Ignite Creation Date:
2025-12-24 @ 6:35 PM
Ignite Modification Date:
2025-12-25 @ 4:05 PM
Study NCT ID:
NCT05107557
Status:
COMPLETED
Last Update Posted:
2022-08-11
First Post:
2021-11-02
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Immunogenicity And Safety of COVID-19 Vaccine , Inactivated Co -Administration With EV71 Vaccine (Vero Cell)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000086382', 'term': 'COVID-19'}], 'ancestors': [{'id': 'D011024', 'term': 'Pneumonia, Viral'}, {'id': 'D011014', 'term': 'Pneumonia'}, {'id': 'D012141', 'term': 'Respiratory Tract Infections'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D014777', 'term': 'Virus Diseases'}, {'id': 'D018352', 'term': 'Coronavirus Infections'}, {'id': 'D003333', 'term': 'Coronaviridae Infections'}, {'id': 'D030341', 'term': 'Nidovirales Infections'}, {'id': 'D012327', 'term': 'RNA Virus Infections'}, {'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 520}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2021-11-05', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-11', 'completionDateStruct': {'date': '2022-07-14', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-08-10', 'studyFirstSubmitDate': '2021-11-02', 'studyFirstSubmitQcDate': '2021-11-02', 'lastUpdatePostDateStruct': {'date': '2022-08-11', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-11-04', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-12-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'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', 'description': 'Seropositive rate and GMT of the neutralizing antibody to live SARS-CoV-2 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', 'description': 'GMT of the neutralizing antibody to live SARS-CoV-2 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', 'description': 'Seropositive rate of the neutralizing antibody to EV71 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', 'description': 'GMT of the neutralizing antibody to EV71 6 months after the second dose of EV71 vaccine.'}], 'primaryOutcomes': [{'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', 'description': 'Seroconversion rate of the neutralizing antibody to live SARS-CoV-2 at 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', 'description': 'Seroconversion rate of the neutralizing antibody to EV71 at day 28 after the second dose of EV71 vaccine'}], 'secondaryOutcomes': [{'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', 'description': 'Seropositivity rate of the neutralizing antibody to live SARS-CoV-2 at 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', 'description': 'GMT of the neutralizing antibody to live SARS-CoV-2 at day 28 after 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', 'description': 'GMI of the neutralizing antibody to live SARS-CoV-2 at day 28 after 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', 'description': 'Seropositive rate of the neutralizing antibody to EV71 at 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', 'description': 'GMT of the neutralizing antibody to EV71 at 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', 'description': 'GMI of the neutralizing antibody to EV71 at 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', 'description': 'Incidence of the adverse reactions 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', 'description': 'Incidence of the adverse reactions 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 concern', 'timeFrame': 'From the beginning vaccination to 6 months after the last dose', 'description': 'Incidence of the serious adverse events and the adverse events of special concern from the beginning vaccination to 6 months after the last dose'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['COVID-19']}, 'descriptionModule': {'briefSummary': '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', 'detailedDescription': '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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '5 Years', 'minimumAge': '3 Years', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Children aged 3-5 years;\n* The subject and/or guardian can understand and voluntarily sign the informed consent form;\n* Proven legal identity.\n\nExclusion Criteria:\n\n* History of contact with a SARS-CoV-2 infection (positive in nucleic acid test) within 14 days;\n* History of multiple system inflammatory syndrome (MIS-C);\n* History of hand, foot and mouth disease, herpetic angina or EV71 vaccination;\n* 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;\n* Congenital malformations or developmental disorders, genetic defects,severe malnutrition, etc.;\n* Autoimmune disease (Systemic lupus erythematosus)or immunodeficiency / immunosuppression(HIV,history after organ transplantation);\n* Severe chronic diseases, severe cardiovascular diseases, hypertension and diabetes that cannot be controlled by drugs, liver or kidney diseases,malignant tumors, etc.;\n* Severe neurological disease (epilepsy, convulsions or convulsions) or mental illness;\n* Thyroid disease or history of thyroidectomy, asplenia,functional asplenia, asplenia or splenectomy resulting from any condition;\n* Diagnosed abnormal blood coagulation function (eg, lack of blood coagulation factors, blood coagulopathy,abnormal platelets) or obvious bruising or blood coagulation;\n* Immunosuppressive therapy, cytotoxic therapy, inhaled corticosteroids (excluding allergic rhinitis corticosteroid spray therapy, acute noncomplicated dermatitis superficial corticosteroid therapy) in the past 6 months;\n* History of drug abuse;\n* Receipt of blood products within in the past 3 months;\n* Receipt of other investigational drugs in the past 30 days;\n* Receipt of attenuated live vaccines in the past 14 days;\n* Receipt of inactivated or subunit vaccines in the past 7 days;\n* Severe neurological disease (epilepsy, convulsions or convulsions) or mental illness;\n* Axillary temperature \\>37.0°C;\n* The subjects participated in other clinical trials during the follow-up period,or will be planned within 3 months;\n* According to the investigator's judgment, the subject has any other factors that are not suitable for participating in the clinical trial."}, 'identificationModule': {'nctId': 'NCT05107557', 'briefTitle': 'Immunogenicity And Safety of COVID-19 Vaccine , Inactivated Co -Administration With EV71 Vaccine (Vero Cell)', 'organization': {'class': 'INDUSTRY', 'fullName': 'Sinovac Biotech Co., Ltd'}, 'officialTitle': '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', 'orgStudyIdInfo': {'id': 'PRO-nCOV-4002-1'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Experimental Group', 'description': '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.', 'interventionNames': ['Biological: Experimental Group']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Control Group', 'description': '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.', 'interventionNames': ['Biological: Experimental Group']}], 'interventions': [{'name': 'Experimental Group', 'type': 'BIOLOGICAL', 'otherNames': ['Combined immunization group'], 'description': '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.', 'armGroupLabels': ['Control Group', 'Experimental Group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '529699', 'city': 'Yangchun', 'state': 'Guangdong', 'country': 'China', 'facility': 'Yangchun City Center for Disease Control and Prevention', 'geoPoint': {'lat': 22.16667, 'lon': 111.78333}}, {'zip': '524005', 'city': 'Zhenjiang', 'state': 'Guangdong', 'country': 'China', 'facility': 'Zhanjiang Center for Diseases Control and Prevention', 'geoPoint': {'lat': 21.86806, 'lon': 110.70556}}], 'overallOfficials': [{'name': 'Zhuhang Huang, Master', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Guangdong Center for Disease Prevention and Control'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Sinovac Biotech Co., Ltd', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}