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Randomized, Blind, Phase III Clinical Trial to Evaluate the Immunogenicity and Safety of Freeze-dried Human Rabies Vaccine (Vero Cell) Inoculated in 4-dose Program (2-1-1)
A phase III clinical trial to evaluate the immunogenicity and safety of freeze-dried human rabies vaccine (Vero cell) developed by Changchun Zhuoyi Biological Co., Ltd. inoculated in a 4-dose procedure (2-1-1)
It is to prove that the freeze-dried human rabies vaccine (Vero cell) in the population aged 10-60 years, the four dose vaccination program is not inferior to the five dose vaccination program, and the safty、antibody positive conversion rate and geometric mean concentration of the four dose group of the test vaccine are not inferior to the five dose program group 14 days after the first dose vaccination. To compare the immunogenicity of people aged 10-60 years old who were vaccinated 6 and 12 months after the whole vaccination, so as to evaluate the antibody positive rate and GMT 6 and 12 months after the test vaccine was vaccinated.
Age
10 - 60 years
Sex
ALL
Healthy Volunteers
Yes
Changchun Zhuoyi Biological Co., Ltd
Changchun, Jilin, China
Start Date
July 22, 2020
Primary Completion Date
October 31, 2021
Completion Date
April 20, 2023
Last Updated
March 13, 2024
1,800
ACTUAL participants
rabies vaccine
BIOLOGICAL
Lead Sponsor
Changchun Zhuoyi Biological Co., Ltd
Data Source & Attribution
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