Clinical trial
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
Name
PRO-nCOV-4002
Description
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
Trial arms
Trial start
2021-11-05
Estimated PCD
2022-07-14
Trial end
2022-07-14
Status
Completed
Phase
Early phase I
Treatment
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.
Arms:
Experimental Group
Other names:
Combined immunization group
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.
Arms:
Control Group
Other names:
Non-combined immunization group
Size
520
Primary endpoint
Immunogenicity index-Seroconversion rate of the neutralizing antibody to live SARS-CoV-2
Day 28 after the second dose of COVID-19 vaccine
Immunogenicity index-Seroconversion rate of the neutralizing antibody to EV71
Day 28 after the second dose of EV71 vaccine
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.
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE4'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'PREVENTION', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 520, 'type': 'ACTUAL'}}
Updated at
2023-10-10
1 organization
2 products
1 indication
Organization
Sinovac Research and DevelopmentProduct
Control GroupIndication
COVID-19Product
Experimental Group