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COMPLETEDPHASE4

Immunogenicity and Safety of an Inactivated COVID-19 Vaccine

Immunogenicity and Safety of an Inactivated COVID-19 Vaccine for Prevention of COVID-19 in Healthy Population Aged 18 Years and Older

NCT04953325•Sinovac Research and Development Co., Ltd.

View on ClinicalTrials.gov

Summary

This study is a randomized, placebo-controlled and open design, phase 4 clinical trial of an inactivated COVID-19 vaccine (CoronaVac) manufactured by Sinovac Research and Development Co., Ltd. The purpose of this study is to evaluate the immunogenicity and safety of the CoronaVac in healthy population aged 18 years and older.

Detailed Description

This study is a randomized, placebo-controlled and opened, phase 4 clinical trial to evaluate the safety and immunogenicity of an inactivated COVID-19 vaccine(CoronaVac）in healthy population aged 18 years and older . The experimental vaccine is manufactured by Sinovac Research and Development Co.,Ltd. A total of 270 healthy subjects will be enrolled, including 135 adults aged 18-59 years and 135 elderly elderly aged 60 years and older. Subjects in each age group will be divided into two groups in a ratio of 1:1. Subjects in the experimental group will receive two doses of CoronaVac on day 0 and day 28. Subjects in the control group will receive one dose of 23-valent Pneumococcal Polysaccharide Vaccine on day 0 and one dose of Inactivated Hepatitis A Vaccine on day 28.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Yes

Inclusion Criteria

•Healthy population aged 18 years and above;
•The subjects can understand and voluntarily sign the informed consent form;
•Proven legal identity.

Exclusion Criteria

•History of SARS-CoV-2 infection;
•Have received any COVID-19 vaccine;
•Participants with abnormal fasting blood glucose or diabetes;
•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;
•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;
•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;
•Diseases or factors that are prone to thrombosis or bleeding, such as thrombophlebitis, major surgery/trauma, hereditary thrombotic disorder, sepsis, inflammatory bowel disease, severe varicose veins, May-Thurner syndrome, fibrinolytic activity enhancement disease, history of cardiac stent surgery, allergic purpura, etc.;
+11 more criteria

Locations (1)

Rushan City Center for Disease Control and Prevention

Weihai, Shandong, China

Key Dates

Start Date

July 9, 2021

Primary Completion Date

October 31, 2021

Completion Date

January 31, 2022

Last Updated

April 14, 2022

Enrollment

270

ACTUAL participants

Conditions

COVID-19

Interventions

Inactivated COVID-19 Vaccine

BIOLOGICAL

23-valent pneumococcal polysaccharide vaccine

BIOLOGICAL

Inactivated Hepatitis A Vaccine

BIOLOGICAL

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COVID-19

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: April 14, 2022Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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Immunogenicity and Safety of an Inactivated COVID-19 Vaccine

Inclusion Criteria

Exclusion Criteria

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