Comparing different methods of trivalent influenza vaccination on the post-vaccination immunogenicity in patients on maintenance hemodialysis
Phase 3
- Conditions
- eed for immunization against influenza.Need for immunization against influenza
- Registration Number
- IRCT2015101724575N1
- Lead Sponsor
- Vice chancellor for research, Shahid Beheshti University of Medical Sciences
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete
- Sex
- All
- Target Recruitment
- 120
Inclusion Criteria
Individuals more than 18 years old who are known to have end stage renal disease and need routine dialysis (i.e. at least 2 times a week for more than one month).
Exclusion criteria: History of influenza or other viral diseases and also live viral vaccination in recent 4 weeks; History of influenza vaccination in prior 6 months; Prior history of hypersensitivity to egg, components of influenza vaccine; Documented primary or secondary immunosuppression especially impaired cellular and humoral immunity.
Exclusion Criteria
Not provided
Study & Design
- Study Type
- interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Comparing the immunogenicity against influenza vaccine via intradermal and intramuscular routes. Timepoint: Obtaining blood samples for antibody titration, before and 14 to 21 days after vaccination. Method of measurement: Antibody titration within the sera obtained before and after vaccination, by hemagglutination inhibition assay test.
- Secondary Outcome Measures
Name Time Method The effect of imiquimod pretreatment before intradermal influenza vaccination on immunogenicity of vaccine. Timepoint: Antibody titration within blood samples obtained before and 14 to 21 days after vaccination. Method of measurement: Antibody titration within the sera obtained before and after vaccination, by hemagglutination inhibition assay test.