An interventional study of 0,5 mg Prevenar i.m. and 0,5 mg seasonal influenza vaccine i.m. in RA, SLE and Vasculitis, sponsored by Region Skane. Completed at 1 site in Sweden. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2018-10-03.
Sponsored by Region Skane · Not applicable, Interventional, and Treatment
The overall objective of this project is to study the influence of modern anti-inflammatory treatments in established inflammatory rheumatic diseases (IRD) on immune response elicited by pneumococcal vaccination using 13-valent conjugate vaccine and influenza vaccination. 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, efficacy in preventing invasive pneumococcal diseases and influenza related serious infections. 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.
230 studies on the registry are indexed under Vasculitis; 68 are open to participants now.
This study's enrollment of 300 is above the median of 48 across 119 interventional studies indexed under Vasculitis.
Browse Vasculitis studies →Region Skane is the lead sponsor of 372 studies on the registry; 113 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
patients with different inflammatory rheumatic disease immunized with 0,5 mg pneumococcal conjugate vaccine i.m.
Biological: 0,5 mg Prevenar i.m. · Biological: 0,5 mg seasonal influenza vaccine i.m.
healthy controls immunized with 0,5 mg pneumococcal conjugate vaccine i.m.
Biological: 0,5 mg Prevenar i.m. · Biological: 0,5 mg seasonal influenza vaccine i.m.
patients with different inflammatory rheumatic diseases immunized with 0,5 mg seasonal influenza vaccine i.m.
Biological: 0,5 mg Prevenar i.m. · Biological: 0,5 mg seasonal influenza vaccine i.m.
healthy controls immunized with 0,5 mg seasonal influenza vaccine i.m.
Biological: 0,5 mg Prevenar i.m. · Biological: 0,5 mg seasonal influenza vaccine i.m.
antibody response following vaccination
measurement of antibody levels against different pneumococcal capsular serotypes and 3 influenza virus strains
Time frame: 4-6 weeks after pneumococcal and influenza vaccination
long-term immunity following pneumococcal vaccination
measurement of antibody levels against different pneumococcal capsular serotypes
Time frame: 3 years after pneumococcal vaccination
long-term immunity after vaccination with pneumococcal conjugate vaccine
measurement of antibody levels against different pneumococcal polysaccharide serotypes
Time frame: 5 years after vaccination
The occurence of severe pneumococcal infections in immunized patients
Analysis of the occurence of severe pneumococcal infections in immunized patients compared to matched not-immunized controls
Time frame: within 5 years after pneumococcal vaccination
This study is completed, as verified in Oct 2018. You cannot join it, but the record below documents what was studied.
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Region Skane