The goal of this clinical trial is to evaluate the immunogenicity and safety of Enterovirus Type 71 Vaccine,Inactivated(Vero Cells) in healthy volunteers aged from 6 to 71 months.
The goal of this clinical trial is to evaluate the immunogenicity and safety of Enterovirus Type 71 Vaccine,Inactivated(Vero Cells) in healthy volunteers aged from 6 to 71 months. Qualified subjects were screened and randomly divided into low-dose group, high-dose group, and control group according to the ratio of 2:2:1. The experimental group was vaccinated with the experimental vaccine (low-dose or high-dose enterovirus 71 inactivated vaccine from Beijing Zhifei Lvzhu Biopharmaceutical Co., Ltd.), and the control group was vaccinated with the control vaccine (enterovirus 71 inactivated vaccine produced by the Institute of Medical Biology of the Chinese Academy of Medical Sciences). All participants received two doses of the vaccine 28 days apart.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Enrollment
470
Participants received two doses of the vaccine, 28 days apart
Hunan Provincial Center for Disease Control and Prevention
Changsha, Hunan, China
Anti-EV71 serum neutralizing antibody positive conversion rate at 28 days after immunization
to evaluate immunogenicity of Enterovirus Type 71 Vaccine
Time frame: 28 days after two doses of vaccination
Geometric mean titer (GMT) and growth factor of anti-EV71 serum neutralizing antibody 28 days after immunization
to evaluate immunogenicity of Enterovirus Type 71 Vaccine
Time frame: 28 days after two doses of vaccination
Ratio of subjects with anti-EV71 serum neutralizing antibody titer ≥ 1:8 28 days after immunization
to evaluate immunogenicity of Enterovirus Type 71 Vaccine
Time frame: 28 days after two doses of vaccination
Adverse events within 0-28 days after each dose of vaccination
to evaluate Safety of Enterovirus Type 71 Vaccine
Time frame: 28 days after each dose of vaccination
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