Phase 4
Completed N=25
Study Response of 13-valent Conjugate Pneumococcal Vaccine in Patients With End Stage Renal Disease
Source: ClinicalTrials.gov NCT01974817 ↗Enrolled (actual)
25
Serious AEs
0.0%
Results posted
Nov 2016
Primary outcomePrimary: Change From Baseline in Antibody Concentrations After 13-valent Conjugate Pneumococcal Vaccination in in Patients 50 Years or Older With End Stage Renal Disease on Dialysis — 1.46; 0.79; 0.57; 2.80 µg/ml
◆ Published Evidence
Established
37citations · ~4 / year
Immunogenicity of 13-Valent Conjugate Pneumococcal Vaccine in Patients 50 Years and Older with End-Stage Renal Disease and on Dialysis.
Summary
The purpose of the study is to determine the response of 13-valent conjugate pneumococcal vaccine in patients 50 years or older with end stage renal disease on dialysis.
The study will also try to determine Streptococcus pneumoniae colonization in patients 50 years or older with end stage renal disease on dialysis.
Linked Publications
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Immunogenicity of 13-Valent Conjugate Pneumococcal Vaccine in Patients 50 Years and Older with End-Stage Renal Disease and on Dialysis.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change From Baseline in Antibody Concentrations After 13-valent Conjugate Pneumococcal Vaccination in in Patients 50 Years or Older With End Stage Renal Disease on Dialysis |
1.46; 0.79; 0.57; 2.80; 1.93; 5.95 | — |
Eligibility Criteria
Inclusion Criteria
- Adult patients ≥ 50years of age with End stage renal disease on dialysis (both hemodialysis and peritoneal dialysis).
- Scheduled to receive pneumococcal vaccine either after 5years of previous vaccination or starting vaccination as part of standard care during the study period
Exclusion Criteria
- History of S. pneumoniae infection within the last 5 years
- Vaccinated with an influenza- or diphtheria-containing vaccine within the last 6 months
- History of any severe adverse reaction associated with a vaccine
- Received gamma-globulins within the previous 6 months
- Known or suspected HIV or on immunosuppressive medications.
- Functional or anatomic asplenia
- serious chronic medical condition
Data sourced from ClinicalTrials.gov (NCT01974817) and the linked publication. Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.