NCT04594551

Study of Purified Vero Rabies Vaccine Compared With a Reference Rabies Vaccine as Simulated Rabies Post-Exposure Prophylaxis in Adults in Thaïland

Immunogenicity and Safety of the Purified Vero Rabies Vaccine - Serum Free (VRVg) Using the Zagreb Regimen as Simulated Rabies Post-exposure Prophylaxis in Healthy Adults in Thailand

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 201 (actual)
• Sponsor: Sanofi Pasteur, a Sanofi Company · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

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.

Detailed description

The duration of each subject's participation in the study will be approximately 7 months (21 day-vaccination period followed by 6 months safety follow-up period).

Conditions

• Rabies (Healthy Volunteers)

Interventions

Type	Name	Description
BIOLOGICAL	Purified vero rabies vaccine - serum free	Pharmaceutical form:freeze-dried - Route of administration: intramuscular
BIOLOGICAL	Purified inactivated rabies vaccine	Pharmaceutical form:freeze-dried - Route of administration: intramuscular
BIOLOGICAL	Human rabies immunoglobulins	Pharmaceutical form:liquid/solution in 2 mL vials - Route of administration: intramuscular

Timeline

• Start date: 2020-10-11
• Primary completion: 2021-06-23
• Completion: 2021-06-23
• First posted: 2020-10-20
• Last updated: 2025-09-19

Locations

3 sites across 1 country: Thailand