Influenza Vaccination in Hemodialysis Patients and Renal Transplant Recipients

Status

Completed

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00776750

Enrollment

407

Registered

2008-10-21

Start date

2003-09-30

Completion date

2004-05-31

Last updated

2008-10-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hemodialysis, Renal Transplantation

Brief 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.

Interventions

BIOLOGICALtrivalent split influenza vaccine

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

Study design

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Yes

Inclusion criteria

* maintenance hemodialysis patients or * renal transplant recipients (beyond month 3 after transplantation)

Exclusion criteria

* patients with known allergy to chicken proteins

Design outcomes

Primary

Measure	Time frame
Seroprotection rate, defined as the percentage of patients with an HI antibody titer ≥ 40,	—

Secondary

Measure	Time frame
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.	—

Countries

Belgium

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026