COVID-19, Influenza
Conditions
Brief summary
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
Detailed description
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.
Interventions
BIOLOGICALTwo doses of inactivated SARS-CoV-2 vaccine at the schedule of day 0,28 and one dose Quadrivalent Influenza Vaccine on day 0 or day 28.
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.
BIOLOGICALTwo doses of inactivated SARS-CoV-2 vaccine at the schedule of day 0,28 and one dose Quadrivalent Influenza Vaccine on day 14.
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.
Sponsors
Sinovac Research and Development Co., Ltd.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 59 Years
Healthy volunteers
Yes
Inclusion criteria
* Healthy adults aged 18-59 years; * The subject can understand and voluntarily sign the informed consent form; * Proven legal identity
Exclusion criteria
* Travel history / residence history of communities with case reports within 14 days; * History of contact with a SARS-CoV-2 infection (positive in nucleic acid test) within 14 days; * Have contacted patients with fever or respiratory symptoms from communities with case reports within 14 days; * Two or more cases of fever and / or respiratory symptoms in a small contact area of volunteers, such as home, office etc. within 14 days; * History of SARS-CoV-2 infection; * History of asthma, history of allergy to the vaccine or vaccine components, or serious adverse reactions to the vaccine, such as urticaria, dyspnea, and angioedema; * Congenital malformations or developmental disorders, genetic defects, severe malnutrition, etc.; * Autoimmune disease or immunodeficiency / immunosuppression; * Severe chronic diseases, severe cardiovascular diseases, hypertension and diabetes that cannot be controlled by drugs, liver or kidney diseases, malignant tumors, etc.; * Severe neurological disease (epilepsy, convulsions or convulsions) or mental illness; * Thyroid disease or history of thyroidectomy, spleenlessness, functional spleenlessness, spleenlessness or splenectomy resulting from any condition; * Diagnosed abnormal blood coagulation function (eg, lack of blood coagulation factors, blood coagulopathy, abnormal platelets) or obvious bruising or blood coagulation; * Immunosuppressive therapy, cytotoxic therapy, inhaled corticosteroids (excluding allergic rhinitis corticosteroid spray therapy, acute noncomplicated dermatitis superficial corticosteroid therapy) in the past 6 months; * Physical examination has clinically significant abnormal hematology and biochemistry laboratory test results that exceed the reference value range (only applicable to phase I clinical trials): 1. Blood routine test: white blood cell count, hemoglobin, platelet count; 2. Detection of blood biochemical indicators: alanine aminotransferase (ALT), aspartate aminotransferase (AST), total bilirubin (TBIL), creatinine (CR), fasting blood glucose; 3. Urine routine index: urine protein (PRO); * History of alcohol or drug abuse; * Receipt of blood products within in the past 3 months; * Receipt of other investigational drugs in the past 30 days; * Receipt of attenuated live vaccines in the past 14 days; * Receipt of inactivated or subunit vaccines in the past 7 days; * Acute diseases or acute exacerbation of chronic diseases in the past 7 days; * Axillary temperature \>37.0°C; * Already pregnant (including a positive urine pregnancy test) or are breastfeeding, planning to get pregnant within 3 months; * According to the investigator's judgment, the subject has any other factors that are not suitable for participating in the clinical trial.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Safety index-incidence of adverse reactions within 7 days after each dose | Day 0-7 after each dose vaccination | Incidence of adverse reactions within 7 days after each dose |
| Immunogenicity index-seroconversion rates of neutralizing antibody against SARS-CoV-2 | The 28th day after the second dose vaccination of the inactivated SARS-CoV-2 vaccine | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Immunogenicity index-seropositive rates of neutralizing antibody against SARS-CoV-2 | The 28th day after each dose vaccination | Neutralizing antibody assay will be performed using the micro-neutralization method, and subjects with a antibody titer ≥1:8 will defined as seropositive. |
| Immunogenicity index-geometric mean titer (GMT) of neutralizing antibody against SARS-CoV-2 | The 28th day after each dose vaccination | Neutralizing antibody assay will be performed using the micro-neutralization method. |
| Immunogenicity index-geometric mean ratio (GMR) of neutralizing antibody against SARS-CoV-2 | The 28th day after each dose vaccination | Neutralizing antibody assay will be performed using the micro-neutralization method. Ratio of post-vaccination titer divided by baseline titer will be calculated. |
| Safety index-incidence of adverse reactions within 56 days after the first dose vaccination | Day 0-56 after the first dose vaccination | Incidence of adverse reactions within 56 days after the first dose vaccination |
| Immunogenicity index-protective rates of influenza HI antibodies | The 28th day after the vaccination | The standard of reaching the protective rate is that the antibody titer ≥1:40. |
| Immunogenicity index-geometric mean titer (GMT) of influenza HI antibodies | The 28th day after the vaccination | influenza HI antibodies assay will be performed using the micro hemagglutination inhibition test |
| Immunogenicity index-geometric mean ratio (GMR) of influenza HI antibodies | The 28th day after the vaccination | influenza HI antibodies assay will be performed using the micro hemagglutination inhibition test |
| Immunogenicity index-seroconversion rates of influenza HI antibodies | The 28th day after the vaccination | Seroconversion will be defined as a change from seronegative (\<1:10) to protective (≥1:40), or ≥4 fold increase from baseline(≥1:10). |
| Safety index-incidence of serious adverse events | Day 0-56 after the first dose vaccination | SAE will be collected throughout the clinical trial. |
Countries
China
Outcome results
None listed