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Human Rotavirus Vaccine- two different formulations · 1 trial · 1 indication
| Arm | Type | Description |
|---|---|---|
| Group A | EXPERIMENTAL | Human Rotavirus Vaccine - Formulation 1 |
| Group B | EXPERIMENTAL | Human Rotavirus Vaccine - Formulation 2 |
| Group C | PLACEBO_COMPARATOR | - |
| Name | Type | Description |
|---|---|---|
| Human Rotavirus Vaccine - two different formulations | BIOLOGICAL | Two oral doses |
| Prevnar | BIOLOGICAL | Three-dose intramuscular injection (US subjects only) |
| IPOL | BIOLOGICAL | Two-dose intramuscular injection (US subjects only) |
| Infanrix | BIOLOGICAL | Three-dose intramuscular injection (US subjects only) |
| OmniHIB | BIOLOGICAL | Three-dose intramuscular injection (US subjects only) |
| Pentacel | BIOLOGICAL | Three-dose intramuscular injection (Canada only) |
Inclusion Criteria: * A male or female child between, and including 6 and 12 weeks (42-90 days) of age at the time of the first vaccination. * Free of obvious health problems as established by medical history and clinical examination before entering into the study. * Written informed consent obtain...
It is an investigational vaccine developed by GSK plc for the prevention of rotavirus infections. The Phase 2 program evaluated two different formulations of a live attenuated human rotavirus vaccine in healthy infants. Rotavirus is a leading cause of severe diarrheal illness in young children worldwide.
It is being studied for the prevention of rotavirus infections in healthy infants. The Phase 2 trial enrolled infants from 6 weeks of age to assess two different formulations of the live attenuated vaccine. Rotavirus infection is the target indication under study.
GSK plc, which trades under the ticker GSK, is the developer of the Human Rotavirus Vaccine (two different formulations). The company sponsored the Phase 2 study of the two formulations in healthy infants.
It is in Phase 2 development. The only listed trial, NCT00729001, is a completed Phase 2 study of two doses of GSK Biologicals' live attenuated human rotavirus vaccine in healthy infants. It is an investigational product and is not described as approved.
One trial is listed: NCT00729001, titled "Study of Two Doses of GSK Biologicals' Live Attenuated HRV Vaccine (Two Different Formulations) in Healthy Infants." It was a completed Phase 2 randomized, double-blind, placebo-controlled study that enrolled 529 healthy infants from 6 weeks of age.
Yes. Human Rotavirus Vaccine - two different formulations is the same asset as the Human Rotavirus Vaccine (two different formulations). Both names refer to the GSK plc Phase 2 program evaluating two formulations of a live attenuated human rotavirus vaccine in healthy infants.