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Trial record 1 of 1 for:    NCT01974817
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Study Response of 13-valent Conjugate Pneumococcal Vaccine in Patients With End Stage Renal Disease

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ClinicalTrials.gov Identifier: NCT01974817
Recruitment Status : Completed
First Posted : November 3, 2013
Results First Posted : November 17, 2016
Last Update Posted : November 17, 2016
Sponsor:
Collaborator:
Pfizer
Information provided by (Responsible Party):
Subhashis Mitra, Michigan State University

Tracking Information
First Submitted Date  ICMJE October 28, 2013
First Posted Date  ICMJE November 3, 2013
Results First Submitted Date  ICMJE September 27, 2016
Results First Posted Date  ICMJE November 17, 2016
Last Update Posted Date November 17, 2016
Study Start Date  ICMJE May 2013
Actual Primary Completion Date December 2013   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 27, 2016)
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.
Original Primary Outcome Measures  ICMJE
 (submitted: October 28, 2013)
Immunogenicity of 13-valent conjugate pneumococcal vaccine in in patients 50 years or older with end stage renal disease on dialysis [ Time Frame: 2 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.
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Study Response of 13-valent Conjugate Pneumococcal Vaccine in Patients With End Stage Renal Disease
Official Title  ICMJE Streptococcus Pneumoniae Colonization and Immunogenicity of 13-valent Conjugate Pneumococcal Vaccine in Patients 50 Years or Older With End Stage Renal Disease on Dialysis.
Brief 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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE End Stage Renal Disease
Intervention  ICMJE Biological: 13-valent conjugate pneumococcal vaccine
0.5ml IM for one dose
Other Name: Prevnar-13
Study Arms  ICMJE Experimental: Vaccine
Patients will receive one dose of 0.5 ml 13-valent conjugate pneumococcal vaccine (Prevnar-13) intra-muscularly.
Intervention: Biological: 13-valent conjugate pneumococcal vaccine
Publications * Mitra S, Stein GE, Bhupalam S, Havlichek DH. Immunogenicity of 13-Valent Conjugate Pneumococcal Vaccine in Patients 50 Years and Older with End-Stage Renal Disease and on Dialysis. Clin Vaccine Immunol. 2016 Nov 4;23(11):884-887. Print 2016 Nov.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: September 27, 2016)
25
Original Estimated Enrollment  ICMJE
 (submitted: October 28, 2013)
40
Actual Study Completion Date  ICMJE December 2014
Actual Primary Completion Date December 2013   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 50 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01974817
Other Study ID Numbers  ICMJE WI170883
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Subhashis Mitra, Michigan State University
Study Sponsor  ICMJE Michigan State University
Collaborators  ICMJE Pfizer
Investigators  ICMJE
Principal Investigator: Subhashis Mitra, M.D Michigan State University
PRS Account Michigan State University
Verification Date September 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP