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ACTIVE NOT RECRUITING
NCT03734237
PHASE4

A Pragmatic Assessment of Influenza Vaccine Effectiveness in the DoD

Sponsor: Henry M. Jackson Foundation for the Advancement of Military Medicine

View on ClinicalTrials.gov

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).

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

15448

Start Date

2018-11-06

Completion Date

2026-06-30

Last Updated

2026-04-02

Healthy Volunteers

Yes

Interventions

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.

Locations (9)

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