Ignite Creation Date:
2025-12-25 @ 1:06 AM
Ignite Modification Date:
2026-01-06 @ 7:11 PM
Study NCT ID:
NCT03853993
Status:
COMPLETED
Last Update Posted:
2019-02-27
First Post:
2019-02-21
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Clinical Trial to Evaluate the Safety and Immunogenicity of Quadrivalent Influenza Vaccine (15µg/0.5ml)
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'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'The phase I clinical trial has single arm, and the phase III clinical trial has 3 parallel arms.'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 2380}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-01-23', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-02', 'completionDateStruct': {'date': '2018-10-08', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-02-25', 'studyFirstSubmitDate': '2019-02-21', 'studyFirstSubmitQcDate': '2019-02-21', 'lastUpdatePostDateStruct': {'date': '2019-02-27', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-02-26', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-08-17', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The lower limit of 95% confidence intervals (95%CI) of the ratio of geometric mean titer of hemagglutination inhibition (HI) antibody titer (experimental group/control group)≥2/3.', 'timeFrame': '28 days after the injection', 'description': 'Immunogenicity index, One of the standard to evaluate the experimental vaccine is non-inferior to the control vaccines'}, {'measure': 'The lower limit of 95% CI of the difference of HI antibody seroconversion rate (experimental group-control group)≥-10%', 'timeFrame': '28 days after the injection', 'description': 'Immunogenicity index, Another standard to evaluate the experimental vaccine is non-inferior to the control vaccines'}], 'secondaryOutcomes': [{'measure': 'The lower limit of 95%CI of the ratio of GMT(experimental group/control group)>1.5 .', 'timeFrame': '28 days after the injection', 'description': 'Immunogenicity index, One of the standard to evaluate the experimental vaccine is superior to the control vaccines for specific antigen type'}, {'measure': 'The lower limit of 95% CI of the difference of HI antibody seroconversion rate (experimental group-control group)>10%', 'timeFrame': '28 days after the injection', 'description': 'Immunogenicity index, Another standard to evaluate the experimental vaccine is superior to the control vaccines for specific antigen type'}, {'measure': 'The 95% CI lower limit of seroconversion rate of HI antibodies in the subjects aged 3-59 years≥40%', 'timeFrame': '28 days after the injection', 'description': 'Immunogenicity index'}, {'measure': 'The 95% CI lower limit of seroconversion rate of HI antibodies in the subjects aged over 60 years≥30%', 'timeFrame': '28 days after the injection', 'description': 'Immunogenicity index'}, {'measure': 'The seroprotective rate (HI antibody titer≥1:40) in the subjects aged 3-59 years ≥70%', 'timeFrame': '28 days after the injection', 'description': 'Immunogenicity index'}, {'measure': 'The seroprotective rate (HI antibody titer≥1:40) in the subjects aged over 60 years ≥60%', 'timeFrame': '28 days after the injection', 'description': 'Immunogenicity index'}, {'measure': 'The geometric mean increase (GMI) in the subjects aged 3-59 years >2.5', 'timeFrame': '28 days after the injection', 'description': 'Immunogenicity index'}, {'measure': 'The geometric mean increase (GMI) in the subjects aged over 60 years >2.0', 'timeFrame': '28 days after the injection', 'description': 'Immunogenicity index'}, {'measure': 'The lower limit of 95%CI of the ratio of GMT(experimental group/control group)≥2/3, in the subjects whose pre-immune HI antibody titer<1:40', 'timeFrame': '28 days after the injection', 'description': 'Immunogenicity index'}, {'measure': 'The lower limit of 95% CI of the difference of HI antibody seroconversion rate (experimental group-control group)≥-10%, in the subjects whose pre-immune HI antibody titer<1:40', 'timeFrame': '28 days after the injection', 'description': 'Immunogenicity index'}, {'measure': 'The incidence of the solicited local and general adverse reactions on day 0-7', 'timeFrame': '0-7 days after the injection', 'description': 'Safety index, The adverse reactions refers to the adverse events which considered related to the vaccination'}, {'measure': 'The incidence of the unsolicited adverse events on day 0-28', 'timeFrame': '0-28 days after the injection', 'description': 'Safety Index'}, {'measure': 'The incidence of the serious adverse events within 6 months after the injection', 'timeFrame': 'Within 6 months after the injection', 'description': 'Safety Index'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Influenza Vaccine', 'Quadrivalent', 'Trivalent'], 'conditions': ['Seasonal Influenza']}, 'referencesModule': {'references': [{'pmid': '32732142', 'type': 'DERIVED', 'citation': 'Chu K, Xu K, Tang R, Tian X, Hu J, Yang T, Li C, Hu Y, Zeng G. Immunogenicity and safety of an inactivated quadrivalent influenza vaccine: A randomized, double-blind, controlled phase III study in healthy population aged >/=3 years. Vaccine. 2020 Aug 18;38(37):5940-5946. doi: 10.1016/j.vaccine.2020.06.071. Epub 2020 Jul 27.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to evaluate the safety and immunogenicity of quadrivalent influenza vaccine in healthy subjects aged over 3 years', 'detailedDescription': 'This study is a phase I\\& III clinical trial. Phase I is open-labelled, and phase III is randomized, double-blind, active-controlled. The purpose of this study is to evaluate the safety and immunogenicity of the quadrivalent influenza vaccine (QIV) (experimental vaccine) manufactured by Sinovac Biotech Co., Ltd in subjects aged over 3 years. In phase I, 60 volunteers received single dose QIV (15µg/0.5ml). In phase III, 2320 volunteers were assigned to receive single dose QIV (15µg/0.5ml) or two commercial trivalent influenza vaccines (TIVs) (15µg/0.5ml) in a ratio of 2:1:1. The commercial TIVs were also manufactured by Sinovac Biotech Co., Ltd.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'minimumAge': '3 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Healthy volunteers aged ≥3 years;\n* Proven legal identity;\n* Participants or (and) guardians of the participants should be capable of understanding the written consent form, and such form should be signed prior to enrolment;\n\nExclusion Criteria:\n\n* Prior vaccination with influenza vaccine of the current year;\n* History of influenza within 6 months prior to study entry;\n* Axillary temperature \\> 37.0 °C;\n* History of allergy to any vaccine, or any ingredient of the experimental vaccine, especially eggs, egg albumin, etc.;\n* Serious adverse reaction(s) to vaccination, such as urticaria, dyspnea, angioneurotic edema, abdominal pain, etc.;\n* Severe/uncontrollable nervous system disease (epilepsy, seizures or convulsions) or mental illness;\n* Autoimmune disease or immunodeficiency/immunosuppressive, or any immunosuppressant receipt within 6 months prior to the study entry;\n* History of asthma, thyroidectomy, angioedema, diabetes or malignancy;\n* No spleen, or functional no spleen, or splenectomy.'}, 'identificationModule': {'nctId': 'NCT03853993', 'briefTitle': 'Clinical Trial to Evaluate the Safety and Immunogenicity of Quadrivalent Influenza Vaccine (15µg/0.5ml)', 'organization': {'class': 'INDUSTRY', 'fullName': 'Sinovac Biotech Co., Ltd'}, 'officialTitle': 'Open Phase I and Randomized, Double-blind, Controlled Phase III Clinical Trial to Evaluate the Safety and Immunogenicity of Quadrivalent Influenza Vaccine in Healthy Subjects Aged Over 3 Years.', 'orgStudyIdInfo': {'id': 'PRO-QINF-3001'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Experimental group-phase I', 'description': 'Quadrivalent influenza vaccine', 'interventionNames': ['Biological: Quadrivalent influenza vaccine']}, {'type': 'EXPERIMENTAL', 'label': 'Experimental group-phase III', 'description': 'Quadrivalent influenza vaccine', 'interventionNames': ['Biological: Quadrivalent influenza vaccine']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Control group-1-phase III', 'description': 'Trivalent influenza vaccine (contains B/Victoria strain)', 'interventionNames': ['Biological: Trivalent influenza vaccine (contains B/Victoria strain)']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Control group-2-phase III', 'description': 'Trivalent influenza vaccine (contains B/Yamagata strain)', 'interventionNames': ['Biological: Trivalent influenza vaccine (contains B/Yamagata strain)']}], 'interventions': [{'name': 'Quadrivalent influenza vaccine', 'type': 'BIOLOGICAL', 'description': 'Received single dose QIV (15µg/0.5ml)', 'armGroupLabels': ['Experimental group-phase I', 'Experimental group-phase III']}, {'name': 'Trivalent influenza vaccine (contains B/Victoria strain)', 'type': 'BIOLOGICAL', 'description': 'Received single dose TIV which contains B/Victoria strain (15µg/0.5ml)', 'armGroupLabels': ['Control group-1-phase III']}, {'name': 'Trivalent influenza vaccine (contains B/Yamagata strain)', 'type': 'BIOLOGICAL', 'description': 'Received single dose TIV which contains B/Yamagata strain (15µg/0.5ml)', 'armGroupLabels': ['Control group-2-phase III']}]}, 'contactsLocationsModule': {'locations': [{'zip': '222200', 'city': 'Lianyungang', 'state': 'Jiangsu', 'country': 'China', 'facility': 'Guanyun Center for Disease Control and Prevention', 'geoPoint': {'lat': 34.59845, 'lon': 119.21556}}, {'zip': '221300', 'city': 'Pizhou', 'state': 'Jiangsu', 'country': 'China', 'facility': 'Pizhou Center for Disease Control and Prevention', 'geoPoint': {'lat': 34.31139, 'lon': 117.95028}}], 'overallOfficials': [{'name': 'Yuemei Hu, Bachelor', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Jiangsu Province Center for Disease Control and Prevention'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Sinovac Biotech Co., Ltd', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}