Ignite Creation Date:
2025-12-24 @ 9:22 PM
Ignite Modification Date:
2026-02-23 @ 6:27 AM
Study NCT ID:
NCT01086904
Status:
COMPLETED
Last Update Posted:
2012-01-02
First Post:
2009-11-16
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Safety and Efficacy of an Inactivated and Non Adjuvanted Vaccine Against Influenza A in Renal Transplant Recipients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 120}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2009-11'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2010-07', 'completionDateStruct': {'date': '2010-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2011-12-29', 'studyFirstSubmitDate': '2009-11-16', 'studyFirstSubmitQcDate': '2010-03-12', 'lastUpdatePostDateStruct': {'date': '2012-01-02', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2010-03-15', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2010-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Specific humoral response 21 days after each administration Seroprotection and seroconversion rates', 'timeFrame': 'after each vaccination and at 6 months'}], 'secondaryOutcomes': [{'measure': 'Seroprotection and seroconversion rates at day 182;Percentage of patients with anti-H1N1v Antibodies >1/40e at day 182; Number of undesired events and of Influenza A cases; Assessment of cellular immune response against Influenza A H1N1; Effect of vacc', 'timeFrame': '6 months'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['renal transplantation', 'immunosuppression', 'inflenza A (H1N1)', 'vaccine'], 'conditions': ['Renal Transplant Recipients', 'Immunosuppression']}, 'descriptionModule': {'briefSummary': 'The study is aimed at assessing the safety and efficacy of an inactivated and non adjuvanted Influenza A (H1N1) vaccine in renal transplant recipients.', 'detailedDescription': '120 renal transplant recipients under triple immunosuppression will be immunized against influenza H1N1v.\n\nThe primary endpoint will be the humoral immunity assessed 21 days after each injection on day 0 and day 21:\n\n* seroprotection rate, defined as the percentage of patients with an antibody title against Hemaglutinin ≥ 1/40e after immunization\n* seroconversion rate, defined as the the percentage of patients with an antibody title against Hemaglutinin \\< 1/10e before immunization and ≥ 1/40e after or with a prevaccine title ≥1/10e increasing at least 4 fold after immunization\n* seroconversion factor, defined as the ratio between pre and post vaccine geometrical means of the antibody titles.\n\nSecondary endpoints will be:\n\n* Seroconversion rate, seroprotection rate and seroconversion factor on day 182\n* Percentage of patients with an antibody title \\> 1/40e on day 182 (Immune memory)\n* Number and severity of clinical and biological adverse events\n* Number of cases of pandemic H1N1v influenza virologically confirmed\n* Study of associated parameters influencing the results of H1N1v vaccination in terms of seroprotection, seroconversion and seroconversion factor\n* Assessment of the cellular immune response against H1N1v\n* Assessment of the H1N1v vaccination on graft function and on humoral anti-HLA response.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '60 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion criteria:\n\n* Age \\> 18 and \\< 60 years old\n* Signed information consent\n* Social security coverage\n* Renal transplantation \\> 6 months with a creatinine clearance \\> 20 ml/mn\n* Stable renal function defined as serum creatinine variation \\< 20 % for the last three months\n* Receiving a triple immunosuppression regimen including steroids, Calcineurine inhibitors (cyclosporine or Tacrolimus), and IMPDH inhibitors (Mycophenolate Mofetil or mycophenolic acid)\n* Regular follow-up\n\nFor child bearing aged female:\n\n* Negative urinary HCG\n* Contraception during the first three months of the study\n\nExclusion criteria:\n\n* Poor renal function defined as creatinine clairance \\< 20 ml/mn\n* Unstable renal function defined as serum creatinine variations \\> 20 % during the last 3 months\n* Cellular or humoral acute rejection episode during the last 3 months before inclusion\n* Known HIV, HBV or HCV infection\n* Other vaccine administered during the last 3 weeks before inclusion or scheduled in the month after the second vaccine injection\n* Known allergy to egg proteins or to one the vaccine compounds\n* Severe adverse events after prior administration of any influenza vaccine\n* Multiple sclerosis\n* Past history of Guillain Barre syndrome\n* Fever at inclusion\n* H1N1 influenza episode with positive virological tests during the last 6 months\n* Contact with people infected with H1N1 influenza during the week prior to inclusion\n* Cancer requiring radiotherapy or chemotherapy during the last 6 months\n* Blood transfusion during the last 3 months\n* Pregnancy during the last 3 months\n* No follow-up'}, 'identificationModule': {'nctId': 'NCT01086904', 'acronym': 'Transfluvac', 'briefTitle': 'Safety and Efficacy of an Inactivated and Non Adjuvanted Vaccine Against Influenza A in Renal Transplant Recipients', 'organization': {'class': 'OTHER_GOV', 'fullName': 'Institut National de la Santé Et de la Recherche Médicale, France'}, 'officialTitle': "Etude de Phase II évaluant l'immunogénicité et la tolérance d'un Vaccin inactivé Non adjuvanté Contre la Grippe A (H1N1) après Transplantation rénale", 'orgStudyIdInfo': {'id': 'C09-32'}, 'secondaryIdInfos': [{'id': '2009-016659-23', 'type': 'EUDRACT_NUMBER'}]}, 'armsInterventionsModule': {'interventions': [{'name': 'inactivated non adjuvanted pandemic H1N1 vaccine', 'type': 'BIOLOGICAL', 'description': 'two administrations at D and D21 (15 µg HA)'}]}, 'contactsLocationsModule': {'locations': [{'zip': '69495', 'city': 'Pierre-Bénite', 'state': 'Lyon', 'country': 'France', 'facility': 'Centre hospitalier Lyon Sud, service de néphrologie transplantation', 'geoPoint': {'lat': 45.70359, 'lon': 4.82424}}, {'zip': '69437', 'city': 'Lyon', 'country': 'France', 'facility': 'Hôpital E. Herriot , Service de néphrologie, transplantation et immunologie clinique', 'geoPoint': {'lat': 45.74906, 'lon': 4.84789}}, {'zip': '75013', 'city': 'Paris', 'country': 'France', 'facility': "Service d'urologie, GH Pitié Salpêtrière", 'geoPoint': {'lat': 48.85341, 'lon': 2.3488}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Institut National de la Santé Et de la Recherche Médicale, France', 'class': 'OTHER_GOV'}, 'collaborators': [{'name': 'MCM Vaccines B.V.', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR'}}}}