Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Also known as Purified Vero Rabies Vaccine (VRVg) - Serum Free, Purified Vero Rabies Vaccine Serum Free (VRVg), VRVg-2, VRVg
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 developed by Sanofi for the prevention of rabies. It is a serum-free formulation produced using Vero cells, a continuous cell line, and is being studied for pre-exposure and simulated post-exposure prophylaxis in healthy volunteers.
Purified Vero Rabies Vaccine - Serum Free is being developed for rabies prevention. Clinical studies have evaluated it for pre-exposure prophylaxis and as simulated rabies post-exposure prophylaxis in healthy adults and children, comparing it with reference rabies vaccines such as human diploid cell vaccine.
Sanofi develops Purified Vero Rabies Vaccine - Serum Free. Sanofi trades on the New York Stock Exchange under the ticker SNY. The vaccine is part of Sanofi's rabies vaccine portfolio and has been studied across multiple countries, including Thailand, the Philippines, the United States, and France.
Purified Vero Rabies Vaccine - Serum Free is in Phase 3 development. It is investigational and has not been approved by the FDA. Four clinical trials have been completed, including one Phase 3 study and three Phase 2 studies, with no active trials currently listed.
Four completed trials have evaluated Purified Vero Rabies Vaccine - Serum Free: NCT04594551, a Phase 3 study in Thailand; NCT01930357 in the Philippines; NCT01784874 in the United States; and NCT00948272 in France. Together these trials enrolled 1,335 participants, all healthy volunteers.
Yes. Purified Vero Rabies Vaccine - Serum Free is also known as Purified Vero Rabies Vaccine (VRVg) - Serum Free, Purified Vero Rabies Vaccine Serum Free (VRVg), and Purified Vero Rabies Vaccine Serum Free. These names refer to the same Sanofi investigational rabies vaccine.