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.
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