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NCT02492438 Clinical Trial

13 Valent Pneumococcal Conjugate Vaccine in Chronic Dialysis Patients

Chronic Kidney Failure Clinical Trial

Official title:
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.

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT02492438
Other study ID # WS2113445
Secondary ID
Status Completed
Phase Phase 4
First received August 24, 2014
Last updated July 5, 2015
Start date February 2013
Est. completion date March 2014

Study information
Verified date July 2015
Source AZ Sint-Jan AV
Contact n/a
Is FDA regulated No
Health authority Belgium: Ethics Committee
Study type Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility
Status Completed
Enrollment 154
Est. completion date March 2014
Est. primary completion date February 2014
Accepts healthy volunteers No
Gender Both
Age group 50 Years and older
Eligibility 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.

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

Intervention

Biological:
• PPV23 vaccination or PCV13 vaccination

Locations
Country Name City State
Belgium Dienst Nefrologie, OLV Ziekenhuis Aalst
Belgium AZ Sint-Jan Brugge Oostende AV Brugge

Sponsors (2)
Lead Sponsor Collaborator
AZ Sint-Jan AV Pfizer

Country where clinical trial is conducted

Belgium, 

Outcome
Type Measure Description Time frame Safety issue
Primary Antibody response after vaccination to involved serotypes measured by OPA and ELISA 52 weeks after vaccination No
Secondary record of side effects of vaccination first week after vaccination Yes
Secondary Antibody response after vaccination to involved serotypes measured by OPA and ELISA 4 weeks after vaccination No
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