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Also known as V260
RotaTeq experimental formulation · 2 trials · 1 indication
The number of participants with rotavirus gastroenteritis (RVGE) caused by naturally-occurring wild-type rotavirus (regardless of serotype or disease severity) was assessed. The case definition of RVGE included 1) 3 or more watery or looser-than-normal stools within a 24-hour period and/or forceful vomiting, and 2) naturally-occurring wild-type rotavirus must be detected in a stool specimen taken within 7 days after the onset of symptoms.
| Arm | Type | Description |
|---|---|---|
| V260 with staggered EPI | EXPERIMENTAL | V260 administered as a 2 mL oral solution at age \~2, 3, and 4 months, and staggered China Expanded Program on Immunizations (EPI) as follows: Oral poliovirus vaccine (OPV) administered as a 1 g oral solution at age \~2.5, 3.5, and 4.5 months, and diphtheria, tetanus, acellular pertussis vaccine (DTaP) administered as a 0.5 mL intramuscular injection at age \~3.5, 4.5, and 5.5 months |
| Placebo with staggered EPI | PLACEBO_COMPARATOR | Placebo administered as a 2 mL oral solution at age \~2, 3, and 4 months, and staggered EPI as follows: OPV administered as a 1 g oral solution at age \~2.5, 3.5, and 4.5 months, and DTaP administered as a 0.5 mL intramuscular injection at age \~3.5, 4.5, and 5.5 months |
| V260 with concomitant EPI | EXPERIMENTAL | V260 administered as a 2 mL oral solution at age \~2, 3, and 4 months, and concomitant EPI as follows: OPV administered as a 1 g oral solution at age \~2, 3, and 4 months and DTaP administered as a 0.5 mL intramuscular injection at age \~3, 4, and 5 months |
| Placebo with concomitant EPI | PLACEBO_COMPARATOR | Placebo administered as a 2 mL oral solution at age \~2, 3, and 4 months, and concomitant EPI as follows: OPV administered as a 1 g oral solution at age \~2, 3, and 4 months and DTaP administered as a 0.5 mL intramuscular injection at age \~3, 4, and 5 months |
| 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 |
|---|---|---|
| V260 | BIOLOGICAL | V260 (RotaTeq™; live, oral, pentavalent rotavirus vaccine) |
| Placebo to V260 | BIOLOGICAL | Placebo control |
| OPV | BIOLOGICAL | Oral poliovirus vaccine administered according to the standard of care |
| DTaP | BIOLOGICAL | Diphtheria, Tetanus, Acellular Pertussis vaccine administered according to the standard of care |
| RotaTeq™ experimental formulation | BIOLOGICAL | - |
| RotaTeq™ existing formulation | BIOLOGICAL | - |
Inclusion Criteria: * Healthy infants at least 6 weeks (42 days) and up to 12 weeks (84 days) of age at the time of the first study vaccination * Parent/legal guardian agrees to participate by giving written informed consent and is willing and able to comply with study requirements Exclusion Crite...
RotaTeq experimental formulation is an investigational monoclonal antibody developed by Merck & Company, Inc. for rotavirus gastroenteritis, an infectious disease. It was studied in a Phase 3 clinical trial in infants. It is a new formulation evaluated for immunogenicity, tolerability, and safety rather than a currently marketed product.
RotaTeq experimental formulation is being studied for rotavirus gastroenteritis, an infectious disease that affects infants. The Phase 3 trial enrolled infants from 6 weeks of age to assess immunogenicity, tolerability, and safety. The condition under study in the trial was rotavirus gastroenteritis.
RotaTeq experimental formulation is developed by Merck & Company, Inc., which trades under the ticker MRK. Merck sponsored the Phase 3 study of this new formulation in infants. The trial was registered as V260-035 and conducted under NCT01600092.
RotaTeq experimental formulation is in Phase 3 development. The single registered trial, NCT01600092, is a completed Phase 3 study. It is an investigational product and is not described as approved. The trial evaluated a new formulation of RotaTeq in infants.
RotaTeq experimental formulation was studied in one 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 is completed and enrolled 1,020 infants aged 6 weeks and older. It was randomized, double blind, and active controlled.
RotaTeq experimental formulation is also known as RotaTeq experimental formulation, written with the trademark symbol. It refers to a new formulation of RotaTeq that Merck studied in a Phase 3 trial in infants. Searches for either name point to the same investigational asset evaluated under NCT01600092.