Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
GSK's liquid live attenuated HRV · 1 trial · 1 indication
Seroconversion rate is defined as the percentage of participants who were initially seronegative (i.e., with anti-RV IgA Ab concentration below \[\<\] 20 unit per milliliter \[U/mL\] prior the first dose of study intervention) and developed anti-RV IgA Ab concentration greater than or equal to (\>=) 20 U/mL at Month 2 (1-month post-Dose 2).
| Arm | Type | Description |
|---|---|---|
| Human Rotavirus (HRV) Group | ACTIVE_COMPARATOR | Participants received 2 doses of GSK's liquid oral live attenuated HRV study intervention at Day 1 and Month 1. |
| HRV Porcine Circovirus (PCV)-free Group | EXPERIMENTAL | Participants received 2 doses of the PCV-free liquid formulation of GSK's oral live attenuated HRV study intervention at Day 1 and Month 1. |
| Name | Type | Description |
|---|---|---|
| GSK's liquid oral live attenuated HRV | COMBINATION_PRODUCT | 2 doses of GSK's liquid oral live attenuated HRV study intervention administered orally at Day 1 and Month 1, according to the immunization schedule for HRV study intervention licensed outside of China. |
| PCV-free liquid formulation of GSK's oral live attenuated HRV | COMBINATION_PRODUCT | 2 doses of PCV-free liquid formulation of GSK's oral live attenuated HRV study intervention administered orally at Day 1 and Month 1, according to the immunization schedule for HRV study intervention licensed outside of China. |
Inclusion Criteria: * Participants' 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 or witnessed/thumb printed informed consent obtained from the parent(s)/LAR(s) of the particip...
GSK's liquid live attenuated HRV is an investigational vaccine being developed for the prevention of gastroenteritis. It is a liquid formulation of a live attenuated human rotavirus vaccine, intended for use in infants. The vaccine is currently in Phase 3 clinical development and is not yet approved.
GSK's liquid live attenuated HRV is developed by GSK plc, a global biopharma company listed on the London Stock Exchange under the ticker GSK. The vaccine is being studied for the prevention of gastroenteritis in infants.
GSK's liquid live attenuated HRV is in Phase 3 clinical development. It is an investigational vaccine and has not been approved by regulatory authorities. A Phase 3 trial has been completed, evaluating the vaccine in healthy infants.
GSK's liquid live attenuated HRV has one completed Phase 3 trial, NCT06025695. This trial enrolled 2,000 healthy infants in China, aged 6 to 16 weeks, to assess the immunogenicity, reactogenicity, and safety of the vaccine compared to Rotarix liquid.
GSK's liquid live attenuated HRV is a live attenuated human rotavirus vaccine. It works by exposing the immune system to a weakened form of the rotavirus, which triggers an immune response without causing the disease. This helps protect against gastroenteritis caused by rotavirus infection.