Last reviewed · How we verify
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.
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.
Details
| Lead sponsor | AZ Sint-Jan AV |
|---|---|
| Phase | Phase 4 |
| Status | COMPLETED |
| Enrolment | 154 |
| Start date | 2013-02 |
| Completion | 2014-03 |
Conditions
- Chronic Kidney Failure
Interventions
- PPV23 vaccination or PCV13 vaccination
Primary outcomes
- Antibody response after vaccination to involved serotypes measured by OPA and ELISA — 52 weeks after vaccination
Countries
Belgium