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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
TRIPLE
Enrollment
304
Influvacplus 2005/2006, Solvay Pharma AG, Bern, Switzerland Assigned to all 4 groups if immunocompromized patients
Influvac 2005/2006, Solvay Pharma AG, Bern, Switzerland Assigned to all 4 groups if immunocompromized patients
Department of Infectious Diseases, Bern University Hospital
Bern, Switzerland
Department of Nephrology/Hypertension, Bern University Hospital
Bern, Switzerland
Department of Rheumatic Diseases, Bern University Hospital
Bern, Switzerland
Immunogenicity defined as seroconversion (1:>=4) and seroprotection rates (1:>=40)
Time frame: >60 Wochen
Reactogenicity in rheumatologic patients by disease specific scores
Time frame: Six weeks after vaccination
Immediate side effects at time of application of vaccination
Time frame: Minutes after vaccination
Side effects after vaccination
Time frame: First week after vaccination
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.