Immunogenicity And Safety of COVID-19 Vaccine , Inactivated Co -Administration With EV71 Vaccine … (NCT04993365) | Clinical Trial Compass
CompletedPhase 4
Immunogenicity And Safety of COVID-19 Vaccine , Inactivated Co -Administration With EV71 Vaccine (Vero Cell)
China520 participantsStarted 2021-11-05
Plain-language summary
This study is a randomized and controlled phase â…£ 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
Who can participate
Age range3 Years – 5 Years
SexALL
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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)ï¼›
* 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…
What they're measuring
1
Immunogenicity index-Seroconversion rate of the neutralizing antibody to live SARS-CoV-2
Timeframe: Day 28 after the second dose of COVID-19 vaccine
2
Immunogenicity index-Seroconversion rate of the neutralizing antibody to EV71
Timeframe: Day 28 after the second dose of EV71 vaccine