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Sponsors and Collaborators: |
University Hospital Inselspital, Berne Boehringer Ingelheim Pharmaceuticals Abbott MSD Chibret Switzerland Solvay Pharmaceuticals |
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Information provided by: | University Hospital Inselspital, Berne |
ClinicalTrials.gov Identifier: | NCT00783380 |
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.
Condition | Intervention | Phase |
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Immunosuppression |
Biological: Virosomal influenza vaccine Biological: Subunit influenza vaccine |
Phase IV |
Study Type: | Interventional |
Study Design: | Prevention, Randomized, Double Blind (Subject, Caregiver, Investigator), Parallel Assignment, Safety/Efficacy Study |
Official Title: | Double Blind Randomized Comparison of a Subunit- and a Virosomal Influenza Vaccine in Immunocom-Promized Patients |
Enrollment: | 304 |
Study Start Date: | October 2005 |
Study Completion Date: | March 2008 |
Primary Completion Date: | July 2006 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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Virosomal influenza vaccine: Experimental |
Biological: Virosomal influenza vaccine
Influvacplus 2005/2006, Solvay Pharma AG, Bern, Switzerland Assigned to all 4 groups if immunocompromized patients
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Subunit influenza vaccine: Active Comparator |
Biological: Subunit influenza vaccine
Influvac 2005/2006, Solvay Pharma AG, Bern, Switzerland Assigned to all 4 groups if immunocompromized patients
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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.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Switzerland | |
Department of Infectious Diseases, Bern University Hospital | |
Bern, Switzerland, 3010 | |
Department of Rheumatic Diseases, Bern University Hospital | |
Bern, Switzerland, 3010 | |
Department of Nephrology/Hypertension, Bern University Hospital | |
Bern, Switzerland, 3010 |
Principal Investigator: | John M Evison, MD | Department of Infectious Diseases, University Hospital Bern, 3010-Bern, Switzerland |
Responsible Party: | Universitätsklinik für Infektiologie, PKT 2B, Inselspital, 3011 Bern, Switzerland ( Evison John, MD Oberarzt ) |
Study ID Numbers: | KEK No 805 (EK 151/03) |
Study First Received: | October 30, 2008 |
Last Updated: | October 31, 2008 |
ClinicalTrials.gov Identifier: | NCT00783380 History of Changes |
Health Authority: | Switzerland: Independent Local Research Ethic Commission |
Influenza vaccination Subunit Virosomal HIV/AIDS Renal Dialysis |
Kidney transplantation Rheumatologic diseases Influenza vaccination Immunogenicity Reactogenicity |
Virus Diseases Respiratory Tract Diseases Respiratory Tract Infections HIV Infections |
Acquired Immunodeficiency Syndrome Influenza, Human Orthomyxoviridae Infections |
Virus Diseases RNA Virus Infections Respiratory Tract Diseases |
Respiratory Tract Infections Influenza, Human Orthomyxoviridae Infections |