Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03833271
Recruitment Status : Completed
First Posted : February 6, 2019
Last Update Posted : June 17, 2020
Sponsor:
Information provided by (Responsible Party):
Nagy Arnold, University of Pecs

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.


Condition or disease Intervention/treatment Phase
Juvenile Idiopathic Arthritis Biological: Influenza vaccine, Immune function Early Phase 1

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 62 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: The Investigation of Immune Function and the Effectiveness of Influenza Vaccine in Children With Juvenile Idiopathic Arthritis Compared to Healthy Control
Actual Study Start Date : October 28, 2018
Actual Primary Completion Date : September 30, 2019
Actual Study Completion Date : September 30, 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: TNF-alpha inhibitor 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.

Active Comparator: Methotrexate 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.

Active Comparator: Healthy 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.




Primary Outcome Measures :
  1. 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.

  2. Immune response to influenza vaccine, the rate of seroconversion [ Time Frame: 12-14 weeks ]
    Measuring seroconversion after influenza vaccine (IU)



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   3 Years to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03833271


Locations
Layout table for location information
Hungary
University of Pécs, Medical School, Department of Paediatrics
Pécs, Hungary
Sponsors and Collaborators
University of Pecs
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Layout table for additonal information
Responsible Party: Nagy Arnold, Principal Investigator, University of Pecs
ClinicalTrials.gov Identifier: NCT03833271    
Other Study ID Numbers: MS Pecs-Paediatrics
First Posted: February 6, 2019    Key Record Dates
Last Update Posted: June 17, 2020
Last Verified: June 2020

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
Layout table for MeSH terms
Arthritis
Arthritis, Juvenile
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases