A Pragmatic Assessment of Influenza Vaccine Effectiveness in the DoD

Running, not enrolling · Phase 4

Conditions studied: Influenza, Influenza-like Illness, Influenza Vaccines

In brief

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).

Key facts

Study ID

NCT03734237

Run by

Henry M. Jackson Foundation for the Advancement of Military Medicine

People needed

15448

Starts

2018-11-06

Expected to finish

2026-06-30

Last updated by the study team

2026-04-02

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Naval Medical Center San Diego — San Diego, California, United States
• United States Naval Academy — Annapolis, Maryland, United States
• USU — Bethesda, Maryland, United States
• Walter Reed National Military Medical Center — Bethesda, Maryland, United States
• Womack Army Medical Center — Fort Bragg, North Carolina, United States
• Brooke Army Medical Center — Fort Sam Houston, Texas, United States
• Lackland Airforce Base — San Antonio, Texas, United States
• Naval Medical Center Portsmouth — Portsmouth, Virginia, United States
• Madigan Army Medical Center — Tacoma, Washington, United States

Full record on ClinicalTrials.gov

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