The purpose of this study is to evaluate the immunogenicity and safety of EV71 vaccine in infants aged 6 to 35 months old, by detecting the dynamic changes of neutralizing antibody at different time after vaccination
This study is an open-labelled, single-centered, stratified-randomized, phase IV clinical trial. The purpose of this study is to evaluate the immunogenicity and safety of EV71 vaccine (developed by Sinovac Biotech Co., Ltd.) in infants aged 6 to 35 months old, by detecting the dynamic changes of neutralizing antibody at different times after vaccination. The enrolled subjects in this study receive two doses of EV71 vaccine with 1-month interval between doses. To evaluate safety of the vaccine, subjects will be observed for 30 days after the injection for the potential adverse events. To evaluate the immunogenicity of the vaccine, venous blood will be collected for the neutralizing antibody detection prior to vaccination, 10/20/30 days after the 1st dose and 30 days after the 2nd dose vaccination. All subjects will receive blood sampling for three times. Subjects will be randomly assigned to receive blood sampling at 10/20/30 days after 1st dose injection, with a ratio of 1: 1: 1.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Enrollment
120
Two doses vaccination of EV71vaccine (Intramuscular injection, 0.5ml) with a schedule of 0, 28 days.
Shangyu District Center for Disease Control and Prevention
Shaoxing, Zhejiang, China
The seroconversion rate of EV71 neutralizing antibody 30 days after the two doses vaccination
Immunogenicity indicator
Time frame: 30 days
The seroconversion rate of EV71 neutralizing antibody 10, 20 and 30 days after the first dose vaccination
Immunogenicity indicator
Time frame: 10,20,and 30 days
The seropositive rate of EV71 neutralizing antibody 10, 20, 30, and 60 days after the first dose vaccination
Immunogenicity indicator
Time frame: 10, 20,30,and 60 days
GMT and GMT increase fold of EV71 neutralizing antibody 10,20,30,and 60 days after the first dose vaccination
Immunogenicity indicator
Time frame: 10,20,30,and 60 days
Incidence of unsolicited local or systemic adverse events within 3 days after each dose
Safety indicator
Time frame: 3 days
Incidence of unsolicited adverse events within 30 days after each dose
Safety indicator
Time frame: 30 days
Incidence of the serious adverse events within 60 days after the first dose vaccination
Safety indicator
Time frame: 60 days
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