Active — Not RecruitingPhase 4

A Pragmatic Assessment of Influenza Vaccine Effectiveness in the DoD

United States15,448 participantsStarted 2018-11-06

Plain-language summary

A total of 18,000 eligible subjects (or 6,000 subject 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 four influenza seasons (2018-2019, 2019-2020, 2020-2021, and 2021-2022).

Who can participate

Age range18 Years

SexALL

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Inclusion criteria

✓. Eligible for care in Department of Defense medical facilities (Defense Enrollment Eligibility Reporting System eligible)
✓. ≥18 years of age.
✓. At a participating Military Treatment Facility site for the purpose of receiving a seasonal (2018-2019, 2019-2020,2020-2021, 2021-2022) influenza vaccination.
✓. Able to speak English and able to provide informed consent
✓. Able to receive and respond to texts and/or emails, or a military recruit

Exclusion criteria

✕. Adults intending to receive or who have received the current seasons FluMist Vaccine (LAIV)
✕. Adults who have already received a flu vaccine within the current season
✕. Individual who cannot receive a flu vaccine or standard dosing due to another medical condition
✕. Allergic to gentamicin, polymyxin and/or neomycin
✕. Individuals who fail to meet the inclusion criteria

What they're measuring

Number of Participants With Laboratory Confirmed Influenza

Timeframe: Onset > 13 days after vaccination up to 1 year

Trial details

NCT IDNCT03734237

SponsorHenry M. Jackson Foundation for the Advancement of Military Medicine

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2022-07-07

Results submitted2023-08-01

View on ClinicalTrials.gov More Influenza trials