This is a randomized, double-blinded, phase ⅠV clinical trial of SARS-CoV-2 inactivated vaccine manufactured by manufactured by Sinovac Research \& Development Co., Ltd. The purpose of this study is to evaluate the safety and immunogenicity of booster vaccination with high-dosage SARS-CoV-2 vaccine in populations who have received two-dose Coronavac with 2nd dose vaccinated more than 6 month.
This study a randomized, double-blinded, phase ⅠV clinical trial of SARS-CoV-2 inactivated vaccine .The purpose of this study is to evaluate the safety and immunogenicity of booster vaccination with high-dosage SARS-CoV-2 vaccine in populations who have received two-dose Coronavac with 2nd dose vaccinated more than 6 month.A total of 1200 subjects who have received two-dose Coronavac with 2nd dose vaccinated more than 6 month will be enrolled.All of subjects will be randomly divided into two groups in a 1:1 ratio .Subjects in experimental group will receive high-dosage SARS-CoV-2 inactivated vaccine.Subjects in control group will receive medium-dosage SARS-CoV-2 inactivated vaccine .
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Enrollment
1,200
SARS-CoV-2 Inactivated Vaccine 1200SU inactivated virus in 0.5 mL of aluminium hydroxide solution per injection
SARS-CoV-2 Inactivated Vaccine 600SU inactivated virus in 0.5 mL of aluminium hydroxide solution per injection
Xinqi City Center for Disease Control and Prevention
Xinqi, Jiangsu, China
Immunogenicity index-GMT of neutralizing antibodies(CZ02 strain)
GMT of neutralizing antibodies(CZ02 strain) 28 days after booster vaccination.
Time frame: Day 28 after booster vaccination
Immunogenicity index-seropositive rate of neutralizing antibodies(CZ02 strain)
The seropositive rate of neutralizing antibodies(CZ02 strain) 28 days after booster vaccination
Time frame: Day 28 after booster vaccination
Immunogenicity index-seroconversion rate of neutralizing antibodies(CZ02 strain)
The seroconversion rate of neutralizing antibodies(CZ02 strain) 28 days after booster vaccination
Time frame: Day 28 after booster vaccination
Immunogenicity index-GMI of neutralizing antibodies(CZ02 strain)
GMI of neutralizing antibodies(CZ02 strain) 28 days after booster vaccination
Time frame: Day 28 after booster vaccination
Immunogenicity index-seropositive rate of neutralizing antibodies(Delta Strain)
The seropositive rate of neutralizing antibodies(Delta Strain) 28 days after booster vaccination
Time frame: Day 28 after booster vaccination
Immunogenicity index-seroconversion rate of neutralizing antibodies(Delta Strain)
The seroconversion rate of neutralizing antibodies(Delta Strain) 28 days after booster vaccination
Time frame: Day 28 after booster vaccination
Immunogenicity index-GMI of neutralizing antibodies(Delta Strain)
GMI of neutralizing antibodies(Delta Strain) 28 days after booster vaccination
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Time frame: Day 28 after booster vaccination
Immunogenicity index-seroconversion rate of neutralizing antibodies(Omicron Strain)
The seroconversion rate of neutralizing antibodies(Omicron Strain) 28 days after booster vaccination
Time frame: Day 28 after booster vaccination
Immunogenicity index-seropositive rate of neutralizing antibodies(Omicron Strain)
The seropositive rate of neutralizing antibodies(Omicron Strain) 28 days after booster vaccination
Time frame: Day 28 after booster vaccination
Immunogenicity index-GMI of neutralizing antibodies(Omicron Strain)
GMI of neutralizing antibodies(Omicron Strain) 28 days after booster vaccination
Time frame: Day 28 after booster vaccination
Immunogenicity index-GMT of neutralizing antibodies(Omicron Strain)
GMT of neutralizing antibodies(Omicron Strain) 28 days after booster vaccination
Time frame: Day 28 after booster vaccination
Immunogenicity index-GMT of neutralizing antibodies(Delta Strain)
GMT of neutralizing antibodies(Delta Strain) 28 days after booster vaccination
Time frame: Day 28 after booster vaccination