Recruiting PHASE4 Autoimmune Rheumatologic Disease

Tests treatment safety and results for Autoimmune Rheumatologic Disease

Official title Safety and Immunogenicity of PCV20 in Pediatric Patients With Autoimmune Rheumatic Diseases

ClinicalTrials.gov ID: NCT07252791

What this study is testing

What is Pneumococcal Vaccine?

Pneumococcal Vaccine 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 20-valent pneumococcal conjugate vaccine.

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
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.
  • Phase 4: studies an already-approved treatment

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

  • Age 2-25 years
  • Diagnosis of JIA, jSLE, or JDM by validated classification criteria
  • Clinically stable
  • Informed consent/assent

You likely can't join if

  • Acute infection or fever at vaccination
  • Severe allergic reaction to vaccine components
  • Recent blood transfusion (\<6 months)
  • Other vaccine within 4 weeks prior at the time of inclusion
  • Pregnancy or breastfeeding
  • Prior PCV20

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.