Phase 4
N=25
Study Response of 13-valent Conjugate Pneumococcal Vaccine in Patients With End Stage Renal Disease
End Stage Renal Disease
Bottom Line
View on ClinicalTrials.gov: NCT01974817 ↗Enrolled (actual)
25
Serious AEs
0.0%
Results posted
Nov 2016
Primary outcome: 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 µg/ml
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- 13-valent conjugate pneumococcal vaccine (Biological)
- Age
- Adult, Older Adult · 50+ yrs
- Sex
- All
- Sponsor
- Michigan State University
- Primary completion
- Dec 2013
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 | — |
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.
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). 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.