Immunogenicity and Safety of MenB Vaccine in Pediatric Patients With Autoimmune Rheumatic Diseases

Recruiting Phase 4 Interventional Study
Autoimmune Rheumatologic Disease
No Placebo Group Every participant receives an active treatment — no one gets a placebo. Prior Safety Data This treatment has already been tested in at least one earlier human trial. Healthy Volunteers Welcome You do not need to have the condition being studied to take part.
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At a Glance
Age
2 – 25
Sex
Any
Trial phase
Phase 4
Study type
Interventional
Purpose
Prevention
Participants needed
263 (estimated)
Sponsor
University of Sao Paulo General Hospital · Other
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About This Trial
The goal of this clinical trial is to evaluate the humoral immunogenicity of the meningococcal B vaccine (MenB-4C) in pediatric patients with autoimmune rheumatic diseases (ARDs), compared to age- and sex-matched non-immunosuppressed controls. The main questions it aims to answer are: * To assess the influence of treatment on the response to the MenB-4C vaccine in patients with ARDs; * To evalua…
Trial Locations
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Eligibility Criteria
Inclusion Criteria: * Participants must be between 2 and 25 years of age with no prior history of MenB-4C vaccination. * Patients classified with autoimmune rheumatic diseases will be invited to participate. Patients with JIA must meet the classification criteria of the International League of Ass…
Contacts

Clovis A Silva, Full Professor

11 2661-6570

reumatologia.fmusp@hc.fm.usp.br

CONTACT