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 immunogenicity and safety of a single dose of varicella vaccine in healthy children aged 1-6 years with different varicella immunization histories, to evaluate the antibody level of varicella-zoster virus in healthy people aged 0-59 years in Zhejiang Province.
This study is Phase Ⅳ clinical trial.The experimental vaccine manufactured by Sinovac(Dalian) Vaccine Technology Co., Ltd.This clinical trial consists of five parts,and A total of 37920 subjects will be enrolled. Study 1,360 subjects including 120 subjects aged 1-3 years with no history of varicella vaccination ,240 subjects aged 4-6 years with a history of 1 dose of varicella vaccine will be enrolled to evaluate the immunogenicity and safety of varicella vaccine.All subjects will receive one dose of varicella vaccine. Study 2,2530 subjects aged 0-59 years old will be enrolled and will be collected venous blood to detect varicella antibody and conduct investigation of varicella antibody level in healthy people. Study 3,30000 subjects aged 1-12 years old will be enrolled to conduct safety observation study.All subjects will receive one dose of varicella vaccine and all adverse events of all subjects will be collected. Study 4,5000 subjects aged 1-12 years old will be enrolled to conduct protective effect study of varicella vaccine after exposure. Study 5,30 subjects aged 1-12 years old will be enrolled. Herpes fluid or pharyngeal swab samples of subjects will be collected to study the pathogenicity of varicella.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Enrollment
37,920
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. And the immunization schedule is one dose of live attenuated varicella vaccine on day 0.
Laian Center for Disease Control and Prevention
Chuzhou, Anhui, China
RECRUITINGLiandu District Center for Disease Control and Prevention
Lishui, Zhejiang, China
RECRUITINGJiangshan Center for Disease Control and Prevention
Quzhou, Zhejiang, China
RECRUITINGGMT of varicella antibody in children aged 1-6 years
GMT of varicella antibody at 30 days after vaccination of varicella vaccine in children aged 1-6 years.
Time frame: 30 days after vaccination
GMT of varicella antibody in healthy people aged 0-59 years
GMT of varicella antibody at 30 days after vaccination in different age groups of healthy people aged 0-59 years.
Time frame: 30 days after vaccination
Seroconversion rates of varicella antibody in children aged 1-6 years
Seroconversion rates of varicella antibody at 30 days after vaccination of varicella vaccine in children aged 1-6 years.
Time frame: 30 days after vaccination
GMI of varicella antibody in children aged 1-6 years
GMI of varicella antibody at 30 days after vaccination of varicella vaccine in children aged 1-6 years.
Time frame: 30 days after vaccination
Incidence of adverse reactions at 24 hours after vaccination
Incidence of adverse reactions at 24 hours after vaccination of varicella vaccine in children aged 1-6 years
Time frame: 24 hours after vaccination
Incidence of adverse reactions at 3 days after vaccination
Incidence of adverse reactions at 3 days after vaccination of varicella vaccine in children aged 1-6 years
Time frame: 3 days after vaccination
Incidence of adverse reactions at 14 days after vaccination
Incidence of adverse reactions at 14 days after vaccination of varicella vaccine in children aged 1-6 years.
Time frame: 14 days after vaccination
Incidence of adverse reactions at 30 days after vaccination
Incidence of adverse reactions at 30 days after vaccination of varicella vaccine in children aged 1-6 years.
Time frame: 30 days after vaccination
Incidence of adverse reactions at 14 days after mass vaccination
Incidence of adverse reactions at 14 days after mass vaccination of varicella vaccine in children aged 1-12 years
Time frame: 14 days after mass vaccination
Incidence of adverse reactions at 30 days after mass vaccination
Incidence of adverse reactions at 30 days after mass vaccination of varicella vaccine in children aged 1-12 years
Time frame: 30 days after mass vaccination
seropositive rates of varicella antibody
Seropositive rates of varicella antibody at 30 days after vaccination in all age groups of healthy people.
Time frame: 30 days after vaccination
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