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.
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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Enrollment
1,200
A rabies vaccine (Vero Cell) for human use produced by Changchun Werersai Biotech Pharmaceutical Co., Ltd. 1.0 ml experimental vaccine on day 0,3,7,14,28
A rabies vaccine (Vero Cell) for human use produced by Jilin Maifeng Biotech Pharmaceutical Co., Ltd. 1.0 ml comparator vaccine on day 0,3,7,14,28
Xinyi Center for Disease Control and Prevention
Xuzhou, Jiangsu, China
Positive seroconversion rate of serum rabies virus neutralizing antibody 42 days after full vaccination
Time frame: 42 days after full vaccination
Geometric mean concentration (GMC) of serum rabies virus neutralizing antibody 42 days after full vaccination
Time frame: 42 days after full vaccination
Positive seroconversion rate of serum rabies virus neutralizing antibody 14 days after full vaccination
Time frame: 14 days after full vaccination
Geometric mean concentration (GMC) of serum rabies virus neutralizing antibody 14 days after full vaccination
Time frame: 14 days after full vaccination
Incidence of local and systemic adverse reactions during safety observation period after each vaccination
Time frame: 0-7 days after each vaccination and 8-28 days after the fifth vaccination
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