This study is a randomized, double-blinded, and placebo controlled phase Ⅰ clinical trial of the SARS-CoV-2 inactivated vaccine to evaluate the safety and immunogenicity of the experimental vaccine in healthy population aged 3 to 17 years.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Enrollment
84
2 doses of SARS-CoV-2 Vaccine (Vero Cells), Inactivated should be administered as an intramuscular injection into the lateral deltoid of the upper arm with a 28-day interval.
2 doses of Placebo should be administered as an intramuscular injection into the lateral deltoid of the upper arm with a 28-day interval.
Hunan Provincial Center for Diseases Control and Prevention
Changsha, Hunan, China
Incidence of adverse reactions/events
Time frame: 0-28 days after each vaccination
Incidence of Serious Adverse Events (SAE)
Time frame: within 12 months post full vaccination
Incidence of abnormal indicators of laboratory safety examinations(including blood routine, blood biochemistry, urine routine, thyroid function and coagulation function)
Time frame: Day 3 after each dose of vaccination
Geometric mean titer of SARS-CoV-2 neutralizing antibody
Time frame: 28 days, 3 months, 6 months and 12 months post full vaccination
Geometric mean titer of SARS-CoV-2 IgG binding antibody
Time frame: 28 days, 3 months, 6 months and 12 months post full vaccination
Seroconversion rate of SARS-CoV-2 neutralizing antibody
Time frame: 28 days post full vaccination
Seroconversion rate of SARS-CoV-2 IgG binding antibody
Time frame: 28 days post full vaccination
Seropositive rate of SARS-CoV-2 neutralizing antibody
Time frame: 3 months, 6 months and 12 months post full vaccination
Seropositive rate of SARS-CoV-2 IgG binding antibody
Time frame: 3 months, 6 months and 12 months post full vaccination
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