This study is a randomized, double-blinded clinical Trial, to evaluate the non-inferiority of the commercial scale Inactivated SARS-CoV-2 vaccine against that of the pilot scale among adults aged 26-45 years, and the open-labelled, bridging non-inferiority of the vaccine induced immunogenicity in elderly against that in adults.
This study is a randomized, double-blinded clinical Trial, to evaluate the non-inferiority of the commercial scale Inactivated SARS-CoV-2 vaccine against that of the pilot scale among adults aged 26-45 years, and the open-labelled, bridging non-inferiority of the vaccine induced immunogenicity in elderly against that in adults. The experimental vaccine was manufactured by Sinovac Research \& Development Co.,Ltd. Totally 1040 subjects,including: 130 subjects aged 18\~25 years; 520 subjects aged 26\~45 years, with 260 in each group; 130 subjects aged 46\~59 years; 260 subjects aged ≥60 years. Subjects will be assigned to receive two doses of medium-dosage vaccine on the schedule of 0,14.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Enrollment
1,040
The antigen content of the commercial scale inactivated SARS-CoV-2 vaccine was 600SU/0.5ml, vaccinated in the age group 26-45.
The antigen content of the pilot scale inactivated SARS-CoV-2 vaccine was 600SU/0.5ml, vaccinated in the age group 18-59.
Dafeng District Center for Disease Prevention and Control
Yancheng, Jiangsu, China
Immunogenicity index-geometric mean titer(GMT) of neutralizing antibody
Neutralizing antibody assay will be performed using the micro-neutralization method
Time frame: Day 14 after the full course vaccination
Immunogenicity index-Seroconversion rate of the 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: Day 14 after the full course vaccination
Immunogenicity index-Seropositive rate of the neutralizing antibody
Neutralizing antibody assay will be performed using the micro-neutralization method. Subjects with a antibody titer ≥1:8 will defined as seropositive
Time frame: Day 14 after the full course vaccination
Safety index-Incidence of adverse reactions
Incidence of adverse reactions from the beginning of the vaccination to 28 days after the full course vaccination
Time frame: From the beginning of the vaccination to 28 days after the full course 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 6 months after the full course vaccination
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The antigen content of the pilot scale inactivated SARS-CoV-2 vaccine was 600SU/0.5ml, vaccinated in the age group above 60.