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Immunogenicity And Safety of COVID-19 Vaccine , Inactivated Co -Administration With EV71 Vaccine (Vero Cell)

Sponsor
Sinovac Biotech Co., Ltd (Industry)
Overall Status
Completed
CT.gov ID
NCT05107557
Collaborator
(none)
520
Enrollment
2
Locations
2
Arms
8.2
Actual Duration (Months)
260
Patients Per Site
31.5
Patients Per Site Per Month

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
  • Biological: Experimental Group
 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 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
Actual Enrollment :
520 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Prevention
Official Title:
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
Actual Study Start Date :
Nov 5, 2021
Actual Primary Completion Date :
Dec 5, 2021
Actual Study Completion Date :
Jul 14, 2022

Arms and Interventions

Arm Intervention/Treatment
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 0.5mL 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:
  • Combined immunization group

    		•
    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: 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 0.5mL 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:
  • Combined immunization group

    		•

    Outcome Measures

    Primary Outcome Measures

    1. 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

    2. 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

    1. 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.

    2. 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.

    3. 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.

    4. 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

    5. 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

    6. 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

    7. 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

    8. 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

    9. 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]

      Incidence of the serious adverse events and the adverse events of special concern from the beginning vaccination to 6 months after the last dose

    Other Outcome Measures

    1. 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

    2. 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

    3. 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

    4. 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

    Ages Eligible for Study:
    3 Years to 5 Years
    Sexes Eligible for Study:
    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.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Yangchun City Center for Disease Control and Prevention Yangchun Guangdong China 529699
    2 Zhanjiang Center for Diseases Control and Prevention Zhenjiang Guangdong China 524005

    Sponsors and Collaborators

    • Sinovac Biotech 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.
    Responsible Party:
    Sinovac Biotech Co., Ltd
    ClinicalTrials.gov Identifier:
    NCT05107557
    Other Study ID Numbers:
    • PRO-nCOV-4002-1
    First Posted:
    Nov 4, 2021
    Last Update Posted:
    Aug 11, 2022
    Last Verified:
    Nov 1, 2021
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    COVID-19

    Study Results

    No Results Posted as of Aug 11, 2022