Study of Purified Vero Rabies Vaccine Compared With a Reference Rabies Vaccine as Simulated Rabies Post-Exposure Prophylaxis in Adult and Pediatric Population in Thaïland
Summary
Primary Objective: To describe the immune response induced by VRVg-2 and Verorab vaccine at Day 14 (to assess the immune response after 3 doses \[2-2-2\]) and Day 42 (to assess the immune response after 4 doses \[2-2-2-0-2\]) when administered as standalone in healthy pediatric population or co-administered with HRIG (Group 5 and Group 6) at Day 0 in healthy adults. Secondary Objectives: * To describe the immune response induced by VRVg-2 and Verorab vaccine at Day 14 (to assess the immune response after 3 doses \[2-2-2\]) when co-administered with ERIG (Group 3 and Group 4) at Day 0 in healthy adults * To describe the immune response induced by VRVg-2 and Verorab vaccine at D90 (to assess the immune response 90 days post-rabies simulated exposure) when administered as standalone in healthy pediatric population or co-administered with HRIG (Group 5 and Group 6) at Day 0 in healthy adults * To describe the safety profile of VRVg-2 and Verorab vaccine as standalone in pediatric population or when co-administered with ERIG (Group 3 and Group 4) or HRIG (Group 5 and Group 6) at Day 0 in adults, after each vaccination.
Timeline
- Start
- 2020-08-04
- Primary completion
- 2022-03-19
- Completion
- 2022-07-21
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Equine rabies immunoglobulins | Protein / enzyme biologic | — | Intramuscular |
| Subject | Human Rabies Immunoglobulins | Protein / enzyme biologic | — | Intramuscular |
| Comparator | Rabies vaccine | Vaccine | — | Intramuscular |
| Subject | VRVg-2 | Vaccine | — | Intramuscular |
Indications
No indication recorded.