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Purified vero rabies vaccine- serum free · 4 trials · 2 indications
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
Rabies virus neutralizing antibody will be measured by rapid fluorescent focus inhibition test (RFFIT)
Rabies virus neutralizing antibody titer will be determined by the rapid fluorescent focus inhibition test (RFFIT)
Rabies virus neutralizing antibody titer will be determined by the rapid fluorescent focus inhibition test (RFFIT)
| 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 |
| VRVg Group | EXPERIMENTAL | Participants will receive receive 3 vaccinations of Purified Vero Rabies Vaccine Serum Free (VRVg) |
| Imovax® Rabies Group | ACTIVE_COMPARATOR | Participants will receive receive 3 vaccinations of Human Diploid Cell Vaccine (HDCV), Imovax® Rabies |
| Purified Vero Rabies Vaccine Group | EXPERIMENTAL | Participants will receive the Purified Vero Rabies Vaccine (VRVg) Serum Free |
| Imovax® Rabies Vaccine Group | EXPERIMENTAL | Participants will receive the Imovax® Rabies |
| Verorab Group | ACTIVE_COMPARATOR | - |
| 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 |
| Purified Vero Rabies Vaccine Serum Free (VRVg) | BIOLOGICAL | 0.5 mL, Intramuscular (Day 0, Day 7 and Day 28). |
| Imovax® Rabies: Human Diploid Cell Vaccine (HDCV), | BIOLOGICAL | 0.5 mL, Intramuscular (Day 0, Day 7 and Day 28). |
| Purified Vero Rabies Vaccine (VRVg) - Serum Free | BIOLOGICAL | 0.5 mL, Intramuscular |
| Imovax® Rabies: inactivated rabies vaccine | BIOLOGICAL | 1.0 mL, 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...
Purified Vero Rabies Vaccine- Serum Free is an investigational vaccine being studied for rabies prevention, including pre-exposure prophylaxis and simulated post-exposure prophylaxis in healthy volunteers. It is developed by Sanofi (SNY) and is currently in Phase 2 clinical development for infectious disease.
Purified Vero Rabies Vaccine- Serum Free is a monoclonal antibody modality vaccine designed to target rabies virus. It is being studied to elicit an immune response against rabies for prevention of the disease.
Purified Vero Rabies Vaccine- Serum Free is developed by Sanofi, a biopharmaceutical company listed on the stock exchange under the ticker SNY. Sanofi is conducting clinical trials to evaluate the vaccine's safety and immunogenicity.
Purified Vero Rabies Vaccine- Serum Free is in Phase 2 clinical development. It is an investigational vaccine, not yet approved by regulatory authorities, and is being studied in healthy volunteers for rabies prevention.
Purified Vero Rabies Vaccine- Serum Free has completed three Phase 2 trials: NCT00948272 in France (384 participants), NCT01784874 in the United States (408 participants), and NCT01930357 in the Philippines (342 participants). All trials were completed and evaluated the vaccine against reference rabies vaccines.
Purified Vero Rabies Vaccine- Serum Free is being compared to reference rabies vaccines in clinical trials, including a purified Vero rabies vaccine and human diploid cell vaccines. It is a distinct vaccine candidate developed by Sanofi, not the same as those comparators.