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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. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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3 August 2015 |
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Main ID: |
NCT02492438 |
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Date of registration:
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24/08/2014 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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13 Valent Pneumococcal Conjugate Vaccine in Chronic Dialysis Patients
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Scientific title:
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Immunogenicity and Safety of the 13-valent Pneumococcal Conjugate Vaccine in Chronic Dialysis Patients That Are 23-valent Pneumococcal Polysaccharide Vaccine Naive and Pre-immunized. |
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Date of first enrolment:
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February 2013 |
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Target sample size:
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154 |
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Recruitment status: |
Completed |
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URL:
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https://clinicaltrials.gov/show/NCT02492438 |
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Study type:
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Interventional |
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Study design:
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Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, 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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Belgium
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Contacts
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Name:
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Stefaan J Vandecasteele, MD, PhD |
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Address:
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Telephone:
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Email:
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Affiliation:
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Department of Nephrology and Infectious Diseases, AZ Sint-Jan Brugge, Belgium |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
1. they are under chronic dialysis treatment
2. are 50 years or older and not pregnant
3. have no immediate life threatening conditions
4. are not allergic to one of the compounds of the vaccine
5. have a known pneumococcal vaccination status
6. give their informed consent.
Exclusion Criteria:
Patients not fulfilling the inclusion criteria.
Age minimum:
50 Years
Age maximum:
N/A
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Chronic Kidney Failure
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Intervention(s)
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Biological: PPV23 vaccination or PCV13 vaccination
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Primary Outcome(s)
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Antibody response after vaccination to involved serotypes measured by OPA and ELISA
[Time Frame: 52 weeks after vaccination]
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Secondary Outcome(s)
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Antibody response after vaccination to involved serotypes measured by OPA and ELISA
[Time Frame: 4 weeks after vaccination]
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record of side effects of vaccination
[Time Frame: first week after vaccination]
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Secondary ID(s)
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WS2113445
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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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