A Pragmatic Assessment of Influenza Vaccine Effectiveness in the DoD



Status:Recruiting
Conditions:Influenza
Therapuetic Areas:Immunology / Infectious Diseases
Healthy:No
Age Range:18 - Any
Updated:12/19/2018
Start Date:November 6, 2018
End Date:September 30, 2021
Contact:Marianne Spevak, BSHS
Email:mspevak@hjf.org
Phone:240-694-2067

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A total of 10,650 eligible subjects (or 3,550 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 two influenza seasons
(2018-2019, 2019-2020).

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
We found this trial at
6
sites
9040 Jackson Ave
Tacoma, Washington 98431
(253) 968-1110
Principal Investigator: Christina Schofield, MD
Phone: 253-968-1643
Madigan Army Medical Center Located on Joint Base Lewis-McChord, Madigan Army Medical Center comprises a...
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Tacoma, WA
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620 John Paul Jones Cir
Portsmouth, Virginia 23708
(757) 953-5008
Principal Investigator: Tyler Warkentien, MD
Phone: 757-953-5603
Naval Medical Center - Portsmouth Naval Medical Center Portsmouth, Virginia has proudly served the military...
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Portsmouth, VA
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34800 Bob Wilson Dr,
San Diego, California 92134
(619) 532-6400
Principal Investigator: Ryan Maves, MD
Phone: 619-532-7483
Naval Medical Center - San Diego We are the largest and most comprehensive military healthcare...
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San Diego, CA
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8901 Rockville Pike
Bethesda, Maryland 20889
(301) 295-4000
Principal Investigator: Casey Geaney, MD
Phone: 301-319-8673
Walter Reed National Military Medical Center The Walter Reed National Military Medical Center is one...
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Bethesda, MD
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Fort Bragg, North Carolina
Principal Investigator: Bruce McClenathan, MD
Phone: 858-361-4706
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Fort Bragg, NC
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Sam Houston, Texas 78234
Principal Investigator: Ana E Markelz, MD
Phone: 210-916-7913
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from
Sam Houston, TX
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