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

Launched by SINOVAC LIFE SCIENCES CO., LTD. · Dec 20, 2021

Trial Information

Current as of June 27, 2025

Completed

Keywords

ClinConnect Summary

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 vaccin...

Gender

ALL

Eligibility criteria

  • 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.

About Sinovac Life Sciences Co., Ltd.

Sinovac Life Sciences Co., Ltd. is a leading biotechnology company focused on the research, development, manufacturing, and commercialization of vaccines and biopharmaceuticals. With a commitment to public health, Sinovac specializes in innovative solutions to prevent infectious diseases, leveraging advanced technologies and rigorous clinical trials to ensure safety and efficacy. The company aims to enhance global health outcomes through its comprehensive portfolio of vaccine candidates, including those for viral infections, and is dedicated to expanding access to life-saving immunizations worldwide.

Locations

Beijing, Beijing, China

Patients applied

0 patients applied

Trial Officials

Yingmei Feng, Master

Principal Investigator

Beijing YouAn Hospital

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported

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