13 Valent Pneumococcal Conjugate Vaccine in Chronic Dialysis Patients
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.
1 other identifier
interventional
154
1 country
2
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_4
Started Feb 2013
Shorter than P25 for phase_4
2 active sites
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
February 1, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 1, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2014
CompletedFirst Submitted
Initial submission to the registry
August 24, 2014
CompletedFirst Posted
Study publicly available on registry
July 8, 2015
CompletedJuly 8, 2015
July 1, 2015
1 year
August 24, 2014
July 5, 2015
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Antibody response after vaccination to involved serotypes measured by OPA and ELISA
52 weeks after vaccination
Secondary Outcomes (2)
record of side effects of vaccination
first week after vaccination
Antibody response after vaccination to involved serotypes measured by OPA and ELISA
4 weeks after vaccination
Study Arms (4)
PPV23 naive, PPV23 vaccination
ACTIVE COMPARATORvaccination with PPV-23 in 40 PPV-23 naive patients
PPV23 naive, PCV13 vaccination
EXPERIMENTALvaccination with PCV-13 in 40 PPV-23 naive patients
PPV23 > 4 years ago, PCV13 vaccination
EXPERIMENTALvaccination with PCV-13 in 40 patients that received PPV-23 more than 4 years ago
PPV23 < 4 years, PCV13 vaccination
EXPERIMENTALvaccination with PCV-13 in 40 patients that received PPV-23 less than 4 years ago
Interventions
Eligibility Criteria
You may qualify if:
- they are under chronic dialysis treatment
- are 50 years or older and not pregnant
- have no immediate life threatening conditions
- are not allergic to one of the compounds of the vaccine
- have a known pneumococcal vaccination status
- give their informed consent.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- AZ Sint-Jan AVlead
- Pfizercollaborator
Study Sites (2)
Dienst Nefrologie, OLV Ziekenhuis
Aalst, 9300, Belgium
AZ Sint-Jan Brugge Oostende AV
Bruges, 8000, Belgium
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Stefaan J Vandecasteele, MD, PhD
Department of Nephrology and Infectious Diseases, AZ Sint-Jan Brugge, Belgium
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Stefaan Johan Vandecasteele, MD, PhD
Study Record Dates
First Submitted
August 24, 2014
First Posted
July 8, 2015
Study Start
February 1, 2013
Primary Completion
February 1, 2014
Study Completion
March 1, 2014
Last Updated
July 8, 2015
Record last verified: 2015-07