Ignite Creation Date:
2025-12-24 @ 11:50 PM
Ignite Modification Date:
2025-12-25 @ 9:44 PM
Study NCT ID:
NCT05547451
Status:
RECRUITING
Last Update Posted:
2024-06-21
First Post:
2022-09-12
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
SARS Cov 2 Vaccination in Adolescents With Juvenile Idiopathic Arthritis
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001171', 'term': 'Arthritis, Juvenile'}], 'ancestors': [{'id': 'D001168', 'term': 'Arthritis'}, {'id': 'D007592', 'term': 'Joint Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}, {'id': 'D012216', 'term': 'Rheumatic Diseases'}, {'id': 'D003240', 'term': 'Connective Tissue Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}, {'id': 'D001327', 'term': 'Autoimmune Diseases'}, {'id': 'D007154', 'term': 'Immune System Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'CROSS_SECTIONAL', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 200}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2024-06-09', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-06', 'completionDateStruct': {'date': '2025-06-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-06-20', 'studyFirstSubmitDate': '2022-09-12', 'studyFirstSubmitQcDate': '2022-09-16', 'lastUpdatePostDateStruct': {'date': '2024-06-21', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-09-21', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-06-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'SARS Cov2 vaccination coverage of this population and factors influencing the realization of the vaccination.', 'timeFrame': 'From june 2021 to December 2022', 'description': 'Percentage of patients vaccinated'}], 'secondaryOutcomes': [{'measure': 'Tolerance of the SARS-Cov2 vaccination', 'timeFrame': 'From june 2021 to December 2022', 'description': 'Occurrence of any side-effects'}, {'measure': 'Effect of the SARS Cov2 vaccination on juvenile arthritis', 'timeFrame': 'From june 2021 to December 2022', 'description': 'Occurrence of flare up of the illness, modification of treatment'}, {'measure': 'SARS-Cov 2 infection after vaccination', 'timeFrame': 'From june 2021 to December 2022', 'description': 'Occurrence and severity of the infection'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['SARS Cov2 vaccination', 'juvenile idiopathic arthritis', 'paediatric', 'safety', 'acceptance'], 'conditions': ['SARS Cov 2 Vaccination in Adolescents With Juvenile Idiopathic Arthritis']}, 'descriptionModule': {'briefSummary': 'Since june 2021, vaccination against the SARS-Cov2 virus is recommanded in France to all children from 12 to 18 years old. In the specific population of teenagers living with juvenile arthritis, the vaccine seems to be safe and well tolerated. It has been shown previously that this population has a vaccine coverage lower than the global population even though few datas are available on this topic The aim of this resarch is to study the vaccination coverage against the SARS-Cov2 virus and more specifically the reasons why adolescents were or were not vaccinated in the population of adolescents with juvenile arthitis followed up in Angers, Nantes and Rennes. For this purpose, a review of the medical record will be done and a questionnaire will be adressed to the family of patients in order to collect informations about the disease, the treatments, the motives or obstacles to vaccination. Secondaries end points are safety of the vaccination, consequences on the juvenile arthritis (such as changes in the medication, flare-up of the illness) and the occurence of covid infection after vaccination.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '18 Years', 'minimumAge': '12 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients from 12 to 18 years old followed up from juvenile arthritis in 2021 and 2022 at Angers, Nantes and Rennes.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients from 12 to 18 years old, on January the 1st 2022\n* Patients followed up from juvenile arthritis\n* Patients followed up in 2021 and 2022\n\nExclusion Criteria:\n\n* Patients under 12 years old.'}, 'identificationModule': {'nctId': 'NCT05547451', 'acronym': 'VACOVAJI', 'briefTitle': 'SARS Cov 2 Vaccination in Adolescents With Juvenile Idiopathic Arthritis', 'organization': {'class': 'OTHER', 'fullName': 'Nantes University Hospital'}, 'officialTitle': 'SARS Cov2 Vaccination in Adolescents From 12 to 18 With Juvenile Idiopathic Arthritis in Angers, Nantes and Rennes : Acceptance and Safety.', 'orgStudyIdInfo': {'id': 'RC22_0237'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Trial population', 'description': 'Children from 12 to 18 years old followed up for juvenile arthritis in Angers, Nantes and Rennes.'}]}, 'contactsLocationsModule': {'locations': [{'zip': '44300', 'city': 'Nantes', 'state': 'Loire-Atlantique', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Soizic Tiriau', 'role': 'CONTACT'}], 'facility': 'CHU de Nantes', 'geoPoint': {'lat': 47.21725, 'lon': -1.55336}}], 'centralContacts': [{'name': 'Soizic TIRIAU, Dr', 'role': 'CONTACT', 'email': 'soizic.tiriau@chu-nantes.fr', 'phone': '02 76 64 39 57'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Nantes University Hospital', 'class': 'OTHER'}, 'collaborators': [{'name': 'University Hospital, Angers', 'class': 'OTHER_GOV'}, {'name': 'Rennes University Hospital', 'class': 'OTHER'}, {'name': "Clinique de l'Anjou", 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}