drugset / Trial / NCT03762824

Combined Pneumococcal Conjugate and Polysaccharide Vaccination in Inflammatory Rheumatic Disease

NCT03762824

Phase 4 Completed 300 enrolled Region Skane
Non-randomizedParallel-groupOpen-labelPrevention

Summary

The overall objective of this project is to study the influence of modern anti-inflammatory treatments in established inflammatory rheumatic diseases (IRD) on antibody response elicited by pneumococcal vaccination using 13-valent conjugate vaccine in combined schedules with 23-valent polysaccharide vaccine. In addition, the aim is to study the clinical aspects of vaccination regarding: tolerability in immunosuppressed patients with IRD, impact on existing rheumatic disease, possible association with onset of new autoimmune diseases, long-term immunity following pneumococcal vaccination and efficacy in preventing invasive pneumococcal disease. Results from this study are expected to bridge the existing knowledge gap and contribute to body of evidence needed for recommendations and implementation of vaccination program in IRD patients.

Timeline

Start
2016-06-14
Primary completion
2018-09-03
Completion
2020-12-21

Publications

Drugs

EvaluationDrugModalityDoseRoute
Comparator Pneumovax 23 Vaccine 0.5 ml Intramuscular
Comparator Prevnar 13 Vaccine 0.5 ml Intramuscular