Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
RotaTeq experimental formulation · 1 trial · 1 indication
| 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...
RotaTeq experimental formulation is used for rotavirus gastroenteritis, a viral infection that causes severe diarrhea and vomiting in infants. It is being studied as a new formulation of the RotaTeq vaccine to assess its immunogenicity, tolerability, and safety in infants.
RotaTeq experimental formulation is developed by Merck & Company, Inc., a pharmaceutical company traded on the New York Stock Exchange under the ticker symbol MRK.
RotaTeq experimental formulation is in Phase 3 clinical development. It is an investigational product and has not been approved for use. A Phase 3 trial has been completed to evaluate its safety and immunogenicity in infants.
RotaTeq experimental formulation has one completed Phase 3 trial, NCT01600092, titled 'A Study of the Immunogenicity, Tolerability, and Safety of a New Formulation of RotaTeq™ in Infants (V260-035)'. The trial enrolled 1020 participants, was randomized, double-blind, and active-controlled.
RotaTeq experimental formulation is a monoclonal antibody designed to target rotavirus, the cause of rotavirus gastroenteritis. It is intended to provide immunity against the virus, though the specific molecular target is not disclosed in the available information.
RotaTeq experimental formulation is a new formulation of the existing RotaTeq vaccine. It is being studied to compare its immunogenicity, tolerability, and safety with the current formulation, but it is not the same product as the approved RotaTeq.