A Pragmatic Assessment of Influenza Vaccine Effectiveness in the DoD
A Pragmatic Assessment of Influenza Vaccine Effectiveness in the DoD
A total of 15,000 eligible subjects (or 5,000subject distributed evenly between the 3 study
 arms) will be enrolled. Eligible subjects will be randomized in 1:1:1 (cell-culture-based
 vaccine, the recombinant vaccine, or the egg-based vaccine) over two influenza seasons
 (2018-2019, 2019-2020, 2020-2021).
This tree-year, pragmatic, prospective study will compare the effectiveness of licensed
 egg-based inactivated influenza vaccines to the effectiveness of two other types of licensed
 vaccines, the cell-culture based inactivated influenza vaccine and the recombinant influenza
 vaccine, in the prevention of laboratory-confirmed influenza infection in active duty
 members, military retirees, and other DoD beneficiaries. Military treatment facilities (MTFs)
 in the United States will participate in this protocol. Enrollment will be restricted to
 adults (≥18 years and older) who are preparing to receive seasonal influenza vaccination at
 participating DoD sites. Subjects will be randomized to receive one of the three licensed
 influenza vaccines types for evaluation of effectiveness. There is no exclusion for
 pregnancy, as none of these licensed products are contraindicated in pregnant women.
Inclusion Criteria:

 1. Eligible for care in Department of Defense medical facilities (Defense Enrollment
 Eligibility Reporting System eligible)

 2. ≥18 years of age.

 3. At a participating Military Treatment Facility site for the purpose of receiving a
 seasonal (2018-2019, 2019-2020,2020-2021) influenza vaccination.

 4. Able to speak English and able to provide informed consent

 5. Able to receive and respond to texts and/or emails, or a military recruit

 Exclusion Criteria:

 1. Adults intending to receive or who have received the current seasons FluMist Vaccine
 (LAIV)

 2. Adults who have already received a flu vaccine within the current season

 3. Individual who cannot receive a flu vaccine or standard dosing due to another medical
 condition

 4. Allergic to gentamicin, polymyxin and/or neomycin

 5. Individuals who fail to meet the inclusion criteria