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

Study Overview
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Brief Summary
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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.

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

Conditions
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Juvenile Idiopathic Arthritis

Intervention / Treatment
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* Biological: Influenza vaccine, Immune function


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 3 Years
Maximum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: TNF-alpha inhibitor<br> | Biological: Influenza vaccine, Immune function<br>* Comparing immune function and seroconversion after immunizing healthy children and juvenile idiopathic arthritis (JIA) children treated with different type of medication with influenza vaccine.<br>|
| Active Comparator: Methotrexate<br> | Biological: Influenza vaccine, Immune function<br>* Comparing immune function and seroconversion after immunizing healthy children and juvenile idiopathic arthritis (JIA) children treated with different type of medication with influenza vaccine.<br>|
| Active Comparator: Healthy<br> | Biological: Influenza vaccine, Immune function<br>* Comparing immune function and seroconversion after immunizing healthy children and juvenile idiopathic arthritis (JIA) children treated with different type of medication with influenza vaccine.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| Immune response to influenza vaccine, the rate of seroconversion | Measuring seroconversion after influenza vaccine (IU) | 12-14 weeks |