Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 9:09 PM
Ignite Modification Date:
2025-12-24 @ 9:09 PM
NCT ID:
NCT07252804
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 Associations for Rheumatology; patients with JSLE, the American College of Rheumatology criteria; and those with JDM, the Bohan \& Peter criteria.
Exclusion Criteria:
* 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.
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
2 Years
Maximum Age:
25 Years
Study:
NCT07252804
Study Brief:
Protocol Section:
NCT07252804