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Pneumococcal Vaccination of Crohn Patients

NCT01947010 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 151

Last updated 2015-02-10

No results posted yet for this study

Summary

Inflammatory bowel disease (IBD) are at increased risk of infections. This increased susceptibility to infections is due to the disease itself, but also be-cause many patients with autoimmune conditions are treated with immuno-suppressive drugs, such as azathioprine and or TNF-a inhibitors.

Streptococcus pneumoniae (pneumococcus) is a cause of worldwide morbidity and mortality and one of the most common cause of bacterial meningitis in adults. Infection with pneumococcus can be prevented with vaccination. Two pneumococcal vaccine are used in Denmark, the 23 valent polysaccharide-based vaccine (23PPV) and the 13 valent of conjugate pneumococcal vaccines (PCV13).

In this study the investigators wish to study the effect of pneumococcal vaccination with either PPV23 or PCV13 in IBD patients treated with either TNF-a inhibitors, azathioprine or untreated.

Conditions

  • Crohns Disease

Interventions

BIOLOGICAL

Prevenar 13

BIOLOGICAL

Pneumovax

Sponsors & Collaborators

  • Hvidovre University Hospital

    collaborator OTHER

  • Herlev Hospital

    collaborator OTHER

  • Statens Serum Institut

    lead OTHER

Principal Investigators

  • Andreas M Petersen, MD · Hvidovre University Hospital

  • Ole Ø Thomsen, MD · Herlev Hospital

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
SINGLE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-07-31
Primary Completion
2014-08-31
Completion
2014-08-31

Countries

  • Denmark

Study Locations

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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 NCT01947010 on ClinicalTrials.gov