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

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.

Conditions

• Rabies

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.

Sponsors & Collaborators

• Ab&B Bio-tech Co., Ltd.JS

  lead OTHER

Study Design

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

DOUBLE

Model

PARALLEL

Eligibility

Min Age

10 Years

Max Age

60 Years

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2026-02-26

Primary Completion

2026-04-26

Completion

2027-04-26

Countries

• China

Study Locations