This is an open phase Ⅲ clinical trial of COVID-19 vaccine (Vero cell), inactivated manufactured by Sinovac Research \& Development Co., Ltd.The purpose of this study is to evaluate Immunogenicity and safety of a third dose at different times after two-dose of COVID-19 vaccine (Vero cell), Inactivated in the Elderly Aged 60 years and above.
This study is an open phase Ⅲ clinical trial. The main purpose of this study is to evaluate Immunogenicity and safety of a third dose at different times after two-dose of COVID-19 vaccine (Vero cell), Inactivated manufactured by Sinovac Research \& Development Co., Ltd. in the elderly aged 60 years and above.A total of 400 subjects aged 60 years and above who had received two doses of COVID-19 vaccine(Vero Cell), inactivated manufactured by Sinovac Research \& Development Co., Ltd. between 3 - 6 months ago (100 subjects for 3 months, 4 months, 5 months and 6 months,respectively) will be enrolled and receive a third dose of two-dose of COVID-19 vaccine (Vero cell), inactivated were enrolled.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Enrollment
400
The COVID-19 vaccine,inactivated was manufactured by Sinovac Research\& Development Co., Ltd.600SU inactivated SARS-CoV-2 CZ strain virus in 0.5 mL of aluminium hydroxide solution per injection.
Yongde Center for Diseases Control and Prevention
Lincang, Yunnan, China
Immunogenicity index-GMT of neutralizing antibodies
GMT of neutralizing antibodies at 14 days after vaccination
Time frame: At 14 days after vaccination
Immunogenicity index- GMT of neutralizing antibodies
GMT of neutralizing antibodies at 28 days after vaccination
Time frame: At 28 days after vaccination
Safety index-Incidence of adverse reactions
Incidence of adverse reactions 0\~28 days after vaccination
Time frame: 0~28 days after vaccination
Immunogenicity index-seropositive rate of neutralizing antibodies
Seropositive rate of neutralizing antibodies of neutralizing antibodies before vaccination and at different points after vaccination
Time frame: Day 0 before vaccination and 14 days, 28 days and 180 days after vaccination
Immunogenicity index-GMT of neutralizing antibodies
GMT of neutralizing antibodies before vaccination and at different points after vaccination.
Time frame: Day 0 before vaccination and 180 days after vaccination
Immunogenicity index-4-fold increase rate of neutralizing antibodies
4-fold increase rate of neutralizing antibodies at different points after vaccination.
Time frame: At 14 days and 28 days after vaccination.
Safety index-Incidence of adverse reactions
Incidence of adverse reactions 0\~7 days after vaccination.
Time frame: 0~7 days after vaccination
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Safety index-Incidence of serious adverse events
Incidence of serious adverse events 6 months after vaccination.
Time frame: 6 months after vaccination