NCT05547451

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.

Trial Health

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Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
200

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jun 2024

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 12, 2022

Completed
9 days until next milestone

First Posted

Study publicly available on registry

September 21, 2022

Completed
1.7 years until next milestone

Study Start

First participant enrolled

June 9, 2024

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2025

Completed
Last Updated

June 21, 2024

Status Verified

June 1, 2024

Enrollment Period

1.1 years

First QC Date

September 12, 2022

Last Update Submit

June 20, 2024

Conditions

Keywords

SARS Cov2 vaccinationjuvenile idiopathic arthritispaediatricsafetyacceptance

Outcome Measures

Primary Outcomes (1)

  • SARS Cov2 vaccination coverage of this population and factors influencing the realization of the vaccination.

    Percentage of patients vaccinated

    From june 2021 to December 2022

Secondary Outcomes (3)

  • Tolerance of the SARS-Cov2 vaccination

    From june 2021 to December 2022

  • Effect of the SARS Cov2 vaccination on juvenile arthritis

    From june 2021 to December 2022

  • SARS-Cov 2 infection after vaccination

    From june 2021 to December 2022

Study Arms (1)

Trial population

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

Eligibility Criteria

Age12 Years - 18 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)
Sampling MethodNon-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.

You may qualify if:

  • 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

You may not qualify if:

  • Patients under 12 years old.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CHU de Nantes

Nantes, Loire-Atlantique, 44300, France

RECRUITING

MeSH Terms

Conditions

Arthritis, Juvenile

Condition Hierarchy (Ancestors)

ArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic DiseasesConnective Tissue DiseasesSkin and Connective Tissue DiseasesAutoimmune DiseasesImmune System Diseases

Central Study Contacts

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 12, 2022

First Posted

September 21, 2022

Study Start

June 9, 2024

Primary Completion

June 30, 2025

Study Completion

June 30, 2025

Last Updated

June 21, 2024

Record last verified: 2024-06

Locations