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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT02141204 | Immunogenicity, Reactogenicity and Safety Study of Two Different Formulations of GSK Biologicals' Human Rotavirus Vaccine, Rotarix, in Healthy Infants | PHASE3 | COMPLETED | 451 | — | — | Feb 20, 2019 | Dec 28, 2019 | Dec 9, 2020 | 8 | India |
Serum anti-RV IgA antibody concentrations were expressed as geometric mean concentrations (GMCs).
| Arm | Type | Description |
|---|---|---|
| HRV Liq Group | EXPERIMENTAL | Subjects aged 6 to 10 weeks at the time of first vaccination, who received two oral doses of Liquid Human Rotavirus Vaccine (HRV) according to a two-dose schedule, at Day 1 and Month 1. |
| HRV Lyo Group | ACTIVE_COMPARATOR | Subjects aged 6 to 10 weeks at the time of first vaccination who received two oral doses of Lyophilized Human Rotavirus Vaccine (HRV) according to a two-dose schedule, at Day 1 and Month 1. |
| Name | Type | Description |
|---|---|---|
| HRV Liquid | BIOLOGICAL | Two doses administered orally according to a 0, 1-month schedule. |
| HRV Lyophilized | BIOLOGICAL | Two doses administered orally according to a 0, 1-month schedule. |
Inclusion Criteria: * Subjects' 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 informed consent obtained from the parent(s)/ LAR(s) of the subject prior to performing any stud...