NCT01974817

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

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

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 25 (actual)
• Sponsor: Michigan State University · Academic / Other
• Sex: All
• Age: 50 Years
• Healthy volunteers: Not accepted

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.

Detailed description

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.

Conditions

• End Stage Renal Disease

Interventions

Type	Name	Description
BIOLOGICAL	13-valent conjugate pneumococcal vaccine	0.5ml IM for one dose

Timeline

• Start date: 2013-05-01
• Primary completion: 2013-12-01
• Completion: 2014-12-01
• First posted: 2013-11-04
• Last updated: 2016-11-17
• Results posted: 2016-11-17

Locations

1 site across 1 country: United States