NCT02492438

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.

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 154 (actual)
• Sponsor: AZ Sint-Jan AV · Academic / Other
• Sex: All
• Age: 50 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Chronic Kidney Failure

Interventions

Type	Name	Description
BIOLOGICAL	PPV23 vaccination or PCV13 vaccination

Timeline

• Start date: 2013-02-01
• Primary completion: 2014-02-01
• Completion: 2014-03-01
• First posted: 2015-07-08
• Last updated: 2015-07-08

Locations

2 sites across 1 country: Belgium