study on combined vaccination with sars-cov-2 inactivated vaccine and quadrivalent influenza vaccine

Conditions: COVID-19; Influenza

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

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.

Eligibility criteria:
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.