Influenza Vaccination in Hemodialysis Patients and Renal Transplant Recipients

Hemodialysis Clinical Trial

Official title:

Influenza Vaccination in Hemodialysis Patients and Renal Transplant Recipients

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00776750
• Other study ID #: ML2394
• Status: Completed
• Phase: Phase 4
• First received: October 20, 2008
• Last updated: October 20, 2008
• Start date: September 2003
• Est. completion date: May 2004

Study information

• Verified date: October 2008
• Source: Universitaire Ziekenhuizen Leuven
• Contact: n/a
• Is FDA regulated: No
• Health authority: Belgium: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

Disturbances of acquired immunity are considered to be responsible, at least partly, for the high infection rate and inadequate response to vaccinations observed in hemodialysis (HD) patients and renal transplant recipient (RTR). The present prospective trial aims at (a) evaluating the immunogenicity of a standard influenza vaccine in HD and RTR patients and (b) at identifying determinants of the immune response.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 407
• Est. completion date: May 2004
• Est. primary completion date: May 2004
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• maintenance hemodialysis patients or

• renal transplant recipients (beyond month 3 after transplantation)

Exclusion Criteria:

• patients with known allergy to chicken proteins

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Hemodialysis
• Renal Transplantation

Intervention

Biological:
• trivalent split influenza vaccine
standard dose of 0.5 ml commercially available trivalent split influenza vaccine (Vaxigrip®, Aventis Pasteur MSD) by intramuscular injection

Locations

Country	Name	City	State
Belgium	University Hospital Leuven	Leuven

Sponsors (1)

Lead Sponsor	Collaborator
Universitaire Ziekenhuizen Leuven

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Seroprotection rate, defined as the percentage of patients with an HI antibody titer = 40,
Secondary	Seroresponse rate, defined as the percentage of patients with a fourfold rise in HI titer after vaccination; impact of booster vaccination on the immune response, and safety of influenza vaccination.			Yes