13 Valent Pneumococcal Conjugate Vaccine in Chronic Dialysis Patients

NCT02492438

Last updated date
Study Location
Dienst Nefrologie, OLV Ziekenhuis
Aalst, , 9300, Belgium
Contact
1-800-718-1021

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Eligibility Criteria
condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Chronic Kidney Failure
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
50 + years
Inclusion Criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

1. they are under chronic dialysis treatment

2. are 50 years or older and not pregnant

3. have no immediate life threatening conditions

4. are not allergic to one of the compounds of the vaccine

5. have a known pneumococcal vaccination status

6. give their informed consent.

Exclusion Criteria
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details


Patients not fulfilling the inclusion criteria.

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Chronic Kidney Failure13 Valent Pneumococcal Conjugate Vaccine in Chronic Dialysis Patients
NCT02492438
  1. Aalst,
  2. Brugge,
ALL GENDERS
50 Years+
years
MULTIPLE SITES
Advanced Information
Descriptive Information
Brief Title  ICMJE 13 Valent Pneumococcal Conjugate Vaccine in Chronic Dialysis Patients
Official Title  ICMJE Immunogenicity and Safety of the 13-valent Pneumococcal Conjugate Vaccine in Chronic Dialysis Patients That Are 23-valent Pneumococcal Polysaccharide Vaccine Naive and Pre-immunized.
Brief Summary To assess the immunogenicity of the PCV13 (13 valent pneumococcal conjugated vaccine) vaccine as compared to the PPV23 (23 valent pneumococcal polysaccharide vaccine) vaccine in patients treated with chronic hemodialysis that are pre-immunized with the PPSV23 vaccine or are PPV23 vaccine naïve by measuring the ELISA and OPA (opsonophagocytic assay) titers after 4 and 52 weeks.
Detailed Description The immunogenicity of the PCV13 (13 valent pneumococcal conjugated vaccine) vaccine as compared to the PPV23 (23 valent pneumococcal polysaccharide vaccine) vaccine in patients treated with chronic hemodialysis that are pre-immunized with the PPV23 vaccine or are PPV23 vaccine naïve will be measured by ELISA and OPA (opsonophagocytic assay) titers after 4 and 52 weeks.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Condition  ICMJE Chronic Kidney Failure
Intervention  ICMJE Biological: PPV23 vaccination or PCV13 vaccination
Other Names:
  • Prevenar 13
  • Pneumovac 23
Study Arms  ICMJE
  • Active Comparator: PPV23 naive, PPV23 vaccination
    vaccination with PPV-23 in 40 PPV-23 naive patients
    Intervention: Biological: PPV23 vaccination or PCV13 vaccination
  • Experimental: PPV23 naive, PCV13 vaccination
    vaccination with PCV-13 in 40 PPV-23 naive patients
    Intervention: Biological: PPV23 vaccination or PCV13 vaccination
  • Experimental: PPV23 > 4 years ago, PCV13 vaccination
    vaccination with PCV-13 in 40 patients that received PPV-23 more than 4 years ago
    Intervention: Biological: PPV23 vaccination or PCV13 vaccination
  • Experimental: PPV23 < 4 years, PCV13 vaccination
    vaccination with PCV-13 in 40 patients that received PPV-23 less than 4 years ago
    Intervention: Biological: PPV23 vaccination or PCV13 vaccination
Publications * Not Provided

*   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: July 5, 2015)
154
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE March 2014
Actual Primary Completion Date February 2014   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  1. they are under chronic dialysis treatment
  2. are 50 years or older and not pregnant
  3. have no immediate life threatening conditions
  4. are not allergic to one of the compounds of the vaccine
  5. have a known pneumococcal vaccination status
  6. give their informed consent.

Exclusion Criteria:

Patients not fulfilling the inclusion criteria.

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 Belgium
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02492438
Other Study ID Numbers  ICMJE WS2113445
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Vandecasteele Stefaan Johan, AZ Sint-Jan AV
Study Sponsor  ICMJE AZ Sint-Jan AV
Collaborators  ICMJE Pfizer
Investigators  ICMJE
Principal Investigator:Stefaan J Vandecasteele, MD, PhDDepartment of Nephrology and Infectious Diseases, AZ Sint-Jan Brugge, Belgium
PRS Account AZ Sint-Jan AV
Verification Date July 2015

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