MedDataX Logo

Influenza Vaccination in Hemodialysis Patients and Renal Transplant Recipients

NCT ID: NCT00776750

Last Updated: 2008-10-21

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

407 participants

Study Classification

INTERVENTIONAL

Study Start Date

2003-09-30

Study Completion Date

2004-05-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Hemodialysis Renal Transplantation

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

influenza vaccination

All participants received a standard dose of 0.5 ml commercially available trivalent split influenza vaccine (Vaxigrip®, Aventis Pasteur MSD) by intramuscular injection. The vaccine contained 15 μg hemagglutinin of each of the following influenza strains: A/ New Caledonia/20/99 (H1N1), A/ Panama/2007/99 (H3N2), and B/Shangdong/7/97, recommended by WHO as components of the influenza vaccine for the epidemic season 2003/2004.

Group Type EXPERIMENTAL

trivalent split influenza vaccine

Intervention Type BIOLOGICAL

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

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

trivalent split influenza vaccine

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

Intervention Type BIOLOGICAL

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

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

Exclusion Criteria

* patients with known allergy to chicken proteins
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Universitaire Ziekenhuizen KU Leuven

OTHER

Sponsor Role lead

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Yves Vanrenterghem, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Universitaire Ziekenhuizen KU Leuven

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

University Hospital Leuven

Leuven, , Belgium

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Belgium

References

Explore related publications, articles, or registry entries linked to this study.

Scharpe J, Peetermans WE, Vanwalleghem J, Maes B, Bammens B, Claes K, Osterhaus AD, Vanrenterghem Y, Evenepoel P. Immunogenicity of a standard trivalent influenza vaccine in patients on long-term hemodialysis: an open-label trial. Am J Kidney Dis. 2009 Jul;54(1):77-85. doi: 10.1053/j.ajkd.2008.11.032. Epub 2009 Apr 1.

Reference Type DERIVED
PMID: 19339089 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

ML2394

Identifier Type: -

Identifier Source: org_study_id