The comparison of antibody response to standard intramuscular and half dose intradermal influenza vaccine in patient on long term hemodialysis in Shiraz in 1388
This study was performed to compare antibody responses following influenza vaccination in two ways (standard dose intramuscular and half dose intradermal) in hemodialysis patients. 110 chronic hemodialysis patients without a history of recent influenza vaccination, hospitalization, or recent flu and taking immune suppressants were chosen. The patients randomly assigned to be vaccinated using standard intramuscular dose (0.5ml), in the deltoid muscle in the control group or half dose intradermal (0.25ml), in the forearm area in the intervention group. Titers of serum antibodies before vaccination was measured a month and three months later by ELISA. The rate of influenza infection was also compared during 6 months after vaccination.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201009044683N1
Registration date:2010-10-25, 1389/08/03
Registration timing:retrospective
Last update:
Update count:0
Registration date
2010-10-25, 1389/08/03
Registrant information
Name
Samira Saeian
Name of organization / entity
Shiraz University of Medical Science&Health Services
Country
Iran (Islamic Republic of)
Phone
+98 71 1647 4316
Email address
saeians@sums.ac.ir
Recruitment status
Recruitment complete
Funding source
Shiraz University of Medical Sciences & Health Services
Expected recruitment start date
2009-10-23, 1388/08/01
Expected recruitment end date
2009-11-11, 1388/08/20
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The comparison of antibody response to standard intramuscular and half dose intradermal influenza vaccine in patient on long term hemodialysis in Shiraz in 1388
Public title
Administration of influenza vaccine
Purpose
Health service research
Inclusion/Exclusion criteria
Inclusion criteria: Patients under chronic hemodialysis
Exclusion criteria: history of flu infection in a month, history of flu vaccination in 1388, hospitalization in last month, taking immune suppressants, hemodialysis less than two times a week
Age
No age limit
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
110
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Shiraz University of Medical Sciences & Health Services
Street address
Shiraz, Zand boulevard
City
Shiraz
Postal code
Approval date
2010-08-23, 1389/06/01
Ethics committee reference number
ct-89-5205
Health conditions studied
1
Description of health condition studied
Influenza vaccination
ICD-10 code
Z25.1
ICD-10 code description
need for immunization against influenza
Primary outcomes
1
Description
Anti influenza antibody titer
Timepoint
Befor vaccination, one month after vaccination, three months after vaccination
Method of measurement
ELISA
Secondary outcomes
1
Description
Influenza infection
Timepoint
Six months after vaccination
Method of measurement
History & Physical exam
Intervention groups
1
Description
Intervention group: intradermal administration of seasonal influenza vaccine, 0.25ml, in forearm area in October 2009
Category
Prevention
2
Description
Control group: intramuscular administration of seasonal influenza vaccine, 0.5ml, in deltoid muscle in October 2009
Category
Prevention
Recruitment centers
1
Recruitment center
Name of recruitment center
Sadra hemodialysis center
Full name of responsible person
Street address
City
Shiraz
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shiraz University of Medical Sciences & Health Services
Full name of responsible person
Mohammad Hossein Dabbaghmanesh
Street address
Internal medicine department, Namazi hospital
City
Shiraz
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shiraz University of Medical Sciences & Health Services
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty
Person responsible for general inquiries
Contact
Name of organization / entity
Shiraz University of Medical Sciences & Health Services
Full name of responsible person
Samira Saeian
Position
Internal medicine assistant
Other areas of specialty/work
Street address
Internal medicine department, Namazi hospital
City
Shiraz
Postal code
Phone
+98 71 1647 4316
Fax
Email
saeians@sums.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shiraz University of Medical Sciences & Health Services
Full name of responsible person
Jamshid Roozbeh
Position
Nephrologist
Other areas of specialty/work
Street address
Internal medicine department, Namazi hospital
City
Shiraz
Postal code
Phone
+98 71 1647 4332
Fax
Email
roozbehj@sums.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Shiraz University of Medical Sciences & Health Services
Full name of responsible person
Samira Saeian
Position
Internal medicine assistant
Other areas of specialty/work
Street address
Internal medicine department, Namazi hospital
City
Shiraz
Postal code
Phone
+98 71 1647 4316
Fax
Email
saeians@sums.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)