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Combined Pneumococcal Conjugate and Polysaccharide Vaccination in Inflammatory Rheumatic Disease

NCT03762824 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 300

Last updated 2023-03-29

No results posted yet for this study

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.

Conditions

Interventions

BIOLOGICAL

13-valent pneumococcal conjugate vaccine

Pneumococcal conjugate vaccination during antirheumatic treatment

BIOLOGICAL

23-valent pneumococcal polysaccharide vaccine

Pneumococcal polysaccharide vaccination during antirheumatic treatment

Sponsors & Collaborators

  • Region Skane

    lead OTHER

Principal Investigators

  • Jehns Martineus, MD · Skåne Universitets sjukhus, dept of rheumatology

Study Design

Allocation
NON_RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

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

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Entities

Diseases

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 NCT03762824 on ClinicalTrials.gov