Status:
COMPLETED
Study on Combined Vaccination With SARS-CoV-2 Inactivated Vaccine and Quadrivalent Influenza Vaccine
Lead Sponsor:
Sinovac Research and Development Co., Ltd.
Conditions:
COVID-19
Influenza
Eligibility:
All Genders
18-59 years
Phase:
PHASE4
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...
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 o...
Eligibility Criteria
Inclusion
- Healthy adults aged 18-59 years;
- The subject can understand and voluntarily sign the informed consent form;
- Proven legal identity
Exclusion
- 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):
- Blood routine test: white blood cell count, hemoglobin, platelet count;
- Detection of blood biochemical indicators: alanine aminotransferase (ALT), aspartate aminotransferase (AST), total bilirubin (TBIL), creatinine (CR), fasting blood glucose;
- 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.
Key Trial Info
Start Date :
March 23 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 28 2021
Estimated Enrollment :
480 Patients enrolled
Trial Details
Trial ID
NCT04801888
Start Date
March 23 2021
End Date
May 28 2021
Last Update
July 26 2021
Active Locations (1)
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1
Kaihua county Center for Disease Control and Prevention
Quzhou, Zhejiang, China, 324300