This study is an open-label, single-center, randomized phase IV 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 concomitant administration of the SARS-CoV-2 Inactivated Vaccine (Vero cell) with Quadrivalent Influenza Vaccine in adults aged from 18 to 59 Years
This study is an open-label, single-center, randomized phase IV clinical trial of the SARS-CoV-2 inactivated vaccine (Vero cell) manufactured by Sinovac Research \& Development Co., Ltd. The purpose of this study is to evaluate the safety and immunogenicity of concomitant administration of the SARS-CoV-2 Inactivated Vaccine (Vero cell) with Quadrivalent Influenza Vaccine in adults aged from 18 to 59 Years. 480 healthy adults as participants are randomly assigned into two groups in the ratio 1:1. The first group was the combined immunization group, which is randomly divided into two subgroups, 120 subjects in each group. The combined immunization subgroup Ⅰ receive SARS-CoV-2 inactivated vaccine \&Quadrivalent Influenza Vaccine on day 0 and SARS-CoV-2 inactivated vaccine (second dose) on day 28.The combined immunization subgroup Ⅱ receive SARS-CoV-2 inactivated vaccine on day 0 and SARS-CoV-2 inactivated vaccine (second dose) \& Quadrivalent Influenza Vaccine on day 28. The second group was the non combined immunization group,which receive SARS-CoV-2 inactivated vaccine (first dose) on day 0, Quadrivalent Influenza Vaccine on day 14 and SARS-CoV-2 inactivated vaccine (second dose) on day 28.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Enrollment
480
The inactivated SARS-CoV-2 vaccine was manufactured by Sinovac Research \& Development Co., Ltd., with a antigen content of 600SU/0.5ml. The Quadrivalent Influenza Vaccine manufactured by Sinovac Biotech Co.,Ltd. including 4 antigens H1N1, H3N2, BV and BY, 15μg for each, 0.5ml per dose.
The inactivated SARS-CoV-2 vaccine was manufactured by Sinovac Research \& Development Co., Ltd., with a antigen content of 600SU/0.5ml. The Quadrivalent Influenza Vaccine manufactured by Sinovac Biotech Co.,Ltd. including 4 antigens H1N1, H3N2, BV and BY, 15μg for each, 0.5ml per dose.
Kaihua county Center for Disease Control and Prevention
Quzhou, Zhejiang, China
Safety index-incidence of adverse reactions within 7 days after each dose
Incidence of adverse reactions within 7 days after each dose
Time frame: Day 0-7 after each dose vaccination
Immunogenicity index-seroconversion rates of neutralizing antibody against SARS-CoV-2
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 of the inactivated SARS-CoV-2 vaccine
Safety index-incidence of adverse reactions within 56 days after the first dose vaccination
Incidence of adverse reactions within 56 days after the first dose vaccination
Time frame: Day 0-56 after the first dose vaccination
Safety index-incidence of serious adverse events
SAE will be collected throughout the clinical trial.
Time frame: Day 0-56 after the first dose vaccination
Immunogenicity index-seropositive rates of neutralizing antibody against SARS-CoV-2
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
Immunogenicity index-geometric mean titer (GMT) of neutralizing antibody against SARS-CoV-2
Neutralizing antibody assay will be performed using the micro-neutralization method.
Time frame: The 28th day after each dose vaccination
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Immunogenicity index-geometric mean ratio (GMR) of neutralizing antibody against SARS-CoV-2
Neutralizing antibody assay will be performed using the micro-neutralization method. Ratio of post-vaccination titer divided by baseline titer will be calculated.
Time frame: The 28th day after each dose vaccination
Immunogenicity index-seroconversion rates of influenza HI antibodies
Seroconversion will be defined as a change from seronegative (\<1:10) to protective (≥1:40), or ≥4 fold increase from baseline(≥1:10).
Time frame: The 28th day after the vaccination
Immunogenicity index-protective rates of influenza HI antibodies
The standard of reaching the protective rate is that the antibody titer ≥1:40.
Time frame: The 28th day after the vaccination
Immunogenicity index-geometric mean titer (GMT) of influenza HI antibodies
influenza HI antibodies assay will be performed using the micro hemagglutination inhibition test
Time frame: The 28th day after the vaccination
Immunogenicity index-geometric mean ratio (GMR) of influenza HI antibodies
influenza HI antibodies assay will be performed using the micro hemagglutination inhibition test
Time frame: The 28th day after the vaccination