Ignite Creation Date:
2025-12-25 @ 3:03 AM
Ignite Modification Date:
2025-12-26 @ 1:43 AM
Study NCT ID:
NCT05234333
Status:
COMPLETED
Last Update Posted:
2022-05-05
First Post:
2022-02-09
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
COVID-19 Vaccines Associated Malaise
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D000086663', 'term': 'COVID-19 Vaccines'}], 'ancestors': [{'id': 'D014765', 'term': 'Viral Vaccines'}, {'id': 'D014612', 'term': 'Vaccines'}, {'id': 'D001688', 'term': 'Biological Products'}, {'id': 'D045424', 'term': 'Complex Mixtures'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'CROSS_SECTIONAL', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 1534706}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2021-01-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-04', 'completionDateStruct': {'date': '2022-01-26', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-04-29', 'studyFirstSubmitDate': '2022-02-09', 'studyFirstSubmitQcDate': '2022-02-09', 'lastUpdatePostDateStruct': {'date': '2022-05-05', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-02-10', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-01-26', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'disproportionality analysis in VigiBase® : search for an over-reporting of malaise with COVID-19 vaccines compared to influenza vaccines', 'timeFrame': 'from the 01/01/2021 to the 26/01/2022', 'description': 'case/no case study'}]}, 'oversightModule': {'isUsExport': True, 'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Vaccine Adverse Reaction']}, 'descriptionModule': {'briefSummary': 'COVID-19 vaccines induced malaise have recently been reported in the literature. Our study aims to identify risk factors associated with the onset of COVID-19 vaccines induced malaise and to assess if certain COVID-19 vaccines could be more prone to cause malaise compared to influenza vaccines.\n\nTo do so we performed a disproportionality analysis adjusted on age class, sex, region and type of reporter in VigiBase®, the WHO pharmacovigilance database, restricted to data from 01/01/2021 to 26/01/2022 to assess the association between all COVID-19 vaccines on the market and malaise. Demographic data were also analyzed.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'All patients', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* all adverse events reported in the WHO pharmacovigilance database\n\nExclusion Criteria:\n\n* none'}, 'identificationModule': {'nctId': 'NCT05234333', 'briefTitle': 'COVID-19 Vaccines Associated Malaise', 'organization': {'class': 'OTHER', 'fullName': 'University Hospital, Caen'}, 'officialTitle': 'COVID-19 Vaccines Induced Malaise: A Retrospective Study and Analysis of the WHO Pharmacovigilance Database', 'orgStudyIdInfo': {'id': 'Pharmaco 20220203'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Patients presenting a malaise after the vaccination by any vaccine', 'interventionNames': ['Drug: SARS-CoV-2 vaccine']}, {'label': 'Patients presenting any other adverse event after the vaccination by any vaccine', 'interventionNames': ['Drug: SARS-CoV-2 vaccine']}], 'interventions': [{'name': 'SARS-CoV-2 vaccine', 'type': 'DRUG', 'description': 'SARS-CoV-2 vaccination', 'armGroupLabels': ['Patients presenting a malaise after the vaccination by any vaccine', 'Patients presenting any other adverse event after the vaccination by any vaccine']}]}, 'contactsLocationsModule': {'locations': [{'zip': '14033', 'city': 'Caen', 'state': 'Normandy', 'country': 'France', 'facility': 'Caen University Hospital, Department of Pharmacology', 'geoPoint': {'lat': 49.18585, 'lon': -0.35912}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Hospital, Caen', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}