MedTrace Logo

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

NCT07252791 · Status: RECRUITING · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 114

Last updated 2026-03-04

No results posted yet for this study

Summary

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 events will be measured up to 6 months post-vaccination. Effects of immunosuppressive therapy and physical activity levels related vaccine response will also be assessed.

Conditions

  • Autoimmune Rheumatologic Disease

Interventions

BIOLOGICAL

Pneumococcal Vaccine

0.5 mL intramuscular dose containing polysaccharide conjugates for 20 pneumococcal serotypes (PCV20, Prevenar 20) vaccine will be administered intramuscularly in 1 dose in patients with ARDs and healthy controls.

Sponsors & Collaborators

  • Insituto Adolfo Lutz

    collaborator UNKNOWN

  • University of Sao Paulo General Hospital

    lead OTHER

Study Design

Allocation
NON_RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
2 Years
Max Age
25 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2026-01-16
Primary Completion
2026-12-30
Completion
2027-12-30

Countries

  • Brazil

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07252791 on ClinicalTrials.gov