Status:
COMPLETED
Efficacy Study of Pneumococcal Vaccination in Crohn's Disease
Lead Sponsor:
Kyunghee University Medical Center
Collaborating Sponsors:
Wonju Severance Christian Hospital
Seoul National University Hospital
Conditions:
Crohn's Disease
Eligibility:
All Genders
18+ years
Phase:
PHASE4
Brief Summary
A growing number of patients with Crohn's disease are treated with immunosuppressive agents, such as anti-tumor necrosis factor blockers and immunomodulators. Several recent studies have indicated tha...
Eligibility Criteria
Inclusion
- Patients over the age of 18
- Informed consent
- Patients who had a definitive diagnosis of Crohn's disease for more than 6 months (documented by the standard clinical, radiographic, endoscopic, and histopathologic criteria)
Exclusion
- Hypersensitivity to any component of the pneumococcal vaccine
- Known allergy to pneumococcal vaccination
- Patients who treated with glucocorticoids (prednisolone \> 20 mg/day equivalent for 2 weeks or more, and within 3 months of stopping
- Patients who inoculate another vaccine in the past 4 weeks
- Significant protein calorie malnutrition
- Current signs or symptoms of severe, progressive or uncontrolled renal, hepatic, hematologic, endocrine, pulmonary, cardiac, infectious, neurologic or cerebral disease
- Any condition which, in the opinion of the Investigator, places the patient at unacceptable risk if he/she were to participate in the study
Key Trial Info
Start Date :
December 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2013
Estimated Enrollment :
197 Patients enrolled
Trial Details
Trial ID
NCT01505855
Start Date
December 1 2011
End Date
June 1 2013
Last Update
October 16 2014
Active Locations (15)
Enter a location and click search to find clinical trials sorted by distance.
1
Yonsei University: Wonju Christian Hospital
Wŏnju, Gangwon-do, South Korea, 220-701
2
Kosin University Gospel Hospital
Busan, South Korea
3
Soonchunhyang University
Cheonan, South Korea
4
Keimyung University; Dongsan Hospital
Daegu, South Korea