Status:
COMPLETED
Immunogenicity and Safety of a Third Dose of COVID-19 Vaccine(Vero Cell), Inactivated in the Elderly
Lead Sponsor:
Sinovac Life Sciences Co., Ltd.
Conditions:
COVID-19
Eligibility:
All Genders
60+ years
Phase:
PHASE4
Brief Summary
This is an open phase Ⅲ clinical trial of COVID-19 vaccine (Vero cell), inactivated manufactured by Sinovac Research \& Development Co., Ltd.The purpose of this study is to evaluate Immunogenicity and...
Detailed Description
This study is an open phase Ⅲ clinical trial. The main purpose of this study is to evaluate Immunogenicity and safety of a third dose at different times after two-dose of COVID-19 vaccine (Vero cell),...
Eligibility Criteria
Inclusion
- Subjects aged 60 years and above;
- Provide legal identification;
- Have completed two-dose of COVID-19 vaccine (Vero cell), inactivated manufactured by Sinovac Research\& Development Co., Ltd. for 3\~6 months（The interval between two doses was 21\~35 days）；
- Be able to understand and voluntarily sign the informed consent form and be willing to complete the study according to the research plan.
Exclusion
- History of SARS-CoV-2 infection(laboratory confirmed);
- Those who have received COVID-19 vaccine from other manufacturers other than Sinovac Research\& Development Co., Ltd., or who have received booster immunization with COVID-19 vaccine after two doses of COVID-19 vaccine (Vero cell),inactivated manufactured by Sinovac Research\& Development Co., Ltd.;
- History of serious adverse reactions to the vaccine or vaccine components, such as urticaria dyspnea and angioneuroedema;
- 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;
- Immunosuppressive therapy, cytotoxic therapy, inhaled corticosteroids(excluding allergic rhinitis corticosteroid spray therapy, acute noncomplicated dermatitis superficial corticosteroid therapy) in the past 6 months or plan to receive these treatments during the study period;
- Receipt of blood products within in the past 3 months or plan to receive these treatments during the study period;
- Receipt of other investigational drugs in the past 30 days;
- Receipt of attenuated live vaccines in the past 14 days,or receipt of inactivated or subunit vaccines in the past 7 days;
- Onset of various acute or chronic diseases within 7 days prior to the study;
- 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 :
December 6 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 30 2022
Estimated Enrollment :
400 Patients enrolled
Trial Details
Trial ID
NCT05398926
Start Date
December 6 2021
End Date
July 30 2022
Last Update
August 11 2022
Active Locations (1)
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1
Yongde Center for Diseases Control and Prevention
Lincang, Yunnan, China, 677600