NCT01974817

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
25

participants targeted

Target at below P25 for phase_4

Timeline
Completed

Started May 2013

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2013

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

October 28, 2013

Completed
7 days until next milestone

First Posted

Study publicly available on registry

November 4, 2013

Completed
27 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2013

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2014

Completed
2 years until next milestone

Results Posted

Study results publicly available

November 17, 2016

Completed
Last Updated

November 17, 2016

Status Verified

September 1, 2016

Enrollment Period

7 months

First QC Date

October 28, 2013

Results QC Date

September 27, 2016

Last Update Submit

September 27, 2016

Conditions

End Stage Renal Disease

Keywords

pneumococcal vaccineend stage renal diseasedialysis

Outcome Measures

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

    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.

    12 months

Study Arms (1)

Vaccine

EXPERIMENTAL

Patients will receive one dose of 0.5 ml 13-valent conjugate pneumococcal vaccine (Prevnar-13) intra-muscularly.

Biological: 13-valent conjugate pneumococcal vaccine

Interventions

13-valent conjugate pneumococcal vaccineBIOLOGICAL

0.5ml IM for one dose

Also known as: Prevnar-13
Vaccine

Eligibility Criteria

Age50 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Sparrow Dialysis at Saint Lawrence Campus

Lansing, Michigan, 48195, United States

Location

Related Publications (1)

  • 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. doi: 10.1128/CVI.00153-16. Print 2016 Nov.

    PMID: 27581438DERIVED

MeSH Terms

Conditions

Kidney Failure, Chronic

Condition Hierarchy (Ancestors)

Renal Insufficiency, ChronicRenal InsufficiencyKidney DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Results Point of Contact

Title
Dr Subhashis Mitra
Organization
Michigan State University
mitrasub@msu.edu
517-353-3128

Study Officials

  • Subhashis Mitra, M.D

    Michigan State University

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
phase 4
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor of Medicine

Study Record Dates

First Submitted

October 28, 2013

First Posted

November 4, 2013

Study Start

May 1, 2013

Primary Completion

December 1, 2013

Study Completion

December 1, 2014

Last Updated

November 17, 2016

Results First Posted

November 17, 2016

Record last verified: 2016-09

Data Sharing

IPD Sharing
Will not share

Locations

US(1)