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).
This four-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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Enrollment
15,448
Participants will be randomly allocated to one of three vaccine types in accordance with standard clinical practices for those in the US military. All vaccines are FDA licensed for use in the United States.
Participants will be randomly allocated to one of three vaccine types in accordance with standard clinical practices for those in the US military. All vaccines are FDA licensed for use in the United States.
Participants will be randomly allocated to one of three vaccine types in accordance with standard clinical practices for those in the US military. All vaccines are FDA licensed for use in the United States.
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
Number of Participants With Laboratory Confirmed Influenza
Laboratory-confirmed influenza as ascertained by a sensitive and specific assay.
Time frame: Onset > 13 days after vaccination up to 1 year
Hemagglutination Inhibition (HI) Titer Responses to Influenza Vaccine Strains.
Strain-specific seroconversion rate determined by reference hemagglutination inhibition assay.
Time frame: Baseline to 21-35 days post vaccine
Pseudovirion Neutralization (PVN) Responses to Influenza Vaccine.
Neutralizing antibody responses (4-fold rise) to HA-psuedoviruses corresponding to vaccine-matched viruses, recently circulating influenza virus, and emerging influenza strain.
Time frame: Baseline to 21-35 days post vaccine
Anti-Neuraminidase (Anti-NA) Titer Responses to Influenza Vaccine.
Anti-Neuraminidase (Anti-NA) titer responses determined by enzyme linked immuno-assay.
Time frame: Baseline to 21-35 days post vaccine
Number of Participants With Influenza-Like Illness
Rate of protocol defined influenza-like illness ascertained by participant response to active surveillance.
Time frame: Onset > 13 days after vaccination up to 1 year
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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