This study is a randomized, double-blinded, placebo-controlled, phase Ⅱb clinical trial of an inactivated SARS-CoV-2 vaccine (CoronaVac) manufactured by Sinovac Life Sciences Co. , Ltd.The purpose of this study is to evaluate the safety of the SARS-CoV-2 Inactivated vaccine in healthy children and adolescents aged 3-17 years.
This study is a randomized, double-blinded, placebo-controlled,phase Ⅱb clinical trial in children and adolescents aged 3-17 years. The experimental vaccine and placebo were both manufactured by Sinovac Life Sciences Co. , Ltd. A total of 500 subjects will be enrolled, including 100 children aged 3-5 years, 200 children aged 6-11 years and 200 adolescents aged 12-17 years. Each age group will be randomly divided into two groups in a 3:1 ratio and received two doses of experimental vaccine or placebo on on day 0 and day 28.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Enrollment
500
600SU inactivated virus in 0·5 mL of aluminium hydroxide solution per injection
aluminium hydroxide solution only
Zanhuang county Center for Disease Control and Prevention
Shijiazhuang, Hebei, China
Safety index-incidence of adverse reactions
Incidence rate of adverse reactions occured from the beginning of the vaccination to 28 days after the second dose.
Time frame: Day 0-28 after each dose
Safety index-incidence of adverse reactions
Incidence rate of adverse reactions within 7 days after each dose
Time frame: Day 0-7 after each dose vaccination
Safety index-incidence of serious adverse events
Incidence rate of serious adverse events from the beginning of the vaccination to 6 months after the second dose vaccination.
Time frame: From the beginning of the vaccination to 6 months after the second dose vaccination
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