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HRV vaccine · 3 trials · 1 indication
A seroconverted subject was defined as a vaccinated subject who had an anti-rotavirus IgA antibody concentration equal to or above (≥) 20 units per milliliter (U/mL) and who was initially (i.e. prior to the first dose of Rotarix™ vaccine) negative for rotavirus.
| Arm | Type | Description |
|---|---|---|
| Liquid Rotarix Group | EXPERIMENTAL | Healthy male and female infants, between and including 6-12 weeks of age, who received two oral doses of the liquid formulation of the Rotarix™ vaccine, according to a 0, 2 month schedule. |
| Lyophilized Rotarix Group | EXPERIMENTAL | Healthy male and female infants, between and including 6-12 weeks of age, who received two oral doses of the lyophilized formulation of the Rotarix™ vaccine, according to a 0, 2 month schedule. |
| Name | Type | Description |
|---|---|---|
| Lyophilized formulation of HRV vaccine | BIOLOGICAL | Lyophilized formulation of HRV vaccine |
| Liquid formulation of HRV vaccine | BIOLOGICAL | Liquid formulation of HRV vaccine |
| HRV vaccine | BIOLOGICAL | Two or three oral doses |
Inclusion Criteria: * Healthy male or female infant between, and including, 6 and 12 weeks of age born after a gestation period of 36 to 42 weeks. * Written informed consent obtained from the parent or guardian of the subject. Exclusion Criteria: * se of any investigational or non-registered prod...
The HRV vaccine is an investigational vaccine being studied for the prevention of rotavirus infections in infants. It is designed to be administered to healthy infants starting at 5 to 6 weeks of age. The vaccine is currently in clinical development and has not been approved by regulatory authorities.
The HRV vaccine is being developed by GSK plc, a global biopharma company listed on the stock exchange under the ticker GSK. GSK is conducting clinical trials to evaluate the vaccine's safety, immunogenicity, and efficacy in preventing rotavirus infections in infants.
The HRV vaccine is in Phase 3 clinical development. GSK has completed three clinical trials for the vaccine, including one Phase 3 trial and two Phase 2 trials. The vaccine remains investigational and is not yet approved for public use.
The HRV vaccine has been studied in three completed clinical trials. The Phase 3 trial, NCT00363545, enrolled 1,274 infants in Panama. Two Phase 2 trials, NCT00383903 and NCT00385320, enrolled 472 and 2,640 infants respectively, with the latter evaluating protective efficacy of different vaccine strengths.
The HRV vaccine is a human rotavirus vaccine developed by GSK. While it shares the same target of preventing rotavirus infections, the data provided does not specify whether it is identical to Rotarix. The vaccine is being evaluated in clinical trials for its safety and efficacy in infants.