Ignite Creation Date:
2025-12-24 @ 11:08 PM
Ignite Modification Date:
2026-01-05 @ 5:53 PM
Study NCT ID:
NCT03191669
Status:
COMPLETED
Last Update Posted:
2018-04-13
First Post:
2017-06-16
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Vaccine Exposure in Patients With MS
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009103', 'term': 'Multiple Sclerosis'}], 'ancestors': [{'id': 'D020278', 'term': 'Demyelinating Autoimmune Diseases, CNS'}, {'id': 'D020274', 'term': 'Autoimmune Diseases of the Nervous System'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D003711', 'term': 'Demyelinating Diseases'}, {'id': 'D001327', 'term': 'Autoimmune Diseases'}, {'id': 'D007154', 'term': 'Immune System Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 335}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-06-26', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-06', 'completionDateStruct': {'date': '2017-07-07', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-04-12', 'studyFirstSubmitDate': '2017-06-16', 'studyFirstSubmitQcDate': '2017-06-16', 'lastUpdatePostDateStruct': {'date': '2018-04-13', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-06-19', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2017-07-07', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Percentage of patients exposed to seasonal flu vaccine in 2016-2017', 'timeFrame': 'Two-weeks period in July 2017'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Multiple Sclerosis']}, 'descriptionModule': {'briefSummary': 'Vaccines in MS patients have been controversial, in particular hepatitis B vaccine in the 90s and more recently human papillomavirus vaccine. There was an important flu incidence during the winter 2016-2017 that has revealed a low exposure to the flu vaccine in health professionals in France. Vaccine exposure of Multiple sclerosis (MS) patients has not been evaluated yet.\n\nObjectives The primary objective is to evaluate exposure to the flu vaccine in patients with MS during the 2016-17 campaign. Secondary objectives are to evaluate exposure to mandatory vaccines, non mandatory vaccines, in the context of immunoactive treatments; to identify potential limitations to vaccines in general in patients with MS.\n\nMethods Cross-sectional observational multicentric study, performed in Auvergne-Rhône-Alpes (France).\n\nData will be collected through an auto-questionnaire administered during an out-patient visit or hospitalization, during a two-week period.\n\nStatistical analysis Description of the percentage of patients exposed to the flu vaccine, and to other vaccines. Stratification according to demographics (age, sex) and MS related criteria (disability level, relapse in the year before, disease-modifiying drug) Expected results Vaccine exposure of patients with MS will be put in perspective with the general population exposure. The study can provide information regarding potential reluctance of patients with MS towards vaccines. This could lead to develop specific communication tools for patients with MS and/or health professionals.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'patients with MS attending an outpatient MS clinic or hospitalization', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Multiple sclerosis according to MacDonald 2010 criteria\n* Age 18 and more\n\nExclusion Criteria:\n\n\\-'}, 'identificationModule': {'nctId': 'NCT03191669', 'acronym': 'Enquête Vaccin', 'briefTitle': 'Vaccine Exposure in Patients With MS', 'organization': {'class': 'OTHER', 'fullName': 'Hospices Civils de Lyon'}, 'officialTitle': 'Vaccine Exposure in Patients With Multiple Sclerosis in the Auvergne-Rhone-Alpes Region', 'orgStudyIdInfo': {'id': '69HCL17_0169'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'MS patients', 'description': 'Single group of patients with MS attending an outpatient MS clinic or hospitalization', 'interventionNames': ['Other: Auto-questionnaire']}], 'interventions': [{'name': 'Auto-questionnaire', 'type': 'OTHER', 'description': 'Single Auto-questionnaire administered during or after a consultation/hospitalization', 'armGroupLabels': ['MS patients']}]}, 'contactsLocationsModule': {'locations': [{'zip': '69500', 'city': 'Bron', 'country': 'France', 'facility': 'Hôpital Neurologique Pierre Wertheimer', 'geoPoint': {'lat': 45.73865, 'lon': 4.91303}}, {'zip': '63003', 'city': 'Clermont-Ferrand', 'country': 'France', 'facility': 'Service de Neurologie - Hôpital G. Montpied', 'geoPoint': {'lat': 45.77969, 'lon': 3.08682}}, {'zip': '38043', 'city': 'Grenoble', 'country': 'France', 'facility': 'Service de Neurologie - CHU de Grenoble', 'geoPoint': {'lat': 45.17869, 'lon': 5.71479}}, {'zip': '69007', 'city': 'Lyon', 'country': 'France', 'facility': 'Service de Neurologie - Hôpital Saint Joseph Saint Luc', 'geoPoint': {'lat': 45.74906, 'lon': 4.84789}}, {'zip': '69009', 'city': 'Lyon', 'country': 'France', 'facility': 'Cabinet de Neurologie - Clinique de la Sauvegarde', 'geoPoint': {'lat': 45.74906, 'lon': 4.84789}}, {'zip': '42055', 'city': 'Saint-Etienne', 'country': 'France', 'facility': 'Service de Neurologie - Hôpital Nord - CHU St Etienne', 'geoPoint': {'lat': 45.43389, 'lon': 4.39}}], 'overallOfficials': [{'name': 'Sandra VUKUSIC', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Hôpital Neurologique Pierre Wertheimer - GHE'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Hospices Civils de Lyon', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}