Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT06025695 | Immunogenicity, Reactogenicity and Safety of GlaxoSmithKline (GSK) Biologicals' Rotarix Porcine Circovirus (PCV)-Free Liquid Compared to Rotarix Liquid Given in 2-doses in Healthy Chinese Infants Starting at Age 6-16 Weeks | PHASE3 | COMPLETED | 2,000 | — | — | Sep 1, 2023 | Oct 23, 2024 | May 9, 2025 | 12 | China |
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...