The purpose of this study is to evaluate the 5-year Immune Persistence of Inactivated Enterovirus Type 71 (EV71) Vaccine manufactured by Sinovac (Beijing) Biotech Co., Ltd.
The phase III, efficacy trial of inactivated vaccine (vero cell) against EV71 has completed on March 2013 in China,and a follow up study for phase III clinical trial has completed on March 2014. On the basis of phase III, this study is the Phase IV, open-labelled research, in order to evaluate the 5-year immune persistence of EV71 vaccine.
Study Type
OBSERVATIONAL
Enrollment
343
Sheyang Center for Disease Control and Prevention
Yancheng, Jiangsu, China
The seropositive rate of EV71 neutralizing antibody-1
Calculated based on the cutoff value of 1:8
Time frame: 5 years (64 months)
The seropositive rate of EV71 neutralizing antibody-2
Calculated based on the cutoff value of 1:16
Time frame: 5 years (64 months)
The seropositive rate of EV71 neutralizing antibody-3
Calculated based on the cutoff value of 1:32
Time frame: 5 years (64 months)
The GMT of EV71 neutralizing antibody
The GMT of EV71 neutralizing antibody 64 months after the first dose injection
Time frame: 5 years (64 months)
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