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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT04478084 | Study of Purified Vero Rabies Vaccine Compared With a Reference Rabies Vaccine as Simulated Rabies Post-Exposure Prophylaxis in Adult and Pediatric Population in Thaïland | PHASE3 | COMPLETED | 403 | — | — | Aug 4, 2020 | Jul 21, 2022 | 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: pediatric participants; VRVg-2 | EXPERIMENTAL | VRVg-2 8 injections: 2 at Day 0, 2 at Day 3, 2 at Day 7, and 2 at Day 28 |
| Group 2: pediatric participants; Verorab | ACTIVE_COMPARATOR | Verorab 8 injections: 2 at Day 0, 2 at Day 3, 2 at Day 7, and 2 at Day 28 |
| Group 3: adult participants; VRVG-2 + ERIG | EXPERIMENTAL | VRVg-2 8 injections: 2 at Day 0, 2 at Day 3 and 2 at Day 7 \+ ERIG at D0 |
| Group 4: adult participants; Verorab + ERIG | ACTIVE_COMPARATOR | Verorab 8 injections: 2 at Day 0, 2 at Day 3 and 2 at Day 7 \+ ERIG at D0 |
| Group 5: adult participants; VRVG-2 + HRIG | EXPERIMENTAL | VRVg-2 8 injections: 2 at Day 0, 2 at Day 3, 2 at Day 7, and 2 at Day 28 \+ HRIG at D0 |
| Group 6: adult participants; Verorab + HRIG | ACTIVE_COMPARATOR | Verorab 8 injections: 2 at Day 0, 2 at Day 3, 2 at Day 7, and 2 at Day 28 \+ HRIG at D0 |
| Name | Type | Description |
|---|---|---|
| Purified vero rabies vaccine - serum free VRVg-2 | BIOLOGICAL | Pharmaceutical form:freeze-dried Route of administration: intradermal |
| Purified inactivated rabies vaccine | BIOLOGICAL | Pharmaceutical form:freeze-dried Route of administration: intradermal |
| Equine rabies immunoglobulins (ERIG) (only Group 3 and Group 4) | BIOLOGICAL | Pharmaceutical form: liquid/solution in 5 mL vials Route of administration: intramuscular |
| Human rabies immunoglobulins (HRIG) (only Group 5 and Group 6) | BIOLOGICAL | Pharmaceutical form: liquid/solution in 2 mL vials Route of administration: intramuscular |
Inclusion Criteria: Inclusion criteria : * Aged ≥ 1 year on the day of inclusion * Participant (adult ≥ 18 years without upper age limit) or participant and participant's parent/LAR (child ≥ 1 to \< 18 years) are able to attend all scheduled visits and to comply with all study procedures The foll...