A Pragmatic Assessment of Influenza Vaccine Effectiveness in the DoD
Last updated on July 2021Recruitment
- Recruitment Status
- Recruiting
- Estimated Enrollment
- 10650
Summary
- Conditions
- Influenza
- Influenza -Like Illness
- Type
- Interventional
- Phase
- Phase 4
- Design
- Allocation: RandomizedIntervention Model: Parallel AssignmentIntervention Model Description: A total of 15,000 eligible subjects (or 5,000 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 three influenza seasons (2018-2019,2019-2020, 2020-2021,).Masking: None (Open Label)Primary Purpose: Prevention
Participation Requirements
- Age
- Between 18 years and 125 years
- Gender
- Both males and females
Description
This tree-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...
This tree-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.
Tracking Information
- NCT #
- NCT03734237
- Collaborators
- National Institute of Allergy and Infectious Diseases (NIAID)
- Food and Drug Administration (FDA)
- Defense Health Agency Immunization Healthcare Branch
- Armed Forces Health Surveillance Branch
- Naval Health Research Center
- United States Air Force School of Aerospace Medicine
- Uniformed Services University of the Health Sciences
- Investigators
- Principal Investigator: Timothy Burgess, MD Uniformed Services University of the Health Sciences Study Director: Christian Coles, PhD Infectious Diseases Clinical Research Program
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