13 Valent Pneumococcal Conjugate Vaccine in Chronic Dialysis Patients
NCT02492438 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 154
Last updated 2015-07-08
Summary
To assess the immunogenicity of the PCV13 (13 valent pneumococcal conjugated vaccine) vaccine as compared to the PPV23 (23 valent pneumococcal polysaccharide vaccine) vaccine in patients treated with chronic hemodialysis that are pre-immunized with the PPSV23 vaccine or are PPV23 vaccine naïve by measuring the ELISA and OPA (opsonophagocytic assay) titers after 4 and 52 weeks.
Conditions
- Chronic Kidney Failure
Interventions
- BIOLOGICAL
-
PPV23 vaccination or PCV13 vaccination
Sponsors & Collaborators
- collaborator INDUSTRY
-
AZ Sint-Jan AV
lead OTHER
Principal Investigators
-
Stefaan J Vandecasteele, MD, PhD · Department of Nephrology and Infectious Diseases, AZ Sint-Jan Brugge, Belgium
Study Design
- Allocation
- NON_RANDOMIZED
- Purpose
- PREVENTION
- Masking
- NONE
- Model
- PARALLEL
Eligibility
- Min Age
- 50 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2013-02-28
- Primary Completion
- 2014-02-28
- Completion
- 2014-03-31
Countries
- Belgium
Study Locations
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