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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT02914184 | Evaluation of Immunogenicity and Safety of Two Formulations of GSK Biologicals' Human Rotavirus (HRV) Vaccine (444563), in Healthy Infants Starting at Age 6-12 Weeks | PHASE3 | COMPLETED | 1,612 | — | — | Oct 27, 2016 | Nov 26, 2018 | Jul 21, 2020 | 66 | United States, Costa Rica +6 |
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...