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

NCT07500207 · Status: ENROLLING_BY_INVITATION · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 3000

Last updated 2026-03-30

No results posted yet for this study

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

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.

Sponsors & Collaborators

  • Changchun BCHT Biotechnology Co.

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
10 Years
Max Age
60 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2026-03-04
Primary Completion
2026-05-25
Completion
2027-03-25

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07500207 on ClinicalTrials.gov