A Phase 2 interventional study of Rabies Vaccine (Serum-free Vero Cell), Freeze-dried and Verorab® in Rabies, sponsored by Sinovac Biotech Co., Ltd. Not yet recruiting at 1 site in Pakistan. Open to participants aged 18 Years to 59 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-07-09.
Sponsored by Sinovac Biotech Co., Ltd · Phase 2, Interventional, and Prevention
To describe the immunogenicity and safety of two dosages of Sinovac rabies vaccine, as well as compared the differences with the marked WHO PQ rabies vaccine Verorab® in a post-exposure prophylaxis (PEP) schedule.
This is a Phase Ⅱ, randomized, double-blind, active-controlled, dose-finding study. A total of 120 healthy participants aged 18\~59 years old will be enrolled. All participants will be randomized at a 1:1:1 ratio to three armes, which receive low-dosage Sinovac rabies vaccine, high-dosage Sinovac rabies vaccine or Sanofi Pasteur Verorab®, in an Essen schedule of 5 doses at D0, 3, 7, 14, 28 through intramuscular route (IM) as a simulated rabies PEP.
Blood samples for immunogenicity assessment will be collected at D0, D14, D28, and D42. For safety assessment, the solicited local and systemic 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. SAEs will also be collected during the whole study period.
Exclusion Criteria:
Participants will be randomly assigned to receive either low-dose or high-dose Sinovac rabies vaccine.
Biological: Rabies Vaccine (Serum-free Vero Cell), Freeze-dried
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 RVNA titer ≥0.5 IU/mL
Time frame: Day 14, Day 28 and Day 42 after the first dose vaccination
GMCs of RVNA titers
Time frame: Day 14, Day 28 and 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