Ignite Creation Date:
2025-12-24 @ 5:49 PM
Ignite Modification Date:
2026-01-08 @ 6:51 AM
Study NCT ID:
NCT01945268
Status:
COMPLETED
Last Update Posted:
2018-10-26
First Post:
2013-09-13
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Influenza Vaccine To Prevent Adverse Vascular Events:Pilot
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'removedCountries': ['Argentina', 'Brazil', 'Chile', 'China', 'Colombia', 'Egypt', 'India', 'Malaysia', 'Nigeria', 'Qatar', 'Saudi Arabia', 'South Africa', 'Sudan']}, 'conditionBrowseModule': {'meshes': [{'id': 'D006333', 'term': 'Heart Failure'}, {'id': 'D007251', 'term': 'Influenza, Human'}], 'ancestors': [{'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'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'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 107}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-04'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-10', 'completionDateStruct': {'date': '2015-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-10-25', 'studyFirstSubmitDate': '2013-09-13', 'studyFirstSubmitQcDate': '2013-09-13', 'lastUpdatePostDateStruct': {'date': '2018-10-26', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2013-09-18', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Feasibility', 'timeFrame': 'Six months', 'description': 'If no more than 5% of all recruited subjects crossed over from one study group to the other, and if there is at least 98% follow up.'}], 'secondaryOutcomes': [{'measure': 'Adverse cardiovascular event', 'timeFrame': 'Six months', 'description': 'The primary outcome will be a composite of cardiovascular death, non-fatal myocardial infarction, non-fatal stroke and hospitalizations for heart failure using standardized criteria.'}, {'measure': 'Cardiovascular death', 'timeFrame': 'Six months', 'description': 'CV death alone will be a secondary outcome.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['vascular, influenza, vaccine, heart failure'], 'conditions': ['Heart Failure']}, 'referencesModule': {'references': [{'type': 'BACKGROUND', 'citation': 'DataFax - Data Management Software for Clinical Trials. http://www.datafax.com/; accessed February 15, 2013.'}, {'pmid': '18539917', 'type': 'BACKGROUND', 'citation': 'Action to Control Cardiovascular Risk in Diabetes Study Group; Gerstein HC, Miller ME, Byington RP, Goff DC Jr, Bigger JT, Buse JB, Cushman WC, Genuth S, Ismail-Beigi F, Grimm RH Jr, Probstfield JL, Simons-Morton DG, Friedewald WT. 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Participants at high-risk for vascular events from the network of INTER- CHF will be randomized to inactivated influenza vaccine or placebo and followed prospectively over three influenza seasons. 600 participants will be enrolled prior to influenza season and randomized to either influenza vaccine or saline placebo.', 'detailedDescription': 'Cardiovascular disease is a major cause of morbidity and mortality. There is recent evidence that infection due to influenza may precipitate vascular events such as myocardial infarctions and strokes. There is some evidence that influenza vaccination may prevent such events but the data are inconclusive. The investigators propose a randomized controlled trial to assess whether influenza vaccination will prevent vascular illness. Adults with clinical heart failure will be randomized to inactivated influenza vaccine or saline placebo. This pilot study will provide needed data to establish the feasibility of a larger study.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age ≥ 18 years and NYHA functional class II, III and IV\n\nExclusion Criteria:\n\n* Anaphylactic reaction to a previous dose of TIV\n* Known IgE-mediated hypersensitivity to eggs manifested as hives, swelling of the mouth and throat, difficulty in breathing, hypotension, or shock\n* Guillain-Barré syndrome within eight weeks of a previous influenza vaccine\n* Anaphylactic reaction to neomycin\n* Patients who have had influenza vaccine in two of the three previous years'}, 'identificationModule': {'nctId': 'NCT01945268', 'acronym': 'IVVE:Pilot', 'briefTitle': 'Influenza Vaccine To Prevent Adverse Vascular Events:Pilot', 'organization': {'class': 'OTHER', 'fullName': 'McMaster University'}, 'officialTitle': 'A Randomized Controlled Trial of Influenza Vaccine to Prevent Adverse Vascular Events: A Pilot Study', 'orgStudyIdInfo': {'id': 'RCT IVVE Pilot'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'influenza vaccine', 'description': 'Participants at high risk for adverse vascular events will be immunized with 0.5 ml dose of inactivated trivalent influenza vaccine', 'interventionNames': ['Drug: inactivated trivalent influenza vaccine']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'placebo vaccination', 'description': 'Participants at high risk for adverse vascular events will be immunized with a 0.5 ml dose of sterile saline inactivated during the influenza season.', 'interventionNames': ['Other: Sterile saline']}], 'interventions': [{'name': 'inactivated trivalent influenza vaccine', 'type': 'DRUG', 'otherNames': ['VAXIGRIP vaccine'], 'description': '0.5 ml dose injected intramuscularly', 'armGroupLabels': ['influenza vaccine']}, {'name': 'Sterile saline', 'type': 'OTHER', 'description': '0.5 ml dose injected intramuscularly', 'armGroupLabels': ['placebo vaccination']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Maputo', 'country': 'Mozambique', 'facility': 'Maputo Central Hospital', 'geoPoint': {'lat': -25.96553, 'lon': 32.58322}}, {'city': 'Manila', 'state': 'Emita', 'country': 'Philippines', 'facility': 'University of Philippines', 'geoPoint': {'lat': 14.6042, 'lon': 120.9822}}, {'city': 'Kampala', 'country': 'Uganda', 'facility': 'Mulago Hospital', 'geoPoint': {'lat': 0.31628, 'lon': 32.58219}}], 'overallOfficials': [{'name': 'Mark Loeb, MD, MSc', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'McMaster University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'McMaster University', 'class': 'OTHER'}, 'collaborators': [{'name': 'Population Health Research Institute', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}