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Tests treatment safety and results for Autoimmune Rheumatologic Disease
Official title Immunogenicity and Safety of MenB Vaccine in Pediatric Patients With Autoimmune Rheumatic Diseases
ClinicalTrials.gov ID: NCT07252804
What this study is testing
What is Meningococcal B (Bexsero)?
Meningococcal B (Bexsero) is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for autoimmune rheumatologic disease.
Also referred to as MenB-4C.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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 evaluate the impact of the MenB-4C vaccine on disease activity in patients with ARDs; To evaluate the safety of the MenB-4C vaccine in pediatric patients with ARDs and controls.
- Phase 4: studies an already-approved treatment
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 2 to 25. Healthy volunteers may be eligible.
You may be able to join if
- 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...
You likely can't join if
- History of any reaction or hypersensitivity to any vaccine component;
- Acute infectious disease and/or fever at the time of vaccination;
- Pregnancy or breastfeeding;
- History of Guillain-Barré syndrome;
- Participants who fail to attend evaluation visits and laboratory sample collection; hospitalization at study inclusion;
- Transfusion of blood products within 6 months prior to the study;
See the full eligibility 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 Associations for Rheumatology; patients with...
- History of any reaction or hypersensitivity to any vaccine component;
- Acute infectious disease and/or fever at the time of vaccination;
- Pregnancy or breastfeeding;
- History of Guillain-Barré syndrome;
- Participants who fail to attend evaluation visits and laboratory sample collection; hospitalization at study inclusion;
- Transfusion of blood products within 6 months prior to the study;
- Application of any vaccine within one month prior to each dose.
The study team makes the final eligibility decision.
Where it's taking place
- São Paulo, São Paulo, Brazil
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 2 years to 25 years. Healthy volunteers may be eligible. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include São Paulo, São Paulo, Brazil. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.