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ACTIVE NOT RECRUITING
NCT07275645
PHASE3

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

Sponsor: Ab&B Bio-tech Co., Ltd.JS

View on ClinicalTrials.gov

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.

Official title: A Phase III, Randomized, Blinded, and Homologous Vaccine-Controlled Clinical Trial to Evaluate the Immunogenicity and Safety of the Rabies Vaccine (Human Diploid Cell), Freeze-dried, Vaccinated With Different Immunization Schedules in a Population Aged 10 to 60 Years

Key Details

Gender

All

Age Range

10 Years - 60 Years

Study Type

INTERVENTIONAL

Enrollment

3000

Start Date

2026-02-26

Completion Date

2027-04-26

Last Updated

2026-03-31

Healthy Volunteers

Yes

Conditions

Interventions

BIOLOGICAL

Rabies Vaccine(Human Diploid Cell)for Human Use,Freeze-dried

The vaccine will be administered via intramuscular injection into the deltoid muscle of the upper arm, with a human dose of 1.0 ml per injection. A total of 5 doses will be administered at Day 0, 3, 7, 14, and 28. Some participants will also undergo re-exposure immunization, receiving one additional dose of the vaccine on Days 0 and 3 of the re-exposure phase.

BIOLOGICAL

Rabies Vaccine(Human Diploid Cell)for Human Use,Freeze-dried

The vaccine will be administered via intramuscular injection into the deltoid muscle of the upper arm, with a human dose of 1.0 ml per injection. Two doses will be administered on Day 0, followed by one dose each on Days 7 and 21, for a total of 4 doses. Some participants will also undergo re-exposure immunization, receiving one additional dose of the vaccine on Days 0 and 3 of the re-exposure phase.

BIOLOGICAL

Rabies Vaccine(Human Diploid Cell)for Human Use,Freeze-dried

The vaccine will be administered via intramuscular injection into the deltoid muscle of the upper arm, with a human dose of 1.0 ml per injection. A total of 4 doses will be administered at Day 0, 3, 7 and 14. Some participants will also undergo re-exposure immunization, receiving one additional dose of the vaccine on Days 0 and 3 of the re-exposure phase.

BIOLOGICAL

Rabies Vaccine(Human Diploid Cell)for Human Use,Freeze-dried

The vaccine will be administered via intramuscular injection into the deltoid muscle of the upper arm, with a human dose of 1.0 ml per injection. A total of 4 doses will be administered at Day 0, 3, 7, and 28. Some participants will also undergo re-exposure immunization, receiving one additional dose of the vaccine on Days 0 and 3 of the re-exposure phase.

BIOLOGICAL

Rabies Vaccine(Human Diploid Cell)for Human Use,Freeze-dried

The vaccine will be administered via intramuscular injection into the deltoid muscle of the upper arm, with a human dose of 1.0 ml per injection. A total of 5 doses will be administered at Day 0, 3, 7, 14, and 28.

Locations (5)

Qichun County Center for Disease Control and Prevention

Huanggang, Hubei, China

Yunyang District Center for Disease Control and Prevention

Shiyan, Hubei, China

Zhushan county Center for Disease control and Prevention

Shiyan, Hubei, China

Gucheng county Center for Disease control and Prevention

Xiangyang, Hubei, China

Xiangzhou District Center for Disease Control and Prevention

Xiangyang, Hubei, China