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NCT03833271 Clinical Trial

The Efficacy of Influenza Vaccine Program in Children With Juvenile Idiopathic Arthritis. A Single Centre Results From Hungary

Juvenile Idiopathic Arthritis Clinical Trial

Official title:
The Investigation of Immune Function and the Effectiveness of Influenza Vaccine in Children With Juvenile Idiopathic Arthritis Compared to Healthy Control

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT03833271
Other study ID # MS Pecs-Paediatrics
Secondary ID
Status Completed
Phase Early Phase 1
First received
Last updated
Start date October 28, 2018
Est. completion date September 30, 2019

Study information
Verified date June 2020
Source University of Pecs
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The aim of our study is to compare the immune function of patient treated with DMARD (methotrexate), or tumor necrosis factor (TNF)-alpha inhibitor (adalimumab) to healthy children. The study consists of three parts. In each part physical examination and routine laboratory tests are done.

At the first examination flow cytometry analysis is performed, after that the participants are immunized with influenza (3Fluart) vaccine. At part two and three further flow cytometry is carried out and seroconversion is measured.

Recruitment information / eligibility
Status Completed
Enrollment 62
Est. completion date September 30, 2019
Est. primary completion date September 30, 2019
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 3 Years to 18 Years
Eligibility Inclusion Criteria:

- JIA (oligoarticular, polyarticular) treated with MTX or MTX/adalimumab

- Healthy controls

Exclusion Criteria:

- Children with infection

- Children with active JIA disease

- JIA other than oligoarticular, polyarticular type

Study Design

Related Conditions & MeSH terms

Intervention

Biological:
• Influenza vaccine, Immune function
Comparing immune function and seroconversion after immunizing healthy children and juvenile idiopathic arthritis (JIA) children treated with different type of medication with influenza vaccine.

Locations
Country Name City State
Hungary University of Pécs, Medical School, Department of Paediatrics Pécs

Sponsors (1)
Lead Sponsor Collaborator
University of Pecs

Country where clinical trial is conducted

Hungary, 

Outcome
Type Measure Description Time frame Safety issue
Primary Comparing the healthy population and the JIA participants treated with DMARD (MTX) or TNF-alpha inhibitor (adalimumab) Analysing T and B cells (%, /microL) by flow cytometry. 12-14 weeks
Primary Immune response to influenza vaccine, the rate of seroconversion Measuring seroconversion after influenza vaccine (IU) 12-14 weeks
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