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
Trial Snapshot
- Phase
- Phase 4
- Status
- Completed
- Sponsor
- Sinovac Biotech Co., Ltd
- Enrollment
- 520
- Locations
- 2
- Primary Endpoint
- Immunogenicity index-Seroconversion rate of the neutralizing antibody to live SARS-CoV-2
Study Overview
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 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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Prevention
- Masking
- None
Eligibility Criteria
- Ages
- 3 Years to 5 Years (Child)
- Sex
- All
- Accepts 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;
- •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.
Arms & Interventions
Experimental Group
The experimental group is also called the combined immunization group.260 participants will receive the first dose of COVID-19 vaccine and EV71 vaccine on day 0 and the second dose of COVID-19 vaccine and EV71 vaccine on day 28.
Intervention: Experimental Group (Biological)
Control Group
The control group is also called the Non-combined immunization group.260 participants 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.
Intervention: Experimental Group (Biological)
Outcomes
Primary Outcomes
Immunogenicity index-Seroconversion rate of the neutralizing antibody to live SARS-CoV-2
Time Frame: Day 28 after the second dose of COVID-19 vaccine
Seroconversion rate of the neutralizing antibody to live SARS-CoV-2 at day 28 after the second dose of COVID-19 vaccine
Immunogenicity index-Seroconversion rate of the neutralizing antibody to EV71
Time Frame: Day 28 after the second dose of EV71 vaccine
Seroconversion rate of the neutralizing antibody to EV71 at day 28 after the second dose of EV71 vaccine
Secondary Outcomes
- Immunogenicity index-GMI of the neutralizing antibody to live SARS-CoV-2(Day 28 after the second dose of COVID-19 vaccine)
- Safety index-Incidence of the serious adverse events and the adverse events of special concern(From the beginning vaccination to 6 months after the last dose)
- Immunogenicity index-GMI of the neutralizing antibody to EV71(Day 28 after the second dose of EV71)
- Immunogenicity index-GMT of the neutralizing antibody to EV71(Day 28 after the second dose of EV71)
- Immunogenicity index-Seropositivity rate of the neutralizing antibody to live SARS-CoV-2(Day 28 after the second dose of COVID-19 vaccine)
- Immunogenicity index- GMT of the neutralizing antibody to live SARS-CoV-2(Day 28 after the second dose of COVID-19 vaccine)
- Immunogenicity index-Seropositive rate of the neutralizing antibody to EV71(Day 28 after the second dose of EV71)
- Safety index-Incidence of the adverse reactions(From day 0 to 28 days after the last dose)
- Safety index-Incidence of the adverse reactions(From day 0 to day 7 after each dose)