MedTrace Logo

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

NCT07672626 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 1200

Last updated 2026-06-29

No results posted yet for this study

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.

Conditions

  • Vaccine

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.

Sponsors & Collaborators

  • Jiangsu Province Centers for Disease Control and Prevention

    lead NETWORK

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
TRIPLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2022-07-19
Primary Completion
2024-08-26
Completion
2024-12-16

Countries

  • China

Study Locations

More Related Trials

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 NCT07672626 on ClinicalTrials.gov