Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Also known as GSK's liquid oral live attenuated HRV
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 being developed for the prevention of gastroenteritis. It is a liquid oral vaccine candidate studied in healthy Chinese infants starting at 6 to 16 weeks of age. The Phase 3 trial evaluated it in this pediatric population.
GSK's liquid live attenuated HRV is being developed by GSK plc, which trades on the New York Stock Exchange under the ticker GSK. GSK is the sponsor of the clinical program for this vaccine candidate.
GSK's liquid live attenuated HRV is in Phase 3 development. One Phase 3 trial has been completed, and no active trials are currently listed. The candidate remains investigational and has not been approved for use.
GSK's liquid live attenuated HRV has been studied in one completed Phase 3 trial, NCT06025695. The trial enrolled 2,000 healthy Chinese infants aged 6 to 16 weeks and compared the PCV-free liquid formulation to Rotarix liquid given in two doses.
Yes, GSK's liquid live attenuated HRV is also known as GSK's liquid oral live attenuated HRV. Both names refer to the same GSK vaccine candidate being developed for gastroenteritis. The oral route reflects that it is given as a liquid by mouth.