The purpose of this study is to evaluate the immunogenicity and safety of sequential vaccination of two EV71 inactived vaccines in healthy infants aged 6-35 months.
This study is a opened,randomized and controlled phase Ⅳ clinical trial. The purpose of this study is to evaluate the immunogenicity and safety of sequential vaccination of two EV71 inactived vaccines in healthy infants aged 6-35 months. EV71 inactived vaccines(Vero cells)was manufactured by Sinovac Biotech Co., Ltd and EV71 inactived vaccines(Human diploid cells)was manufactured by Institute of Medical Biology Chinese Academy of Medical Sciences.300 infants aged between 6-35 months will be randomly assigned into experimental group in the ratio 1:1:1:1.The experimental group 1 received two doses EV71 inactived vaccines(Vero cells)on day 0 and 30. The experimental group 2 received two doses EV71 inactived vaccines (Human diploid cells)on day 0 and 30. The experimental group 3 received one dose EV71 inactived vaccines (Vero cells)on day 0 and one dose EV71 inactived vaccines (Human diploid cells)on day 30.The experimental group 4 received one dose EV71 inactived vaccines (Human diploid cells)on day 0 and one dose EV71 inactived vaccines (Vero cells)on day 30. To evaluate the immunogenicity of the vaccine, venous blood will be collected for the EV71 neutralizing antibody detection prior to vaccination and 30 days after the 2nd dose vaccination.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Enrollment
300
The EV71 inactived vaccine(Vero cells) was manufactured by Sinovac Biotech Co., Ltd.
The EV71 inactived vaccine(Human diploid cells) was manufactured by Institute of Medical Biology Chinese Academy of Medical Sciences.
Rushan City Center for Disease Control and Prevention
Xiacun, Shandong, China
The seroconversion rates (SCR) of the EV71 neutralizing antibody calculated based on the cutoff value of 1:8.
Subjects whose pre-immune EV71 antibody level \< 1:8 and post-immune antibody level ≥ 1:8, or those whose pre-immune antibody level ≥ 1:8 and the increase of post-immune EV71 antibody level ≥ 4 folds are considered seroconverted
Time frame: 30 days after two doses
The incidences of adverse reactions after each does
After each dose, a 30-minute safety observation will be conducted immediately. The body temperature, solicited local and general adverse events (AE) on day 0-7 were reported. Unsolicited adverse events on day 0-30 were also reported. Each AE case will be reviewed by the investigator to determine whether or not it was an adverse reaction (The vaccination-related AE).
Time frame: 0-30 days after each dose
The incidence of solicited local and general adverse events after each does
After each dose, a 30-minute safety observation will be conducted immediately. The body temperature, solicited local and general adverse events (AE) on day 0-7 were reported. Each AE case will be reviewed by the investigator to determine whether or not it was an adverse reaction (The vaccination-related AE).
Time frame: 0-7 days after each dose
Incidence of serious adverse events (SAEs) during the period of safety monitoring
Serious adverse events (SAEs) will be collected during the period of safety monitoring after each dose.
Time frame: 0-30 days after each dose
EV71 neutralizing antibody positive rate of each group after two doses.
Subjects whose post-immune antibody level ≥ 1:8 are considered antibody positive.
Time frame: 30 days after two doses
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The Geometric mean titer (GMT) of the EV71 neutralizing antibody
The GMT 30 days of each group after two doses.
Time frame: 30 days after two doses
The geometric mean fold increase (GMI) of the EV71 neutralizing antibody
The GMI 30 days of each group after two doses.
Time frame: 30 days after two doses