Clinical trial NCT04993365: Immunogenicity And Safety of COVID-19 Vaccine , Inactivated Co -Administration With EV71 Vaccine (Vero Cell)
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: COVID-19
Lead sponsor: Sinovac Biotech Co., Ltd
Sponsor class: INDUSTRY
First posted: 2021-08-06
Enrollment: 520
Sex: ALL
Minimum age (years): 3
Maximum age (years): 5
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

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.

Primary outcomes:
measure: Immunogenicity index-Seroconversion rate of the neutralizing antibody to live SARS-CoV-2
timeFrame: Day 28 after the second dose of COVID-19 vaccine
measure: Immunogenicity index-Seroconversion rate of the neutralizing antibody to EV71
timeFrame: Day 28 after the second dose of EV71 vaccine
Secondary outcomes:
measure: Immunogenicity index-Seropositivity rate of the neutralizing antibody to live SARS-CoV-2
timeFrame: Day 28 after the second dose of COVID-19 vaccine
measure: Immunogenicity index- GMT of the neutralizing antibody to live SARS-CoV-2
timeFrame: Day 28 after the second dose of COVID-19 vaccine
measure: Immunogenicity index-GMI of the neutralizing antibody to live SARS-CoV-2
timeFrame: Day 28 after the second dose of COVID-19 vaccine
measure: Immunogenicity index-Seropositive rate of the neutralizing antibody to EV71
timeFrame: Day 28 after the second dose of EV71
measure: Immunogenicity index-GMT of the neutralizing antibody to EV71
timeFrame: Day 28 after the second dose of EV71
measure: Immunogenicity index-GMI of the neutralizing antibody to EV71
timeFrame: Day 28 after the second dose of EV71
measure: Safety index-Incidence of the adverse reactions
timeFrame: From day 0 to day 7 after each dose
measure: Safety index-Incidence of the adverse reactions
timeFrame: From day 0 to 28 days after the last dose
measure: Safety index-Incidence of the serious adverse events and the adverse events of special interest
timeFrame: From the beginning vaccination to 6 months after the last dose
Other outcomes:
measure: Immunogenicity index-Seropositive rate of the neutralizing antibody to live SARS-CoV-2
timeFrame: 6 months after the second dose of COVID-19 vaccine
measure: Immunogenicity index- GMT of the neutralizing antibody to live SARS-CoV-2
timeFrame: 6 months after the second dose of COVID-19 vaccine
measure: Immunogenicity index-Seropositive rate of the neutralizing antibody to EV71
timeFrame: 6 months after the second dose of EV71 vaccine
measure: Immunogenicity index-GMT of the neutralizing antibody to EV71
timeFrame: 6 months after the second dose of EV71 vaccine
Locations:
city: Yangchun
country: China
facility: Yangchun Center for Disease Control and Prevention
state: Guangdong
city: Zhanjiang
country: China
facility: Zhanjiang Center for Disease Control and Prevention
state: Guangdong
Study officials:
affiliation: Guangdong Center for Disease Prevention and Control
name: Zhuhang Huang, Master
role: PRINCIPAL_INVESTIGATOR
References: