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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 vaccine being studied for the prevention of rabies. It is being evaluated in healthy volunteers and in the context of rabies post-exposure prophylaxis. The vaccine is developed by Sanofi and is currently in Phase 3 clinical development.
Purified vero rabies vaccine- serum free VRVg-2 is developed by Sanofi, a company listed on the stock exchange under the ticker SNY. Sanofi is conducting Phase 3 clinical trials to evaluate the vaccine's safety and immunogenicity in comparison with reference rabies vaccines.
Purified vero rabies vaccine- serum free VRVg-2 is in Phase 3 clinical development. It is an investigational vaccine and has not been approved by regulatory authorities. Two Phase 3 trials have been completed, with a total enrollment of over 2,000 participants.
Purified vero rabies vaccine- serum free VRVg-2 has been studied in two completed Phase 3 trials. NCT04127786 compared the vaccine with two reference rabies vaccines in a pre-exposure regimen in children and adults, with a booster dose in a subset of adults. NCT04478084 evaluated the vaccine as simulated rabies post-exposure prophylaxis in adults and children in Thailand.
Yes, Purified vero rabies vaccine- serum free VRVg-2 is also known as VRVg-2. The vaccine is a purified vero cell rabies vaccine produced under serum-free conditions. It is being developed by Sanofi for the prevention of rabies.