A Phase III, Randomized, Controlled, Open Label Study to Evaluate the Immunogenicity, Safety, and Tolerability of an Adjuvanted A(H1N1) Vaccine Versus Non-Adjuvanted Vaccines Against Novel H1N1 Virus in Patients With Invasive Solid Tumors
Sponsor study identifier
interventional
59
1 country
3
Study Start
August 2010
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
September 2011
Actual (reported)Study Completion
July 2012
Actual (reported)This is a phase III, randomized, controlled, open label study with two vaccine regimens. The study will assess the relative safety and immunogenicity of vaccine regimens comparing adjuvanted versus non-adjuvanted formulations of A(H1N1) inactivated influenza virus vaccine in subjects with Solid Invasive Tumors and to compare safety and immunogenicity data with a contemporaneously enrolled control group of age-comparable, healthy subjects. Because certain individuals may be hypo-responsive to influenza vaccination, additional studies with high-risk groups are warranted in order to determine the optimal vaccine formulation and dosing schedule for prevention of novel H1N1 virus infection.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
July 2012
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.
December 14, 2009
Actual (reported)December 15, 2009
Actual (reported)August 2010
Date type not reportedThis date has not been verified as actual or estimated.
September 2011
Actual (reported)July 2012
Actual (reported)The primary objective of this study is to determine the optimal influenza vaccination strategy in patients with invasive solid tumors
3 months
Assess whether the adjuvanted vaccine offers a meaningful benefit in relation to the non-adjuvanted vaccine in this at-risk population
3 months
Assess whether two doses of either study vaccine will provide meaningful benefit in comparison to one dose
3 months
Each subject will receive two doses of the assigned vaccine, the first on Study Day 1, and the second on Study Day 22
Each subject will receive two doses of the assigned vaccine, the first on Study Day 1, and the second on Study Day 22
Each subject will receive two doses of the assigned vaccine, the first on Study Day 1, and the second on Study Day 22
7.5 ug of HA antigen; adjuvanted; monovalent
15ug of HA antigen, non-adjuvanted; trivalent
BIOCANCER Clinical Research
Belo Horizonte, Minas Gerais, Brazil
Centro de Estudos e Pesquisas de Oncologia e Hematologia da Faculdade de Medicina da Fundação do ABC
Santo André, São Paulo, Brazil
Universidade Federal de São Paulo
São Paulo, São Paulo, Brazil
Clark TW, Pareek M, Hoschler K, Dillon H, Nicholson KG, Groth N, Stephenson I. Trial of 2009 influenza A (H1N1) monovalent MF59-adjuvanted vaccine. N Engl J Med. 2009 Dec 17;361(25):2424-35. doi: 10.1056/NEJMoa0907650. Epub 2009 Sep 10.
Novel Swine-Origin Influenza A (H1N1) Virus Investigation Team; Dawood FS, Jain S, Finelli L, Shaw MW, Lindstrom S, Garten RJ, Gubareva LV, Xu X, Bridges CB, Uyeki TM. Emergence of a novel swine-origin influenza A (H1N1) virus in humans. N Engl J Med. 2009 Jun 18;360(25):2605-15. doi: 10.1056/NEJMoa0903810. Epub 2009 May 7.
59 participants (actual enrollment reported by the registry).
First Submitted
December 14, 2009
First Posted
December 15, 2009
Study Start
August 2010
Date type not reportedThis date has not been verified as actual or estimated.
Assess the persistence of antibody levels in the two vaccine groups
3 months
Gain further insight into the safety of the adjuvanted and non-adjuvanted H1N1 vaccines in this high-risk patient population
3 months
Each subject will receive two doses of the assigned vaccine, the first on Study Day 1, and the second on Study Day 22
15 mcg of antigen; non-adjuvanted; trivalent
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Contact the study team to confirm eligibility.
Gross PA, Gould AL, Brown AE. Effect of cancer chemotherapy on the immune response to influenza virus vaccine: review of published studies. Rev Infect Dis. 1985 Sep-Oct;7(5):613-8. doi: 10.1093/clinids/7.5.613.
Kunisaki KM, Janoff EN. Influenza in immunosuppressed populations: a review of infection frequency, morbidity, mortality, and vaccine responses. Lancet Infect Dis. 2009 Aug;9(8):493-504. doi: 10.1016/S1473-3099(09)70175-6.
Primary Completion
September 2011
Actual (reported)Study Completion
July 2012
Actual (reported)Last Updated
September 13, 2012
Record last verified: 2012-09
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Source: ClinicalTrials.gov.
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