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

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.

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Key information

Conditions

Juvenile Idiopathic Arthritis Arthritis Arthritis, Juvenile Autoimmune Diseases Connective Tissue Diseases Immune System Diseases Joint Diseases Musculoskeletal Diseases Rheumatic Diseases Skin and Connective Tissue Diseases

Age range

3 year–18 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Early Phase 1

Primary location

University of Pécs, Medical School, Department of Paediatrics

Pécs, Hungary

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Influenza vaccine, Immune function

Biological

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

Primary outcomes

Comparing the healthy population and the JIA participants treated with DMARD (MTX) or TNF-alpha inhibitor (adalimumab)

Time frame: 12-14 weeks

Analysing T and B cells (%, /microL) by flow cytometry.
Immune response to influenza vaccine, the rate of seroconversion

Time frame: 12-14 weeks

Measuring seroconversion after influenza vaccine (IU)

Sponsors and collaborators

Lead sponsor

University of Pecs

Other

Registry information

Official study title

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

Important dates

Study start: 2018
Primary completion: 2019
Study completion: 2019
First posted: Feb 6, 2019
Registry last updated: Jun 17, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed