A Pragmatic Assessment of Influenza Vaccine Effectiveness in the DoD

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).

Conditions

• Influenza
• Influenza-like Illness
• Influenza Vaccines

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.

Sponsors & Collaborators

• National Institute of Allergy and Infectious Diseases (NIAID)

  collaborator NIH

• Food and Drug Administration (FDA)

  collaborator FED

• US Department of Defense Armed Forces Health Surveillance Center

  collaborator FED

• Naval Health Research Center

  collaborator FED

• United States Air Force School of Aerospace Medicine

  collaborator FED

• Uniformed Services University of the Health Sciences

  collaborator FED

• Defense Health Agency

  collaborator FED

• Henry M. Jackson Foundation for the Advancement of Military Medicine

  lead OTHER

Principal Investigators

• Timothy Burgess, MD · Uniformed Services University of the Health Sciences

• Rhonda Colombo, MD · Infectious Diseases Clinical Research Program

Study Design

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2018-11-06

Primary Completion

2022-07-07

Completion

2026-06-30

FDA Drug

Yes

Countries

• United States

Study Locations