Immunogenicity And Safety of COVID-19 Vaccine , Inactivated Co -Administration With EV71 Vaccine (Vero Cell)
Study Details
Study Description
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
Condition or Disease | Intervention/Treatment | Phase |
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Phase 4 |
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.
Study Design
Arms and Interventions
Arm | Intervention/Treatment |
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Experimental: 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. |
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 Names:
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Active Comparator: 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. |
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 Names:
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Outcome Measures
Primary Outcome Measures
- Immunogenicity index-Seroconversion rate of the neutralizing antibody to live SARS-CoV-2 [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 [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 Outcome Measures
- Immunogenicity index-Seropositivity rate of the neutralizing antibody to live SARS-CoV-2 [Day 28 after the second dose of COVID-19 vaccine]
Seropositivity rate of the neutralizing antibody to live SARS-CoV-2 at 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]
GMT of the neutralizing antibody to live SARS-CoV-2 at day 28 after after the second dose of COVID-19 vaccine.
- Immunogenicity index-GMI of the neutralizing antibody to live SARS-CoV-2 [Day 28 after the second dose of COVID-19 vaccine]
GMI of the neutralizing antibody to live SARS-CoV-2 at day 28 after 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]
Seropositive rate of the neutralizing antibody to EV71 at 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]
GMT of the neutralizing antibody to EV71 at day 28 after the second dose of EV71
- Immunogenicity index-GMI of the neutralizing antibody to EV71 [Day 28 after the second dose of EV71]
GMI of the neutralizing antibody to EV71 at day 28 after the second dose of EV71
- Safety index-Incidence of the adverse reactions [From day 0 to day 7 after each dose]
Incidence of the adverse reactions from day 0 to day 7 after each dose
- Safety index-Incidence of the adverse reactions [From day 0 to 28 days after the last dose]
Incidence of the adverse reactions from day 0 to 28 days after the last dose
- Safety index-Incidence of the serious adverse events and the adverse events of special interest [From the beginning vaccination to 6 months after the last dose]
Incidence of the serious adverse events and the adverse events of special interest from the beginning vaccination to 6 months after the last dose
Other Outcome Measures
- Immunogenicity index-Seropositive rate of the neutralizing antibody to live SARS-CoV-2 [6 months after the second dose of COVID-19 vaccine]
Seropositive rate and GMT of the neutralizing antibody to live SARS-CoV-2 6 months after the second dose of COVID-19 vaccine
- Immunogenicity index- GMT of the neutralizing antibody to live SARS-CoV-2 [6 months after the second dose of COVID-19 vaccine]
GMT of the neutralizing antibody to live SARS-CoV-2 6 months after the second dose of COVID-19 vaccine
- Immunogenicity index-Seropositive rate of the neutralizing antibody to EV71 [6 months after the second dose of EV71 vaccine]
Seropositive rate of the neutralizing antibody to EV71 6 months after the second dose of EV71 vaccine
- Immunogenicity index-GMT of the neutralizing antibody to EV71 [6 months after the second dose of EV71 vaccine]
GMT of the neutralizing antibody to EV71 6 months after the second dose of EV71 vaccine.
Eligibility Criteria
Criteria
Inclusion Criteria:
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Children aged 3-5 years ;
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The subject and/or guardian can understand and voluntarily sign the informed consent form
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Proven legal identity;
Exclusion Criteria:
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History of contact with a SARS-CoV-2 infection (positive in nucleic acid test) within 14 days;
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History of multiple system inflammatory syndrome (MIS-C);
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History of hand, foot and mouth disease, herpetic angina or EV71 vaccination;
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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;
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Congenital malformations or developmental disorders, genetic defects,severe malnutrition, etc.;
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Autoimmune disease (Systemic lupus erythematosus)or immunodeficiency / immunosuppression(HIV,history after organ transplantation);
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Severe chronic diseases, severe cardiovascular diseases, hypertension and diabetes that cannot be controlled by drugs, liver or kidney diseases,malignant tumors, etc.;
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Severe neurological disease (epilepsy, convulsions or convulsions) or mental illness;
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Thyroid disease or history of thyroidectomy, asplenia,functional asplenia, asplenia or splenectomy resulting from any condition;
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Diagnosed abnormal blood coagulation function (eg, lack of blood coagulation factors, blood coagulopathy,abnormal platelets) or obvious bruising or blood coagulation;
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Immunosuppressive therapy, cytotoxic therapy, inhaled corticosteroids (excluding allergic rhinitis corticosteroid spray therapy, acute noncomplicated dermatitis superficial corticosteroid therapy) in the past 6 months;
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History of drug abuse;
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Receipt of blood products within in the past 3 months;
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Receipt of other investigational drugs in the past 30 days;
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Receipt of attenuated live vaccines in the past 14 days;
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Receipt of inactivated or subunit vaccines in the past 7 days;
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Severe neurological disease (epilepsy, convulsions or convulsions) or mental illness;
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Axillary temperature >37.0°C;
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The subjects participated in other clinical trials during the follow-up period, or will be planned within 3 months;
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According to the investigator's judgment, the subject has any other factors that are not suitable for participating in the clinical trial.
Contacts and Locations
Locations
Site | City | State | Country | Postal Code | |
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1 | Yangchun Center for Disease Control and Prevention | Yangchun | Guangdong | China | 529699 |
2 | Zhanjiang Center for Disease Control and Prevention | Zhanjiang | Guangdong | China | 524005 |
Sponsors and Collaborators
- Sinovac Research and Development Co., Ltd.
Investigators
- Principal Investigator: Zhuhang Huang, Master, Guangdong Center for Disease Prevention and Control
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- PRO-nCOV-4002