Ignite Creation Date:
2025-12-24 @ 4:14 PM
Ignite Modification Date:
2025-12-26 @ 3:01 AM
Study NCT ID:
NCT05003466
Status:
UNKNOWN
Last Update Posted:
2021-08-18
First Post:
2021-08-10
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Study of Inactivated SARS-CoV-2 Vaccine (Vero Cells) in Healthy Population Aged 3 to 17 Years(COVID-19)
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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000086663', 'term': 'COVID-19 Vaccines'}], 'ancestors': [{'id': 'D014765', 'term': 'Viral Vaccines'}, {'id': 'D014612', 'term': 'Vaccines'}, {'id': 'D001688', 'term': 'Biological Products'}, {'id': 'D045424', 'term': 'Complex Mixtures'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 480}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2021-09', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-08', 'completionDateStruct': {'date': '2023-04', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2021-08-11', 'studyFirstSubmitDate': '2021-08-10', 'studyFirstSubmitQcDate': '2021-08-10', 'lastUpdatePostDateStruct': {'date': '2021-08-18', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-08-12', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-03', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Seroconversion rate of SARS-CoV-2 neutralizing antibody', 'timeFrame': '28 days post full primary immunization course'}, {'measure': 'Geometric mean titer of SARS-CoV-2 neutralizing antibody', 'timeFrame': '28 days post full primary immunization course'}], 'secondaryOutcomes': [{'measure': 'Incidence of adverse reactions/events', 'timeFrame': '0-28 days after each vaccination'}, {'measure': 'Serious Adverse Events (SAE)', 'timeFrame': 'within 12 months post full primary immunization course and the booster dose respectively'}, {'measure': 'Seroconversion rate of SARS-CoV-2 IgG binding antibody', 'timeFrame': '28 days post full primary immunization course'}, {'measure': 'Geometric mean titer of SARS-CoV-2 IgG binding antibody', 'timeFrame': '28 days, 3 months, 6 months and 12 months post full primary immunization course'}, {'measure': 'Geometric mean titer of SARS-CoV-2 IgG binding antibody', 'timeFrame': '28 days, 3 months, 6 months and 12 months after the booster dose'}, {'measure': 'Geometric mean titer of SARS-CoV-2 neutralizing antibody', 'timeFrame': '3 months, 6 months and 12 months post full primary immunization course'}, {'measure': 'Geometric mean titer of SARS-CoV-2 neutralizing antibody', 'timeFrame': '28 days, 3 months, 6 months and 12 months after the booster dose'}, {'measure': 'Seropositive rate of SARS-CoV-2 neutralizing antibody', 'timeFrame': '3 months, 6 months and 12 months post full primary immunization course'}, {'measure': 'Seropositive rate of SARS-CoV-2 neutralizing antibody', 'timeFrame': '28 days, 3 months, 6 months and 12 months after the booster dose'}, {'measure': 'Seropositive rate of SARS-CoV-2 IgG binding antibody', 'timeFrame': '3 months, 6 months and 12 months post full primary immunization course'}, {'measure': 'Seropositive rate of SARS-CoV-2 IgG binding antibody', 'timeFrame': '28 days, 3 months, 6 months and 12 months after the booster dose'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['COVID-19']}, 'descriptionModule': {'briefSummary': 'This study is a randomized, double-blinded, and placebo controlled phase Ⅱ clinical trial of the SARS-CoV-2 inactivated vaccine to evaluate the safety and immunogenicity of the experimental vaccine in healthy population aged 3 to 17 years.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '17 Years', 'minimumAge': '3 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Healthy residents aged 3 to 17 years at the time of consent\n* Subjects and/or their guardian agree to sign the informed consent forms voluntarily.\n* Be able to comply with study requirements/procedures.\n* Axillary temperature ≤ 37.0℃\n\nExclusion Criteria:\n\n* Within 14 days before vaccination, subjects have been abroad and to villages/communities experienced COVID-19 epidemics, and in contact with COVID-19 cases or suspected cases. Subjects are under isolation observation, or living in the villages/communities with COVID-19 cases or suspected cases;\n* Confirmed cases, suspected cases or asymptomatic cases with COVID-19 (refer to Information System of China Disease Prevention and Control);\n* Subjects with history of SARS virus infection by self-reported;\n* Positive in throat swab through RT-PCR;\n* History of vaccination of various COVID-19 vaccines or positive in SARS-CoV-2 antibody test;\n* Positive urine pregnancy test for females with menarche\n* History of severe allergic reactions (such as acute anaphylaxis, urticaria, skin eczema, dyspnea, angioneurotic edema or abdominal pain) or allergy to known composition of inactivated SARS-CoV-2 vaccine;\n* History or family history of convulsion, epilepsy, encephalopathy or mental illness;\n* Subjects with congenital malformations or developmental disorders, genetic defects, severe malnutrition, etc.;\n* Subjects with known or suspected diseases include: severe respiratory diseases, severe cardiovascular diseases, severe liver and kidney diseases, drug-uncontrollable hypertension, diabetic complications, malignant tumors, various acute diseases or acute onset of chronic diseases;\n* Diagnosed with congenital or acquired immunodeficiency, HIV infection, lymphoma, leukemia or other autoimmune diseases;\n* History of coagulation dysfunction (e.g. Coagulation factor deficiency, coagulation disease);\n* Subjects receiving anti-TB treatment;\n* Subjects receiving other research drugs within 6 months before vaccination;\n* Subjects receiving immunotherapy or inhibitor therapy within 3 months (consistently oral or infusion for more than 14 days);\n* Subjects receiving blood products within 3 months before administration;\n* Subjects vaccinated with live attenuated vaccine within 14 days before vaccination;\n* Subjects vaccinated with other vaccine within 7 days before vaccination;\n* The researchers shall judge the other conditions which might be not in compliance with the requirements of this clinical trial.'}, 'identificationModule': {'nctId': 'NCT05003466', 'briefTitle': 'Study of Inactivated SARS-CoV-2 Vaccine (Vero Cells) in Healthy Population Aged 3 to 17 Years(COVID-19)', 'organization': {'class': 'INDUSTRY', 'fullName': 'Shenzhen Kangtai Biological Products Co., LTD'}, 'officialTitle': 'A Randomized, Double-blind, Placebo-controlled Phase Ⅱ Clinical Study to Evaluate the Safety and Immunogenicity of Inactivated SARS-CoV-2 Vaccine (Vero Cells) in Healthy Population Aged 3 to 17 Years', 'orgStudyIdInfo': {'id': '2020L001-2B'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'candidate vaccine', 'interventionNames': ['Biological: SARS-CoV-2 Vaccine (Vero Cells), Inactivated']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'interventionNames': ['Biological: Placebo']}], 'interventions': [{'name': 'SARS-CoV-2 Vaccine (Vero Cells), Inactivated', 'type': 'BIOLOGICAL', 'description': '2 doses of SARS-CoV-2 Vaccine (Vero Cells), Inactivated with a 28-day interval constitute a primary immunization course. The third dose on 6 months after primary course is the booster dose.\n\nAdminister as an intramuscular injection into the lateral deltoid of the upper arm.', 'armGroupLabels': ['candidate vaccine']}, {'name': 'Placebo', 'type': 'BIOLOGICAL', 'description': '2 doses of Placebo should be administered as an intramuscular injection into the lateral deltoid of the upper arm with a 28-day interval.', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '410005', 'city': 'Changsha', 'state': 'Hunan', 'country': 'China', 'contacts': [{'name': 'Tao Huang', 'role': 'CONTACT', 'email': 'ymlc01@hncdc.com', 'phone': '+8673184305935'}], 'facility': 'Hunan Provincial Center for Diseases Control and Prevention', 'geoPoint': {'lat': 28.19874, 'lon': 112.97087}}], 'centralContacts': [{'name': 'Guifan Li, M.S', 'role': 'CONTACT', 'email': 'liguifan@biominhai.com', 'phone': '+861059613591'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Shenzhen Kangtai Biological Products Co., LTD', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'Beijing Minhai Biotechnology Co., Ltd', 'class': 'INDUSTRY'}, {'name': 'Hunan Provincial Center for Disease Control and Prevention', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}