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HRV PCV-free liquid vaccine · 1 trial · 2 indications
Antibody concentrations against Rota Virus (RV) were determined as Geometric Mean Antibody Concentration (GMC) and expressed as Units per milliliter (U/mL).
Seroconversion rate (SCR) was defined as the percentage of subjects who were initially seronegative (i.e., with anti-RV IgA antibody concentration less than (\<) 20 U/mL before the first dose of HRV vaccine) and developed anti-RV IgA antibody concentration greater than or equal to (≥) 20 U/mL at Month 2-4 (1-2 months after dose 2). SCR was analysed using Enzyme Linked Immunosorbent Assay (ELISA). For this outcome measure, the three groups (Liq\_A, Liq\_B \& Liq\_C) were pooled into a single group (Liq\_Pool group) as they all received PCV free-liquid HRV vaccine, and as pre-specified in the protocol, the immunological non-inferiority of the Liq\_Pool group was compared to the currently licensed lyophilized HRV vaccine (Lyo\_Control group) in terms of seroconversion rates of 1-2 months after Dose 2.
Seroconversion rate (SCR) was defined as the percentage of subjects who were initially seronegative (i.e., with anti-RV IgA antibody concentration less than (\<) 20 U/mL before the first dose of HRV vaccine) and developed anti-RV IgA antibody concentration greater than or equal to (≥) 20 U/mL at Month 2-4 (1-2 months after dose 2). SCR was analysed using Enzyme Linked Immunosorbent Assay (ELISA). The analysis was assessed to demonstrate the immunogenicity of PCV-free liquid HRV vaccine as compared to the currently licensed lyophilised HRV vaccine (individual HRV liquid groups) in terms of seroconversion rates 1-2 months after Dose 2.
Antibody concentrations against RV were determined as GMCs and expressed as U/mL. For this outcome measure, the three groups (Liq\_A, Liq\_B \& Liq\_C) were pooled into a single group (Liq\_Pool group) as they all received PCV free-liquid HRV vaccine, and as pre-specified in the protocol, the immunological non-inferiority of the Liq\_Pool group was compared to the currently licensed lyophilized HRV vaccine (Lyo\_Control group) in terms of antibody concentrations at 1-2 months after Dose 2.
Antibody concentrations against RV were determined as GMCs and expressed as U/mL. The analysis was assessed to demonstrate the immunogenicity of the PCV-free liquid HRV vaccine (individual HRV liquid groups) to that of the currently licensed lyophilised HRV vaccine in terms of serum anti-RV IgA antibody concentrations 1-2 months after Dose 2.
| Arm | Type | Description |
|---|---|---|
| Liq_A Group | EXPERIMENTAL | All subjects will receive two doses of PCV-free HRV liquid formulation lot A, at 6 and 12 weeks of age |
| Liq_B Group | EXPERIMENTAL | All subjects will receive two doses of PCV-free HRV liquid formulation lot B, at 6 and 12 weeks of age |
| Liq_C Group | EXPERIMENTAL | All subjects will receive two doses of PCV-free HRV liquid formulation lot C, at 6 and 12 weeks of age |
| Lyo Group | ACTIVE_COMPARATOR | All subjects will receive two doses of currently licensed lyophilised HRV vaccine, at 6 and 12 weeks of age |
| Name | Type | Description |
|---|---|---|
| HRV PCV-free liquid vaccine | BIOLOGICAL | Subjects will receive two doses of PCV-free HRV vaccine at 6 and 12 weeks of age. The vaccine will be administered orally |
| Rotarix | BIOLOGICAL | Subjects will receive two doses of currently licensed lyophilised HRV vaccine at 6 and 12 weeks of age. The vaccine will be administered orally |
Inclusion Criteria: * Subjects' parent(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) (Legally acceptable representatives) of the subject prior to performing any study specifi...
GSK's HRV PCV-free liquid vaccine is an investigational human rotavirus vaccine being developed to prevent rotavirus infections, which cause severe diarrhea in infants. It is designed for healthy infants starting vaccination at 6 to 12 weeks of age. The vaccine is currently in Phase 3 clinical development.
The HRV PCV-free liquid vaccine is being developed by GSK plc, a global biopharma company listed on the London Stock Exchange under the ticker GSK. GSK is conducting clinical trials to evaluate the vaccine's immunogenicity and safety in healthy infants.
The HRV PCV-free liquid vaccine is in Phase 3 clinical development. A Phase 3 trial has been completed, evaluating the vaccine in healthy infants. The vaccine remains investigational and is not yet approved for public use.
The HRV PCV-free liquid vaccine has been studied in one completed Phase 3 trial, NCT02914184. This randomized, double-blind, active-controlled study evaluated the immunogenicity and safety of two formulations of the vaccine in 1,612 healthy infants starting at 6 to 12 weeks of age.
Yes, the HRV PCV-free liquid vaccine is the same as GSK Biologicals' human rotavirus vaccine, also referred to as 444563. The Phase 3 trial NCT02914184 evaluated two formulations of this vaccine, which is being developed to prevent rotavirus infections in infants.