This is a randomized, double blind, positive controlled study to evaluate the safety and immunogenicity of Omicron COVID-19 Vaccine (Vero Cell), Inactivated in population aged 18 years old and above who have been vaccinated with 2 or 3 doses of COVID-19 Vaccine (Vero Cell), Inactivated manufactured by Beijing Institute of Biological Products, Co., Ltd.
This is a randomized, double blind, positive controlled study to evaluate the safety and immunogenicity of Omicron COVID-19 Vaccine (Vero Cell), Inactivated in population aged 18 years old and above who have been vaccinated with 2 or 3 doses of COVID-19 Vaccine (Vero Cell), Inactivated manufactured by Beijing Institute of Biological Products, Co., Ltd. According to subject's age (18-59 vs 60 and above), doses of vaccination history ( 2 doses vs 3 doses), and vaccination interval, the subjects will be stratified and assigned randomly to the study groups ( Omicron inactivated COVID-19 Vaccine) or the control groups ( Prototype inactivated COVID-19 Vaccine) in a 2:1 ratio. All subjects will receive single dose or two doses of vaccine with a interval of 28 days. The occurrence of adverse events within 28 days and serious adverse events within 12 months after vaccination will be observed. The serum antibody levels, cellular immune responses will be analyzed at different time points.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Enrollment
4,200
intramuscular injection in the deltoid muscle
intramuscular injection in the deltoid muscle
Linli County Center for Disease Control and Prevention
Changde, Hunan, China
Changning Center for Disease Control and Prevention
Changning, Hunan, China
Ningxiang Center for Disease Control and Prevention
Changsha, Hunan, China
The Geometric Mean Titer (GMT) of neutralizing antibody against Omicron SARS-CoV-2
Time frame: On Day 28 after vaccination
The four-fold increase rate of neutralizing antibody against Omicron SARS-CoV-2
Time frame: On Day 28 after vaccination
Incidence of adverse reactions
Time frame: within 28 days after vaccination
The GMT of neutralizing antibody against Omicron SARS-CoV-2
Time frame: On Day 14 after vaccination
The four-fold increase rate of neutralizing antibody against Omicron SARS-CoV-2
Time frame: On Day 14 after vaccination
Specific cellular immune response
Time frame: within 28 days after vaccination
The neutralizing antibody GMT
Time frame: on 3rd month, 6th month, 9th month, and 12th month after vaccination
The proportion of subjects with neutralizing antibody GMT ≥1:16,≥1:32 and ≥1:64
Time frame: on 3rd month, 6th month, 9th month, and 12th month after vaccination
The incidence of any adverse reactions/events
Time frame: 28 days after each immunization
The incidence of serious adverse events (SAE) and adverse events special interest (AESI)
Time frame: From the beginning of the first dose to 12 months after vaccination
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Outpatient Department of Hunan Provincial Center for Disease Control and Prevention
Changsha, Hunan, China
Loudi Public Health Hospital
Loudi, Hunan, China
Xiangtan Center for Disease Control and Prevention
Xiangtan, Hunan, China
Luxi County Center for Disease Control and Prevention
Xiangxi, Hunan, China
Xiangxiang Center for Disease Control and Prevention
Xiangxiang, Hunan, China
Huarong County Center for Disease Control and Prevention
Yueyang, Hunan, China
You County Center for Disease Control and Prevention
Zhuzhou, Hunan, China