Safety and Immunogenicity Study of Booster Vaccination in Different Doses of COVID-19 Vaccine (Vero Cell),Inactivated for Prevention of COVID-19

Sinovac

Status and phase

Completed

Phase 4

Conditions

COVID-19

Treatments

Biological: Medium-dose COVID-19 Vaccine(Vero Cell),Inactivated

Biological: High-dosage of COVID-19 vaccine (Vero cell), Inactivated

Study type

Interventional

Funder types

Industry

Identifiers

NCT05165966

PRO-nCOV-4010

Details and patient eligibility

About

This is a randomized, double-blinded, phase Ⅳ clinical trial of COVID-19 vaccine (Vero cell), Inactivated manufactured by Sinovac Life Sciences Co. , Ltd. The purpose of this study is to evaluate the safety and immunogenicity of booster vaccination using high-dosage or medium-dosage of COVID-19 vaccine (Vero cell), Inactivated in populations who have completed primary immunization 5-9 months

Full description

This study a randomized, double-blinded, phase Ⅳ clinical trial of COVID-19 vaccine (Vero cell), Inactivated.The purpose of this study is to evaluate the safety and immunogenicity of booster vaccination using high-dosage or medium-dosage of COVID-19 vaccine (Vero cell), Inactivated in populations who have completed primary immunization 5-9 months.A total of 340 subjects who have completed primary immunization using two-dose Coronavac® 5-9 months were be enrolled.All of subjects were be randomly divided into two groups in a 1:1 ratio to receive high-dosage or medium-dosage of COVID-19 vaccine (Vero cell), Inactivated.

Enrollment

340 patients

Sex

All

Ages

18+ years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

Healthy participants aged 18 years and above;
Proven legal identity;
The subjects can understand and voluntarily sign the informed consent form and be willing to complete the study in accordance with the study plan;
Have received two doses of inactivated COVID-19 vaccine (CoronaVac®) manufactured by Sinovac Research & Development Co., Ltd and that is currently 5-9 months after the second dose.

Exclusion criteria

History of SARS-CoV-2 infection(laboratory confirmed);
Have received three and more doses of inactivated COVID-19 vaccine;
Known allergy to vaccines or vaccine ingredients, and serious adverse reactions to vaccines, such as urticaria, dyspnea, angioneurotic edema;
Autoimmune disease such as systemic lupus erythematosus or immunodeficiency / immunosuppression such as AIDS, post-transplant;
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;
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;
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;
Acute diseases or acute exacerbation of chronic diseases within 7 days prior to booster vaccination;
Axillary temperature >37.0°C;
Participated in other clinical trials prior to enrollment and during the followup period, or planned to participate in other clinical trials during the clinical trial period;
According to the investigator's judgment, the subject has any other factors that are not suitable for participating in the clinical trial.