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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT01600092 | A Study of the Immunogenicity, Tolerability, and Safety of a New Formulation of RotaTeq™ in Infants (V260-035) | PHASE3 | COMPLETED | 1,020 | — | — | Apr 29, 2013 | Mar 25, 2014 | Nov 14, 2018 | - | — |
| Arm | Type | Description |
|---|---|---|
| RotaTeq™ Experimental Formulation | EXPERIMENTAL | Three 2.0 mL oral doses of RotaTeq™ experimental formulation. Vaccination 1 will be administered between 6 and 12 weeks of age and the third vaccination will be administered before 32 weeks of age. Each vaccination will be separated from the next by ≥ 4 weeks (28 days) |
| RotaTeq™ Existing Formulation | ACTIVE_COMPARATOR | Three 2.0 mL oral doses of RotaTeq™ existing formulation. Vaccination 1 will be administered between 6 and 12 weeks of age and the third vaccination will be administered before 32 weeks of age. Each vaccination will be separated from the next by ≥ 4 weeks (28 days). |
| Name | Type | Description |
|---|---|---|
| RotaTeq™ experimental formulation | BIOLOGICAL | - |
| RotaTeq™ existing formulation | BIOLOGICAL | - |
Inclusion Criteria: * Parent or legal guardian agrees to have infant participate by giving written informed consent Exclusion Criteria: * History of congenital abdominal disorders, prior rotavirus gastroenteritis, chronic diarrhea, failure to thrive, or abdominal surgery * History of intussuscept...