The purpose of this post-marketing study is to evaluate the efficacy, immunogenicity, and safety of the EV71 vaccine post marketing, and explore the protective levels of various enterovirus neutralizing antibodies
This study is a post-marketing aims to evaluate the efficacy, immunogenicity, and safety of the EV71 vaccine, and explore the protective levels of various enterovirus neutralizing antibodies. This study includes the following three sections: (1) efficacy study of EV71 vaccine based on enhanced cases monitoring, using prospective cohort study design (2) study on correlation between EV71 vaccine protection and EV71 antibody levels, using case-control study design (3) pathogenic spectrum and sero-epidemiological investigation of hand, foot and mouth disease (HFMD) in children. 15500 volunteers aged 6-71 months are expected to participate in this study, among which 5000 volunteers aged 6-35 months will receive two doses EV71 vaccine manufactured by Sinovac Biotech Co., Ltd, and constitute the experimental cohort. 10000 unvaccinated volunteers aged 6-35 months will constitute the the control cohort. The efficacy evaluation will be conducted based on the abovementioned two cohort. Enhanced HFMD surveillance system will be established to report the HFMD cases in the abovementioned 2 cohorts, as well as another cohort consisting of 500 volunteers aged 36-71 months. The case surveillance period of this study is one year. Laboratory tests will be conducted for case confirmation.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Enrollment
15,500
two doses EV71 vaccines will be administrated on day 0, 30 respectively
Songzi Center for Disease Control and Prevention
Jingzhou, Hubei, China
Xiantao Center for Disease Control and Prevention
Xiantao, Hubei, China
The efficacy of two doses EV71 vaccine in the 6-35 months old subjects
Vaccine Efficacy (VE)=(incidence difference between vaccinated and unvaccinated group/incidence of vaccinated group)\*100%
Time frame: During the case monitoring period of 1 year
The seroprotective titers of the EV71 neutralizing antibody in the 6-35 months old subjects
Immune correlates of protection
Time frame: Through study completion, an average of 1 year
The incidence of adverse events after the EV71 vaccination in the 6-35 months old subjects
Safety index
Time frame: Within 6 months after each dose injection
The seroprotective titers of the CA16, CA6, CA10 neutralizing antibody in the 6-35 months old subjects
Immune correlates of protection
Time frame: Through study completion, an average of 1 year
The seropositive rate of the EV71, CA16, CA6, CA10 neutralizing antibody in the 6-71 months old subjects
Serum epidemiological index
Time frame: During the study period, 2 months after the study beginning
The geometric mean titer (GMT) of the EV71, CA16, CA6, CA10 neutralizing antibody in the 6-71 months old subjects
Serum epidemiological index
Time frame: During the study period, 2 months after the study beginning
The seroconversion rate of the EV71 neutralizing antibody after vaccination in the 6-35 months old subjects
Immunogenicity index
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Time frame: 30 days after two doses
The geometric mean increase (GMI) of the EV71 neutralizing antibody after vaccination in the 6-35 months old subjects
Immunogenicity index
Time frame: 30 days after two doses
Proportions of various pathogens in the confirmed HFMD cases
Pathogen spectrum index
Time frame: Through study completion, an average of 1 year