A Pragmatic Assessment of Influenza Vaccine Effectiveness in the DoD
Trial Snapshot
- Phase
- Phase 4
- Status
- Active, not recruiting
- Sponsor
- Enrollment
- 15,448
- Locations
- 9
- Primary Endpoint
- Number of Participants With Laboratory Confirmed Influenza
Study Overview
Brief 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).
Detailed Description
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 Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Prevention
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
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
Arms & Interventions
Egg based influenza vaccines
Quadrivalent egg-based vaccines, which contain an inactivated form of the virus. Vaccines will be given to the participant in accordance with standard clinical practices for those in the US military. All egg-based vaccines are FDA licensed for use in the United States.
Intervention: Egg based influenza vaccines (Biological)
Recombinant influenza vaccines
FluBlok, recombinant HA influenza vaccine. Vaccines will be given to the participant in accordance with standard clinical practices for those in the US military. Flublok Quadrivalent is a quadrivalent recombinant influenza vaccine that has been licensed by the FDA for use in the United States.
Intervention: Recombinant influenza vaccines (Biological)
Cell-culture based influenza vaccines
Flucelvax, Madin-Darby canine kidney (MDCK)-cell-culture based inactivated influenza vaccine. Vaccines will be given to the participant in accordance with standard clinical practices for those in the US military. Flucelvax quadrivalent, the only cell-based flu vaccine FDA licensed for use in the United States.
Intervention: Cell-culture based influenza vaccines (Biological)
Outcomes
Primary Outcomes
Number of Participants With Laboratory Confirmed Influenza
Time Frame: Onset > 13 days after vaccination up to 1 year
Laboratory-confirmed influenza as ascertained by a sensitive and specific assay.
Secondary Outcomes
- Pseudovirion Neutralization (PVN) Responses to Influenza Vaccine.(Baseline to 21-35 days post vaccine)
- Number of Participants With Influenza-Like Illness(Onset > 13 days after vaccination up to 1 year)
- Hemagglutination Inhibition (HI) Titer Responses to Influenza Vaccine Strains.(Baseline to 21-35 days post vaccine)
- Anti-Neuraminidase (Anti-NA) Titer Responses to Influenza Vaccine.(Baseline to 21-35 days post vaccine)