NCT00783380

Influenza Vaccination in Immunocompromized Patients

Double Blind Randomized Comparison of a Subunit- and a Virosomal Influenza Vaccine in Immunocom-Promized Patients

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 304 (actual)
• Sponsor: Insel Gruppe AG, University Hospital Bern · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Evaluation of the immunogenicity and reactogenicity of two different formulations of commercially avail-able influenza vaccines in 4 different groups of immunocompromized outpatients (HIV positive patients, patients suffering from rheumatologic diseases and receiving treatment with immunosuppressive drugs and patients undergoing hemodialysis or continuous ambulatory peritoneal dialysis). The aim of the study was to investigate if the newest formulation of influenza vaccines (virosomal vaccines) offer a benefit in immunocompromized patients in comparison to an older subunit formulation.

Detailed description

The infection with influenza is associated with higher morbidity and mortality in risk groups including immunocompromized patients. The virosomal influenza vaccines have been associated with improved immunogenicity in former trials. No direct comparison with older formulations has been conducted so far.

Conditions

• Immunosuppression

Interventions

Type	Name	Description
BIOLOGICAL	Virosomal influenza vaccine	Influvacplus 2005/2006, Solvay Pharma AG, Bern, Switzerland Assigned to all 4 groups if immunocompromized patients
BIOLOGICAL	Subunit influenza vaccine	Influvac 2005/2006, Solvay Pharma AG, Bern, Switzerland Assigned to all 4 groups if immunocompromized patients

Timeline

• Start date: 2005-10-01
• Primary completion: 2006-07-01
• Completion: 2008-03-01
• First posted: 2008-10-31
• Last updated: 2008-11-03

Locations

3 sites across 1 country: Switzerland