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Trial record 1 of 13 for:    Recruiting, Enrolling by invitation Studies | Juvenile Arthritis | France
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SARS Cov 2 Vaccination in Adolescents With Juvenile Idiopathic Arthritis (VACOVAJI)

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ClinicalTrials.gov Identifier: NCT05547451
Recruitment Status : Recruiting
First Posted : September 21, 2022
Last Update Posted : September 21, 2022
Sponsor:
Collaborators:
University Hospital, Angers
Rennes University Hospital
Clinique de l'Anjou
Information provided by (Responsible Party):
Nantes University Hospital

Study Description
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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
SARS Cov 2 Vaccination in Adolescents With Juvenile Idiopathic Arthritis

Study Design
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Study Type : Observational
Estimated 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 : September 12, 2022
Estimated Primary Completion Date : September 12, 2022
Estimated Study Completion Date : March 31, 2023

Resource links provided by the National Library of Medicine


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


Outcome Measures
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Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. Tolerance of the SARS-Cov2 vaccination [ Time Frame: From june 2021 to December 2022 ]
    Occurrence of any side-effects

  2. 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

  3. SARS-Cov 2 infection after vaccination [ Time Frame: From june 2021 to December 2022 ]
    Occurrence and severity of the infection


Eligibility Criteria
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Ages Eligible for Study:   12 Years to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
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.
Criteria

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
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05547451


Contacts
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Contact: Soizic TIRIAU, Dr 02 76 64 39 57 soizic.tiriau@chu-nantes.fr

Locations
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France
CHU de Nantes Recruiting
Nantes, Loire-Atlantique, France, 44300
Contact: Soizic Tiriau         
Sponsors and Collaborators
Nantes University Hospital
University Hospital, Angers
Rennes University Hospital
Clinique de l'Anjou
More Information
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Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information
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Responsible Party: Nantes University Hospital
ClinicalTrials.gov Identifier: NCT05547451    
Other Study ID Numbers: RC22_0237
First Posted: September 21, 2022    Key Record Dates
Last Update Posted: September 21, 2022
Last Verified: September 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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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:
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Arthritis
Arthritis, Juvenile
Joint Diseases
Musculoskeletal Diseases
 Rheumatic Diseases
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases