Ignite Creation Date:
2025-12-25 @ 3:11 AM
Ignite Modification Date:
2025-12-26 @ 1:49 AM
Study NCT ID:
NCT01022905
Status:
COMPLETED
Last Update Posted:
2010-03-01
First Post:
2009-11-30
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Vaccine Responses to Influenza A H1N1/09 Immunization in High-risk Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D015658', 'term': 'HIV Infections'}, {'id': 'D012216', 'term': 'Rheumatic Diseases'}, {'id': 'D009369', 'term': 'Neoplasms'}], 'ancestors': [{'id': 'D000086982', 'term': 'Blood-Borne Infections'}, {'id': 'D003141', 'term': 'Communicable Diseases'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D015229', 'term': 'Sexually Transmitted Diseases, Viral'}, {'id': 'D012749', 'term': 'Sexually Transmitted Diseases'}, {'id': 'D016180', 'term': 'Lentivirus Infections'}, {'id': 'D012192', 'term': 'Retroviridae Infections'}, {'id': 'D012327', 'term': 'RNA Virus Infections'}, {'id': 'D014777', 'term': 'Virus Diseases'}, {'id': 'D000091662', 'term': 'Genital Diseases'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D007153', 'term': 'Immunologic Deficiency Syndromes'}, {'id': 'D007154', 'term': 'Immune System Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}, {'id': 'D003240', 'term': 'Connective Tissue Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D014612', 'term': 'Vaccines'}, {'id': 'C556153', 'term': 'pandemrix'}, {'id': 'C023768', 'term': 'halofantrine'}, {'id': 'C558220', 'term': 'focetria'}, {'id': 'C014635', 'term': 'lactitol'}], 'ancestors': [{'id': 'D001688', 'term': 'Biological Products'}, {'id': 'D045424', 'term': 'Complex Mixtures'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 1141}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2009-11'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2009-02', 'completionDateStruct': {'date': '2010-02', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2010-02-26', 'studyFirstSubmitDate': '2009-11-30', 'studyFirstSubmitQcDate': '2009-11-30', 'lastUpdatePostDateStruct': {'date': '2010-03-01', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2009-12-01', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2010-02', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Antibody responses (inhibition of hemagglutination)', 'timeFrame': '4-6 weeks after immunization'}], 'secondaryOutcomes': [{'measure': 'Antibody responses (neutralization)', 'timeFrame': '4-6 weeks after immunization'}, {'measure': 'Vaccine safety : - Solicited adverse events - graft function before / after immunization - influence of immunization on underlying disease (HIV infection, autoimmune diseases)', 'timeFrame': '4-6 weeks after immunization'}, {'measure': 'T cell responses', 'timeFrame': '4-6 wks after immunization'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['HIV infection', 'transplant', 'rheumatic disease', 'cancer', 'children'], 'conditions': ['HIV Infection', 'Rheumatic Disease', 'Cancer', 'Transplant', 'Pediatrics']}, 'referencesModule': {'references': [{'pmid': '22848378', 'type': 'DERIVED', 'citation': 'Siegrist CA, van Delden C, Bel M, Combescure C, Delhumeau C, Cavassini M, Clerc O, Meier S, Hadaya K, Soccal PM, Yerly S, Kaiser L, Hirschel B, Calmy A; H1N1 Study Group; Swiss HIV Cohort Study (SHCS). Higher memory responses in HIV-infected and kidney transplanted patients than in healthy subjects following priming with the pandemic vaccine. PLoS One. 2012;7(7):e40428. doi: 10.1371/journal.pone.0040428. Epub 2012 Jul 27.'}, {'pmid': '22228003', 'type': 'DERIVED', 'citation': 'Schappi MG, Meier S, Bel M, Siegrist CA, Posfay-Barbe KM; H1N1 Study Group. Protective antibody responses to influenza A/H1N1/09 vaccination in children with celiac disease. J Pediatr Gastroenterol Nutr. 2012 Jun;54(6):817-9. doi: 10.1097/MPG.0b013e318248e7be.'}, {'pmid': '21422117', 'type': 'DERIVED', 'citation': 'Mohty B, Bel M, Vukicevic M, Nagy M, Levrat E, Meier S, Grillet S, Combescure C, Kaiser L, Chalandon Y, Passweg J, Siegrist CA, Roosnek E; Blood and Marrow Transplant Program; Geneva University Hospitals H1N1 study group. Graft-versus-host disease is the major determinant of humoral responses to the AS03-adjuvanted influenza A/09/H1N1 vaccine in allogeneic hematopoietic stem cell transplant recipients. Haematologica. 2011 Jun;96(6):896-904. doi: 10.3324/haematol.2011.040386. Epub 2011 Mar 21.'}, {'pmid': '21419775', 'type': 'DERIVED', 'citation': "Meier S, Bel M, L'huillier A, Crisinel PA, Combescure C, Kaiser L, Grillet S, Posfay-Barbe K, Siegrist CA; H1N1 Epidemiology Study Group of Geneva. Antibody responses to natural influenza A/H1N1/09 disease or following immunization with adjuvanted vaccines, in immunocompetent and immunocompromised children. Vaccine. 2011 Apr 27;29(19):3548-57. doi: 10.1016/j.vaccine.2011.02.094. Epub 2011 Mar 17."}, {'pmid': '21384334', 'type': 'DERIVED', 'citation': 'Gabay C, Bel M, Combescure C, Ribi C, Meier S, Posfay-Barbe K, Grillet S, Seebach JD, Kaiser L, Wunderli W, Guerne PA, Siegrist CA; H1N1 Study Group. Impact of synthetic and biologic disease-modifying antirheumatic drugs on antibody responses to the AS03-adjuvanted pandemic influenza vaccine: a prospective, open-label, parallel-cohort, single-center study. Arthritis Rheum. 2011 Jun;63(6):1486-96. doi: 10.1002/art.30325.'}]}, 'descriptionModule': {'briefSummary': 'The objective of this study is to assess vaccine responses to novel adjuvanted influenza A(H1N1) vaccines in patients at high risks of influenza A(H1N1) complications.', 'detailedDescription': 'This prospective, open-label, parallel-cohorts study will include up to 1250 patients and 250 controls to whom influenza A(H1N1) immunization was recommended.\n\nSix cohort have been established, enrolling patients with HIV infection, rheumatic diseases, organ transplant, cancer, pediatric patients and healthy controls.\n\nSubjects will be assessed for specific antibody responses (all), T cell responses (subset) and solicited vaccine adverse events. Vaccine safety evaluation will include the influence of immunization on underlying diseases (HIV infected patients, patients with auto-immune diseases) or graft function (transplant patients) - as appropriate.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'minimumAge': '6 Months', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* medically recommended influenza A(H1N1) immunization\n* signed informed consent\n\nExclusion Criteria:\n\n* failure or refusal to provide sufficient blood for antibody determination'}, 'identificationModule': {'nctId': 'NCT01022905', 'briefTitle': 'Vaccine Responses to Influenza A H1N1/09 Immunization in High-risk Patients', 'organization': {'class': 'OTHER', 'fullName': 'University Hospital, Geneva'}, 'officialTitle': 'Prospective Cohort Study of the Influence of Age, Underlying Disease and Immunosuppression on Vaccine Responses to Influenza A H1N1/09 Immunization in High-risk Patients.', 'orgStudyIdInfo': {'id': 'CER-09-234'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'High-risk patients ( 5 cohorts)', 'interventionNames': ['Biological: Adjuvanted influenza A(H1N1) vaccines']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Healthy controls', 'interventionNames': ['Biological: Adjuvanted influenza A(H1N1) vaccines']}], 'interventions': [{'name': 'Adjuvanted influenza A(H1N1) vaccines', 'type': 'BIOLOGICAL', 'otherNames': ['Pandemrix (GSK)', 'Focetria (Novartis)'], 'description': 'Immunization (1-2 doses)', 'armGroupLabels': ['Healthy controls', 'High-risk patients ( 5 cohorts)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '1211', 'city': 'Geneva', 'country': 'Switzerland', 'facility': 'University Hospitals of Geneva', 'geoPoint': {'lat': 46.20222, 'lon': 6.14569}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Hospital, Geneva', 'class': 'OTHER'}, 'responsibleParty': {'oldNameTitle': 'Prof. Claire-Anne Siegrist', 'oldOrganization': 'University Hospital, Geneva'}}}}