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VACOVAJI: SARS Cov 2 Vaccination in Adolescents With Juvenile Idiopathic Arthritis

Sponsor
Nantes University Hospital (Other)
Overall Status
Recruiting
CT.gov ID
NCT05547451
Collaborator
University Hospital, Angers (Other), Rennes University Hospital (Other), Clinique de l'Anjou (Other)
200
Enrollment
1
Location
6.6
Anticipated Duration (Months)
30.4
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease Intervention/Treatment Phase

    Study Design

    Study Type:
    Observational
    Anticipated Enrollment :
    200 participants
    Observational Model:
    Cohort
    Time Perspective:
    Cross-Sectional
    Official Title:
    SARS Cov2 Vaccination in Adolescents From 12 to 18 With Juvenile Idiopathic Arthritis in Angers, Nantes and Rennes : Acceptance and Safety.
    Actual Study Start Date :
    Sep 12, 2022
    Anticipated Primary Completion Date :
    Sep 12, 2022
    Anticipated Study Completion Date :
    Mar 31, 2023

    Arms and Interventions

    Arm Intervention/Treatment
    Trial population

    Children from 12 to 18 years old followed up for juvenile arthritis in Angers, Nantes and Rennes.

    Outcome Measures

    Primary Outcome Measures

    1. SARS Cov2 vaccination coverage of this population and factors influencing the realization of the vaccination. [From june 2021 to December 2022]

      Percentage of patients vaccinated

    Secondary Outcome Measures

    1. Tolerance of the SARS-Cov2 vaccination [From june 2021 to December 2022]

      Occurrence of any side-effects

    2. Effect of the SARS Cov2 vaccination on juvenile arthritis [From june 2021 to December 2022]

      Occurrence of flare up of the illness, modification of treatment

    3. SARS-Cov 2 infection after vaccination [From june 2021 to December 2022]

      Occurrence and severity of the infection

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    12 Years to 18 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    • Patients from 12 to 18 years old, on January the 1st 2022

    • Patients followed up from juvenile arthritis

    • Patients followed up in 2021 and 2022

    Exclusion Criteria:
    • Patients under 12 years old.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 CHU de Nantes Nantes Loire-Atlantique France 44300

    Sponsors and Collaborators

    • Nantes University Hospital
    • University Hospital, Angers
    • Rennes University Hospital
    • Clinique de l'Anjou

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Nantes University Hospital
    ClinicalTrials.gov Identifier:
    NCT05547451
    Other Study ID Numbers:
    • RC22_0237
    First Posted:
    Sep 21, 2022
    Last Update Posted:
    Sep 21, 2022
    Last Verified:
    Sep 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    Undecided
    Plan to Share IPD:
    Undecided
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Nantes University Hospital
    SARS Cov2 vaccination
    juvenile idiopathic arthritis
    paediatric
    safety
    acceptance
    Additional relevant MeSH terms:
    Arthritis
    Arthritis, Juvenile

    Study Results

    No Results Posted as of Sep 21, 2022