NCT07500207

A Phase III Clinical Trial on Immunogenicity and Safety of Lyophilized Rabies Vaccine for Human Use (Human Diploid Cell)

A Phase III Clinical Trial to Evaluate the Immunogenicity and Safety of Lyophilized Human Rabies Vaccine (Human Diploid Cell) Administered Via Different Immunization Schedules Using a Randomized, Blinded, Positive-Controlled Design

• Status: Enrolling By Invitation
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 3,000 (estimated)
• Sponsor: Changchun BCHT Biotechnology Co. · Industry
• Sex: All
• Age: 10 Years – 60 Years
• Healthy volunteers: Accepted

Summary

Neutralizing antibody seroconversion rate and geometric mean concentration in seronegative participants of each group at 14 days after the first dose of immunization. The seroconversion rate of neutralizing antibodies 42 days after the first dose among seronegative participants before vaccination in each group

Conditions

• Rabies Prevention

Interventions

Type	Name	Description
BIOLOGICAL	Experimental Lyophilized Human Rabies Vaccine (Human Diploid Cell)	Dosage schedule: Five-dose regimen: one dose on days 0, 3, 7, 14, and 28 respectively; 2-1-1 regimen: administration on days 0, 7, and 21, with 2 doses on day 0 and 1 dose on each of the other days; Simplified four-dose regimen: one dose on days 0, 3, 7, and 14, or one dose on days 0, 3, 7, and 28 respectively.
BIOLOGICAL	approved Rabies vaccine	One dose shall be administered on days 0, 3, 7, 14, and 28 respectively.

Timeline

• Start date: 2026-03-04
• Primary completion: 2026-05-25
• Completion: 2027-03-25
• First posted: 2026-03-30
• Last updated: 2026-03-30

Locations

1 site across 1 country: China