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COMPLETED
NCT07672626
PHASE3

Safety and Immune Response of a Rabies Vaccine With the Essen Schedule and a Two-Dose Booster

Sponsor: Jiangsu Province Centers for Disease Control and Prevention

View on ClinicalTrials.gov

Summary

Rabies is caused by rabies virus with a 100% mortality rate in humans. Most of cases occur in Africa and Asia, mainly in underserved populations. Rabies is a vaccine-preventable disease in both humans and animals. Over the years, the Vero cell rabies vaccine has been recognized by the World Health Organization (WHO) and the European Union, and is widely used globally. Currently, one of the post-exposure prophylaxis (PEP) regimens recommended by the World Health Organization (WHO) is the five-dose "Essen" regimen (1-1-1-1-1), involving one intramuscular dose administered on days 0, 3, 7, 14, and 28 respectively. This clinical trial was to assess the immunogenicity and safety of a freeze-dried human rabies vaccine (Vero Cell) in healthy population for the large-scale developing, and explore the booster vaccination.

Official title: Immunogenicity and Safety of Freeze-Dried Human Rabies Vaccine (Vero Cell) With the "Essen" Immunization Schedule and a Two-Dose Booster in Chinese Healthy Subjects Aged 10-60 Years: A Randomized, Blinded, and Comparable Vaccine-Controlled Non-Inferiority Phase III Clinical Trial.

Key Details

Gender

All

Age Range

10 Years - 60 Years

Study Type

INTERVENTIONAL

Enrollment

1200

Start Date

2022-07-19

Completion Date

2024-12-16

Last Updated

2026-06-29

Healthy Volunteers

Yes

Conditions

Interventions

BIOLOGICAL

the tested vaccine

The tested vaccine is a lyophilized human rabies vaccine (Vero Cells) produced by Shanghai Rongsheng Biotech Co., Ltd.

BIOLOGICAL

the control vaccine

The control vaccine is a lyophilized human rabies vaccine (Vero Cells) produced by Liaoning Chengda Biotechnology Co., Ltd.

Locations (1)

Pizhou county Center for Disease Control and Prevention

Pizhou, Jiangsu, China