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The Immunogenicity of Intradermal Influenza Vaccination in Hemodialysis Patients

Primary Purpose

Hemodialysis Patients

Status
Completed
Phase
Phase 2
Locations
Iran, Islamic Republic of
Study Type
Interventional
Intervention
intradermal influenza vaccine
intramuscular influenza vaccine
Sponsored by
Shiraz University of Medical Sciences
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Hemodialysis Patients focused on measuring intradermal influenza vaccine, hemodialysis patients

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Shiraz University Of Medical Science

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

intradermal influenza vaccine

intramuscular influenza vaccine

Arm Description

Outcomes

Primary Outcome Measures

vaccine effectiveness
serum antibody response measured by ELIZA method time frame:1 and 3 months after vaccination

Secondary Outcome Measures

Full Information

First Posted
January 10, 2011
Last Updated
January 10, 2011
Sponsor
Shiraz University of Medical Sciences
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1. Study Identification

Unique Protocol Identification Number
NCT01273974
Brief Title
The Immunogenicity of Intradermal Influenza Vaccination in Hemodialysis Patients
Official Title
The Comparison of Serum Antibody Response to Standard Intramuscular and Half Dose Intradermal Influenza Vaccine in Hemodialysis Patients in Shiraz City in 1388.
Study Type
Interventional

2. Study Status

Record Verification Date
August 2010
Overall Recruitment Status
Completed
Study Start Date
October 2009 (undefined)
Primary Completion Date
November 2009 (Actual)
Study Completion Date
February 2010 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Shiraz University of Medical Sciences

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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.
Detailed Description
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hemodialysis Patients
Keywords
intradermal influenza vaccine, hemodialysis patients

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 2, Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
130 (Actual)

8. Arms, Groups, and Interventions

Arm Title
intradermal influenza vaccine
Arm Type
Experimental
Arm Title
intramuscular influenza vaccine
Arm Type
Active Comparator
Intervention Type
Biological
Intervention Name(s)
intradermal influenza vaccine
Intervention Description
0.25ml ,intradermal
Intervention Type
Biological
Intervention Name(s)
intramuscular influenza vaccine
Intervention Description
0.5ml,intramuscular
Primary Outcome Measure Information:
Title
vaccine effectiveness
Description
serum antibody response measured by ELIZA method time frame:1 and 3 months after vaccination
Time Frame
3 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mohammad mahdi Sagheb
Organizational Affiliation
Shiraz University Of Medical Science
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Samira Saeian
Organizational Affiliation
Shiraz University Of Medical Science
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Jamshid Roozbeh
Organizational Affiliation
Shiraz University Of Medical Science
Official's Role
Principal Investigator
Facility Information:
Facility Name
Shiraz University Of Medical Science
City
Shiraz
Country
Iran, Islamic Republic of

12. IPD Sharing Statement

Learn more about this trial

The Immunogenicity of Intradermal Influenza Vaccination in Hemodialysis Patients

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