Ignite Creation Date:
2025-12-24 @ 9:11 PM
Ignite Modification Date:
2026-03-09 @ 8:37 AM
Study NCT ID:
NCT03744104
Status:
COMPLETED
Last Update Posted:
2024-01-02
First Post:
2018-11-14
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Clinical Trial of A Quadrivalent Influenza Vaccine
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D007251', 'term': 'Influenza, Human'}], 'ancestors': [{'id': 'D012141', 'term': 'Respiratory Tract Infections'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D009976', 'term': 'Orthomyxoviridae Infections'}, {'id': 'D012327', 'term': 'RNA Virus Infections'}, {'id': 'D014777', 'term': 'Virus Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D007252', 'term': 'Influenza Vaccines'}], 'ancestors': [{'id': 'D014765', 'term': 'Viral Vaccines'}, {'id': 'D014612', 'term': 'Vaccines'}, {'id': 'D001688', 'term': 'Biological Products'}, {'id': 'D045424', 'term': 'Complex Mixtures'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2018-10-12', 'size': 475282, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2018-11-14T02:23', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 2688}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-10-11', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-12', 'completionDateStruct': {'date': '2019-10-08', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-12-22', 'studyFirstSubmitDate': '2018-11-14', 'studyFirstSubmitQcDate': '2018-11-15', 'lastUpdatePostDateStruct': {'date': '2024-01-02', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-11-16', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-10-08', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of participants that presented seroconversion post injection', 'timeFrame': '30 days after inoculation', 'description': '* Seroconvertion is defined as: prevaccination Hemagglutination-inhibition test (HI) antibody titer ≤1:10 and postvaccination HI antibody titer ≥1:40, or prevaccination HI antibody titer ≥1:10 and a postvaccination increase by a factor of four or more.\n* Participants will be collected blood post first study injection, when blood samples will be taken for HI testing'}, {'measure': 'Geometric mean of Hemagglutination-inhibition titre post first study injection', 'timeFrame': '30 days after inoculation', 'description': '* Geometric mean of Hemagglutination-inhibition test titre will be calculated for the different groups of participants post first study injection.\n* Participants will be collected blood post first study injection, when blood samples will be taken for HI testing.'}], 'secondaryOutcomes': [{'measure': 'Number of participants that presented seroprotection post injection', 'timeFrame': '30 days after inoculation', 'description': '* Seroprotection is defined as postvaccination Hemagglutination-inhibition test (HI) antibody titer ≥ 1:40.\n* Participants will be collected blood post first study injection, when blood samples will be taken for HI testing'}, {'measure': 'Number of Subjects Reporting Solicited and Unsolicited Adverse Events (AEs)', 'timeFrame': 'Continuous observation for 30 days after two inoculations', 'description': '* For each group the incidence rate of subjects with solicited AE(s) with 95% confidence interval\n* For each group the incidence rate of subjects with unsolicited AE(s) with 95% confidence interval'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Influenza']}, 'descriptionModule': {'briefSummary': 'The aim of this study is to assess the immunogenicity and safety of a quadrivalent influenza vaccine compared with a trivalent influenza vaccine in participants aged above 3 years.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'minimumAge': '3 Years', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Over the age of three years,healthy population\n* Subjects/ (and the guardian) informed consent, voluntarily participated and signed the informed consent form, with the ability to use thermometers, scales and to fill in diary cards as required\n* To comply with the requirements of clinical trial program\n* Temperature≤37.0℃ on day of enrollment\n\nExclusion Criteria:\n\n* A history of influenza virus infection or suspected infection Abnormal blood routine, blood biochemistry and urine routine examination indexes in last three months\n* Any prior administration of influenza vaccine in last six months\n* Allergy to any component in the vaccine, especially for egg allergy\n* Allergy history of any previous vaccination or drug\n* Acute episodes of chronic illness or acute illness on the day of vaccination\n* Received a live vaccine within fourteen days prior to receiving the vaccine, or received a subunit or inactivated vaccine within seven days\n* Congenital or acquired immune deficiencies, or treatment with immunosuppressive agents, such as long-term treatment with systemic corticosteroids\n* Suffering from severe chronic diseases (such as Down's syndrome, diabetes, sicklemia or neurological disorders, Green's Barre syndrome)\n* Asthma, required urgent treatment in last two years\n* The blood products were received prior to the acceptance of the vaccine\n* Known or suspected of respiratory disease, acute infection or chronic disease active period, HIV infection, cardiovascular disease, severe hypertension, malignant tumor during treatment, skin diseases\n* History of epilepsy, convulsions, or a family history of psychosis\n* Abnormal coagulation function (such as coagulation factor deficiency, coagulation disorders, platelet abnormalities), or obvious bruising or coagulopathy\n* Plan to move or leave the area for an extended period of time before the end of the study\n* Under anti-tb treatment\n* Any prior administration of other research medicine/vaccine in last one month\n* Women are pregnant or in the near future planned pregnancy or pregnancy test positive"}, 'identificationModule': {'nctId': 'NCT03744104', 'briefTitle': 'A Clinical Trial of A Quadrivalent Influenza Vaccine', 'organization': {'class': 'INDUSTRY', 'fullName': 'Shanghai Institute Of Biological Products'}, 'officialTitle': 'Immunogenicity and Safety of a Quadrivalent Influenza Vaccine in Participants Aged Above 3 Years', 'orgStudyIdInfo': {'id': 'JSVCT060'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Quadrivalent influenza vaccine', 'description': 'Quadrivalent influenza vaccine(containing 2 subtypes of B lineage)', 'interventionNames': ['Biological: Quadrivalent influenza vaccine']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Trivalent influenza vaccine A', 'description': 'Trivalent influenza vaccine (containing B/Victoria lineage)', 'interventionNames': ['Biological: Trivalent influenza vaccine A']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Trivalent influenza vaccine B', 'description': 'Trivalent influenza vaccine (containing B/Yamagata lineage)', 'interventionNames': ['Biological: Trivalent influenza vaccine B']}], 'interventions': [{'name': 'Quadrivalent influenza vaccine', 'type': 'BIOLOGICAL', 'description': '0.5 mL, intramuscular, one dose', 'armGroupLabels': ['Quadrivalent influenza vaccine']}, {'name': 'Trivalent influenza vaccine A', 'type': 'BIOLOGICAL', 'description': '0.5 mL, intramuscular, one dose', 'armGroupLabels': ['Trivalent influenza vaccine A']}, {'name': 'Trivalent influenza vaccine B', 'type': 'BIOLOGICAL', 'description': '0.5 mL, intramuscular, one dose', 'armGroupLabels': ['Trivalent influenza vaccine B']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Xuzhou', 'state': 'Jiangsu', 'country': 'China', 'facility': 'Suining County Center for Disease Control and Prevention', 'geoPoint': {'lat': 34.20442, 'lon': 117.28386}}, {'city': 'Xuzhou', 'state': 'Jiangsu', 'country': 'China', 'facility': 'Xinyi County Center for Disease Control and Prevention', 'geoPoint': {'lat': 34.20442, 'lon': 117.28386}}], 'overallOfficials': [{'name': 'Hu Yuemei, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Jiangsu Province Centers for Disease Control and Prevention'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Shanghai Institute Of Biological Products', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}