NCT04478084

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

Immunogenicity and Safety of a Purified Vero Rabies Vaccine-Serum Free (VRVg) Assessed With the Institut Pasteur du Cambodge (IPC: 2-2-2-0-0) and the Thai Red Cross (TRC: 2-2-2-0-2) Intradermal Regimens as Simulated Rabies Post-exposure Prophylaxis in Healthy Subjects in Thailand

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 403 (actual)
• Sponsor: Sanofi Pasteur, a Sanofi Company · Industry
• Sex: All
• Age: 1 Year
• Healthy volunteers: Accepted

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.

Detailed description

The duration of each participant's participation in the study is approximately 7 months (28 day-vaccination period followed by 6 month safety follow-up period).

Conditions

• Rabies (Healthy Volunteers)

Interventions

Type	Name	Description
BIOLOGICAL	Purified vero rabies vaccine - serum free VRVg-2	Pharmaceutical form:freeze-dried Route of administration: intradermal
BIOLOGICAL	Purified inactivated rabies vaccine	Pharmaceutical form:freeze-dried Route of administration: intradermal
BIOLOGICAL	Equine rabies immunoglobulins (ERIG) (only Group 3 and Group 4)	Pharmaceutical form: liquid/solution in 5 mL vials Route of administration: intramuscular
BIOLOGICAL	Human rabies immunoglobulins (HRIG) (only Group 5 and Group 6)	Pharmaceutical form: liquid/solution in 2 mL vials Route of administration: intramuscular

Timeline

• Start date: 2020-08-04
• Primary completion: 2022-03-19
• Completion: 2022-07-21
• First posted: 2020-07-20
• Last updated: 2025-09-19

Locations

3 sites across 1 country: Thailand