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Purified vero rabies vaccine- serum free- VRVg-2 · 1 trial · 1 indication
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...
Purified vero rabies vaccine serum free VRVg-2 is an investigational rabies vaccine developed by Sanofi. It is a serum-free formulation of a purified Vero cell rabies vaccine, studied as simulated rabies post-exposure prophylaxis in healthy adult and pediatric volunteers. It is in Phase 3 clinical development.
Purified vero rabies vaccine serum free VRVg-2 is being studied for rabies prevention, specifically as simulated rabies post-exposure prophylaxis. The Phase 3 trial enrolled healthy adult and pediatric volunteers in Thailand, including children as young as 1 year old, to evaluate the vaccine in a post-exposure setting.
Sanofi develops purified vero rabies vaccine serum free VRVg-2. Sanofi trades on the New York Stock Exchange under the ticker SNY. The company is the sponsor of the vaccine's clinical development program.
Purified vero rabies vaccine serum free VRVg-2 is in Phase 3 clinical development. It is an investigational vaccine and is not approved. The Phase 3 study has been completed, and no active trials are currently listed for this vaccine.
Purified vero rabies vaccine serum free VRVg-2 was studied in the Phase 3 trial NCT04478084, titled Study of Purified Vero Rabies Vaccine Compared With a Reference Rabies Vaccine as Simulated Rabies Post-Exposure Prophylaxis in Adult and Pediatric Population in Thailand. The trial enrolled 403 participants, was randomized, double-blind, and active-controlled, and has completed.