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A Pragmatic Assessment of Influenza Vaccine Effectiveness in the DoD — PAIVED  

Influenza Clinical Trial

Official title:
A Pragmatic Assessment of Influenza Vaccine Effectiveness in the DoD

Clinical Trial 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).

Clinical Trial 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

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT03734237
Study type Interventional
Source Henry M. Jackson Foundation for the Advancement of Military Medicine
Contact
Status Active, not recruiting
Phase Phase 4
Start date November 6, 2018
Completion date May 31, 2024
View Details
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