Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
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...
It is used to prevent rotavirus gastroenteritis, a diarrheal illness caused by rotavirus infection. The vaccine is given orally to healthy infants, with clinical studies enrolling babies from 6 to 8 weeks of age. It is intended for prophylaxis of rotavirus gastroenteritis and related rotavirus infections.
GSK plc, which trades under the ticker GSK, is the developer of the live attenuated human rotavirus vaccine. The company has sponsored Phase 3 clinical studies of the vaccine in infant populations across multiple countries, including India, Thailand, and South Korea.
The live attenuated human rotavirus vaccine is in Phase 3 clinical development. It is an investigational vaccine and is not described as approved. Three Phase 3 trials have been completed, and no trials are currently active. The completed studies enrolled a total of 510 participants across India, Thailand, and South Korea.
Three completed Phase 3 trials have evaluated the live attenuated human rotavirus vaccine: NCT00289172 in India with 360 infants, NCT00169455 in Thailand with 450 infants, and NCT00134732 in South Korea with 150 infants. All three studies are completed, and none are currently active.
The live attenuated human rotavirus vaccine is given orally. Trial titles describe it as an oral vaccine, and one Phase 3 study assessed immunogenicity after reconstitution without a buffering agent and after storage at 37 degrees Celsius for 7 days. It is administered as a two-dose regimen to healthy infants.