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Live attenuated human rotavirus vaccine · 3 trials · 2 indications
| Name | Type | Description |
|---|---|---|
| Live attenuated human rotavirus vaccine | BIOLOGICAL | - |
"Inclusion criteria: * A male or female between, and including, 8 and 10 weeks of age at the time of the first vaccination. * Written informed consent obtained from the parent or guardian of the subject. * Free of obvious health problems as established by medical history and clinical examination be...
Live attenuated human rotavirus vaccine is an investigational vaccine being developed for the prophylaxis of rotavirus gastroenteritis and rotavirus infections. It is administered orally in healthy infants to prevent disease caused by rotavirus.
Live attenuated human rotavirus vaccine is being developed by GSK plc, a pharmaceutical company listed on the stock exchange under the ticker GSK.
Live attenuated human rotavirus vaccine is in Phase 3 clinical development. It is an investigational vaccine and has not been approved by regulatory authorities. Clinical trials are completed, and it remains under evaluation.
Live attenuated human rotavirus vaccine has completed three Phase 3 trials: NCT00134732 in South Korea with 150 participants, NCT00169455 in Thailand with 450 participants, and NCT00289172 in India with 360 participants. All trials involved healthy infants aged 6 weeks or older.
Live attenuated human rotavirus vaccine is given orally as a liquid suspension. Clinical trials evaluated two doses of the vaccine in healthy infants to assess immunogenicity, reactogenicity, and safety.