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Clinical Study of the Third Dose Immunization Schedule of COVID-19 Inactivated Vaccine, (Vero Cells) in Adults Aged 18 Years and Above (6 Months After Two Doses)

NCT05216484•Chinese Academy of Medical Sciences

Summary

To evaluate the immunogenicity and safety of the third dose SARS-CoV-2 Vaccine, Inactivated (Vero Cell) in adults aged 18 years and above, who inoculated the third dose after 6 months since finished two doses schedule of CoronaVac or BBIBP-CorV.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Yes

Inclusion Criteria

•1. Axillary temperature ≤37.0 ℃.
•2. aged 18 years and above, after 6 months since finished two doses schedule of CoronaVac or BBIBP-CorV, or one does CoronaVac and one does BBIBP-CorV.
•3. Proven legal identity, could come each visit.
•4. Participants should understand the contents of the informed consent form, the vaccine in this trial, voluntarily sign the informed consent form.

Exclusion Criteria

•1. Persons with a clear history of SARS-CoV-2 infection.
•2. Using blood products after basic immunization or receiving immunosuppressive therapy.
•3. Participants who have a positive pregnancy test, or are breastfeeding, or plan to become pregnant, or plan to donate sperm or eggs from the screening to 6 months after vaccination.
•4. Allergic to the active substance in the vaccine, any inactive substance or substance used in the preparation process (aluminum hydroxide, glycine);
•5. History of abnormal clinical manifestations and serious diseases to be excluded, including but not limited to nervous system, cardiovascular system, blood and lymphatic system, immune system, kidney, liver, gastrointestinal tract, respiratory system, metabolism, bones and other system diseases, and a history of malignant tumors.
•6. Diseases beyond drug control, such as high blood pressure, diabetes, asthma.
•7. Those who developed acute disease within 2 weeks, or had symptoms of fever or upper respiratory tract infection within 7 days.
•8. Immunization with any vaccine within 14 days.
•9. Any other situations judged by investigators as not suitable for participating in this study.

Locations (1)

Xiangyang City Centers for Disease Control and Prevention

Xiangyang, Hubei, China

Key Dates

Start Date

February 18, 2022

Primary Completion Date

October 30, 2022

Completion Date

December 30, 2022

Last Updated

May 23, 2022

Enrollment

480

ESTIMATED participants

Conditions

SARS-CoV-2 Infection

Interventions

SARS-CoV-2 Vaccine, Inactivated (Vero Cell)

BIOLOGICAL

Contacts

Jingsi Yang, Master

CONTACT

86-0871-68334551 yjs@imbcams.com.cn

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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: May 23, 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.

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Clinical Study of the Third Dose Immunization Schedule of COVID-19 Inactivated Vaccine, (Vero Cells) in Adults Aged 18 Years and Above (6 Months After Two Doses)

Inclusion Criteria

Exclusion Criteria

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