The Immunogenicity of Intradermal Influenza Vaccination in Hemodialysis 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

PHASE2/PHASE3

Total Enrollment

130 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-10-31

Study Completion Date

2010-02-28

Brief Summary

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The purpose of this study is to determine whether half-dose intradermal influenza vaccine is as immunogenic as standard dose intramuscular vaccine in hemodialysis patients.

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Detailed Description

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Hemodialysis patients are at high risk of influenza infection due to suppress immune status.It is recommended to immunize them against influenza annually.in intradermal vaccination antigens directly present to the large numbers of antigen-presenting cells in the skin and it may cause greater immunogenicity than in the intramuscular method. Reduced-dose intradermal influenza vaccine is immunogenic in healthy adult, patients with solid cancer and three groups of immunocompromized patients including Rheumatologic patients treated with anti-TNF, HIV-infected and stem cell transplanted patients.

In this study we compare the efficacy of influenza vaccines in half dose intradermal and standard intramuscular methods among hemodialysis patients.

Conditions

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Hemodialysis Patients

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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intradermal influenza vaccine

Group Type EXPERIMENTAL

intradermal influenza vaccine

Intervention Type BIOLOGICAL

0.25ml ,intradermal

intramuscular influenza vaccine

Group Type ACTIVE_COMPARATOR

intramuscular influenza vaccine

Intervention Type BIOLOGICAL

0.5ml,intramuscular

Interventions

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intradermal influenza vaccine

0.25ml ,intradermal

Intervention Type BIOLOGICAL

intramuscular influenza vaccine

0.5ml,intramuscular

Intervention Type BIOLOGICAL

Eligibility Criteria

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Inclusion Criteria

* Patients under chronic hemodialysis

Exclusion Criteria

* history of flu infection in last month
* history of flu vaccination in 2009
* hospitalization in last month
* taking immune suppressants drugs
* hemodialysis less than twice weekly

Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No