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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT04594551 | Study of Purified Vero Rabies Vaccine Compared With a Reference Rabies Vaccine as Simulated Rabies Post-Exposure Prophylaxis in Adults in Thaïland | PHASE3 | COMPLETED | 201 | — | — | Oct 11, 2020 | Jun 23, 2021 | Sep 19, 2025 | 3 | Thailand |
RVNA titers will be measured by rapid fluorescent focus inhibition test (RFFIT)
RVNA titers will be measured by RFFIT
RVNA titers will be measured by RFFIT - Lower limit of quantification for RFFIT assay is 0.2 IU/mL
RVNA titers against rabies virus will be measured by RFFIT at Day 0 and Day 14 - RVNA ratios Day14/Day0 will be calculated
| Arm | Type | Description |
|---|---|---|
| Group 1: VRVg-2 + HRIG | EXPERIMENTAL | VRVg-2 4 injections: 2 at Day 0, 1 at Day 7, 1 at Day 21 \+ HRIG at D0 |
| Group 2: Verorab + HRIG | ACTIVE_COMPARATOR | Verorab 4 injections: 2 at Day 0, 1 at Day 7, 1 at Day 21 \+ HRIG at D0 |
| Name | Type | Description |
|---|---|---|
| Purified vero rabies vaccine - serum free | BIOLOGICAL | Pharmaceutical form:freeze-dried - Route of administration: intramuscular |
| Purified inactivated rabies vaccine | BIOLOGICAL | Pharmaceutical form:freeze-dried - Route of administration: intramuscular |
| Human rabies immunoglobulins | BIOLOGICAL | Pharmaceutical form:liquid/solution in 2 mL vials - Route of administration: intramuscular |
Inclusion criteria : * Aged ≥ 18 years on the day of inclusion * Able to attend all scheduled visits and to comply with all study procedures * Body Mass Index (BMI): 18.5 kg/m2 ≤ BMI ≤ 30 kg/m2s Exclusion criteria: * Subject is pregnant, or lactating, or of childbearing potential and not using an...