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Purified vero rabies vaccine- serum free- VRVg-2 · 1 trial · 2 indications
RVNA titer against rabies virus was assessed using the Rapid Fluorescent Focus Inhibition test (RFFIT) assay method.
| Arm | Type | Description |
|---|---|---|
| Group1:VRVg2 Cohort1(C1)-1ry Series:pediatric&adult participants-Booster:102 adult participants | EXPERIMENTAL | VRVg-2, 3 injections at Day 0, Day 7, and Day 28 Booster dose of VRVg-2 for a subset of 102 adult participants at Month 12 |
| Group 2:Verorab C1-1ry Series:pediatric&adult participants-Booster Phase:34 adult participants | ACTIVE_COMPARATOR | Verorab, 3 injections at Day 0, Day 7, and Day 28 Booster dose of VRVg-2 for a subset of 34 adult participants at Month 12 |
| Group 3:Imovax Rabies C1-1ry Series:pediatric&adult participants-Booster Phase:34 adult participants | ACTIVE_COMPARATOR | Imovax Rabies, 3 injections at Day 0, Day 7, and Day 28 Booster dose of VRVg-2 for a subset of 34 adult participants at Month 12 |
| Group 4:VRVg-2 Cohort 2(C2)-1ry Series:Adult participants-Booster Phase:138 adult participants | EXPERIMENTAL | VRVg-2, 2 injections at Day 0 and Day 7 Booster dose of VRVg-2 for a subset of 138 adult participants between Month 24 up to Month 36 |
| Group 5:Verorab C2-1ry Series:adult participants-Booster Phase:46 adult participants | ACTIVE_COMPARATOR | Verorab, 2 injections at Day 0 and Day 7 Booster dose of VRVg-2 for a subset of 46 adult participants between Month 24 up to Month 36 |
| Group 6:Imovax Rabies C2-1ry Series:adult participants-Booster Phase:46 adult participants | ACTIVE_COMPARATOR | Imovax Rabies, 2 injections at Day 0 and Day 7 Booster dose of VRVg-2 for a subset of 46 adult participants between Month 24 up to Month 36 |
| Name | Type | Description |
|---|---|---|
| Purified vero rabies vaccine - serum free - VRVg-2 | BIOLOGICAL | Pharmaceutical form: Freeze-dried Route of administration: Intramuscular |
| Purified inactivated rabies vaccine - Verorab® | BIOLOGICAL | Pharmaceutical form:Freeze-dried Route of administration: Intramuscular |
| Purified inactivated rabies vaccine - Imovax® Rabies | BIOLOGICAL | Pharmaceutical form: Freeze-dried Route of administration: Intramuscular |
Inclusion Criteria: * Aged ≥1 year on the day of inclusion * Cohort 1 - pediatrics (\>1 to 17 years old) and adult (≥18 years old) * Cohort 2 - all adults (≥18 years old) * Informed consent form has been signed and dated by the participant and /or and parent(s) or legally acceptable representa...
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.