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Completed

NCT Number: NCT01974817

Study Response of 13-valent Conjugate Pneumococcal Vaccine in Patients With End Stage Renal Disease

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.

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Key information

About this study

The purpose of the study is to determine the immunogenicity of 13-valent conjugate pneumococcal vaccine in patients 50 years or older with end stage renal disease on dialysis. Patients will receive one dose of 0.5ml of Prevnar-13 intra-muscularly. Antibody response to pneumococcal serotypes will be studied ar 2months and 12 months after administration of vaccine.

The study will try to determine Streptococcus pneumoniae colonization in patients 50 years or older with end stage renal disease on dialysis and also investigate if there are any change in Streptococcus pneumoniae colonization after Prevnar-13 vaccination.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

13-valent conjugate pneumococcal vaccine

Biological

0.5ml IM for one dose

Other names: Prevnar-13

Primary outcomes

  1. 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

    Time frame: 12 months

    Study the immunologic response after administration of single dose 13-valent conjugate pneumococcal vaccine in patients 50 years or older with end stage renal disease on dialysis.

Sponsors and collaborators

Lead sponsor

Michigan State University

Other

Collaborators

  • Pfizer

Registry information

Official study title

Streptococcus Pneumoniae Colonization and Immunogenicity of 13-valent Conjugate Pneumococcal Vaccine in Patients 50 Years or Older With End Stage Renal Disease on Dialysis.

Important dates

Study start
2013
Primary completion
2013
Study completion
2014
First posted
Nov 4, 2013
Registry last updated
Nov 17, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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