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

University of Pecs

Status and phase: Completed; Early Phase 1

Conditions: Juvenile Idiopathic Arthritis

Treatments: Biological: Influenza vaccine, Immune function

Study type: Interventional

Funder types: Other

Identifiers

NCT03833271

MS Pecs-Paediatrics

Details and patient eligibility

About

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.

Enrollment: 62 patients

Sex: All

Ages: 3 to 18 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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62 participants in 3 patient groups

TNF-alpha inhibitor

Active Comparator group

Treatment:

Biological: Influenza vaccine, Immune function

Methotrexate

Active Comparator group

Treatment:

Biological: Influenza vaccine, Immune function

Healthy

Active Comparator group

Treatment:

Biological: Influenza vaccine, Immune function