Ignite Creation Date:
2025-12-26 @ 10:19 PM
Ignite Modification Date:
2026-03-01 @ 5:48 AM
Study NCT ID:
NCT00538512
Status:
COMPLETED
Last Update Posted:
2017-12-06
First Post:
2007-10-01
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Comparative Study of Influenza Vaccines in Adults, FLUVACS-year 4
Sponsor:
Organization:
Raw JSON
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Monto, MD', 'organization': 'University of Michigan School of Public Health'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'timeFrame': '6 months', 'eventGroups': [{'id': 'EG000', 'title': 'Fluzone - Trivalent Inactivated Influenza Vaccine', 'description': 'the trivalent inactivated influenza vaccine - Fluzone, manufactured by Sanofi-Pasteur', 'otherNumAtRisk': 814, 'otherNumAffected': 0, 'seriousNumAtRisk': 814, 'seriousNumAffected': 8}, {'id': 'EG001', 'title': 'Flumist - Live-attenuated Influenza Vaccine', 'description': 'live-attenuated influenza vaccine Flumist, manufactured by MedImmune', 'otherNumAtRisk': 813, 'otherNumAffected': 0, 'seriousNumAtRisk': 813, 'seriousNumAffected': 4}, {'id': 'EG002', 'title': 'Placebo', 'description': 'Physiologic saline administered as a nasal spray or intramuscular injection', 'otherNumAtRisk': 325, 'otherNumAffected': 0, 'seriousNumAtRisk': 325, 'seriousNumAffected': 3}], 'seriousEvents': [{'term': 'Abdominal pain, vomiting, diarrhea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 814, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 813, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 325, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders'}, {'term': 'Anorexia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 814, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 813, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 325, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders'}, {'term': 'Appendicitis, appendectomy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 814, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 813, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 325, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders'}, {'term': 'Breast Cancer/Mastectomy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 814, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 813, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 325, 'numAffected': 0}], 'organSystem': 'Reproductive system and breast disorders'}, {'term': 'Cellulitis left leg', 'stats': [{'groupId': 'EG000', 'numAtRisk': 814, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 813, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 325, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders'}, {'term': 'Cervical cancer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 814, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 813, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 325, 'numAffected': 0}], 'organSystem': 'Reproductive system and breast disorders'}, {'term': 'Cholecystitis, cholecystectomy, cholelithiasis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 814, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 813, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 325, 'numAffected': 2}], 'organSystem': 'Hepatobiliary disorders'}, {'term': 'Depression/anxiety', 'stats': [{'groupId': 'EG000', 'numAtRisk': 814, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 813, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 325, 'numAffected': 1}], 'organSystem': 'Nervous system disorders'}, {'term': 'Head injury bike accident', 'stats': [{'groupId': 'EG000', 'numAtRisk': 814, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 813, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 325, 'numAffected': 0}], 'organSystem': 'Surgical and medical procedures'}, {'term': 'Mononucleosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 814, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 813, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 325, 'numAffected': 0}], 'organSystem': 'Infections and infestations'}, {'term': 'Pneumothorax', 'stats': [{'groupId': 'EG000', 'numAtRisk': 814, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 813, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 325, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders'}, {'term': 'surgical repair of torn ACL', 'stats': [{'groupId': 'EG000', 'numAtRisk': 814, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 813, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 325, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders'}, {'term': 'surgury - remove tumor in left ovary/fallopian tube', 'stats': [{'groupId': 'EG000', 'numAtRisk': 814, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 813, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 325, 'numAffected': 0}], 'organSystem': 'Reproductive system and breast disorders'}, {'term': 'Cholecystitis, cholecystectomy, cholelithiasis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 814, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 813, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 325, 'numAffected': 0}], 'organSystem': 'Hepatobiliary disorders'}, {'term': 'Appendectomy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 814, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 813, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 325, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Laboratory-confirmed (Culture and/or PCR) Symptomatic Influenza', 'denoms': [{'units': 'Participants', 'counts': [{'value': '814', 'groupId': 'OG000'}, {'value': '813', 'groupId': 'OG001'}, {'value': '325', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Fluzone - 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2007-2008'}], 'secondaryOutcomes': [{'measure': 'Measure Immune Response Induced by the Vaccines and Identify Serologic Correlates of Immune Protection', 'timeFrame': 'Time between prevaccination visit and postvaccination visit; typically about 30 days.', 'description': 'Measure immune response induced by the vaccines. Response was defined as greater than or equal to 4 fold rise in antibody titers measured by hemagglutination inhibition (HAI), microneutralization (MN), or neuraminidase inhibition (NAI) assays between sera collected at the prevaccination visit and those collected at the postvaccination visit.'}, {'measure': 'Immune Response to Vaccination and Infection', 'timeFrame': 'Postvaccination to postseason visit; typically about 3 months.', 'description': 'Response was defined as greater than or equal to 4 fold rise in antibody titers measured by hemagglutination inhibition (HAI), microneutralization (MN), or neuraminidase inhibition (NAI) assays between sera collected at the postvaccination visit and those collected at the postseason visit.'}, {'measure': 'Identify Serologic Correlates of Immune Protection. Suggest Changing to: Number of Participants Demonstrating Postvaccination Seroconversion.', 'timeFrame': 'Time between prevaccination and postvaccination, typically about 30 days.', 'description': 'Identify serologic correlates of immune protection. Seroconversion is defined as either prevaccination titer of less than 8 and postvaccination titer of greater than or equal to 32 or prevaccination titer of greater than or equal to 8 and greater than or equal to 4 fold rise in strain specific hemagglutination-inhibition (HAI) antibody titer between prevaccination and postvaccination sera. Data is shown separately for cases (subjects with symptomatic influenza A laboratory confirmed by isolation in cell culture or identification in real-time polymerase chain reaction (PCR) assay) and non-cases (subjects without cell culture, real time PCR or serologic evidence of influenza infection).'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Influenza', 'Live attenuated influenza vaccine', 'Inactivated influenza vaccine', 'Vaccine Efficacy'], 'conditions': ['Influenza']}, 'referencesModule': {'references': [{'pmid': '17167134', 'type': 'BACKGROUND', 'citation': 'Ohmit SE, Victor JC, Rotthoff JR, Teich ER, Truscon RK, Baum LL, Rangarajan B, Newton DW, Boulton ML, Monto AS. Prevention of antigenically drifted influenza by inactivated and live attenuated vaccines. N Engl J Med. 2006 Dec 14;355(24):2513-22. doi: 10.1056/NEJMoa061850.'}, {'pmid': '19776407', 'type': 'RESULT', 'citation': 'Monto AS, Ohmit SE, Petrie JG, Johnson E, Truscon R, Teich E, Rotthoff J, Boulton M, Victor JC. Comparative efficacy of inactivated and live attenuated influenza vaccines. N Engl J Med. 2009 Sep 24;361(13):1260-7. doi: 10.1056/NEJMoa0808652.'}, {'pmid': '25858957', 'type': 'RESULT', 'citation': 'Monto AS, Petrie JG, Cross RT, Johnson E, Liu M, Zhong W, Levine M, Katz JM, Ohmit SE. Antibody to Influenza Virus Neuraminidase: An Independent Correlate of Protection. J Infect Dis. 2015 Oct 15;212(8):1191-9. doi: 10.1093/infdis/jiv195. Epub 2015 Apr 8.'}, {'pmid': '21998477', 'type': 'RESULT', 'citation': 'Ohmit SE, Petrie JG, Cross RT, Johnson E, Monto AS. Influenza hemagglutination-inhibition antibody titer as a correlate of vaccine-induced protection. J Infect Dis. 2011 Dec 15;204(12):1879-85. doi: 10.1093/infdis/jir661. Epub 2011 Oct 12.'}, {'pmid': '31117986', 'type': 'DERIVED', 'citation': 'Gilbert PB, Fong Y, Juraska M, Carpp LN, Monto AS, Martin ET, Petrie JG. HAI and NAI titer correlates of inactivated and live attenuated influenza vaccine efficacy. BMC Infect Dis. 2019 May 22;19(1):453. doi: 10.1186/s12879-019-4049-5.'}, {'pmid': '21378375', 'type': 'DERIVED', 'citation': 'Petrie JG, Ohmit SE, Johnson E, Cross RT, Monto AS. Efficacy studies of influenza vaccines: effect of end points used and characteristics of vaccine failures. J Infect Dis. 2011 May 1;203(9):1309-15. doi: 10.1093/infdis/jir015. Epub 2011 Mar 4.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to evaluate the absolute (versus placebo) and relative (one vaccine compared to the other) efficacies of the live attenuated and inactivated influenza vaccines in preventing laboratory confirmed symptomatic influenza caused by circulating strains whether similar or dissimilar to strains included in the vaccines.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '49 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Healthy adult men and women\n* Age 18-49 years\n* Who reside geographically close to one of the four study sites in Michigan\n\nExclusion Criteria:\n\n* Persons with any of the health conditions for which the inactivated vaccine is recommended\n* Persons for whom either vaccine is contraindicated'}, 'identificationModule': {'nctId': 'NCT00538512', 'acronym': 'FLUVACS', 'briefTitle': 'Comparative Study of Influenza Vaccines in Adults, FLUVACS-year 4', 'organization': {'class': 'OTHER', 'fullName': 'University of Michigan'}, 'officialTitle': 'Comparative Study of Influenza Vaccines in Adults, FLUVACS-year 4', 'orgStudyIdInfo': {'id': 'FLUVACS'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'TIV', 'description': 'the trivalent inactivated influenza vaccine - Fluzone, manufactured by Sanofi-Pasteur', 'interventionNames': ['Biological: Fluzone']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'LAIV', 'description': 'live-attenuated influenza vaccine Flumist, manufactured by MedImmune', 'interventionNames': ['Biological: Flumist']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'Physiologic saline administered as a nasal spray or intramuscular injection', 'interventionNames': ['Other: Physiologic saline']}], 'interventions': [{'name': 'Fluzone', 'type': 'BIOLOGICAL', 'description': 'single dose licensed trivalent inactivated influenza vaccine (2007-08)', 'armGroupLabels': ['TIV']}, {'name': 'Flumist', 'type': 'BIOLOGICAL', 'description': 'single dose licensed live-attenuated influenza vaccine Flumist (2007-08)', 'armGroupLabels': ['LAIV']}, {'name': 'Physiologic saline', 'type': 'OTHER', 'description': 'single dose placebo administered as an intranasal spray or intramuscular injection', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '48109', 'city': 'Ann Arbor', 'state': 'Michigan', 'country': 'United States', 'facility': 'University of Michigan School of Public Heatlh', 'geoPoint': {'lat': 42.27756, 'lon': -83.74088}}, {'zip': '49008', 'city': 'Kalamazoo', 'state': 'Michigan', 'country': 'United States', 'facility': 'Western Michigan University Health Services', 'geoPoint': {'lat': 42.29171, 'lon': -85.58723}}, {'zip': '48859', 'city': 'Mount Pleasant', 'state': 'Michigan', 'country': 'United States', 'facility': 'Central Michigan University Health Services', 'geoPoint': {'lat': 43.59781, 'lon': -84.76751}}, {'zip': '48197', 'city': 'Ypsilanti', 'state': 'Michigan', 'country': 'United States', 'facility': 'Eastern Michigan University Health Services', 'geoPoint': {'lat': 42.24115, 'lon': -83.61299}}], 'overallOfficials': [{'name': 'Arnold S. Monto, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Michigan School of Public Health'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Michigan', 'class': 'OTHER'}, 'collaborators': [{'name': 'Sanofi Pasteur, a Sanofi Company', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Arnold S. Monto', 'investigatorAffiliation': 'University of Michigan'}}}}