Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
Register:
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ClinicalTrials.gov |
Last refreshed on:
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19 February 2015 |
Main ID: |
NCT01947010 |
Date of registration:
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09/09/2013 |
Prospective Registration:
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No |
Primary sponsor: |
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Public title:
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Pneumococcal Vaccination of Crohn Patients
PneuVAC |
Scientific title:
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Pneumococcal Vaccination of Crohn Patients - A Randomized, Non-blinded Phase 4 Clinical Trial With the Purpose of Investigating the Immune Response Against Two Different Pneumococcal Vaccines in Patients With Crohn's Disease |
Date of first enrolment:
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July 2013 |
Target sample size:
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151 |
Recruitment status: |
Completed |
URL:
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http://clinicaltrials.gov/show/NCT01947010 |
Study type:
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Interventional |
Study design:
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Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Single Blind (Investigator), Primary Purpose: Prevention
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Phase:
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Phase 4
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Countries of recruitment
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Denmark
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Contacts
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Name:
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Ole Ø Thomsen, MD |
Address:
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Telephone:
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Email:
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Affiliation:
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Herlev Hospital |
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Name:
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Andreas M Petersen, MD |
Address:
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Telephone:
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Email:
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Affiliation:
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Hvidovre University Hospital |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- Crohn's disease, receive immunosuppressive treatment or no treatment
Exclusion Criteria:
- <18 years of age,
- pregnant,
- anemia,
- previously pneumococcus vaccination
Age minimum:
18 Years
Age maximum:
N/A
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Crohns Disease
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Intervention(s)
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Biological: Pneumovax
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Biological: Prevenar 13
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Primary Outcome(s)
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Change in antibody titers
[Time Frame: Day 0, 4 weeks post vaccination, 1 year post vaccination]
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Secondary Outcome(s)
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Change in antibody titers as a function of Crohns disease treatment
[Time Frame: Day 0, 4 weeks post vaccination, 1 year post vaccination]
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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