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
1 other identifier
interventional
62
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for early_phase_1
Started Oct 2018
Shorter than P25 for early_phase_1
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 28, 2018
CompletedFirst Submitted
Initial submission to the registry
January 21, 2019
CompletedFirst Posted
Study publicly available on registry
February 6, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 30, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
September 30, 2019
CompletedJune 17, 2020
June 1, 2020
11 months
January 21, 2019
June 15, 2020
Conditions
Outcome Measures
Primary Outcomes (2)
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
Study Arms (3)
TNF-alpha inhibitor
ACTIVE COMPARATORMethotrexate
ACTIVE COMPARATORHealthy
ACTIVE COMPARATORInterventions
Comparing immune function and seroconversion after immunizing healthy children and juvenile idiopathic arthritis (JIA) children treated with different type of medication with influenza vaccine.
Eligibility Criteria
You may qualify if:
- JIA (oligoarticular, polyarticular) treated with MTX or MTX/adalimumab
- Healthy controls
You may not qualify if:
- Children with infection
- Children with active JIA disease
- JIA other than oligoarticular, polyarticular type
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
University of Pécs, Medical School, Department of Paediatrics
Pécs, Hungary
Related Publications (1)
Nagy A, Mosdosi B, Simon D, Dergez T, Berki T. Peripheral Blood Lymphocyte Analysis in Oligo- and Polyarticular Juvenile Idiopathic Arthritis Patients Receiving Methotrexate or Adalimumab Therapy: A Cross-Sectional Study. Front Pediatr. 2020 Dec 10;8:614354. doi: 10.3389/fped.2020.614354. eCollection 2020.
PMID: 33363071DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- early phase 1
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal Investigator
Study Record Dates
First Submitted
January 21, 2019
First Posted
February 6, 2019
Study Start
October 28, 2018
Primary Completion
September 30, 2019
Study Completion
September 30, 2019
Last Updated
June 17, 2020
Record last verified: 2020-06