Ignite Creation Date:
2025-12-24 @ 10:35 PM
Ignite Modification Date:
2025-12-28 @ 5:07 AM
Study NCT ID:
NCT01289535
Status:
UNKNOWN
Last Update Posted:
2011-12-30
First Post:
2011-02-02
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Immune Response Analysis to Influenza Vaccine in Elderly Aged Over 65 Years
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': 'D001800', 'term': 'Blood Specimen Collection'}], 'ancestors': [{'id': 'D013048', 'term': 'Specimen Handling'}, {'id': 'D019411', 'term': 'Clinical Laboratory Techniques'}, {'id': 'D019937', 'term': 'Diagnostic Techniques and Procedures'}, {'id': 'D003933', 'term': 'Diagnosis'}, {'id': 'D011677', 'term': 'Punctures'}, {'id': 'D013514', 'term': 'Surgical Procedures, Operative'}, {'id': 'D008919', 'term': 'Investigative Techniques'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 750}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2010-11'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2011-12', 'completionDateStruct': {'date': '2012-04', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2011-12-29', 'studyFirstSubmitDate': '2011-02-02', 'studyFirstSubmitQcDate': '2011-02-02', 'lastUpdatePostDateStruct': {'date': '2011-12-30', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2011-02-03', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-04', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'antibody rates after influenza vaccination', 'timeFrame': 'up to 3 months after vaccination'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Influenza vaccine', 'immune response', 'elderly'], 'conditions': ['Immune Response']}, 'descriptionModule': {'briefSummary': 'This study is the first step in a clinical research program that aims to study the immune response to influenza vaccine in the elderly and then to propose a new method of administering the vaccine.\n\nInfluenza can cause severe complications in patients at risk (elderly and subjects vulnerable because of a chronic underlying disease). Over 90% of deaths related to influenza occur in people aged over 65 years.\n\nVaccination is the most effective way to prevent infection. The World Health Organization recommends annual immunization for people at risk, including all persons aged over 65 years, to reduce the risk of morbidity and mortality related to influenza.\n\nHowever, the immune response to influenza vaccine appears to be lower in elderly than in young people.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['OLDER_ADULT'], 'minimumAge': '65 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Subject aged 65 years or over\n* Influenza vaccination without adjuvant, within 3 weeks and 3 months before inclusion visit\n* Legal capacity to consent\n* Subject had given written consent before his participation\n\nExclusion Criteria:\n\n* Adjuvanted influenza vaccine (e.g: Fluad, Gripguard)\n* Live vaccines within 3 weeks before and after influenza vaccination\n* Inactivated vaccines within 2 weeks before and after influenza vaccination\n* Chronic disease non-stabilized under treatment\n* Severe malnutrition in the opinion of the investigator\n* Congenital immunodeficiency\n* Chemotherapy or radiotherapy over the last 6 months\n* Immunosuppressive therapy or corticosteroid (daily dose of prednisone or equivalent \\>/= 20 mg/d over 14 days) from 1 month before vaccination until the study visit\n* Participation in another clinical study that could interfere with the present study'}, 'identificationModule': {'nctId': 'NCT01289535', 'acronym': 'Expand IDWP21', 'briefTitle': 'Immune Response Analysis to Influenza Vaccine in Elderly Aged Over 65 Years', 'organization': {'class': 'OTHER', 'fullName': 'Hospices Civils de Lyon'}, 'officialTitle': 'Immune Response Analysis to Influenza Vaccine in Elderly Aged Over 65 Years', 'orgStudyIdInfo': {'id': '2010.621'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'antibody rates', 'interventionNames': ['Procedure: Blood sample']}], 'interventions': [{'name': 'Blood sample', 'type': 'PROCEDURE', 'description': 'Blood sample of 7 ml', 'armGroupLabels': ['antibody rates']}]}, 'contactsLocationsModule': {'locations': [{'zip': '69495', 'city': 'Pierre-Bénite', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Catherine GOUJON, Dr', 'role': 'CONTACT', 'email': 'catherine.goujon@chu-lyon.fr', 'phone': '+33 478 86 41 25'}, {'name': 'Catherine GOUJON, Dr', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': "Unité de Recherche Clinique en Immunologie Lyon Sud (URCI-LS) et Service d'Immunologie clinique et allergologie", 'geoPoint': {'lat': 45.70359, 'lon': 4.82424}}], 'centralContacts': [{'name': 'Catherine GOUJON, Dr', 'role': 'CONTACT', 'email': 'catherine.goujon@chu-lyon.fr', 'phone': '+33 478 86 41 25'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Hospices Civils de Lyon', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}