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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT01470287 | Immunogenicity, Safety and Tolerability of a Fully Liquid Pentavalent (DTwP-Hib-Hep B) Vaccine in Infants 6-8 Weeks of Age | PHASE3 | COMPLETED | 175 | — | — | Dec 1, 2011 | Apr 1, 2012 | May 19, 2017 | 3 | India |
| Arm | Type | Description |
|---|---|---|
| Arm 1 | EXPERIMENTAL | - |
| Name | Type | Description |
|---|---|---|
| DTwP-HepB-Hib Vaccine | BIOLOGICAL | Open label, Single arm study to evaluate immunogenicity, safety and tolerability of a fully liquid pentavalent (DTwP-HepB-Hib) vaccine in infants of 6-8 weeks of age. |
Inclusion Criteria: 1. Male and female subjects ≥ 42 days to ≤ 64 days of age. 2. Written informed consent obtained from either parents/ legal guardian after the nature of the study has been explained according to local regulatory requirements Exclusion Criteria: 1. Subjects whose parents or lega...