NCT07416110

Phase IIIb Clinical Trial to Evaluate Lot-to-lot Consistency of Sinovac Rabies Vaccine

Lot-to-lot Consistency and Safety of Rabies Vaccine (Vero Cell) for Human Use, Freeze-dried in Healthy Individuals Aged 18-45 Years: A Randomized, Double-Blind Phase IIIb Clinical Trial

• Status: Not Yet Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 912 (estimated)
• Sponsor: Sinovac Biotech Co., Ltd · Industry
• Sex: All
• Age: 18 Years – 45 Years
• Healthy volunteers: Accepted

Summary

To evaluate immunogenicity consistency between three consecutive batches of commercial-scale productions for Sinovac Rabies vaccine

Detailed description

This clinical trial employed a randomized, double-blind design, enrolling a total of 912 participants aged 18 to 45 years. The investigational vaccine was the serum-free rabies vaccine produced by Sinovac. Eligible participants were enrolled and randomized in a 1:1:1 ratio into Trial group 1, Trial group 2, and Trial group 3, with 304 participants in each group. They received vaccination according to the Essen regimen (1-1-1-1-1) on days 0, 3, 7, 14, and 28, for a total of 5 doses of tjhree commercially scaled batches of the rabies vaccine. Blood samples will be collection at baseline before the first dose of immunization (D0), 14 days after the first dose (D14, before the third vaccination), and 14 days after the full course of immunization (D42), as well as 3, 6, and 12 months after the full course of immunization. All participants were required to complete immediate reaction observation within 30 minutes after each vaccine dose, and adverse events and serious adverse events were collected from the first dose of baseline immunization vaccination until 30 days after the last dose.

Conditions

• Rabies (Healthy Volunteers)

Interventions

Type	Name	Description
BIOLOGICAL	Sinovac rabies vaccine	Three batchs of Rabies Vaccine (Serum-free Vero Cell), Freeze-dried using five doses of PEP schedules

Timeline

• Start date: 2026-03-04
• Primary completion: 2026-09-30
• Completion: 2027-06-30
• First posted: 2026-02-17
• Last updated: 2026-02-17

Locations

2 sites across 1 country: China