
|---|---|---|
| TAK-816 | EXPERIMENTAL | - |
| ActHIB | ACTIVE_COMPARATOR | - |
| Name | Type | Description |
|---|---|---|
| TAK-816+ DPT-TAKEDA | BIOLOGICAL | TAK-816 0.5 mL and DPT-TAKEDA 0.5.mL, subcutaneous injections, three doses administered at 4-week intervals over 8 weeks, followed by a fourth dose 52 weeks after third dose. |
| ActHIB+ DPT-TAKEDA | BIOLOGICAL | ActHIB 0.5 mL and DPT-TAKEDA 0.5.mL, subcutaneous injections, three doses administered at 4-week intervals over 8 weeks, followed by a fourth dose 52 weeks after third dose. |
Inclusion Criteria: 1. Male or female infants aged ≥3 and \<7 months (excluding hospitalized infants). 2. Infants whose legal acceptable representatives have given informed consent to the study prior to enrollment. 3. Infants whose parents or legal guardians have agreed to cooperate with the invest...