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| Name | Class |
|---|---|
| Pfizer | INDUSTRY |
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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.
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 PPV23 vaccine or are PPV23 vaccine naïve will be measured by ELISA and OPA (opsonophagocytic assay) titers after 4 and 52 weeks.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| PPV23 naive, PPV23 vaccination | Active Comparator | vaccination with PPV-23 in 40 PPV-23 naive patients |
|
| PPV23 naive, PCV13 vaccination | Experimental | vaccination with PCV-13 in 40 PPV-23 naive patients |
|
| PPV23 > 4 years ago, PCV13 vaccination | Experimental | vaccination with PCV-13 in 40 patients that received PPV-23 more than 4 years ago |
|
| PPV23 < 4 years, PCV13 vaccination | Experimental | vaccination with PCV-13 in 40 patients that received PPV-23 less than 4 years ago |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| PPV23 vaccination or PCV13 vaccination | Biological |
|
| Measure | Description | Time Frame |
|---|---|---|
| Antibody response after vaccination to involved serotypes measured by OPA and ELISA | 52 weeks after vaccination |
| Measure | Description | Time Frame |
|---|---|---|
| record of side effects of vaccination | first week after vaccination | |
| Antibody response after vaccination to involved serotypes measured by OPA and ELISA | 4 weeks after vaccination |
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Inclusion Criteria:
Exclusion Criteria:
Patients not fulfilling the inclusion criteria.
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| Name | Affiliation | Role |
|---|---|---|
| Stefaan J Vandecasteele, MD, PhD | Department of Nephrology and Infectious Diseases, AZ Sint-Jan Brugge, Belgium | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Dienst Nefrologie, OLV Ziekenhuis | Aalst | 9300 | Belgium | |||
| AZ Sint-Jan Brugge Oostende AV |
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| ID | Term |
|---|---|
| D007676 | Kidney Failure, Chronic |
| ID | Term |
|---|---|
| D051436 | Renal Insufficiency, Chronic |
| D051437 | Renal Insufficiency |
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
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| ID | Term |
|---|---|
| C538862 | 13-valent pneumococcal vaccine |
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|
| Bruges |
| 8000 |
| Belgium |
| D052776 |
| Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |