SARS Cov 2 Vaccination in Adolescents With Juvenile Idiopathic Arthritis (VACOVAJI)

March 20, 2024 updated by: Nantes University Hospital

SARS Cov2 Vaccination in Adolescents From 12 to 18 With Juvenile Idiopathic Arthritis in Angers, Nantes and Rennes : Acceptance and Safety.

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.

Study Overview

Status

Recruiting

Conditions

Study Type

Observational

Enrollment (Estimated)

200

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • France
    • Loire-Atlantique
      • Nantes, Loire-Atlantique, France, 44300
        • Recruiting
        • CHU de Nantes
        • Contact:
          • Soizic Tiriau

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

12 years to 18 years (Child, Adult)

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Patients from 12 to 18 years old followed up from juvenile arthritis in 2021 and 2022 at Angers, Nantes and Rennes.

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Trial population
Children from 12 to 18 years old followed up for juvenile arthritis in Angers, Nantes and Rennes.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
SARS Cov2 vaccination coverage of this population and factors influencing the realization of the vaccination.
Time Frame: From june 2021 to December 2022
Percentage of patients vaccinated
From june 2021 to December 2022

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Tolerance of the SARS-Cov2 vaccination
Time Frame: From june 2021 to December 2022
Occurrence of any side-effects
From june 2021 to December 2022
Effect of the SARS Cov2 vaccination on juvenile arthritis
Time Frame: From june 2021 to December 2022
Occurrence of flare up of the illness, modification of treatment
From june 2021 to December 2022
SARS-Cov 2 infection after vaccination
Time Frame: From june 2021 to December 2022
Occurrence and severity of the infection
From june 2021 to December 2022

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Nantes University Hospital

Collaborators

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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

September 30, 2024

Primary Completion (Estimated)

September 30, 2025

Study Completion (Estimated)

September 30, 2025

Study Registration Dates

First Submitted

September 12, 2022

First Submitted That Met QC Criteria

September 16, 2022

First Posted (Actual)

September 21, 2022

Study Record Updates

Last Update Posted (Actual)

March 21, 2024

Last Update Submitted That Met QC Criteria

March 20, 2024

Last Verified

March 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • RC22_0237

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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