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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT03965962 | Study of Purified Vero Rabies Vaccine Compared With Two Reference Rabies Vaccines in a Simulated Post-Exposure Regimen in Adults | PHASE3 | COMPLETED | 640 | — | — | Jul 1, 2019 | Jul 1, 2021 | Sep 18, 2025 | 2 | France |
RVNA titer against rabies virus was assessed using the Rapid Fluorescent Focus Inhibition test (RFFIT) assay method.
| Arm | Type | Description |
|---|---|---|
| Group 1: VRVg-2 + HRIG | EXPERIMENTAL | Participants received 0.5 milliliters (mL) intramuscular (IM) injection of VRVg-2 formulation on Days 0, 3, 7, 14 and 28 along with HRIG injection at Day 0. |
| Group 2: Verorab + HRIG | ACTIVE_COMPARATOR | Participants received 0.5 mL IM injection of Verorab on Days 0, 3, 7, 14 and 28 along with HRIG injection at Day 0. |
| Group 3: Imovax Rabies + HRIG | ACTIVE_COMPARATOR | Participants received 1 mL IM injection of Imovax Rabies on Days 0, 3, 7, 14 and 28 along with HRIG injection at Day 0. |
| Group 4: VRVg-2 | EXPERIMENTAL | Participants received 0.5 mL IM injection of VRVg-2 formulation on Days 0, 3, 7, 14 and 28. |
| Name | Type | Description |
|---|---|---|
| VRVg-2 | BIOLOGICAL | Pharmaceutical form: Powder and solvent for suspension for injection; Route of administration: IM |
| Purified Inactivated Rabies Vaccine | BIOLOGICAL | Pharmaceutical form: Powder and solvent for suspension for injection; Route of administration: IM |
| Human Diploid Cell Vaccine (HDCV) | BIOLOGICAL | Pharmaceutical form: Powder and solvent for suspension for injection; Route of administration: IM |
| Rabies immune globulin (human) | BIOLOGICAL | Pharmaceutical form: Solution for injection; Route of administration: IM |
Inclusion criteria : * Men or women aged \>=18 years on the day of inclusion (\>= 18 years means from the day of the 18th birthday onwards, with no upper age limit). * Able to attend all scheduled visits and to comply with all trial procedures. * Body Mass Index (BMI): 18.5 kilograms per square met...