Safety and Immunogenicity of PCV20 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
- 114 (estimated)
- Sponsor
- University of Sao Paulo General Hospital · Other
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About This Trial
This clinical trial evaluates the immunogenicity (humoral and cellular) and safety of the 20-valent pneumococcal conjugate vaccine (PCV20) in children, adolescents, and young adults aged 2-25 years with autoimmune rheumatic diseases (ARDs). All participants will receive PCV20 according to prior vaccine history. Antibody titers, opsonophagocytic activity, cellular immune responses, and adverse even…
Trial Locations
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Eligibility Criteria
Inclusion Criteria:
* Age 2-25 years
* Diagnosis of JIA, jSLE, or JDM by validated classification criteria
* Clinically stable
* Informed consent/assent
Exclusion Criteria:
* Acute infection or fever at vaccination
* Severe allergic reaction to vaccine components
* Recent blood transfusion (\<6 m…
Contacts