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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01273974
Other study ID # 89-5905
Secondary ID
Status Completed
Phase Phase 2/Phase 3
First received January 10, 2011
Last updated January 10, 2011
Start date October 2009
Est. completion date February 2010

Study information

Verified date August 2010
Source Shiraz University of Medical Sciences
Contact n/a
Is FDA regulated No
Health authority Iran: Ministry of Health
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 130
Est. completion date February 2010
Est. primary completion date November 2009
Accepts healthy volunteers No
Gender Both
Age group 18 Years to 80 Years
Eligibility 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

Study Design

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


Related Conditions & MeSH terms


Intervention

Biological:
intradermal influenza vaccine
0.25ml ,intradermal
intramuscular influenza vaccine
0.5ml,intramuscular

Locations

Country Name City State
Iran, Islamic Republic of Shiraz University Of Medical Science Shiraz

Sponsors (1)

Lead Sponsor Collaborator
Shiraz University of Medical Sciences

Country where clinical trial is conducted

Iran, Islamic Republic of, 

Outcome

Type Measure Description Time frame Safety issue
Primary vaccine effectiveness serum antibody response measured by ELIZA method time frame:1 and 3 months after vaccination 3 months Yes
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