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GSK Biologicals' human rotavirus vaccine 444563 · 1 trial · 1 indication
| Arm | Type | Description |
|---|---|---|
| HRV group | EXPERIMENTAL | Subjects will receive GSK Biologicals' human rotavirus vaccine 444563. |
| Placebo Group | PLACEBO_COMPARATOR | Subjects will receive placebo. |
| Name | Type | Description |
|---|---|---|
| GSK Biologicals' human rotavirus vaccine 444563 | BIOLOGICAL | Oral, two doses. |
| Placebo | BIOLOGICAL | Oral, two doses. |
Inclusion Criteria: * Subjects who the investigator believes that their parent(s)/Legally Acceptable Representative(s) can and will comply with the requirements of the protocol. * A male or female infant of Chinese origin between, and including, 6 and 16 weeks of age at the time of the first vaccin...
It is an investigational vaccine developed by GSK plc for the prevention of rotavirus infections. Rotavirus is a leading cause of severe diarrhea in infants and young children. This candidate is a liquid formulation studied in healthy infants, and it remains in clinical development rather than being an approved product.
It is being studied for the prevention of rotavirus infections in healthy infants. Rotavirus causes gastroenteritis, which can lead to severe diarrhea and dehydration in young children. The vaccine candidate was evaluated in a Phase 1 study conducted in China in infants from 6 weeks of age.
The vaccine is developed by GSK plc, which trades under the ticker GSK. It is a GSK Biologicals candidate, reflecting the company's vaccines business. GSK plc is the sole developer named for this asset.
It is in Phase 1 clinical development. One Phase 1 trial has been completed, and no trials are currently active. The candidate is investigational and has not been established as an approved vaccine.
The candidate has been studied in one completed Phase 1 trial, NCT01107587, titled a study to assess the safety of GSK Biologicals' liquid human rotavirus vaccine in healthy infants. That trial enrolled 50 participants in China, was randomized, double blind, and placebo controlled, and included infants from 6 weeks of age.