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A Phase 3 Clinical Trial for a Rabies Vaccine (Vero Cell) for Human Use in Healthy Chinese Subjects

2015-07-09 08:38:24 | BioPortfolio

Summary

The purpose of this single-centre, randomized, double-blind, parallel control, phase 3 study is to evaluate the safety and immunogenicity of a rabies vaccine (Vero Cell) for human use in healthy Chinese subjects aged 10-60 years, according to the Essen methods (1-1-1-1-1) vaccination.

Description

There will be two immunization arms. 1200 healthy subjects will be randomly assigned (1:1) to receive an experimental vaccine or a parallel comparator vaccine. All of them will be received five doses of rabies vaccine at day 0,3,7,14,28 according to the traditional Essen methods (1-1-1-1-1) vaccination.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Prevention

Conditions

Rabies

Intervention

Rabies vaccine (Vero Cell) for human use produced by Changchun Werersai Biotech Pharmaceutical Co., Ltd., Rabies vaccine (Vero Cell) for human use produced by Jilin Maifeng Biotech Pharmaceutical Co., Ltd.

Location

Xinyi Center for Disease Control and Prevention
Xuzhou
Jiangsu
China
221400

Status

Completed

Source

Jiangsu Province Centers for Disease Control and Prevention

Results (where available)

View Results

Links

Published on BioPortfolio: 2015-07-09T08:38:24-0400

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A vaccine is a biological preparation that improves immunity to a particular disease. A vaccine typically contains an agent that resembles a disease-causing microorganism, and is often made from weakened or killed forms of the microbe, its toxins or one ...


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