This study is a randomized, double-blinded, and placebo controlled phase Ⅱ clinical trial of the SARS-CoV-2 inactivated vaccine to evaluate the safety and immunogenicity of the experimental vaccine in healthy adults ⩾18 years.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Enrollment
1,000
Jiangsu Provincial Center for Diseases Control and Prevention
Nanjing, Jiangsu, China
The seropositive rates of SARS-CoV-2 neutralizing antibody
Time frame: Day 28 post full vaccination
The seropositive level of SARS-CoV-2 neutralizing antibody
Time frame: Day 28 post full vaccination
The seropositive rates of SARS-CoV-2 IgG antibody (tested by ELISA)
Time frame: Day 28 post full vaccination
Incidence of adverse reactions/events
Time frame: 0-28 days after each dose of vaccination
Serious Adverse Events (SAE)
Time frame: within 12 months post full vaccination
Level of SARS-CoV-2 IgG antibody (tested by ELISA)
Time frame: Day 28 post full vaccination
The seropositive rates of SARS-CoV-2 neutralizing antibody
Time frame: Day 28 after the second dose of the 3 doses group, day 14 after the full immunization of the 2 doses group, and 3, 6 and 12 months post full vaccination of all groups
The seropositive rates of SARS-CoV-2 IgG antibody (tested by ELISA)
Time frame: Day 28 after the second dose of the 3 doses group, day 14 after the full immunization of the 2 doses group, and 3, 6 and 12 months post full vaccination of all groups
The seropositive level of SARS-CoV-2 neutralizing antibody
Time frame: Day 28 after the second dose of the 3 doses group, day 14 after the full immunization of the 2 doses group, and 3, 6 and 12 months post full vaccination of all groups
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The seropositive level of SARS-CoV-2 IgG antibody (tested by ELISA)
Time frame: Day 28 after the second dose of the 3 doses group, day 14 after the full immunization of the 2 doses group, and 3, 6 and 12 months post full vaccination of all groups