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Live attenuated rotavirus vaccine · 1 trial · 1 indication
| Name | Type | Description |
|---|---|---|
| Live attenuated rotavirus vaccine | BIOLOGICAL | - |
Inclusion Criteria: * Subjects with parents/guardians who the investigator believes can and will comply with the requirements of the protocol should be enrolled in the study. * Males or females between, and including, 6 and 12 weeks (42 - 90 days) of age at the time of the first vaccination. * Writ...
The live attenuated rotavirus vaccine is an investigational vaccine being developed by GSK plc for the prevention of rotavirus gastroenteritis. It uses weakened, live rotavirus to stimulate an immune response. It is in Phase 2 clinical development and is not approved.
It is being studied for the prophylaxis of rotavirus gastroenteritis and rotavirus infections. Rotavirus is a leading cause of severe diarrhea in infants and young children. The vaccine is intended to prevent gastroenteritis caused by rotavirus infection.
GSK plc, which trades under the ticker GSK, is the developer of the live attenuated rotavirus vaccine. The company is studying two different formulations of the human rotavirus vaccine in its clinical program.
The live attenuated rotavirus vaccine is in Phase 2 clinical development. It is investigational and has not been approved by the FDA. One Phase 2 trial has been completed, and no trials are currently active.
The live attenuated rotavirus vaccine has been studied in one completed Phase 2 trial, NCT00137930, titled a study of immunogenicity and safety of two different formulations of human rotavirus vaccine for the prophylaxis of rotavirus gastroenteritis. It enrolled 250 healthy volunteers in Finland, starting at 6 weeks of age.