This study is a randomized, double-blinded, and placebo controlled phase 1\&2 clinical trial of the SARS-CoV-2 inactivated vaccine manufactured by Sinovac Research \& Development Co., Ltd. The purpose of this study is to evaluate the safety and immunogenicity of the experimental vaccine in healthy children and adolescents aged 3-17 years
This study is a randomized, double-blinded, single-center, placebo-controlled phase 1\&2 clinical trial in children and adolescents aged 3-17 years. The experimental vaccine and placebo were both manufactured by Sinovac Research \& Development Co., Ltd. A total of 552 subjects will be enrolled, with 72 at phase 1, and 480 at phase 2. Subjects will be assigned to receive two doses of different dosage of experimental vaccine or placebo on the schedule of day 0,28. Subjects in Phase receive the second dose 10 months or 12 months after the second dose.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Enrollment
552
The inactivated SARS-CoV-2 vaccine was manufactured by Sinovac Research \& Development Co., Ltd., with a antigen content of 300SU/0.5ml
The inactivated SARS-CoV-2 vaccine was manufactured by Sinovac Research \& Development Co., Ltd., with a antigen content of 600SU/0.5ml
Zanhuang county Center for Disease Control and Prevention
Shijiazhuang, Hebei, China
Safety index-incidence of adverse reactions
Incidence of adverse reactions after each dose vaccination.
Time frame: Day 0-28 after each dose vaccination
Immunogenicity index-seroconversion rates of neutralizing antibody
Neutralizing antibody assay will be performed using the micro-neutralization method. Seroconversion will be defined as a change from seronegative (\<1:8) to seropositive (≥1:8), or ≥4 fold increase from baseline.
Time frame: The 28th day after the second dose vaccination
Safety index-incidence of serious adverse events
SAE will be collected throughout the clinical trial.
Time frame: From the beginning of the vaccination to 12 months after the second dose vaccination
Immunogenicity index-seropositive rates of neutralizing antibody
Neutralizing antibody assay will be performed using the micro-neutralization method, and subjects with a antibody titer ≥1:8 will defined as seropositive.
Time frame: The 28th day after each dose vaccination and the 12 month after the second dose vaccination
Immunogenicity index-geometric mean titer (GMT) of neutralizing antibody
Neutralizing antibody assay will be performed using the micro-neutralization method.
Time frame: The 28th day after each dose vaccination and the 12 month after the second dose vaccination
Immunogenicity index-geometric mean ratio (GMR) of neutralizing antibody
Neutralizing antibody assay will be performed using the micro-neutralization method. Ratio of post-vaccination titer divided by baseline titer will be calculated.
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
The placebo contains no active ingredient and manufactured by Sinovac Research \& Development Co., Ltd.
Time frame: The 28th day after each dose vaccination and the 12 month after the second dose vaccination
Safety index-Incidence rate of adverse reactions
Incidence rate of adverse reactions within 7 days after each dose vaccination
Time frame: Within 7 days after each dose vaccination
Safety index-Incidence of abnormal laboratory index
Incidence of abnormal laboratory index (blood routine test, blood chemistry test, and urine routine test) on the 3th day after each dose of vaccination in phase Ⅰ
Time frame: On the 3th day after each dose of vaccination in phase Ⅰ
Safety index-Incidence rate of AESIs
Incidence rate of SAEs and AESIs from the beginning of the vaccination to 12 months after the last dose vaccination
Time frame: From the beginning of the vaccination to 12 months after the last dose vaccination
Immunogenicity index- GMI of neutralizing antibody
GMI of neutralizing antibodies 28 days after the second dose vaccination
Time frame: 28 days after the second dose vaccination
Immunogenicity index-the seroconversion rate
The seroconversion rate 28 days after the first dose vaccination in phase Ⅰ
Time frame: 28 days after the first dose vaccination in phase Ⅰ
Immunogenicity index-the seropositive rate
Seropositive rate 28 days after the first dose vaccination in phase Ⅰ
Time frame: 28 days after the first dose vaccination in phase Ⅰ
Immunogenicity index-the GMT
The GMT 28 days after the first dose vaccination in phase Ⅰ
Time frame: 28 days after the first dose vaccination in phase Ⅰ
Immunogenicity index-the GMI
The GMI 28 days after the first dose vaccination in phase Ⅰ
Time frame: 28 days after the first dose vaccination in phase Ⅰ