Clinical Trial

A Clinical Trial of Rabies Vaccine(Human Diploid Cell)for Human Use,Freeze-dried in a Population Aged 10 to 60 Years

Active, Not Recruiting Phase 3
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Record status
This record was last updated March 31, 2026 (before its estimated April 26, 2026 completion). Its status may not reflect the trial's current state.
Summary
A total of 3,000 participants will be enrolled, stratified by age into two groups: 600 participants aged 10-17 years and 2,400 participants aged 18-60 years. Within each age group, participants will be randomly assigned in a 1:1:1:1:1 ratio to one of five vaccination schedule groups: Essen Control Group (Group A), Essen Experimental Group (Group B), Zagreb Experimental Group (Group C), Simplified Four-Dose Group 1 (Group D), and Simplified Four-Dose Group 2 (Group E). Among participants in the four experimental groups-Essen Experimental Group, Zagreb Experimental Group, Simplified Four-Dose Group 1, and Simplified Four-Dose Group 2-stratified block randomization will be applied. Within each age group and each vaccination schedule group, participants will be further randomized in a 1:1:1 ratio into three subgroups: those receiving a booster dose at Day 90 after completion of the primary immunization, those receiving a booster dose at Day 180, and those undergoing assessment of immune persistence at Day 360 after completion of the primary immunization.
Protocol Amendment History 2 amendments
This ClinicalTrials.gov record has been amended 2 times since 2025-11-28; most recent amendment 2026-03-29.
Status change: Not Yet Recruiting → Active, Not Recruiting 2026-03-29
Trial Details
NCT Number NCT07275645
Lead Sponsor Ab&B Bio-tech Co., Ltd.JS
Conditions Rabies
Enrollment 3,000 participants
Start Date 2026-02-26
Primary Completion 2026-04-26 (estimated)
Study Completion 2027-04-26 (estimated)
Updated on ClinicalTrials.gov 2026-03-31