NCT07055295

Immunogenicity and Safety of Rabies Vaccine (Serum-free Vero Cell) in a Pre-exposure Prophylaxis Regimen

Immunogenicity and Safety of a Rabies Vaccine (Serum-free Vero Cell), Freeze-dried in Comparison With Verorab®, in a Pre-exposure Prophylaxis Regimen in Healthy Populations Aged ≥1 Years: A Randomized, Double-Blind, Active-controlled Phase Ⅲ Clinical Trial

• Status: Not Yet Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 390 (estimated)
• Sponsor: Sinovac Biotech Co., Ltd · Industry
• Sex: All
• Age: 1 Year
• Healthy volunteers: Accepted

Summary

To demonstrate the immunogenicity of Sinovac rabies vaccine is non-inferior to the active-controlled rabies vaccine (Verorab®) after pre-exposure prophylaxis (PrEP) vaccination, and to confirm its satisfying safety profile in the pediatric and adult population in a PrEP schedule

Detailed description

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 a three doses of PrEP schedule at Day 0, Day 7 and Day 28 through intramuscular route (IM) that covers a two doses of IM PrEP schedule at Day 0, Day 7 as well. Blood samples for immunogenicity assessment will be collected at Day 0, Day 28, and Day 42. For immunogenicity assessment, the blood sample at Day 28 will be used for the two-doses IM PrEP schedule, and the blood sample at Day 42 will be used for the three-doses IM PrEP schedule, in comparison with the active-control vaccine Verorab®. 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.

Conditions

• Rabies

Interventions

Type	Name	Description
BIOLOGICAL	Rabies Vaccine (Serum-free Vero Cell), Freeze-dried	Receiving three doses of rabies vaccine rabies vaccine manufactured by Sinovac using a three-dose PrEP schedule
BIOLOGICAL	Verorab®	Receiving three doses of marketed rabies vaccine manufactured by Sanofi using the three-dose PrEP schedule

Timeline

• Start date: 2026-03-01
• Primary completion: 2026-12-30
• Completion: 2026-12-30
• First posted: 2025-07-08
• Last updated: 2025-07-08

Locations

1 site across 1 country: Pakistan