Ignite Creation Date:
2025-12-24 @ 5:29 PM
Ignite Modification Date:
2026-02-24 @ 12:14 AM
Study NCT ID:
NCT01815268
Status:
UNKNOWN
Last Update Posted:
2018-07-16
First Post:
2013-03-11
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
High-Dose Influenza Vaccine in Nursing Homes
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'submissionInfos': [{'resetDate': '2019-07-31', 'releaseDate': '2019-07-10'}, {'resetDate': '2019-12-05', 'releaseDate': '2019-11-13'}, {'releaseDate': '2020-02-05', 'unreleaseDate': '2020-02-10'}, {'resetDate': '2020-03-05', 'releaseDate': '2020-02-10'}], 'estimatedResultsFirstSubmitDate': '2019-07-10'}}, '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': 'C000618615', 'term': 'Fluzone High-Dose'}, {'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': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 823}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2013-02'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-07', 'completionDateStruct': {'date': '2018-09', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2018-07-13', 'studyFirstSubmitDate': '2013-03-11', 'studyFirstSubmitQcDate': '2013-03-18', 'lastUpdatePostDateStruct': {'date': '2018-07-16', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2013-03-21', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2017-05-15', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Difference in hospitalization claims based on staff vaccination status', 'timeFrame': 'up to 1 year', 'description': 'Effect on clinical outcomes of nursing home residents based on staff vaccine uptake.'}], 'primaryOutcomes': [{'measure': 'Hospitalization rate', 'timeFrame': 'up to 1 year'}], 'secondaryOutcomes': [{'measure': 'Change in activities of daily living (ADL) scores', 'timeFrame': 'up to 1 year'}, {'measure': 'Facility-level mortality rate', 'timeFrame': 'up to 1 year'}, {'measure': 'Hospitalization rate based on vaccine type and influenza strain', 'timeFrame': 'Up to 3 years'}, {'measure': 'Cost difference between vaccine types', 'timeFrame': 'up to 3 years'}, {'measure': 'Effect of facility policies on staff vaccination rates', 'timeFrame': 'up to 3 years'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Randomized Controlled Trial', 'Influenza', 'Influenza vaccine', 'Flu Vaccine', 'Fluzone', 'HD Fluzone', 'Nursing Home', 'Hospitalization', 'Mortality', 'Health Care worker vaccination', 'ADL decline', 'Effectiveness', 'Elderly', 'Morbidity', 'Nursing Home resident', 'Frail', 'Institutionalized', 'Epidemiology', 'CDC', 'US', 'city'], 'conditions': ['Influenza']}, 'referencesModule': {'references': [{'pmid': '22724499', 'type': 'BACKGROUND', 'citation': 'Gozalo PL, Pop-Vicas A, Feng Z, Gravenstein S, Mor V. Effect of influenza on functional decline. J Am Geriatr Soc. 2012 Jul;60(7):1260-7. doi: 10.1111/j.1532-5415.2012.04048.x. Epub 2012 Jun 21.'}, {'pmid': '17625497', 'type': 'BACKGROUND', 'citation': 'Fiore AE, Shay DK, Haber P, Iskander JK, Uyeki TM, Mootrey G, Bresee JS, Cox NJ; Advisory Committee on Immunization Practices (ACIP), Centers for Disease Control and Prevention (CDC). Prevention and control of influenza. Recommendations of the Advisory Committee on Immunization Practices (ACIP), 2007. MMWR Recomm Rep. 2007 Jul 13;56(RR-6):1-54.'}, {'pmid': '25119609', 'type': 'BACKGROUND', 'citation': 'DiazGranados CA, Dunning AJ, Kimmel M, Kirby D, Treanor J, Collins A, Pollak R, Christoff J, Earl J, Landolfi V, Martin E, Gurunathan S, Nathan R, Greenberg DP, Tornieporth NG, Decker MD, Talbot HK. Efficacy of high-dose versus standard-dose influenza vaccine in older adults. N Engl J Med. 2014 Aug 14;371(7):635-45. doi: 10.1056/NEJMoa1315727.'}, {'pmid': '16717175', 'type': 'BACKGROUND', 'citation': 'Keitel WA, Atmar RL, Cate TR, Petersen NJ, Greenberg SB, Ruben F, Couch RB. Safety of high doses of influenza vaccine and effect on antibody responses in elderly persons. Arch Intern Med. 2006 May 22;166(10):1121-7. doi: 10.1001/archinte.166.10.1121.'}, {'pmid': '19508159', 'type': 'BACKGROUND', 'citation': 'Falsey AR, Treanor JJ, Tornieporth N, Capellan J, Gorse GJ. Randomized, double-blind controlled phase 3 trial comparing the immunogenicity of high-dose and standard-dose influenza vaccine in adults 65 years of age and older. J Infect Dis. 2009 Jul 15;200(2):172-80. doi: 10.1086/599790.'}, {'pmid': '28736045', 'type': 'DERIVED', 'citation': 'Gravenstein S, Davidson HE, Taljaard M, Ogarek J, Gozalo P, Han L, Mor V. Comparative effectiveness of high-dose versus standard-dose influenza vaccination on numbers of US nursing home residents admitted to hospital: a cluster-randomised trial. Lancet Respir Med. 2017 Sep;5(9):738-746. doi: 10.1016/S2213-2600(17)30235-7. Epub 2017 Jul 20.'}, {'pmid': '26908539', 'type': 'DERIVED', 'citation': 'Gravenstein S, Dahal R, Gozalo PL, Davidson HE, Han LF, Taljaard M, Mor V. A cluster randomized controlled trial comparing relative effectiveness of two licensed influenza vaccines in US nursing homes: Design and rationale. Clin Trials. 2016 Jun;13(3):264-74. doi: 10.1177/1740774515625976. Epub 2016 Feb 11.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to prospectively evaluate relative effectiveness of high dose influenza vaccine in preventing influenza mortality, hospitalization, and functional decline in a nursing home population in the U.S., compared to the standard dose trivalent seasonal influenza vaccine.', 'detailedDescription': 'SUMMARY: This nationally representative study samples from estimated 6782 Medicare-certified nursing homes co-located within 50 miles of the 122 cities reporting to Center for Disease Control and Prevention (CDC) weekly influenza surveillance. In total, 1000 facilities will be enrolled for random assignment to either: 1) the licensed high dose (HD) trivalent influenza vaccine (High-Dose Fluzone \\[HD vaccine\\]), or 2) the standard dose (SD) trivalent influenza vaccine (Fluzone \\[SD vaccine\\]) for their residents. Additionally, half the facilities will receive free SD vaccine for their staff and the remaining facilities will practice usual care (no free vaccine) for staff.\n\nBACKGROUND: Influenza and pneumonia (P\\&I) are leading infectious causes of hospitalization and mortality in community-dwelling older adults and residents of long-term custodial care facilities or nursing homes (NH), and produce substantial annual health care costs. The elderly incur over 90% of this disease burden and NH residents are especially vulnerable given immune senescence, multimorbidity, and close living quarters. While hospitalization rates for NH residents vary considerably between facilities, most occur during the sixteen weeks of peak influenza activity annually. Influenza vaccination, a mainstay in prevention, is recommended in the U.S. for all individuals six months of age and older. Vaccination associates with reduced rates of stroke, heart attack, hospitalization, and death in non-institutional older adult populations. However, the benefit of influenza vaccine for the elderly in general has been questioned, a salient concern for frail elderly, such as NH residents. Influenza vaccination rates vary substantially between nursing homes. Influenza vaccine response declines with advancing age, indicating the need for a better vaccine.\n\nOBJECTIVES: The primary objective is to estimate the differences in all-cause hospitalization rates during influenza season experienced by long-stay nursing home residents, between facilities using HD vaccine vs. SD vaccine. The secondary objective is to estimate the differences in the likelihood of Activities of Daily Living (ADL) functional decline and mortality rates in the study nursing homes.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['OLDER_ADULT'], 'minimumAge': '65 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Long-term care facilities within 50 miles of one of the 122 cities that serve as CDC surveillance sites\n\nExclusion Criteria:\n\n* Facilities already systematically administering HD vaccine to their residents\n* Facilities having fewer than 50 long-stay residents\n* Hospital-based facilities\n* Facilities with more than 20% of the population under age 65\n* Facilities not submitting Minimum Data Set (MDS) data'}, 'identificationModule': {'nctId': 'NCT01815268', 'briefTitle': 'High-Dose Influenza Vaccine in Nursing Homes', 'organization': {'class': 'OTHER', 'fullName': 'Insight Therapeutics, LLC'}, 'officialTitle': 'High Dose Influenza Vaccination and Morbidity & Mortality in U.S. Nursing Homes', 'orgStudyIdInfo': {'id': 'GRC75-EXT'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'HD Vaccine (Residents) + Free Vaccine (Staff)', 'description': 'NH facilities randomized to receive high-dose trivalent influenza vaccine (Fluzone High-Dose) for the residents and provided free SD vaccine (Fluzone) for the staff.', 'interventionNames': ['Biological: HD Vaccine', 'Biological: Free Vaccine']}, {'type': 'EXPERIMENTAL', 'label': 'HD Vaccine (Residents) + Usual Care (Staff)', 'description': 'NH facilities randomized to receive high-dose trivalent influenza vaccine (Fluzone High-Dose) for the residents and not provided free vaccine for the staff.', 'interventionNames': ['Biological: HD Vaccine', 'Biological: Usual Care']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'SD Vaccine (Residents) + Free Vaccine (Staff)', 'description': 'NH facilities randomized to receive standard dose influenza vaccine (Fluzone) for the residents and provided free standard dose vaccine (Fluzone) for the staff.', 'interventionNames': ['Biological: SD Vaccine', 'Biological: Free Vaccine']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'SD Vaccine (Residents) + Usual Care (Staff)', 'description': 'NH facilities randomized to receive standard dose influenza vaccine (Fluzone) for the residents and not provided free vaccine for the staff.', 'interventionNames': ['Biological: SD Vaccine', 'Biological: Usual Care']}], 'interventions': [{'name': 'HD Vaccine', 'type': 'BIOLOGICAL', 'otherNames': ['Fluzone High-Dose'], 'description': 'Nursing home residents over 65 years are allocated to receive high-dose vaccine. Residents under 65 years are provided standard-dose vaccine.', 'armGroupLabels': ['HD Vaccine (Residents) + Free Vaccine (Staff)', 'HD Vaccine (Residents) + Usual Care (Staff)']}, {'name': 'SD Vaccine', 'type': 'BIOLOGICAL', 'otherNames': ['Fluzone'], 'description': 'Nursing home residents are allocated to receive standard-dose vaccine.', 'armGroupLabels': ['SD Vaccine (Residents) + Free Vaccine (Staff)', 'SD Vaccine (Residents) + Usual Care (Staff)']}, {'name': 'Free Vaccine', 'type': 'BIOLOGICAL', 'otherNames': ['Fluzone'], 'description': 'Nursing home facilities are provided free standard-dose vaccine for their staff.', 'armGroupLabels': ['HD Vaccine (Residents) + Free Vaccine (Staff)', 'SD Vaccine (Residents) + Free Vaccine (Staff)']}, {'name': 'Usual Care', 'type': 'BIOLOGICAL', 'description': 'Nursing home staff will have access to influenza vaccine, per standard of care. No free vaccine provided as part of study.', 'armGroupLabels': ['HD Vaccine (Residents) + Usual Care (Staff)', 'SD Vaccine (Residents) + Usual Care (Staff)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '44106', 'city': 'Cleveland', 'state': 'Ohio', 'country': 'United States', 'facility': 'Case Western Reserve University', 'geoPoint': {'lat': 41.4995, 'lon': -81.69541}}, {'zip': '02912', 'city': 'Providence', 'state': 'Rhode Island', 'country': 'United States', 'facility': 'Brown University', 'geoPoint': {'lat': 41.82399, 'lon': -71.41283}}, {'zip': '23510', 'city': 'Norfolk', 'state': 'Virginia', 'country': 'United States', 'facility': 'Insight Therapeutics, LLC', 'geoPoint': {'lat': 36.84681, 'lon': -76.28522}}], 'overallOfficials': [{'name': 'Stefan Gravenstein, MD, MPH', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Case Western Reserve University'}, {'name': 'Vincent Mor, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Brown University'}, {'name': 'Ed Davidson, PharmD, MPH', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Insight Therapeutics, LLC'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Insight Therapeutics, LLC', 'class': 'OTHER'}, 'collaborators': [{'name': 'Brown University', 'class': 'OTHER'}, {'name': 'Case Western Reserve University', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}, 'annotationSection': {'annotationModule': {'unpostedAnnotation': {'unpostedEvents': [{'date': '2019-07-10', 'type': 'RELEASE'}, {'date': '2019-07-31', 'type': 'RESET'}, {'date': '2019-11-13', 'type': 'RELEASE'}, {'date': '2019-12-05', 'type': 'RESET'}, {'date': '2020-02-05', 'type': 'RELEASE'}, {'date': '2020-02-10', 'type': 'UNRELEASE'}, {'date': '2020-02-10', 'type': 'RELEASE'}, {'date': '2020-03-05', 'type': 'RESET'}], 'unpostedResponsibleParty': 'Insight Therapeutics, LLC'}}}}