Ignite Creation Date:
2025-12-25 @ 1:23 AM
Ignite Modification Date:
2025-12-27 @ 10:48 PM
Study NCT ID:
NCT04236193
Status:
COMPLETED
Last Update Posted:
2020-01-22
First Post:
2019-11-15
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Ultrasound and Immunological Findings in Patients With Shoulder Injury Related to Vaccine Administration (SIRVA)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 30}, 'targetDuration': '12 Months', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-04-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-01', 'completionDateStruct': {'date': '2019-12-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-01-16', 'studyFirstSubmitDate': '2019-11-15', 'studyFirstSubmitQcDate': '2020-01-16', 'lastUpdatePostDateStruct': {'date': '2020-01-22', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-01-22', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-11-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Pathological Findings in Ultrasound', 'timeFrame': 'Ultrasound of the shoulder is performed at Baseline/Inclusion', 'description': 'Cross-sectional assessment and description of pathological ultrasound findings in subjects with shoulder pain after influenza vaccination'}], 'secondaryOutcomes': [{'measure': 'Increased Vaccine response', 'timeFrame': 'Baseline and 12 months', 'description': 'Antibodies against Influenza, Plasmablasts and T follicular helper cell increase'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Shoulder Injury Related to Vaccine Administration', 'Erosion, Localized']}, 'descriptionModule': {'briefSummary': 'Accidental vaccine injection into adjunct shoulder structures can cause tissue damage, termed Shoulder injury related to vaccine administration (SIRVA). The immunopathological mechanisms and consequences of SIRVA are unknown.\n\nThe study assesses the clinical and immunological consequences of an influenza vaccine if accidentally administered in periarticular space.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Subjects receiving the Influenza vaccine at a local vaccination campaign in Basel, Switzerland', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* participation at a local vaccination campaign\n* Shoulder pain \\>3 days after vaccination\n\nExclusion Criteria:\n\n* no vaccine received\n* preexisting shoulder pathology'}, 'identificationModule': {'nctId': 'NCT04236193', 'acronym': 'SIRVA', 'briefTitle': 'Ultrasound and Immunological Findings in Patients With Shoulder Injury Related to Vaccine Administration (SIRVA)', 'organization': {'class': 'OTHER', 'fullName': 'University Hospital, Basel, Switzerland'}, 'officialTitle': 'Ultrasound and Immunological Findings in Patients With Shoulder Injury Related to Vaccine Administration (SIRVA)', 'orgStudyIdInfo': {'id': 'SIRVA'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'SIRVA', 'description': 'Subjects with shoulder pain \\>7 days after vaccination', 'interventionNames': ['Diagnostic Test: Ultrasound Shoulder and Immunological Phenotyping by FACS']}, {'label': 'Controls', 'description': 'Subjects from a prospective influenza vaccine study', 'interventionNames': ['Diagnostic Test: Ultrasound Shoulder and Immunological Phenotyping by FACS']}], 'interventions': [{'name': 'Ultrasound Shoulder and Immunological Phenotyping by FACS', 'type': 'DIAGNOSTIC_TEST', 'description': 'Cross-sectional Ultrasound exam of the affected shoulder. Peripheral blood measurements of the T and B cell subsets. Anti-Influenza Antibody measurements', 'armGroupLabels': ['Controls', 'SIRVA']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Basel', 'country': 'Switzerland', 'facility': 'University Hospital Basel', 'geoPoint': {'lat': 47.55839, 'lon': 7.57327}}], 'overallOfficials': [{'name': 'Christoph Berger, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University Hospital, Basel, Switzerland'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED', 'description': 'Data on flowcytometry based immunophenotyping'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Hospital, Basel, Switzerland', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'PI Translational Immunology', 'investigatorFullName': 'Christoph Berger', 'investigatorAffiliation': 'University Hospital, Basel, Switzerland'}}}}