Status:
COMPLETED
Safety and Immunogenicity Study of Inactivated Vaccine for Prophylaxis of SARS CoV-2 Infection (COVID-19)
Lead Sponsor:
Sinovac Research and Development Co., Ltd.
Conditions:
COVID-19
Eligibility:
All Genders
18-59 years
Phase:
PHASE1
PHASE2
Brief Summary
This study is a randomized, double-blinded, and placebo controlled phase Ⅰ/Ⅱ clinical trial of the SARS-CoV-2 inactivated vaccine manufactured by Sinovac Research \& Development Co., Ltd. The purpose ...
Detailed Description
This study is a randomized, double-blinded, single-center, placebo-controlled phase Ⅰ/Ⅱ clinical trial in adults aged 18\~59 years. The purpose of this study is to evaluate the immunogenicity and safe...
Eligibility Criteria
Inclusion
- Healthy adults aged 18-59 years;
- Proven legal identity;
- Participants should be capable of understanding the informed consent form, and such form should be signed prior to enrolment ;
Exclusion
- Travel history / residence history of Wuhan city and surrounding areas, or other 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 Wuhan and surrounding areas, or from communities with case reports within 14 days;
- Have contacted patients with fever or respiratory symptoms from Wuhan and surrounding areas, or from communities with case reports within 14 days;
- Self-reported history of SARS;
- Self-reported history of new coronavirus infection;
- Positive in serum antibodies (IgG or IgM) screening of COVID-19;
- Positive in nasopharyngeal swabs or anal swabs through RT-PCR;
- Women who are breastfeeding, pregnant or planning to become pregnant during the study period;
- BMI≥35 kg/m2;
- 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;
- Suffering from severe chronic diseases, severe cardiovascular diseases, hypertension and diabetes that cannot be controlled by drugs, liver and 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 non-complicated dermatitis superficial corticosteroid therapy) in the past 6 months;
- Abnormal laboratory test results in the physical examination such as clinically significant abnormal hematology and biochemistry beyond the reference value range (only applicable to Phase I clinical trials);
- 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;
- Attacks of acute diseases or chronic diseases in the past 7 days;
- Axillary temperature \>37.0°C;
- 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 :
April 16 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 24 2021
Estimated Enrollment :
744 Patients enrolled
Trial Details
Trial ID
NCT04352608
Start Date
April 16 2020
End Date
July 24 2021
Last Update
February 24 2022
Active Locations (1)
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1
Suining County Center for Disease Control and Prevention
Xuzhou, Jiangsu, China, 221200