Study Response of 13-valent Conjugate Pneumococcal Vaccine in Patients With End Stage Renal Disease
NCT01974817
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Adult Trials: 18+ Years
- 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
- 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
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| 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 | 25 | |||
| Original Estimated Enrollment ICMJE | 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:
Exclusion Criteria:
| |||
| Sex/Gender ICMJE |
| |||
| 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 |
| |||
| Responsible Party | Subhashis Mitra, Michigan State University | |||
| Study Sponsor ICMJE | Michigan State University | |||
| Collaborators ICMJE | Pfizer | |||
| Investigators ICMJE |
| |||
| 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 | ||||