This study is an open-label phase Ⅳ clinical trial of the inactivated SARS-CoV-2 vaccine(CoronaVac)manufactured by Sinovac Research \& Development Co., Ltd. The purpose of this study is to evaluate the immunogenicity and safety of the Inactivated SARS-CoV-2 Vaccine (Vero Cell) in Healthy Population Aged From 18 to 59 Years.
This study is an open-label phase Ⅳ clinical trial in healthy adult aged 18-59 years. The experimental vaccine was manufactured by Sinovac Research and Development Co.,Ltd.. A total of 1400 subjects will be enrolled,the safety and immunogenicity of booster immunization were evaluated in 400 subjects (group A) who received two doses of primary immunization at an interval of 21 to 31 days. And the safety of booster immunization was evaluated in the extended safety group (group B), which included 1000 subjects.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Enrollment
1,400
600SU inactivated virus in 0·5 mL of aluminiumhydroxide solution per injection
600SU inactivated virus in 0·5 mL of aluminiumhydroxide solution per injection
Beijing Centers for Diseases Control and Prevention
Beijing, China
RECRUITINGGeometric mean titer(GMT) of neutralizing antibody to live SARS-CoV-2
GMT of the neutralizing antibody to live SARS-CoV-2 within 1month after booster immunization of the Inactivated SARS-CoV-2 vaccine.
Time frame: 1 month after booster immunization
Safety index-incidence of adverse reactions
Incidence rate of adverse reactions within 1 month after booster immunization of the Inactivated SARS-CoV-2 vaccine
Time frame: 1 month after booster immunization
Safety index-incidence of serious adverse events
Incidence rate of serious adverse events within 1 month after booster immunization of the Inactivated SARS-CoV-2 vaccine
Time frame: 1 month after booster immunization
Seroconversion rate,seropositivity rate and GMI of the neutralizing antibody to SARS-CoV-2
Seroconversion rate,seropositivity rate and GMI of the neutralizing antibody to SARS-CoV-2 within 1 month after booster immunization of the Inactivated SARS-CoV-2 vaccine
Time frame: 1 month after booster immunization
Seropositivity rate of IgG antibody
Seropositivity rate of IgG antibody within 1 month after booster immunization of the Inactivated SARS-CoV-2 vaccine
Time frame: 1 month after booster immunization
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