Clinical trial NCT00538512: Comparative Study of Influenza Vaccines in Adults, FLUVACS-year 4
Official title: Comparative Study of Influenza Vaccines in Adults, FLUVACS-year 4
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Influenza
Keywords: Influenza
Live attenuated influenza vaccine
Inactivated influenza vaccine
Vaccine Efficacy
Lead sponsor: University of Michigan
Sponsor class: OTHER
Collaborators: name: Sanofi Pasteur, a Sanofi Company
First posted: 2007-10-02
Enrollment: 1952
Sex: ALL
Minimum age (years): 18
Maximum age (years): 49
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

Brief summary: The purpose of this study is to evaluate the absolute (versus placebo) and relative (one vaccine compared to the other) efficacies of the live attenuated and inactivated influenza vaccines in preventing laboratory confirmed symptomatic influenza caused by circulating strains whether similar or dissimilar to strains included in the vaccines.


Eligibility criteria: Inclusion Criteria:

* Healthy adult men and women
* Age 18-49 years
* Who reside geographically close to one of the four study sites in Michigan

Exclusion Criteria:

* Persons with any of the health conditions for which the inactivated vaccine is recommended
* Persons for whom either vaccine is contraindicated

Primary outcomes:
measure: Laboratory-confirmed (Culture and/or PCR) Symptomatic Influenza
timeFrame: one influenza season - 2007-2008
Secondary outcomes:
measure: Measure Immune Response Induced by the Vaccines and Identify Serologic Correlates of Immune Protection
timeFrame: Time between prevaccination visit and postvaccination visit; typically about 30 days.
measure: Immune Response to Vaccination and Infection
timeFrame: Postvaccination to postseason visit; typically about 3 months.
measure: Identify Serologic Correlates of Immune Protection. Suggest Changing to: Number of Participants Demonstrating Postvaccination Seroconversion.
timeFrame: Time between prevaccination and postvaccination, typically about 30 days.
Other outcomes:
Locations:
city: Ann Arbor
country: United States
facility: University of Michigan School of Public Heatlh
state: Michigan
city: Kalamazoo
country: United States
facility: Western Michigan University Health Services
state: Michigan
city: Mount Pleasant
country: United States
facility: Central Michigan University Health Services
state: Michigan
city: Ypsilanti
country: United States
facility: Eastern Michigan University Health Services
state: Michigan
Study officials:
affiliation: University of Michigan School of Public Health
name: Arnold S. Monto, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.