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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02240888
Other study ID # 2011/341
Secondary ID Vaccimil
Status Completed
Phase N/A
First received
Last updated
Start date October 2011
Est. completion date May 31, 2018

Study information

Verified date October 2018
Source Region Skane
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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.


Recruitment information / eligibility

Status Completed
Enrollment 300
Est. completion date May 31, 2018
Est. primary completion date December 31, 2017
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria:

- Adult patients with IRD receiving active anti-rheumatic treatments with DMARDs or biological remedies are offered to participate in the study. The protocol permits stratification for prednisolone usage, smoking habits and alcohol consumption.

Exclusion Criteria:

- age <18 years;

- pregnancy,

- known intolerance of vaccine,

- ongoing infection

Study Design


Related Conditions & MeSH terms


Intervention

Biological:
0,5 mg Prevenar i.m.

0,5 mg seasonal influenza vaccine i.m.


Locations

Country Name City State
Sweden Skåne University hospital, Dept of rheumatology Lund

Sponsors (1)

Lead Sponsor Collaborator
Region Skane

Country where clinical trial is conducted

Sweden, 

Outcome

Type Measure Description Time frame Safety issue
Other 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 within 5 years after pneumococcal vaccination
Primary antibody response following vaccination measurement of antibody levels against different pneumococcal capsular serotypes and 3 influenza virus strains 4-6 weeks after pneumococcal and influenza vaccination
Secondary long-term immunity following pneumococcal vaccination measurement of antibody levels against different pneumococcal capsular serotypes 3 years after pneumococcal vaccination
Secondary long-term immunity after vaccination with pneumococcal conjugate vaccine measurement of antibody levels against different pneumococcal polysaccharide serotypes 5 years after vaccination
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