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Immunogenicity And Safety of COVID-19 Vaccine , Inactivated Co -Administration With EV71 Vaccine (Vero Cell) | Clinical Trials | Clareo Health

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Immunogenicity And Safety of COVID-19 Vaccine , Inactivated Co -Administration With EV71 Vaccine (Vero Cell)

A Randomized and Controlled Phase IV Clinical Trial to Evaluate the Immunogenicity and Safety of COVID-19 Vaccine (Vero Cell), Inactivated Co-administrated With EV71 Vaccine (Vero Cell) in Children Aged 3-5 Years Old

NCT05107557•Sinovac Biotech Co., Ltd

View on ClinicalTrials.gov

Summary

This study is a randomized and controlled Phase IV clinical trial of the COVID-19 vaccine (Vero cell), Inactivated manufactured by Sinovac Research \& Development Co., Ltd. The purpose of this study is to evaluate the immunogenicity and safety of COVID-19 vaccine (Vero cell), Inactivated co-administration with EV71 vaccine

Detailed Description

This study is a randomized and controlled phase IV clinical trial in children aged 3-5 years old. The purpose of this study is to evaluate the immunogenicity and safety of COVID-19 vaccine (Vero cell), Inactivated co-administration with EV71 vaccine.The COVID-19 vaccine was manufactured by Sinovac Research \& Development Co., Ltd and the EV71 vaccine was manufactured by Sinovac Biotech Co.A total of 520 subjects aged 3-5 years old will be enrolled.Subjects will be randomly divided into 2 groups in a ratio of 1:1.The experimental group is the combined immunization group, which will receive the first dose of COVID-19 vaccine and the first dose of EV71 vaccine on day 0 and the second dose of COVID-19 vaccine and EV71 vaccine on day 28;Control group is the Non-combined immunization group , which will receive the first dose of COVID-19 vaccine on day 0 ,the first dose of EV71 vaccine on day 14, the second dose of COVID-19 vaccine on day 28 and the second dose of EV71 vaccine on day 42.

Eligibility

Age

3 - 5 years

Sex

ALL

Healthy Volunteers

Yes

Inclusion Criteria

•Children aged 3-5 years;
•The subject and/or guardian can understand and voluntarily sign the informed consent form;
•Proven legal identity.

Exclusion Criteria

•History of contact with a SARS-CoV-2 infection (positive in nucleic acid test) within 14 days;
•History of multiple system inflammatory syndrome (MIS-C);
•History of hand, foot and mouth disease, herpetic angina or EV71 vaccination;
•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;
•Congenital malformations or developmental disorders, genetic defects,severe malnutrition, etc.;
•Autoimmune disease (Systemic lupus erythematosus)or immunodeficiency / immunosuppression(HIV,history after organ transplantation);
•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, asplenia,functional asplenia, asplenia 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;
+10 more criteria

Locations (2)

Yangchun City Center for Disease Control and Prevention

Yangchun, Guangdong, China

Zhanjiang Center for Diseases Control and Prevention

Zhenjiang, Guangdong, China

Key Dates

Start Date

November 5, 2021

Primary Completion Date

December 5, 2021

Completion Date

July 14, 2022

Last Updated

August 11, 2022

Enrollment

520

ACTUAL participants

Conditions

COVID-19

Interventions

Experimental Group

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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: August 11, 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 COVID-19 Vaccine , Inactivated Co -Administration With EV71 Vaccine (Vero Cell)

Inclusion Criteria

Exclusion Criteria

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