Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
HRV PCV-free · 1 trial · 1 indication
Seroconversion for anti-poliovirus types 1, 2 and 3 neutralizing Ab is defined as: - Ab titer greater than or equal to (\>=) 1:8 at 1 month after the 3 dose primary vaccination schedule of IPV in participants with Ab titer lower than (\<) 1:8 at pre-vaccination, \>= 4-fold increase in Ab titer at 1 month after the 3 dose primary vaccination schedule of IPV in participants with Ab titer \>= 1:8 at pre-vaccination.
| Arm | Type | Description |
|---|---|---|
| Co-administration Group | EXPERIMENTAL | Participants received 2 doses of PCV-free liquid formulation of GSK's oral live attenuated HRV vaccine co-administered with the first 2 doses of IPV vaccine at Month 0.5 and Month 1.5, followed by the third dose of IPV vaccine administered at Month 2.5. |
| Staggered Group | ACTIVE_COMPARATOR | Participants received 2 doses of Porcine circovirus (PCV)-free liquid formulation of GSK's oral live attenuated human rotavirus (HRV) vaccine at Day 1 and Month 1, and 3 doses of Inactivated poliovirus vaccine (IPV) vaccine administered at Month 0.5, Month 1.5, and Month 2.5. |
| Name | Type | Description |
|---|---|---|
| HRV PCV-free | COMBINATION_PRODUCT | 2 doses of HRV PCV-free vaccine are administered orally at Month 0.5 and Month 1.5 (Co-administration Group) and at Day 1 and Month 1 (Staggered Group), according to the immunization schedule for HRV vaccine licensed outside of China. PCV-free implies no detection of PCV-1 and PCV-2 according to the limit of detection of the tests used. |
| IPV | COMBINATION_PRODUCT | 3 doses of IPV vaccine are administered intramuscularly at Month 0.5, Month 1.5 and Month 2.5 (Co-administration Group and Staggered Group), according to the recommended schedule for vaccination against poliovirus in 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...
HRV PCV-free is an investigational vaccine being studied for the prevention of gastroenteritis caused by human rotavirus. It is currently in Phase 3 clinical development and is intended for use in healthy infants, with the goal of generating an immune response against rotavirus infection.
HRV PCV-free 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 vaccine's immune response and safety profile in pediatric populations.
HRV PCV-free is in Phase 3 clinical development. It is an investigational vaccine and has not been approved by regulatory authorities. The Phase 3 trial has been completed, and the vaccine remains under evaluation for its safety and immunogenicity in healthy infants.
HRV PCV-free has one completed Phase 3 clinical trial registered as NCT06331156. This study evaluated the immune response and safety of the vaccine when co-administered with inactivated poliovirus vaccine in healthy Chinese infants aged 6 weeks and older. The trial enrolled 400 participants.
HRV PCV-free is a human rotavirus vaccine specifically designed to be free of porcine circovirus (PCV) components. It is being developed to prevent rotavirus gastroenteritis in infants, and the name distinguishes it from other rotavirus vaccines that may contain PCV residuals.