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ENROLLING BY INVITATION
NCT07500207
PHASE3

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

Sponsor: Changchun BCHT Biotechnology Co.

View on ClinicalTrials.gov

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

Official title: 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

Key Details

Gender

All

Age Range

10 Years - 60 Years

Study Type

INTERVENTIONAL

Enrollment

3000

Start Date

2026-03-04

Completion Date

2027-03-25

Last Updated

2026-03-30

Healthy Volunteers

Yes

Interventions

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.

Locations (1)

sichuan CDC

Neijiang, Sichuan, China