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 population aged 3 to 17 years.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Enrollment
480
2 doses of SARS-CoV-2 Vaccine (Vero Cells), Inactivated with a 28-day interval constitute a primary immunization course. The third dose on 6 months after primary course is the booster dose. Administer as an intramuscular injection into the lateral deltoid of the upper arm.
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
Seroconversion rate of SARS-CoV-2 neutralizing antibody
Time frame: 28 days post full primary immunization course
Geometric mean titer of SARS-CoV-2 neutralizing antibody
Time frame: 28 days post full primary immunization course
Incidence of adverse reactions/events
Time frame: 0-28 days after each vaccination
Serious Adverse Events (SAE)
Time frame: within 12 months post full primary immunization course and the booster dose respectively
Seroconversion rate of SARS-CoV-2 IgG binding antibody
Time frame: 28 days post full primary immunization course
Geometric mean titer of SARS-CoV-2 IgG binding antibody
Time frame: 28 days, 3 months, 6 months and 12 months post full primary immunization course
Geometric mean titer of SARS-CoV-2 IgG binding antibody
Time frame: 28 days, 3 months, 6 months and 12 months after the booster dose
Geometric mean titer of SARS-CoV-2 neutralizing antibody
Time frame: 3 months, 6 months and 12 months post full primary immunization course
Geometric mean titer of SARS-CoV-2 neutralizing antibody
Time frame: 28 days, 3 months, 6 months and 12 months after the booster dose
Seropositive rate of SARS-CoV-2 neutralizing antibody
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Time frame: 3 months, 6 months and 12 months post full primary immunization course
Seropositive rate of SARS-CoV-2 neutralizing antibody
Time frame: 28 days, 3 months, 6 months and 12 months after the booster dose
Seropositive rate of SARS-CoV-2 IgG binding antibody
Time frame: 3 months, 6 months and 12 months post full primary immunization course
Seropositive rate of SARS-CoV-2 IgG binding antibody
Time frame: 28 days, 3 months, 6 months and 12 months after the booster dose