Ignite Creation Date:
2025-12-24 @ 10:37 PM
Ignite Modification Date:
2025-12-28 @ 7:17 AM
Study NCT ID:
NCT01520935
Status:
COMPLETED
Last Update Posted:
2012-09-10
First Post:
2012-01-23
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Influenza Burden Assessment in the United Kingdom, 1996-2008
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': 'D003625', 'term': 'Data Collection'}], 'ancestors': [{'id': 'D004812', 'term': 'Epidemiologic Methods'}, {'id': 'D008919', 'term': 'Investigative Techniques'}, {'id': 'D017531', 'term': 'Health Care Evaluation Mechanisms'}, {'id': 'D011787', 'term': 'Quality of Health Care'}, {'id': 'D017530', 'term': 'Health Care Quality, Access, and Evaluation'}, {'id': 'D011634', 'term': 'Public Health'}, {'id': 'D004778', 'term': 'Environment and Public Health'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 1}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2011-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-09', 'completionDateStruct': {'date': '2012-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2012-09-06', 'studyFirstSubmitDate': '2012-01-23', 'studyFirstSubmitQcDate': '2012-01-26', 'lastUpdatePostDateStruct': {'date': '2012-09-10', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2012-01-30', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Incidence of medically attended health outcomes (~20 relevant mild and severe) related to influenza', 'timeFrame': 'From 1996 to 2008 (up to 13 years)'}, {'measure': 'Relative impact of influenza on high versus low risk populations', 'timeFrame': 'From 1996 to 2008 (up yo 13 years)'}, {'measure': 'Relative impact of influenza during match versus mismatched seasons', 'timeFrame': 'From 1996 to 2008 (up to 13 years)'}, {'measure': 'Relative impact of influenza on vaccinated versus unvaccinated populations', 'timeFrame': 'From 1996 to 2008 (up to 13 years)'}]}, 'conditionsModule': {'keywords': ['Office of National Statistics', 'Burden of Disease', 'Influenza', 'Hospital Episode Statistics', 'General Practitioners Research Database'], 'conditions': ['Influenza']}, 'referencesModule': {'references': [{'pmid': '27278794', 'type': 'DERIVED', 'citation': 'Matias G, Taylor RJ, Haguinet F, Schuck-Paim C, Lustig RL, Fleming DM. Modelling estimates of age-specific influenza-related hospitalisation and mortality in the United Kingdom. BMC Public Health. 2016 Jun 8;16:481. doi: 10.1186/s12889-016-3128-4.'}, {'pmid': '26168005', 'type': 'DERIVED', 'citation': 'Fleming DM, Taylor RJ, Haguinet F, Schuck-Paim C, Logie J, Webb DJ, Lustig RL, Matias G. Influenza-attributable burden in United Kingdom primary care. Epidemiol Infect. 2016 Feb;144(3):537-47. doi: 10.1017/S0950268815001119. Epub 2015 Jul 13.'}]}, 'descriptionModule': {'briefSummary': 'The study will assess the burden of influenza by age, risk status, vaccination status and influenza subtype, in order to create a complete profile of the burden of influenza-related morbidity and mortality in United Kingdom from 1996 to 2008.', 'detailedDescription': 'This epidemiological study is a modelling of time series retrospectively extracted from multiple databases. The data collection will be a query of existing electronic healthcare databases.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'People of any age in the United Kingdom who were registered with an acceptable flag in the GPRD, or with a potentially influenza-related event in the HES database or the ONS mortality data.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n• Registration with an acceptable flag in the GPRD, or registration with a potentially influenza-related event in the HES database or the ONS mortality data.\n\nExclusion Criteria:\n\n\\-'}, 'identificationModule': {'nctId': 'NCT01520935', 'briefTitle': 'Influenza Burden Assessment in the United Kingdom, 1996-2008', 'organization': {'class': 'INDUSTRY', 'fullName': 'GlaxoSmithKline'}, 'officialTitle': 'Burden of Influenza in the United Kingdom, 1996-2008', 'orgStudyIdInfo': {'id': '116273'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Cohort Group', 'interventionNames': ['Other: Data collection']}], 'interventions': [{'name': 'Data collection', 'type': 'OTHER', 'description': 'The study, will use four primary data sources: the General Practice Research Database (GPRD, for mild outcomes), the Hospital Episode Statistics database (HES, for hospitalizations), the Office of National Statistics mortality database (ONS, for mortality), and weekly virology data from the Health Protection Agency (HPA).\n\nWeekly time series of the rates of various influenza-related health outcomes in the various databases, such as office visits for acute otitis media and hospitalizations for pneumonia will be constructed. Statistical models, guided by weekly numbers of cases of laboratory-confirmed influenza and respiratory syncytial virus (RSV) contained in the HPA virology data, to estimate the portions of the various outcomes that can be attributed to influenza will be constructed. Finally, the seasonal impact of influenza by risk status, vaccination status, and seasons in which a well-matched versus mismatched influenza vaccine was used, will be assessed.', 'armGroupLabels': ['Cohort Group']}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'GSK Clinical Trials', 'role': 'STUDY_DIRECTOR', 'affiliation': 'GlaxoSmithKline'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'GlaxoSmithKline', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'Sage Analytica', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR'}}}}