Ignite Creation Date:
2025-12-24 @ 3:01 PM
Ignite Modification Date:
2025-12-30 @ 5:11 AM
Study NCT ID:
NCT00606359
Status:
COMPLETED
Last Update Posted:
2014-01-14
First Post:
2008-01-21
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Immunogenicity of the Inactivated Split-Virion Influenza Vaccine in Renal Transplant Subjects
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D007251', 'term': 'Influenza, Human'}, {'id': 'D009976', 'term': 'Orthomyxoviridae Infections'}], 'ancestors': [{'id': 'D012141', 'term': 'Respiratory Tract Infections'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D012327', 'term': 'RNA Virus Infections'}, {'id': 'D014777', 'term': 'Virus Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C478242', 'term': 'vaxigrip'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 62}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2007-11'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-01', 'completionDateStruct': {'date': '2008-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2014-01-10', 'studyFirstSubmitDate': '2008-01-21', 'studyFirstSubmitQcDate': '2008-01-31', 'lastUpdatePostDateStruct': {'date': '2014-01-14', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2008-02-01', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2008-02', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Anti-HA individual titers', 'timeFrame': '21 Days Post-vaccination 2'}, {'measure': 'Individual titers ratio', 'timeFrame': '21 Days Post-vaccination 2'}, {'measure': 'Seroconversion or significant increase', 'timeFrame': '21 Days Post-vaccination 2'}], 'secondaryOutcomes': [{'measure': 'Safety: Adverse events in the first 21 days after each vaccination; Pre-listed reactions in the 7 days following each vaccination; Serious adverse events during the entire trial.', 'timeFrame': '21 days following each vaccination'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Influenza', 'Orthomyxoviridae Infections', 'Renal Transplant'], 'conditions': ['Influenza', 'Orthomyxoviridae Infections']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'http://www.sanofipasteur.com', 'label': 'Related Info'}]}, 'descriptionModule': {'briefSummary': 'Primary Objective:\n\nTo describe the immunogenicity of an injection of the investigational inactivated, split-virion influenza vaccine 21 days after vaccination in 18 to 60 years old renal transplant subjects identified as non-responder to previous vaccination with the IM reference vaccine (Vaxigrip®).\n\nSecondary Objective:\n\nTo describe the safety of an injection of the investigational inactivated, split-virion influenza vaccine in 18 to 60 years old renal transplant subjects identified as non-responder to previous vaccination with the IM reference vaccine', 'detailedDescription': 'The trial is a multicenter, randomized, controlled trial in renal transplant subjects aged 18 to 60 years who are non-responders to vaccination with the reference vaccine. Subjects will be randomized to receive either the 2007-2008 15 µg investigational vaccine or the 2007-2008 IM reference vaccine.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '60 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Able to attend all scheduled visits and to comply with all trial procedures.\n* Subject with renal transplant for at least 6 months.\n* Subject with stable renal function, i.e. with a variation of creatinin value \\< 20% and with a creatinin clearance estimated according to Cockroft and Gault calculation \\> 20 mL/min during the 3 months preceding inclusion.\n* Aged 18 to 59 years on the day of the screening visit.\n* Informed Consent Form signed.\n* Subject entitled to national social security.\n* Subject under immunosuppressive therapy.\n* For a woman, inability to bear a child or negative urine pregnancy test.\n* Subject non-responder to previous IM vaccination with the 2006-2007 Northern Hemisphere Vaxigrip® formulation.\n\nExclusion Criteria:\n\n* Subject with sign of transplanted kidney reject within 3 months preceding vaccination according to medical practice.\n* Systemic hypersensitivity to any of the vaccine components or history of a life-threatening reaction to the trial vaccine or a vaccine containing the same substances.\n* Febrile illness (oral temperature ≥ 37.5°C, or rectal equivalent temperature ≥ 38.0°C) on the day of inclusion.\n* Breast-feeding.\n* Participation in another clinical trial in the 4 weeks preceding the trial vaccination.\n* Planned participation in another clinical trial during the present trial period.\n* Congenital immunodeficiency, anti-cancer chemotherapy or radiation therapy within the preceding 6 months.\n* Chronic illness, except renal failure or renal disorders, at a stage that could interfere with trial conduct or completion.\n* Current abuse of alcohol or drug addiction that may interfere with the subject's ability to comply with trial procedures.\n* Blood or blood-derived products received in the past 3 months .\n* Any vaccination in the 4 weeks preceding the trial vaccination.\n* Vaccination planned in the 4 weeks following the trial vaccination.\n* Thrombocytopenia or bleeding disorder contraindicating intramuscular (IM) vaccination\n* Previous vaccination against influenza in the preceding 6 months.\n* Subject deprived of freedom by an administrative or court order, or in an emergency setting, or hospitalized without his/her consent."}, 'identificationModule': {'nctId': 'NCT00606359', 'briefTitle': 'Immunogenicity of the Inactivated Split-Virion Influenza Vaccine in Renal Transplant Subjects', 'organization': {'class': 'INDUSTRY', 'fullName': 'Sanofi'}, 'officialTitle': 'Immunogenicity of the Inactivated Split-Virion Influenza Vaccine Administered by the Intradermal Route in Renal Transplant Subjects', 'orgStudyIdInfo': {'id': 'GID26'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Study Group 1', 'interventionNames': ['Biological: Inactivated, split-virion influenza virus']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Study Group 2', 'interventionNames': ['Biological: Inactivated, split-virion influenza virus']}], 'interventions': [{'name': 'Inactivated, split-virion influenza virus', 'type': 'BIOLOGICAL', 'description': '0.1 mL, Intradermal. 2 vaccinations 12 months apart', 'armGroupLabels': ['Study Group 1']}, {'name': 'Inactivated, split-virion influenza virus', 'type': 'BIOLOGICAL', 'otherNames': ['Vaxigrip®'], 'description': '0.5 mL, Intramuscular. 2 vaccinations, 12 months apart', 'armGroupLabels': ['Study Group 2']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Lyon', 'country': 'France', 'geoPoint': {'lat': 45.74906, 'lon': 4.84789}}], 'overallOfficials': [{'name': 'Medical Director', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Sanofi Pasteur Inc.'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Sanofi Pasteur, a Sanofi Company', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}