Ignite Creation Date:
2025-12-24 @ 3:41 PM
Ignite Modification Date:
2025-12-28 @ 9:32 AM
Study NCT ID:
NCT01715792
Status:
COMPLETED
Last Update Posted:
2014-02-10
First Post:
2012-10-25
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Assess the Risk of Solid Organ Transplant Rejection Following Vaccination With Pandemrix™ in UK
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': 587}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2012-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-02', 'completionDateStruct': {'date': '2013-08', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2014-02-06', 'studyFirstSubmitDate': '2012-10-25', 'studyFirstSubmitQcDate': '2012-10-25', 'lastUpdatePostDateStruct': {'date': '2014-02-10', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2012-10-29', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-08', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Assessment of the risk of solid organ transplant rejection (liver, kidney, lung, heart, pancreas).', 'timeFrame': 'Within one month after vaccination with Pandemrix™ (from 01 October 2009 to 31 October 2010).', 'description': 'Assessed by case data collection from CPRD GOLD and HES, and additional data obtained from complementary information provided by the GPs using a standardised questionnaire.'}], 'secondaryOutcomes': [{'measure': 'Assessment of the risk of solid organ transplant rejection (liver, kidney, lung, heart, pancreas).', 'timeFrame': 'Within two months after vaccination with Pandemrix™ ( from 01 October 2009 to 31 October 2010).', 'description': 'Assessed by case data collection from CPRD GOLD and HES, and additional data obtained from complementary information provided by the GPs using a standardised questionnaire.'}]}, 'conditionsModule': {'keywords': ['Solid organ transplant rejection', 'United Kingdom', 'Influenza', 'H1N1', 'Pandemrix™'], 'conditions': ['Influenza']}, 'referencesModule': {'references': [{'pmid': '26823177', 'type': 'DERIVED', 'citation': 'Cohet C, Haguinet F, Dos Santos G, Webb D, Logie J, Lc Ferreira G, Rosillon D, Shinde V. Effect of the adjuvanted (AS03) A/H1N1 2009 pandemic influenza vaccine on the risk of rejection in solid organ transplant recipients in England: a self-controlled case series. BMJ Open. 2016 Jan 28;6(1):e009264. doi: 10.1136/bmjopen-2015-009264.'}]}, 'descriptionModule': {'briefSummary': 'This study aims to assess the risk of solid organ transplant (SOT) rejection following vaccination with Pandemrix™ and/ or seasonal influenza vaccination.', 'detailedDescription': 'Data on the safety of pandemic H1N1 vaccination in transplanted patients is relatively limited; to date, although some studies showed transient increases in alloreactivity, there is no evidence that H1N1 vaccines caused clinical rejection or organ dysfunction. In addition, studies have shown that influenza infection is a known independent risk factors for rejection. Considering that transplant recipients are a target population for immunisation with future pandemic vaccines, it is important to investigate the risk of rejection following vaccination in this patient population.\n\nUsing the self-controlled case series design that allows to control implicitly for potential confounding factors, this study aims at investigating the risk of solid organ transplant rejection (liver, kidney, lung, heart, pancreas) following vaccination with Pandemrix™ in the United Kingdom Clinical Practice Research Datalink GP Online Database (CPRD GOLD). Data from the Hospital Episodes Statistics database will also be used. The effect of seasonal influenza vaccination and of various infections including influenza H1N1 will also be explored.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Subject defined as acceptable in the CPRD GOLD with at least one solid organ transplant rejection reported during the overall study periods (01 September 2006 to 31 October 2010).', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Subject defined as acceptable in the CPRD GOLD.\n* Subject with at least one solid organ transplant rejection reported in the CPRD GOLD and/or HES during the overall study periods (01 September 2006 to 31 October 2010).\n\nExclusion Criteria:\n\n• Subject from HES matched to more than one subject in the CPRD GOLD.'}, 'identificationModule': {'nctId': 'NCT01715792', 'briefTitle': 'Assess the Risk of Solid Organ Transplant Rejection Following Vaccination With Pandemrix™ in UK', 'organization': {'class': 'INDUSTRY', 'fullName': 'GlaxoSmithKline'}, 'officialTitle': 'Risk of Solid Organ Transplant Rejection Following Vaccination With Pandemrix™ in the United Kingdom', 'orgStudyIdInfo': {'id': '116602'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Group 1', 'description': 'Subject defined as acceptable in the CPRD GOLD with at least one solid organ transplant rejection reported during the overall study period (01 September to 31 October 2010).', 'interventionNames': ['Other: Data collection']}], 'interventions': [{'name': 'Data collection', 'type': 'OTHER', 'description': 'Data extraction from the CPRD GOLD and HES, and additional data obtained from complementary information provided by the GPs using a standardised questionnaire.', 'armGroupLabels': ['Group 1']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'SW1W 9SZ', 'city': 'London', 'country': 'United Kingdom', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 51.50853, 'lon': -0.12574}}], 'overallOfficials': [{'name': 'GSK Clinical Trials', 'role': 'STUDY_DIRECTOR', 'affiliation': 'GlaxoSmithKline'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'GlaxoSmithKline', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}