NCT00542776|CompletedDMC
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Sponsor study identifier
observational
146
1 country
1
Study Start
October 2007
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
February 2008
Actual (reported)Study Completion
February 2008
Actual (reported)The purpose of this study is to compare the efficacy and safety of influenza vaccine in patients with inflammatory bowel disease (IBD) on immunosuppressive therapy with IBD patients on aminosalicylates and healthy historical controls.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
February 2008
Actual (reported)Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
October 2007
Date type not reportedThis date has not been verified as actual or estimated.
October 9, 2007
Actual (reported)October 11, 2007
Actual (reported)February 2008
Actual (reported)February 2008
Actual (reported)seroprotection rate
3-8 weeks after vaccination
vaccine-associated adverse events
up to 8 weeks after vaccination
antibody titer levels
3-8 weeks after vaccination
IBD patients on immunosuppressive therapy
IBD patients on non-immunosuppressive therapy (e.g., aminosalicylates, antibiotics) or on no medications
drawing blood for seroprotection and antibody titers to the 3 strains of influenza on Day 1 and Month 1 (3-8 weeks)
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Patients aged 5 years and older with documented inflammatory bowel disease (Crohn's disease, ulcerative colitis, indeterminate colitis)
Children's Hospital Boston
Boston, Massachusetts, 02115, United States
Blumberg EA, Albano C, Pruett T, Isaacs R, Fitzpatrick J, Bergin J, Crump C, Hayden FG. The immunogenicity of influenza virus vaccine in solid organ transplant recipients. Clin Infect Dis. 1996 Feb;22(2):295-302. doi: 10.1093/clinids/22.2.295.
Soesman NM, Rimmelzwaan GF, Nieuwkoop NJ, Beyer WE, Tilanus HW, Kemmeren MH, Metselaar HJ, de Man RA, Osterhaus AD. Efficacy of influenza vaccination in adult liver transplant recipients. J Med Virol. 2000 May;61(1):85-93.
Blood for seroprotection rate and antibody titers
Ying Lu, MD
Boston Children's Hospital
146 participants (actual enrollment reported by the registry).
First Submitted
October 9, 2007
First Posted
October 11, 2007
Study Start
October 2007
Date type not reportedThis date has not been verified as actual or estimated.
An In-vitro Standardization of B Cell Elispot Assays
Contact the study team to confirm eligibility.
Banic S, Koren S, Tomazic J, Vidmar L, Ihan A, Poljak M, Avsic-Zupanc A. Influenza vaccination of human immunodeficiency virus 1-infected patients receiving antiretroviral therapy. Acta Virol. 2001 Feb;45(1):39-44.
Matsuzaki A, Suminoe A, Koga Y, Kinukawa N, Kusuhara K, Hara T. Immune response after influenza vaccination in children with cancer. Pediatr Blood Cancer. 2005 Nov;45(6):831-7. doi: 10.1002/pbc.20470.
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.
Suga T, Niki H, Niikura M, Matsumoto Y, Nishimura T, Nakajima K, Miyazaki M, Endoh M, Nomoto Y, Sakai H. Influenza antibody titers after vaccination of chronic renal failure patients; before and during hemodialysis, or on continuous ambulatory peritoneal dialysis. Tokai J Exp Clin Med. 1990 May;15(2-3):245-51.
Holvast A, Huckriede A, Wilschut J, Horst G, De Vries JJ, Benne CA, Kallenberg CG, Bijl M. Safety and efficacy of influenza vaccination in systemic lupus erythematosus patients with quiescent disease. Ann Rheum Dis. 2006 Jul;65(7):913-8. doi: 10.1136/ard.2005.043943. Epub 2005 Dec 1.
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.
Mamula P, Markowitz JE, Piccoli DA, Klimov A, Cohen L, Baldassano RN. Immune response to influenza vaccine in pediatric patients with inflammatory bowel disease. Clin Gastroenterol Hepatol. 2007 Jul;5(7):851-6. doi: 10.1016/j.cgh.2007.02.035. Epub 2007 Jun 4.
Primary Completion
February 2008
Actual (reported)Study Completion
February 2008
Actual (reported)Last Updated
May 1, 2008
Record last verified: 2007-12
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Source: ClinicalTrials.gov.
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