Prevention of serious pneumococcal infections in people with Crohn's disease
- Conditions
- Crohn's DiseaseMedDRA version: 15.1Level: LLTClassification code 10069594Term: Pneumococcal immunizationSystem Organ Class: 100000004865Therapeutic area: Diseases [C] - Immune System Diseases [C20]
- Registration Number
- EUCTR2012-002867-86-DK
- Lead Sponsor
- Statens Serum Institut
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- Not specified
Inclusion Criteria
Crohn's disease, receive immunosuppressive treatment or no treatment
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 150
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range
Exclusion Criteria
<18 years of age, pregnant, anemia, previously pneumococcus vaccination
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: To evaluate the impact of immunosuppressive drugs on the vaccination response in patients with Crohn's disease<br><br>;Secondary Objective: To evaluate the specific antibody production of two different pneumococcal vaccines (mentioned below) in patients with Crohn's disease<br>A)pneumococcal polysaccharide vaccine (23GPS)<br>B)pneumococcal conjugate vaccine (PCV13)<br>;Primary end point(s): Significant difference of antibody levels between pre-vaccnation sample and post-vaccination sample, independent of treatment for CD.;Timepoint(s) of evaluation of this end point: 4 weeks and one year past vaccination
- Secondary Outcome Measures
Name Time Method Secondary end point(s): Significant difference of antibody levels between pre-vaccnation sample and post-vaccination sample, as function off CD treatment..;Timepoint(s) of evaluation of this end point: 4 weeks and one year past vaccination