This study is an open phase 4 clinical trial of an inactivated COVID-19 vaccine (CoronaVac) manufactured by Sinovac Research and Development Co., Ltd. The purpose of this study is to evaluate the immunogenicity of the CoronaVac in healthy children aged 3-11 years old.
This study is an open phase 4 clinical trial to evaluate the immunogenicity of an inactivated COVID-19 vaccine(CoronaVac)in healthy children aged 3-11 years old.A total of 400 healthy subjects who have received two doses of inactivated COVID-19 vaccine(CoronaVac) manufactured by Sinovac Research \& Development Co., Ltd and is currently 28-42 days after the second dose will be enrolled, including 200 subjects aged 3-5 years and 200 subjects aged 6-11 years old.All of subjects will be collected 3ml venous blood to evaluate the immunogenicity of the CoronaVac.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Enrollment
395
600SU inactivated virus in 0.5 mL of aluminium hydroxide solution per injection
Rushan City Center for Disease Control and Prevention
Weihai, Shandong, China
Immunogenicity index-Seropositivity rate of the neutralizing antibody to SARS-CoV-2
Seropositivity rate of the neutralizing antibody day 28(+14 days) after the second dose of vaccine
Time frame: Day 28(+14 days) after the second dose of vaccine
Immunogenicity index-GMT of the neutralizing antibody to SARS-CoV-2
GMT of the neutralizing antibody to SARS-CoV-2 day 28(+14 days) after the second dose of vaccine
Time frame: Day 28(+14 days) after the second dose of vaccine
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