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Clinical Trial of Inactivated SARS-CoV-2 Vaccine for Prevention of COVID-19 in Healthy Adults | Clinical Trials | Clareo Health

UNKNOWNPHASE4

Clinical Trial of Inactivated SARS-CoV-2 Vaccine for Prevention of COVID-19 in Healthy Adults

An Open-label,Phase Ⅳ Clinical Trial to Evaluate the Immunogenicity and Safety of the Inactivated SARS-CoV-2 Vaccine (Vero Cell) in Healthy Population Aged From 18 to 59 Years.

NCT04962308•Sinovac Research and Development Co., Ltd.

View on ClinicalTrials.gov

Summary

This study is an open-label phase Ⅳ clinical trial of the inactivated SARS-CoV-2 vaccine(CoronaVac)manufactured by Sinovac Research \& Development Co., Ltd. The purpose of this study is to evaluate the immunogenicity and safety of the Inactivated SARS-CoV-2 Vaccine (Vero Cell) in Healthy Population Aged From 18 to 59 Years.

Detailed Description

This study is an open-label phase Ⅳ clinical trial in healthy adult aged 18-59 years. The experimental vaccine was manufactured by Sinovac Research and Development Co.,Ltd.. A total of 1400 subjects will be enrolled,the safety and immunogenicity of booster immunization were evaluated in 400 subjects (group A) who received two doses of primary immunization at an interval of 21 to 31 days. And the safety of booster immunization was evaluated in the extended safety group (group B), which included 1000 subjects.

Eligibility

Age

18 - 59 years

Sex

ALL

Healthy Volunteers

Yes

Inclusion Criteria

•Healthy adults aged 18-59;
•Have been received two doses of inactivated SARS-CoV-2 vaccine(CoronaVac)manufactured by Sinovac Research \& Development Co., Ltd at an interval of 21 to 31 days for group A.Have been vaccination two doses of inactivated SARS-CoV-2 vaccine(CoronaVac)manufactured by Sinovac Research \& Development Co., Ltd for group B;
•The subjects can understand and voluntarily sign the informed consent form;
•Proven legal identity.

Exclusion Criteria

•History of SARS-CoV-2 infection;
•Any serious adverse reactions that are causally related to vaccination during the primary immunization of the previous inactivated SARS-CoV-2 vaccine;
•Severe allergic reactions after primary immunization (including urticaria/rash within 30 minutes after vaccination);
•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) within 6 months before primary immunization and before booster immunization;
•Already pregnant or are breastfeeding, planning to get pregnant (according to subjects' self-report and urine pregnancy test results)
•Receipt of attenuated live vaccines within 14 days prior to booster vaccination;
•Receipt of inactivated or subunit vaccines within 7 days prior to booster vaccination;
+3 more criteria

Locations (1)

Beijing Centers for Diseases Control and Prevention

Beijing, China

Key Dates

Start Date

June 19, 2021

Primary Completion Date

August 19, 2021

Completion Date

December 19, 2021

Last Updated

September 24, 2021

Enrollment

1,400

ESTIMATED participants

Conditions

COVID-19

Interventions

SARS-CoV-2 Inactivated Vaccine

BIOLOGICAL

The SARS-CoV-2 Inactivated Vaccine

BIOLOGICAL

Contacts

Jiang Wu, Master

CONTACT

13381081732 wj81732@hotmail.com

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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: September 24, 2021Data 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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Clinical Trial of Inactivated SARS-CoV-2 Vaccine for Prevention of COVID-19 in Healthy Adults

Inclusion Criteria

Exclusion Criteria

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