A Phase 3 interventional study of Rabies vaccine and Verorab® in Rabies (Healthy Volunteers), sponsored by Sinovac Biotech Co., Ltd. Not yet recruiting at 1 site in Pakistan. Open to participants aged 1 Year and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-07-09.
Sponsored by Sinovac Biotech Co., Ltd · Phase 3, Interventional, and Prevention
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
This is a Phase Ⅲ, randomized, double-blind, active-controlled study. A total of 390 healthy participants aged ≥1 years old will be enrolled. All participants will be randomized at a 2:1 ratio to receive Sinovac rabies vaccine (Trial group) or Sanofi Pasteur Verorab® (Control group), in an Essen schedule of 5 doses at Day 0, Day 3, Day 7, Day 14, Day 28 through intramuscular route (IM) as a simulated rabies PEP.
Blood samples for immunogenicity assessment will be collected at Day 0, Day 14, Day 28, and Day 42. For safety assessment, the solicited local and systemic adverse events (AEs) within 7 days after each-dose vaccination (If the vaccination interval is less than 7 days, the actual interval shall prevail), as well as unsolicited AEs from the first-dose vaccination until 28 days after the last-dose vaccination will be actively monitored. Serious adverse events (SAEs) will also be collected during the whole study period.
Exclusion Criteria:
Participants will be randomly assigned to receive Sinovac rabies vaccine.
Biological: Rabies vaccine
Participants will be randomly assigned to receive the marketed rabies vaccine Verorab®
Biological: Verorab®
Receiving five doses of rabies vaccine manufactured by Sinovac using the "Essen" PEP schedule
Receiving five doses of marketed rabies vaccine manufactured by Sanofi using the "Essen" PEP schedule
Proportion of participants achieving a rabies virus neutralizing antibody (RVNA) titer ≥0.5 IU/mL
Time frame: Day 14 and Day 28 after the first dose vaccination
Geometric mean concentrations (GMCs) of RVNA titers
Time frame: Day 14, Day 28 and Day 42 after the first dose vaccination
Proportion of participants achieving a RVNA titer ≥0.5 IU/mL
Time frame: Day 42 after the first dose vaccination
Incidence of adverse reactions
Time frame: Up to 28 days after the last-dose vaccination
Plan to share: No
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This study is not yet recruiting, as verified in Jun 2025. You cannot join it, but the record below documents what was studied.
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Sinovac Biotech Co., Ltd