13 Valent Pneumococcal Conjugate Vaccine in Chronic Dialysis Patients

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

154 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-02-28

Study Completion Date

2014-03-31

Brief Summary

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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.

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Detailed Description

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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

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Chronic Kidney Failure

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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PPV23 naive, PPV23 vaccination

vaccination with PPV-23 in 40 PPV-23 naive patients

Group Type ACTIVE_COMPARATOR

PPV23 vaccination or PCV13 vaccination

Intervention Type BIOLOGICAL

PPV23 naive, PCV13 vaccination

vaccination with PCV-13 in 40 PPV-23 naive patients

Group Type EXPERIMENTAL

PPV23 vaccination or PCV13 vaccination

Intervention Type BIOLOGICAL

PPV23 > 4 years ago, PCV13 vaccination

vaccination with PCV-13 in 40 patients that received PPV-23 more than 4 years ago

Group Type EXPERIMENTAL

PPV23 vaccination or PCV13 vaccination

Intervention Type BIOLOGICAL

PPV23 < 4 years, PCV13 vaccination

vaccination with PCV-13 in 40 patients that received PPV-23 less than 4 years ago

Group Type EXPERIMENTAL

PPV23 vaccination or PCV13 vaccination

Intervention Type BIOLOGICAL

Interventions

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PPV23 vaccination or PCV13 vaccination

Intervention Type BIOLOGICAL

Other Intervention Names

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Prevenar 13 Pneumovac 23

Eligibility Criteria

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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.

Minimum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No