Immunogenicity and Safety of Rabies Vaccine (Serum-free Vero Cell) in a Simulated Post-exposure Prophylaxis Regimen
NCT07055893 · Status: NOT_YET_RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 390
Last updated 2025-07-09
Summary
To demonstrate the immunogenicity of Sinovac rabies vaccine is non-inferior to the active-controlled rabies vaccine (Verorab®) after post-exposure prophylaxis (PEP) vaccination, and to confirm its satisfying safety profile in the pediatric and adult population in a PEP schedule
Conditions
- Rabies (Healthy Volunteers)
Interventions
- BIOLOGICAL
-
Rabies vaccine
Receiving five doses of rabies vaccine manufactured by Sinovac using the "Essen" PEP schedule
- BIOLOGICAL
-
Verorab®
Receiving five doses of marketed rabies vaccine manufactured by Sanofi using the "Essen" PEP schedule
Sponsors & Collaborators
-
Sinovac Biotech Co., Ltd
lead INDUSTRY
Principal Investigators
-
Ume Sughra, Dr. · Director Research, Al-Shifa Research Centre; Professor of Public Health, Al-Shifa Trust Eye Hospital
Study Design
- Allocation
- RANDOMIZED
- Purpose
- PREVENTION
- Masking
- QUADRUPLE
- Model
- PARALLEL
Eligibility
- Min Age
- 1 Year
- Sex
- ALL
- Healthy Volunteers
- Yes
Timeline & Regulatory
- Start
- 2026-03-01
- Primary Completion
- 2027-01-30
- Completion
- 2027-01-30
Countries
- Pakistan
Study Locations
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