Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE4
304 participants
INTERVENTIONAL
2005-10-31
2008-03-31
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
TRIPLE
Study Groups
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Virosomal influenza vaccine
Virosomal influenza vaccine
Influvacplus 2005/2006, Solvay Pharma AG, Bern, Switzerland Assigned to all 4 groups if immunocompromized patients
Subunit influenza vaccine
Subunit influenza vaccine
Influvac 2005/2006, Solvay Pharma AG, Bern, Switzerland Assigned to all 4 groups if immunocompromized patients
Interventions
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Virosomal influenza vaccine
Influvacplus 2005/2006, Solvay Pharma AG, Bern, Switzerland Assigned to all 4 groups if immunocompromized patients
Subunit influenza vaccine
Influvac 2005/2006, Solvay Pharma AG, Bern, Switzerland Assigned to all 4 groups if immunocompromized patients
Eligibility Criteria
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Inclusion Criteria
* HIV infection
* rheumatologic diseases and receiving immunosuppressive drugs
* kidney transplant recipients
* undergoing hemodialysis or continuous ambulatory peritoneal dialysis
* written informed consent
Exclusion Criteria
* Former adverse reactions to prior vaccination
* Febrile conditions at the time of study inclusion
18 Years
ALL
No
Sponsors
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Boehringer Ingelheim
INDUSTRY
Abbott
INDUSTRY
Merck Sharp & Dohme LLC
INDUSTRY
Solvay Pharmaceuticals
INDUSTRY
Insel Gruppe AG, University Hospital Bern
OTHER
Responsible Party
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Universitätsklinik für Infektiologie, PKT 2B, Inselspital, 3011 Bern, Switzerland
Principal Investigators
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John M Evison, MD
Role: PRINCIPAL_INVESTIGATOR
Department of Infectious Diseases, University Hospital Bern, 3010-Bern, Switzerland
Locations
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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
Countries
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References
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Vilchez RA, Fung J, Kusne S. The pathogenesis and management of influenza virus infection in organ transplant recipients. Transpl Infect Dis. 2002 Dec;4(4):177-82. doi: 10.1034/j.1399-3062.2002.t01-4-02001.x.
Bridges CB, Fukuda K, Cox NJ, Singleton JA; Advisory Committee on Immunization Practices. Prevention and control of influenza. Recommendations of the Advisory Committee on Immunization Practices (ACIP). MMWR Recomm Rep. 2001 Apr 20;50(RR-4):1-44.
Kroon FP, van Dissel JT, de Jong JC, van Furth R. Antibody response to influenza, tetanus and pneumococcal vaccines in HIV-seropositive individuals in relation to the number of CD4+ lymphocytes. AIDS. 1994 Apr;8(4):469-76. doi: 10.1097/00002030-199404000-00008.
Dorrell L, Hassan I, Marshall S, Chakraverty P, Ong E. Clinical and serological responses to an inactivated influenza vaccine in adults with HIV infection, diabetes, obstructive airways disease, elderly adults and healthy volunteers. Int J STD AIDS. 1997 Dec;8(12):776-9. doi: 10.1258/0956462971919264.
Chalmers A, Scheifele D, Patterson C, Williams D, Weber J, Shuckett R, Teufel A. Immunization of patients with rheumatoid arthritis against influenza: a study of vaccine safety and immunogenicity. J Rheumatol. 1994 Jul;21(7):1203-6.
Abu-Shakra M, Press J, Varsano N, Levy V, Mendelson E, Sukenik S, Buskila D. Specific antibody response after influenza immunization in systemic lupus erythematosus. J Rheumatol. 2002 Dec;29(12):2555-7.
Cavdar C, Sayan M, Sifil A, Artuk C, Yilmaz N, Bahar H, Camsari T. The comparison of antibody response to influenza vaccination in continuous ambulatory peritoneal dialysis, hemodialysis and renal transplantation patients. Scand J Urol Nephrol. 2003;37(1):71-6. doi: 10.1080/00365590310008749.
Conne P, Gauthey L, Vernet P, Althaus B, Que JU, Finkel B, Gluck R, Cryz SJ Jr. Immunogenicity of trivalent subunit versus virosome-formulated influenza vaccines in geriatric patients. Vaccine. 1997 Oct;15(15):1675-9. doi: 10.1016/s0264-410x(97)00087-x.
Baldo V, Menegon T, Bonello C, Floreani A, Trivello R; Collaborative Group. Comparison of three different influenza vaccines in institutionalised elderly. Vaccine. 2001 May 14;19(25-26):3472-5. doi: 10.1016/s0264-410x(01)00060-3.
Zanetti AR, Amendola A, Besana S, Boschini A, Tanzi E. Safety and immunogenicity of influenza vaccination in individuals infected with HIV. Vaccine. 2002 Dec 20;20 Suppl 5:B29-32. doi: 10.1016/s0264-410x(02)00511-x.
Evison J, Farese S, Seitz M, Uehlinger DE, Furrer H, Muhlemann K. Randomized, double-blind comparative trial of subunit and virosomal influenza vaccines for immunocompromised patients. Clin Infect Dis. 2009 May 15;48(10):1402-12. doi: 10.1086/598193.
Other Identifiers
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KEK No 805 (EK 151/03)
Identifier Type: -
Identifier Source: org_study_id