drugset / Trial / NCT04594551
Study of Purified Vero Rabies Vaccine Compared With a Reference Rabies Vaccine as Simulated Rabies Post-Exposure Prophylaxis in Adults in Thaïland
RandomizedParallel-groupQuadruple-blindPrevention
Summary
Primary Objective: To describe the immune response induced by VRVg-2 and Verorab vaccines at D14 and D35 when co-administered with Human Rabies Immunoglobulins (HRIG) at D0, according to the Zagreb (2-1-1) IM regimen in healthy adult subjects. Secondary Objective: Immunogenicity To describe the immune response induced by VRVg-2 and Verorab vaccines at D90 when co-administered with HRIG at D0, according to the Zagreb (2-1-1) IM regimen in healthy adult subjects. Safety To describe the safety profile of VRVg-2 and Verorab vaccines when co administered with HRIG at D0, after each vaccination.
Timeline
- Start
- 2020-10-11
- Primary completion
- 2021-06-23
- Completion
- 2021-06-23
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | Rabies vaccine | Vaccine | — | Intramuscular |
| Subject | VRVg-2 | Vaccine | — | Intramuscular |
| Background | Human Rabies Immunoglobulins | Protein / enzyme biologic | — | Intramuscular |
Indications
No indication recorded.