Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
HRV Liquid · 1 trial · 1 indication
Serum anti-RV IgA antibody concentrations were expressed as geometric mean concentrations (GMCs).
| Arm | Type | Description |
|---|---|---|
| HRV Liq Group | EXPERIMENTAL | Subjects aged 6 to 10 weeks at the time of first vaccination, who received two oral doses of Liquid Human Rotavirus Vaccine (HRV) according to a two-dose schedule, at Day 1 and Month 1. |
| HRV Lyo Group | ACTIVE_COMPARATOR | Subjects aged 6 to 10 weeks at the time of first vaccination who received two oral doses of Lyophilized Human Rotavirus Vaccine (HRV) according to a two-dose schedule, at Day 1 and Month 1. |
| Name | Type | Description |
|---|---|---|
| HRV Liquid | BIOLOGICAL | Two doses administered orally according to a 0, 1-month schedule. |
| HRV Lyophilized | BIOLOGICAL | Two doses administered orally according to a 0, 1-month schedule. |
Inclusion Criteria: * Subjects' parent(s)/ Legally Acceptable Representative (s) \[LAR(s)\] who, in the opinion of the investigator, can and will comply, with the requirements of the protocol. * Written informed consent obtained from the parent(s)/ LAR(s) of the subject prior to performing any stud...
HRV Liquid is an investigational monoclonal antibody being developed for the prevention of rotavirus infection. It is being studied in healthy infants as a potential vaccine against rotavirus, a common cause of severe diarrhea in young children.
HRV Liquid is being developed by GSK plc, a global biopharma company listed on the London Stock Exchange under the ticker GSK. The company is conducting clinical trials to evaluate the safety and immunogenicity of this investigational rotavirus vaccine.
HRV Liquid is in Phase 3 clinical development. It is an investigational product and has not been approved by regulatory authorities. The Phase 3 trial has been completed, and the results will inform potential regulatory submissions.
HRV Liquid has been studied in one completed Phase 3 clinical trial, identified as NCT02141204. This trial evaluated the immunogenicity, reactogenicity, and safety of two different formulations of the vaccine in healthy infants aged 6 weeks and older in India.
HRV Liquid is being studied as a liquid formulation of GSK's rotavirus vaccine, which is known as Rotarix. The Phase 3 trial compared two different formulations of the vaccine, both based on the Rotarix strain, to assess their immune response and safety profile.