This is a non-randomized, open-label, externally controlled study to evaluate the safety and immnunogenicity of the Omicron COVID-19 Vaccine (Vero Cell), Inactivated in population aged 18 years old and above with no vaccination history of the COVID-19 vaccine. 200 health subjects will be recruited in this study, including 150 aged 18-59 years old and 50 aged 60 years old and above. All subjects will be received 2 doses of Omicron COVID-19 Vaccine (Vero Cell), Inactivated according to the immunization schedule of 0, 21-28 days. The change in neutralizing antibody level at 28 days after the second dose was used to determine whether to receive a further booster dose for ≥3 months. The occurrence of adverse events within 28 days and serious adverse events within 6 months after vaccination will be observed. In addition, blood samples will be collected on Day 0 before vaccination,Day 14 after dose 1, before dose 2 and on day 14, 28 and month 3, 6, 9, 12 after dose 2. Serum antibody levels, cellular immune responses will be analyzed.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Enrollment
280
2 doses of vaccine according to the immunization schedule of 0, 21-28 days
Shulan (hangzhou) Hospital
Hangzhou, Zhejiang, China
The Geometric Mean Titer (GMT) of neutralizing antibody against Omicron SARS-CoV-2
Time frame: On Day 28 after Dose 2
The four-fold increase rate of neutralizing antibody against Omicron SARS-CoV-2
Time frame: On Day 28 after Dose 2
Incidence of adverse reactions
Time frame: within 28 days after vaccination
The Geometric Mean Titer (GMT) of neutralizing antibody against Omicron SARS-CoV-2
Time frame: On Day 14 after Dose 2
The four-fold increase rate of neutralizing antibody against Omicron SARS-CoV-2
Time frame: On Day 14 after Dose 2
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 the second immunization
The neutralizing antibody GMT
Time frame: on 3rd month, 6th month, 9th month, and 12th month after Dose 2
The proportion of subjects of neutralizing antibody GMT ≥1:16,≥1:32 and ≥1:64
Time frame: on 3rd month, 6th month, 9th month, and 12th month after Dose 2
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