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

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

Status
Completed
Phases
Early Phase 1
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03833271
Enrollment
62
Registered
2019-02-06
Start date
2018-10-28
Completion date
2019-09-30
Last updated
2020-06-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Juvenile Idiopathic Arthritis

Brief 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.

Interventions

BIOLOGICALInfluenza 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.

Sponsors

University of Pecs
Lead SponsorOTHER

Study design

Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
3 Years to 18 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Comparing the healthy population and the JIA participants treated with DMARD (MTX) or TNF-alpha inhibitor (adalimumab)12-14 weeksAnalysing T and B cells (%, /microL) by flow cytometry.
Immune response to influenza vaccine, the rate of seroconversion12-14 weeksMeasuring seroconversion after influenza vaccine (IU)

Countries

Hungary

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 16, 2026