Because of near universal recommendation for annual vaccination (all aged 6 months) only observational studies of influenza vaccine effectiveness can be performed for ethical reasons. However, results from observational studies may be subject to unrecognized selection biases, and study design strategies to identify and adjust for these biases are necessary. We propose estimation of influenza vaccine effectiveness in preventing medically attended influenza in two health systems, and influenza of all severities in a cohort of households with children, in Michigan. We will conduct surveillance at multiple outpatient health centers, three hospitals, and in ~300 enrolled households during the influenza season, and will enroll adult and pediatric patients and household members meeting various case definitions. Vaccination status will be reported and validated, and considered with laboratory-confirmed influenza outcomes to estimate vaccine effectiveness separately for ambulatory, inpatient and household populations, with estimates compared across studies. Analyses will use a test-negative control approach-those testing positive for influenza are cases, those testing negative are controls. Modifiers and confounders of vaccine effectiveness such as age, health status, household size and composition, health care utilization, subjective socio-economic status, and health system characteristics will be assessed and considered in analytic models.

Public Health Relevance

MFIVE-HIVE combined Annual estimation of influenza vaccine effectiveness is necessary to guide vaccination and control policy. We propose estimation of influenza vaccine effectiveness in preventing medically attended influenza among patients in two health systems, and influenza of all severities in a cohort of households with children, in Michigan. Laboratory confirmed influenza outcomes and verified influenza vaccination status will be used to calculate vaccine effectiveness using a test- negative control approach.

National Institute of Health (NIH)
National Center for Immunication and Respiratory Diseases (NCIRD)
Research Project--Cooperative Agreements (U01)
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Special Emphasis Panel (ZIP1-GCA (19))
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O'Neill, Eduardo
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University of Michigan Ann Arbor
Ann Arbor
United States
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Garretson, Tyler A; Petrie, Joshua G; Martin, Emily T et al. (2018) Identification of human vaccinees that possess antibodies targeting the egg-adapted hemagglutinin receptor binding site of an H1N1 influenza vaccine strain. Vaccine 36:4095-4101
McCrone, John T; Woods, Robert J; Martin, Emily T et al. (2018) Stochastic processes constrain the within and between host evolution of influenza virus. Elife 7:
Segaloff, H E; Petrie, J G; Malosh, R E et al. (2018) Severe morbidity among hospitalised adults with acute influenza and other respiratory infections: 2014-2015 and 2015-2016. Epidemiol Infect 146:1350-1358
Jackson, Michael L; Phillips, C Hallie; Benoit, Joyce et al. (2018) Burden of medically attended influenza infection and cases averted by vaccination - United States, 2013/14 through 2015/16 influenza seasons. Vaccine 36:467-472
Russell, Kate; Chung, Jessie R; Monto, Arnold S et al. (2018) Influenza vaccine effectiveness in older adults compared with younger adults over five seasons. Vaccine 36:1272-1278
Shang, Mei; Chung, Jessie R; Jackson, Michael L et al. (2018) Influenza vaccine effectiveness among patients with high-risk medical conditions in the United States, 2012-2016. Vaccine 36:8047-8053
Harrison, Samantha M; Wei, Melissa Y; Lamerato, Lois E et al. (2018) Multimorbidity is associated with uptake of influenza vaccination. Vaccine 36:3635-3640
Davis, Amy K F; McCormick, Kevin; Gumina, Megan E et al. (2018) Sera from Individuals with Narrowly Focused Influenza Virus Antibodies Rapidly Select Viral Escape Mutations In Ovo. J Virol 92:
Petrie, Joshua G; Eisenberg, Marisa C; Ng, Sophia et al. (2017) Application of an Individual-Based Transmission Hazard Model for Estimation of Influenza Vaccine Effectiveness in a Household Cohort. Am J Epidemiol 186:1380-1388
Jackson, Michael L; Chung, Jessie R; Jackson, Lisa A et al. (2017) Influenza Vaccine Effectiveness in the United States during the 2015-2016 Season. N Engl J Med 377:534-543

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