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Serological Response to Pneumococcal Vaccination in Crohn's Disease: A Prospective Multicenter Study

Phase 4
18 Years
Open (Enrolling)
Crohn's Disease

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Trial Information

Serological Response to Pneumococcal Vaccination in Crohn's Disease: A Prospective Multicenter Study

Inclusion Criteria:

- 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

Exclusion Criteria:

- 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

- Any condition which, in the opinion of the Investigator, places the patient at
unacceptable risk if he/she were to participate in the study

Type of Study:


Study Design:

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Outcome Measure:

Serological response rates

Outcome Description:

Serological response rates, defined by number of patients showing adequate response to pneumococcal vaccination (at least a 2-fold increase in antipneumococcal antibodies in the serum compared with baseline)

Outcome Time Frame:

4 weeks

Safety Issue:


Principal Investigator

Hyun-Soo Kim, MD, PhD

Investigator Role:

Study Chair

Investigator Affiliation:

Yonsei University


Korea: Food and Drug Administration

Study ID:

CD vaccination 1.2



Start Date:

December 2011

Completion Date:

January 2013

Related Keywords:

  • Crohn's Disease
  • Crohn's disease
  • Pneumococcal vaccination
  • Crohn Disease