Official Title
A Randomized and Controlled 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
Brief 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 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.

Suspended
COVID-19

Biological: Experimental Group

The COVID-19 vaccine was manufactured by Sinovac Research & Development Co., Ltd, and the EV71 vaccine was manufactured by Sinovac Biotech Co. The COVID-19 vaccine:600SU inactivated virus in 0.5 mL of aluminium hydroxide solution per injection;The EV71 vaccine:Inactivated EV71 virus antigen no less than 3.0EU in 0.5 mL of aluminium hydroxide solution per injection.
Other Name: Combined immunization group

Biological: Control Group

The COVID-19 vaccine was manufactured by Sinovac Research & Development Co., Ltd, and the EV71 vaccine was manufactured by Sinovac Biotech Co. The COVID-19 vaccine:600SU inactivated virus in 0.5 mL of aluminium hydroxide solution per injection;The EV71 vaccine:Inactivated EV71 virus antigen no less than 3.0EU in 0.5 mL of aluminium hydroxide solution per injection.
Other Name: Non-combined immunization group

Eligibility Criteria

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;

- 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 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;

- Receipt of inactivated or subunit vaccines in the past 7 days;

- Severe neurological disease (epilepsy, convulsions or convulsions) or mental illness;

- Axillary temperature >37.0°C;

- The subjects participated in other clinical trials during the follow-up period, or
will be planned within 3 months;

- According to the investigator's judgment, the subject has any other factors that are
not suitable for participating in the clinical trial.

Eligibility Gender
All
Eligibility Age
Minimum: 3 Years ~ Maximum: 5 Years
Countries
China
Locations

Yangchun Center for Disease Control and Prevention
Yangchun, Guangdong, China

Zhanjiang Center for Disease Control and Prevention
Zhanjiang, Guangdong, China

Zhuhang Huang, Master, Principal Investigator
Guangdong Center for Disease Prevention and Control

Sinovac Research and Development Co., Ltd.
NCT Number
MeSH Terms
COVID-19