This is Phase 4 clinical trial of live attenuated varicella vaccines manufactured by Sinovac (Dalian) Vaccine Technology Co., Ltd .The purpose of this study is to evaluate the protective effect of varicella vaccine in children aged 1-12 years and the correlation between varicella antibody and protective effect,to evaluate the immunogenicity and safety of varicella vaccine in children aged 1-12 years.
This study is Phase Ⅳ clinical trial.The experimental vaccine manufactured by Sinovac(Dalian) Vaccine Technology Co., Ltd.This clinical trial consists of four parts,and A total of 45400 subjects will be enrolled. Study 1,45000 subjects including 15000 subjects aged 1-3 years with no history of varicella vaccination ,15000 subjects aged 4-6 years with a history of 1 dose of varicella vaccine,15000 subjects aged 7-12 years with a history of 1 dose of varicella vaccine will be enrolled to evaluate protective effect of varicella vaccine. There will be 7500 subjects in the experimental group and 7500 in the control group in each age group.And subjects who voluntarily receive varicella vaccine will be included in the experimental group and other subjects will be included in the control group.All subjects in the experimental group will receive one dose of varicella vaccine. Study 2,400 healthy children including 100 subjects aged 1-3 years with no history of varicella ,150 subjects aged 4-6 years(50 children with no history of varicella vaccination and 100 children with a history of one dose of varicella vaccine),150 subjects aged 7-12 years (50 children with no history of varicella vaccination and 100 children with a history of one dose of varicella vaccine),each subject will receive one or two doses (0,3 months) of varicella vaccine. Study 3,30000 subjects from study 1 will be enrolled to conduct safety observation study,all adverse events of all subjects will be collected. Study 4,Herpes fluid collected from study 1 varicella cases will be used to conduct etiological study on the pathogenic strains of varicella cases.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Enrollment
45,400
The live attenuated varicella vaccine was manufactured by Sinovac (Dalian) Vaccine Technology Co., Ltd. Live attenuated varicella-virus in 0.5 mL injection water with sucrose,sodium glutamate,sodium chloride,potassium chloride, sodium dihydrogen phosphate, potassium dihydrogen phosphate per injection.The routine of administration is intramuscular injection into deltoid region of the lateral upper arm.
Susong County Center for Disease Control and Prevention
Anqing, Anhui, China
Laian Center for Disease Control and Prevention
Chuzhou, Anhui, China
Funan County Center for Disease Control and Prevention
Fuyang, Anhui, China
Huoqiu County Center for Disease Control and Prevention
Liu‘an, Anhui, China
The incidence density
The incidence density will be calculated by the number of confirmed cases of varicella at 42 days after vaccination.
Time frame: 42 days after vaccination
The protection rate
The protection rate will be calculated by the number of confirmed cases of varicella at 42 days after vaccination.
Time frame: 42 days after vaccination
GMT of varicella antibody
GMT of varicella antibody at 42 days after varicella vaccination.
Time frame: 42 days after varicella vaccination
GMI of varicella antibody
GMI of varicella antibody at 42 days after varicella vaccination.
Time frame: 42 days after varicella vaccination
Positive rates of varicella antibody
Positive rate of varicella antibody at 42 days after varicella vaccination.
Time frame: 42 days after varicella vaccination
Immunogenicity index-GMT of varicella antibody
GMT of varicella antibody at 4 months after varicella vaccination.
Time frame: 4 months after varicella vaccination
Immunogenicity index-GMI of varicella antibody
GMI of varicella antibody at 4 months after varicella vaccination.
Time frame: 4 months after varicella vaccination
Immunogenicity index- positive rates
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Ningguo Center for Disease Control and Prevention
Xuancheng, Anhui, China
Positive rates of varicella antibody at 4 months after varicella vaccination.
Time frame: 4 months after varicella vaccination
The incidence of adverse events, serious adverse events and adverse reactions
The incidence of adverse events, serious adverse events and adverse reactions at 14 days after varicella vaccination.
Time frame: 14 days after varicella vaccination
Incidence of adverse events, serious adverse events and adverse reactions
The incidence of adverse events, serious adverse events and adverse reactions at 42 days after varicella vaccination.
Time frame: 42 days after varicella vaccination.
Safety index-Incidence of adverse events, serious adverse events and adverse reactions
The incidence of adverse events, serious adverse events and adverse reactions in 3 months after varicella vaccination.
Time frame: 3 months after varicella vaccination
Safety index-incidence of adverse events, serious adverse events and adverse reactions
The incidence of adverse events, serious adverse events and adverse reactions in 6 months after varicella vaccination.
Time frame: 6 months after varicella vaccination
Safety index- incidence of adverse events, serious adverse events and adverse reactions
The incidence of adverse events, serious adverse events and adverse reactions in 9 months after varicella vaccination.
Time frame: 9 months after varicella vaccination
The incidence of adverse events, serious adverse events and adverse reactions
The incidence of adverse events, serious adverse events and adverse reactions in 12 months after varicella vaccination.
Time frame: 12 months after varicella vaccination