Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
V260 · 1 trial · 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 |
| 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 |
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...
V260 is an investigational monoclonal antibody being studied for the prevention of rotavirus gastroenteritis in infants. It is currently in Phase 3 clinical development and has not been approved by regulatory authorities. The drug is being evaluated in healthy infants starting at 6 weeks of age.
V260 is being developed by Merck & Company, Inc., a pharmaceutical company traded on the New York Stock Exchange under the ticker symbol MRK. The company is conducting clinical trials to evaluate the efficacy, safety, and immunogenicity of V260 in preventing rotavirus gastroenteritis.
V260 is in Phase 3 clinical development. It is an investigational drug and has not been approved by the FDA or other regulatory agencies. A Phase 3 trial has been completed, but the drug remains under investigation and is not yet available for clinical use.
V260 has one completed Phase 3 clinical trial registered as NCT02062385, titled "Efficacy, Safety, and Immunogenicity of V260 in Healthy Chinese Infants (V260-024)." This randomized, double-blind, placebo-controlled study enrolled 4,040 healthy infants aged 6 weeks and older to evaluate the drug's effects.
V260 is a monoclonal antibody designed to target rotavirus, the pathogen that causes rotavirus gastroenteritis. By binding to the virus, it is intended to neutralize the infection and prevent the disease in infants. The drug is administered to healthy infants to provide passive immunity against rotavirus.
No, V260 is not the same as Rotarix or RotaTeq. Rotarix and RotaTeq are live attenuated rotavirus vaccines, while V260 is a monoclonal antibody. V260 is an investigational drug being developed by Merck & Company, Inc. for the prevention of rotavirus gastroenteritis, and it is not a vaccine.