NCT03734237

A Pragmatic Assessment of Influenza Vaccine Effectiveness in the DoD

• Status: Active Not Recruiting
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 15,448 (actual)
• Sponsor: Henry M. Jackson Foundation for the Advancement of Military Medicine · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

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.

Conditions

• Influenza
• Influenza-like Illness
• Influenza Vaccines

Interventions

Type	Name	Description
BIOLOGICAL	Egg based influenza vaccines	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.
BIOLOGICAL	Recombinant influenza vaccines	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.
BIOLOGICAL	Cell-culture based influenza vaccines	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.

Timeline

• Start date: 2018-11-06
• Primary completion: 2022-07-07
• Completion: 2026-06-30
• First posted: 2018-11-07
• Last updated: 2026-04-02
• Results posted: 2023-11-24

Locations

9 sites across 1 country: United States

Regulatory

• FDA-regulated drug study