Ignite Creation Date:
2025-12-24 @ 2:31 PM
Ignite Modification Date:
2025-12-25 @ 7:23 PM
Study NCT ID:
NCT04363359
Status:
COMPLETED
Last Update Posted:
2023-12-26
First Post:
2020-04-17
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Clinical Trial of Quadrivalent Influenza Virus Split 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': '2020-01-01', 'size': 363278, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2020-04-22T02:33', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 1980}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-01-15', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-12', 'completionDateStruct': {'date': '2021-09-14', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-12-21', 'studyFirstSubmitDate': '2020-04-17', 'studyFirstSubmitQcDate': '2020-04-22', 'lastUpdatePostDateStruct': {'date': '2023-12-26', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-04-27', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-09-14', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'seroconversion rate of HI antibodies', 'timeFrame': '56 days', 'description': '28 days after receiving two doses of vaccine in subjects aged 6-35 months, seroconversion rate of HI antibodies against any subtype of influenza virus in each group.'}, {'measure': 'seroprotection rate of HI antibodies', 'timeFrame': '56 days', 'description': '28 days after receiving two doses of vaccine in subjects aged 6-35 months, seroprotection rate of HI antibodies against any subtype of influenza virus in each group.'}, {'measure': 'GMT and GMI of HI antibodies', 'timeFrame': '56 days', 'description': '28 days after receiving two doses of vaccine in subjects aged 6-35 months, GMT and GMI of HI antibodies against any subtype of influenza virus in each group.'}], 'secondaryOutcomes': [{'measure': 'Reactogenicity Events', 'timeFrame': '30 days and 6 months', 'description': '1. The proportion of all adverse reactions/events in each group through 30 days after the second dose.\n2. The proportion of serious adverse events (SAE) within 6 months after inoculation in each group.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Influenza']}, 'descriptionModule': {'briefSummary': 'To evaluate the immunogenicity and safety of 2 doses of quadrivalent influenza virus split vaccine in healthy population aged 6-35 month., so as to provide a data support for phase III clinical trials.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '35 Months', 'minimumAge': '6 Months', 'genderBased': True, 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Healthy infants aged 6-35 months.\n* Volunteer legal guardian or client informed consent, voluntarily participate in and sign informed consent.\n* The volunteer legal guardian or client has the ability (non-illiterate) to understand the study procedures, to use a thermometer, scale, and fill in a diary card as required, and be able to complete the clinical study in compliance with the clinical trial protocol.\n\nExclusion Criteria:\n\n* The underarm body temperature on the day of enrollment was \\> 37.0℃.\n* Have been suffering from influenza within the previous 3 months (confirmed by either clinical, serological or microbiological methods).\n* Any previous influenza vaccination (registered or experimental) within 6 months or any planned influenza vaccination during the study period.\n* Allergic to any component of the vaccine, a history of allergic reactions to eggs or gentamicin sulfate.\n* A history of severe allergy to any vaccine or drug.\n* Preterm birth (delivered before 37 weeks of gestation), low birth weight baby (birth weight \\< 2300g for girls, \\<2500g for boys).\n* Dystocia, asphyxia rescue, nervous system damage history;\n* Congenital malformations or developmental disorders, genetic defects, severe malnutrition, etc.\n* Acute illness, severe chronic illness or acute attack of chronic disease on the day of vaccination;\n* A history of live attenuated vaccination within 14 days prior to vaccination and a history of other vaccinations within 7 days prior to vaccination;\n* Patients who received immunoenhancement or inhibitor therapy within 3 months (continued oral or intravenous administration for more than 14 days);\n* Congenital or acquired immune deficiency, HIV infection, lymphoma, leukemia or other autoimmune diseases;\n* History of asthma, past two years of instability requiring emergency treatment, hospitalization, intubation, oral or intravenous administration of corticosteroids;\n* Have received blood or blood-related products;\n* A history of convulsion, epilepsy, encephalopathy, guillain-barre syndrome, a history of mental illness or a family history;\n* A history of abnormal coagulation function (such as coagulation factor deficiency, coagulation disease);\n* Planning to relocate before the end of the study or to leave for an extended -period during the scheduled study visit;\n* Participating in or planning to participate in other clinical trials in the near future;\n* The investigators determined that any conditions were inappropriate to participate in the clinical trial.'}, 'identificationModule': {'nctId': 'NCT04363359', 'briefTitle': 'Clinical Trial of Quadrivalent Influenza Virus Split Vaccine', 'organization': {'class': 'INDUSTRY', 'fullName': 'Shanghai Institute Of Biological Products'}, 'officialTitle': 'Immunogenicity and Safety of Quadrivalent Influenza Vaccine In 6 to 35 Months Population: a Randomized, Double-blind, Parallel-group Ⅱ Phase of Clinical Trials', 'orgStudyIdInfo': {'id': 'CXSL1900048-Ⅰ+Ⅱ'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Quadrivalent influenza vaccine HD', 'description': 'Participants randomized to receive two injections of 0.5 mL quadrivalent influenza vaccine at Day 0 and 28.', 'interventionNames': ['Biological: 0.5ml Quadrivalent influenza vaccine']}, {'type': 'EXPERIMENTAL', 'label': 'Quadrivalent influenza vaccine LD', 'description': 'Participants randomized to receive two injections of 0.25 mL quadrivalent influenza vaccine at Day 0 and 28.', 'interventionNames': ['Biological: 0.25ml Quadrivalent influenza vaccine']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Trivalent influenza vaccine Victoria', 'description': 'Participants randomized to receive two injections of 0.25 mL trivalent influenza vaccine containing B/Victoria strain at Day 0 and 28.', 'interventionNames': ['Biological: 0.25ml Trivalent influenza vaccine(B/V)']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Trivalent influenza vaccine Yamagata', 'description': 'Participants randomized to receive two injections of 0.25 mL trivalent influenza vaccine containing B/Yamagata strain at Day 0 and 28.', 'interventionNames': ['Biological: 0.25ml Trivalent influenza vaccine(B/Y)']}], 'interventions': [{'name': '0.5ml Quadrivalent influenza vaccine', 'type': 'BIOLOGICAL', 'description': 'The inactivated split virion vaccines contained 15 μg of each hemagglutinin antigen of influenza A/H1N1, A/H3N2, B/Victoria and B/Yamagata strains', 'armGroupLabels': ['Quadrivalent influenza vaccine HD']}, {'name': '0.25ml Quadrivalent influenza vaccine', 'type': 'BIOLOGICAL', 'description': 'The inactivated split virion vaccines contained 7.5 μg of each hemagglutinin antigen of influenza A/H1N1, A/H3N2, B/Victoria and B/Yamagata strains', 'armGroupLabels': ['Quadrivalent influenza vaccine LD']}, {'name': '0.25ml Trivalent influenza vaccine(B/V)', 'type': 'BIOLOGICAL', 'description': 'The inactivated split virion vaccines contained 7.5 μg of each hemagglutinin antigen of influenza A/H1N1, A/H3N2 and B/Victoria strains', 'armGroupLabels': ['Trivalent influenza vaccine Victoria']}, {'name': '0.25ml Trivalent influenza vaccine(B/Y)', 'type': 'BIOLOGICAL', 'description': 'The inactivated split virion vaccines contained 7.5 μg of each hemagglutinin antigen of influenza A/H1N1, A/H3N2 and B/Yamagata strains', 'armGroupLabels': ['Trivalent influenza vaccine Yamagata']}]}, 'contactsLocationsModule': {'locations': [{'zip': '450016', 'city': 'Shangqiu', 'state': 'Henan', 'country': 'China', 'facility': 'Henan Provincial Center for Disease Control and Prevention', 'geoPoint': {'lat': 34.45, 'lon': 115.65}}], 'overallOfficials': [{'name': 'Shilei Wang, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Shanghai Institute Of Biological Products'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Shanghai Institute Of Biological Products', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}