Immunogenicity of a Trivalent Influenza Vaccine in Chronic Kidney Disease Patients Undergoing Hemodialysis

NCT ID: NCT02686398

Last Updated: 2016-02-19

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

174 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-10-31

Study Completion Date

2014-11-30

Brief Summary

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During the 2013-2014 influenza season, CKD patients undergoing HD participated in the study. The patients were randomized into two groups (MF59-adjuvanted vaccine group or non-adjuvanted vaccine group) and were immunized with the respective vaccine. Sera were collected prior to vaccination and at 1and 6 months post vaccination. Levels of hemagglutination inhibition (HI) antibodies were measured.

Detailed Description

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Conditions

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Influenza End Stage Renal Failure Chronic Kidney Disease

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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Fluad

88 CKD patients were vaccinated with Fluad.

Group Type ACTIVE_COMPARATOR

Fluad

Intervention Type BIOLOGICAL

Agrippal

86 CKD patients were vaccinated with Agrippal.

Group Type ACTIVE_COMPARATOR

Agrippal

Intervention Type BIOLOGICAL

Interventions

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Fluad

Intervention Type BIOLOGICAL

Agrippal

Intervention Type BIOLOGICAL

Eligibility Criteria

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Inclusion Criteria

* Chronic kidney disease patients undergoing hemodialysis
* Who have given written informed consent at the time of enrollment

Exclusion Criteria

* Recipients of influenza vaccine of 2013-2014 season before the study
* History of egg allergy
Minimum Eligible Age

19 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Korea University Guro Hospital

OTHER

Sponsor Role lead

Responsible Party

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Hee Jin Cheong

MD, PhD

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Hee Jin Cheong, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Korea University Guro Hospital

Other Identifiers

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KUGH13170

Identifier Type: -

Identifier Source: org_study_id

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