Comparative Study of Influenza Vaccines in Adults, FLUVACS-year 4
NCT ID: NCT00538512
Last Updated: 2017-12-06
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE4
1952 participants
INTERVENTIONAL
2007-09-30
2008-05-31
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
SINGLE_GROUP
PREVENTION
DOUBLE
Study Groups
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TIV
the trivalent inactivated influenza vaccine - Fluzone, manufactured by Sanofi-Pasteur
Fluzone
single dose licensed trivalent inactivated influenza vaccine (2007-08)
LAIV
live-attenuated influenza vaccine Flumist, manufactured by MedImmune
Flumist
single dose licensed live-attenuated influenza vaccine Flumist (2007-08)
Placebo
Physiologic saline administered as a nasal spray or intramuscular injection
Physiologic saline
single dose placebo administered as an intranasal spray or intramuscular injection
Interventions
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Fluzone
single dose licensed trivalent inactivated influenza vaccine (2007-08)
Flumist
single dose licensed live-attenuated influenza vaccine Flumist (2007-08)
Physiologic saline
single dose placebo administered as an intranasal spray or intramuscular injection
Eligibility Criteria
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Inclusion Criteria
* Age 18-49 years
* Who reside geographically close to one of the four study sites in Michigan
Exclusion Criteria
* Persons for whom either vaccine is contraindicated
18 Years
49 Years
ALL
Yes
Sponsors
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Sanofi Pasteur, a Sanofi Company
INDUSTRY
University of Michigan
OTHER
Responsible Party
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Arnold S. Monto
Principal Investigator
Principal Investigators
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Arnold S. Monto, MD
Role: PRINCIPAL_INVESTIGATOR
University of Michigan School of Public Health
Locations
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University of Michigan School of Public Heatlh
Ann Arbor, Michigan, United States
Western Michigan University Health Services
Kalamazoo, Michigan, United States
Central Michigan University Health Services
Mount Pleasant, Michigan, United States
Eastern Michigan University Health Services
Ypsilanti, Michigan, United States
Countries
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References
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Ohmit SE, Victor JC, Rotthoff JR, Teich ER, Truscon RK, Baum LL, Rangarajan B, Newton DW, Boulton ML, Monto AS. Prevention of antigenically drifted influenza by inactivated and live attenuated vaccines. N Engl J Med. 2006 Dec 14;355(24):2513-22. doi: 10.1056/NEJMoa061850.
Monto AS, Ohmit SE, Petrie JG, Johnson E, Truscon R, Teich E, Rotthoff J, Boulton M, Victor JC. Comparative efficacy of inactivated and live attenuated influenza vaccines. N Engl J Med. 2009 Sep 24;361(13):1260-7. doi: 10.1056/NEJMoa0808652.
Monto AS, Petrie JG, Cross RT, Johnson E, Liu M, Zhong W, Levine M, Katz JM, Ohmit SE. Antibody to Influenza Virus Neuraminidase: An Independent Correlate of Protection. J Infect Dis. 2015 Oct 15;212(8):1191-9. doi: 10.1093/infdis/jiv195. Epub 2015 Apr 8.
Ohmit SE, Petrie JG, Cross RT, Johnson E, Monto AS. Influenza hemagglutination-inhibition antibody titer as a correlate of vaccine-induced protection. J Infect Dis. 2011 Dec 15;204(12):1879-85. doi: 10.1093/infdis/jir661. Epub 2011 Oct 12.
Gilbert PB, Fong Y, Juraska M, Carpp LN, Monto AS, Martin ET, Petrie JG. HAI and NAI titer correlates of inactivated and live attenuated influenza vaccine efficacy. BMC Infect Dis. 2019 May 22;19(1):453. doi: 10.1186/s12879-019-4049-5.
Petrie JG, Ohmit SE, Johnson E, Cross RT, Monto AS. Efficacy studies of influenza vaccines: effect of end points used and characteristics of vaccine failures. J Infect Dis. 2011 May 1;203(9):1309-15. doi: 10.1093/infdis/jir015. Epub 2011 Mar 4.
Other Identifiers
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FLUVACS
Identifier Type: -
Identifier Source: org_study_id