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Human rotavirus liquid vaccine · 1 trial · 1 indication
| Name | Type | Description |
|---|---|---|
| Human rotavirus liquid vaccine | BIOLOGICAL | - |
Inclusion Criteria: * Healthy male or female infant between, and including, 6 and 10 weeks of age with a birth weight of \> 2000 grams. * Written informed consent obtained from the parent or guardian of the subject. Exclusion Criteria: * Use of any investigational or non-registered product (drug ...
The human rotavirus liquid vaccine is an investigational vaccine developed by GSK plc for the prevention of rotavirus infections. It is a liquid formulation given to infants and is designed to protect against rotavirus, a leading cause of severe diarrhea in young children. It is currently in Phase 3 clinical development.
The human rotavirus liquid vaccine is being developed for the prevention of rotavirus infections in infants. Rotavirus causes gastroenteritis, which can lead to severe diarrhea and dehydration in young children. The vaccine is intended for use in healthy infants, with dosing starting at 6 weeks of age.
The human rotavirus liquid vaccine is developed by GSK plc, which trades under the ticker GSK. GSK is the sponsor of the clinical program evaluating this liquid rotavirus vaccine candidate for infants.
The human rotavirus liquid vaccine is in Phase 3 clinical development. It is an investigational vaccine and has not been approved by the FDA. The Phase 3 trial evaluating it has been completed.
The human rotavirus liquid vaccine has been studied in one completed Phase 3 trial, NCT00345956. This trial evaluated the immunogenicity, reactogenicity, and safety of two doses of the GSK Bio HRV liquid vaccine given to infants in Vietnam. It enrolled 375 participants, was randomized and double blind, and included healthy volunteers aged 6 weeks and older.