Ignite Creation Date:
2025-12-25 @ 4:02 AM
Ignite Modification Date:
2026-03-07 @ 9:26 PM
Study NCT ID:
NCT01298102
Status:
COMPLETED
Last Update Posted:
2011-02-17
First Post:
2011-02-16
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Influenza A/H1N1/2009-adjuvanted Vaccine in Renal Disease Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D007251', 'term': 'Influenza, Human'}, {'id': 'D012059', 'term': 'Rejection, Psychology'}], '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'}, {'id': 'D012919', 'term': 'Social Behavior'}, {'id': 'D001519', 'term': 'Behavior'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C556153', 'term': 'pandemrix'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 185}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2009-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2010-06', 'completionDateStruct': {'date': '2010-03', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2011-02-16', 'studyFirstSubmitDate': '2011-02-16', 'studyFirstSubmitQcDate': '2011-02-16', 'lastUpdatePostDateStruct': {'date': '2011-02-17', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2011-02-17', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2010-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'to determine the efficacy aand safety of influenza A/H1N1 adjuvanted-vaccination among renal transplant and haemodialyzed patients as compared to controls', 'timeFrame': 'one month post-vaccination', 'description': 'measures of anti-A/H1N1 antibodies with a method of microneutralizing test (seroneutralization) to follow-up the secondary effects of the vaccine and follow-up of renal function in renal transplanted patients.'}], 'secondaryOutcomes': [{'measure': 'to controls and to assess the safety of the vaccine among renal transplanted patients by studying HLA or MICA sensitization before and following vaccination', 'timeFrame': 'follow-up 6 months', 'description': 'To measure the Anti-HLA and anti-MICA antibodies with luminex-test'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['kidney', 'transplantation', 'haemodialysis', 'vaccination', 'influenza H1N1 2009'], 'conditions': ['Decreased Immunologic Activity [PE]', 'Influenza', 'Rejection']}, 'referencesModule': {'references': [{'pmid': '19656126', 'type': 'BACKGROUND', 'citation': 'Candon S, Thervet E, Lebon P, Suberbielle C, Zuber J, Lima C, Charron D, Legendre C, Chatenoud L. Humoral and cellular immune responses after influenza vaccination in kidney transplant recipients. Am J Transplant. 2009 Oct;9(10):2346-54. doi: 10.1111/j.1600-6143.2009.02787.x. Epub 2009 Jul 28.'}]}, 'descriptionModule': {'briefSummary': 'In 2009, the pandemic influenza A/H1N1 accounted for worldwide recommendations about vaccination. There is no data concerning the immunogenicity nor the security of the adjuvanted-A/H1N1 vaccine in renal disease patients. The aim of this study is to observe the effects of this vaccine on transplanted and hemodialyzed patients.', 'detailedDescription': 'The serologic responses to the Pandemrix vaccine will assess the efficacy, with the determination of the seroconversion rate among the patients.\n\nThe anti-HLA and anti-MICA antibodies will be determined to assess the safety among the renal transplanted patients.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Adult patients\n2. Haemodialyzed patients\n3. Renal transplant recipients who have stable renal function for the last 3 months\n\nExclusion Criteria:\n\n1. No pneumonia or severe infection during 1 month before vaccination\n2. No Ivig (intravenous immunoglobulins) treatment during the last 3 months'}, 'identificationModule': {'nctId': 'NCT01298102', 'briefTitle': 'Influenza A/H1N1/2009-adjuvanted Vaccine in Renal Disease Patients', 'organization': {'class': 'OTHER', 'fullName': 'Erasme University Hospital'}, 'officialTitle': 'Safety and Efficacy of Influenza A/H1N1/2009-adjuvanted Vaccine in Renal Transplant and Dialyzed Patients: a Prospective Cohort Study.', 'orgStudyIdInfo': {'id': 'Etude 2009/INT044'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'influenza vaccine', 'description': 'Pandemrix vaccine (Influenza A/H1N1 2009)to be injected to renal transplant patients, haemodialyzed patients, and controls', 'interventionNames': ['Biological: Influenza A/H1N1 2009-AS03 adjuvanted (Pandemrix)']}], 'interventions': [{'name': 'Influenza A/H1N1 2009-AS03 adjuvanted (Pandemrix)', 'type': 'BIOLOGICAL', 'otherNames': ['Pandemrix'], 'description': 'intramuscular injection of 1 dose vaccine', 'armGroupLabels': ['influenza vaccine']}]}, 'contactsLocationsModule': {'locations': [{'zip': '1070', 'city': 'Brussels', 'state': 'Brabant', 'country': 'Belgium', 'facility': 'Hospital Erasme', 'geoPoint': {'lat': 50.85045, 'lon': 4.34878}}], 'overallOfficials': [{'name': 'Daniel Abramowicz, PhD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Hospital Erasme'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Erasme University Hospital', 'class': 'OTHER'}, 'responsibleParty': {'oldNameTitle': 'Broeders Nilufer', 'oldOrganization': 'Hospital Erasme'}}}}