A Pragmatic Assessment of Influenza Vaccine Effectiveness in the DoD

This two-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. Six military treatment facilities
(MTFs) in the United States will participate in this protocol. Enrollment will be restricted
to adults (≥18 years and older, or ≥17 years old if an active duty member) 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 Defence medical facilities (Defense Enrollment
Eligibility Reporting System eligible)

2. ≥17 years of age and above for active duty members and ≥18 years of age for other
beneficiaries.

3. At a participating Military Treatment Facility site for the purpose of receiving a
seasonal (2018-19 and 2019-2020) influenza vaccination.

4. Speak English and able to provide informed consent

Exclusion Criteria:

1. Adults intending to receive or who have received the 2018-2019 and 2019-2020 FluMist
vaccine (LAIV).

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

3. Allergic to gentamicin, polymyxin and/or neomycin

4. Individuals who fail to meet the inclusion criteria