Status:
COMPLETED
Safety and Immunogenicity Study of Inactivated Vaccine for Prevention of SARS-CoV-2 Infection(COVID-19)
Lead Sponsor:
Sinovac Life Sciences Co., Ltd.
Conditions:
COVID-19
Eligibility:
All Genders
60+ years
Phase:
PHASE1
PHASE2
Brief Summary
This study is a randomized, double-blinded, and placebo controlled phase 1\&2 clinical trial of the SARS-CoV-2 inactivated vaccine manufactured by Sinovac Life Sciences Co. , Ltd. The purpose of this ...
Detailed Description
This study is a randomized, double-blinded, single-center, placebo-controlled phase 1\&2 clinical trial in healthy elderly aged 60 years and above. The experimental vaccine and placebo were both manuf...
Eligibility Criteria
Inclusion
- Healthy adults aged ≥60 years;
- Be able to understand and sign the informed consent voluntarily;
- Provide legal identification;
Exclusion
- Travel / residence history of Wuhan city and surrounding areas or other communities with case reports within 14 days prior to the enrolment;
- Contact with SARS-CoV-2 infected persons (positive for nucleic acid detection) within 14 days prior to the enrolment;
- Contact patients with fever or respiratory symptoms from Wuhan city and surrounding areas, or from communities with case reports within 14 days prior to the enrolment;
- Two or more cases of fever and / or respiratory symptoms in a small contact area of subjects, such as family, office, school class or other places within 14 days prior to the enrolment;
- History of SARS;
- History of SARS-CoV-2 infection;
- History of asthma, allergy to vaccines or vaccine ingredients, and serious adverse reactions to vaccines, such as urticaria, dyspnea, angioneuroedema;
- Congenital malformation or developmental disorder, genetic defect, severe malnutrition, etc;
- Autoimmune disease or immunodeficiency / immunosuppression;
- Serious chronic disease, serious cardiovascular disease, hypertension and diabetes that cannot be controlled by drugs, hepatorenal disease, malignant tumor, etc;
- Serious nervous system disease (epilepsy, convulsion or convulsion) or psychosis;
- Thyroid disease or history of thyroidectomy, asplenia, functional asplenia, asplenia 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;
- Long history of alcohol or drug abuse;
- Receipt of blood products 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;
- According to the investigator's judgment, the subject has any other factors that are not suitable for the clinical trial.
Key Trial Info
Start Date :
May 22 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 31 2022
Estimated Enrollment :
422 Patients enrolled
Trial Details
Trial ID
NCT04383574
Start Date
May 22 2020
End Date
May 31 2022
Last Update
August 11 2022
Active Locations (1)
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1
Renqiu City Center for Disease Control and Prevention
Renqiu, Hebei, China, 062550