A Pragmatic Assessment of Influenza Vaccine Effectiveness in the DoD (PAIVED)

March 13, 2026 updated by: Henry M. Jackson Foundation for the Advancement of Military Medicine
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).

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

15448

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • San Diego, California, United States, 34800
        • Naval Medical Center San Diego
    • Maryland
      • Annapolis, Maryland, United States, 21402
        • United States Naval Academy
      • Bethesda, Maryland, United States, 20814
        • Walter Reed National Military Medical Center
      • Bethesda, Maryland, United States, 20307
        • USU
    • North Carolina
      • Fort Bragg, North Carolina, United States, 28310
        • Womack Army Medical Center
    • Texas
      • Fort Sam Houston, Texas, United States, 78234
        • Brooke Army Medical Center
      • San Antonio, Texas, United States, 78243
        • Lackland Airforce Base
    • Virginia
      • Portsmouth, Virginia, United States, 23704
        • Naval Medical Center Portsmouth
    • Washington
      • Tacoma, Washington, United States, 98431
        • Madigan Army Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

14 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  1. Eligible for care in Department of Defense medical facilities (Defense Enrollment Eligibility Reporting System eligible)
  2. ≥18 years of age.
  3. At a participating Military Treatment Facility site for the purpose of receiving a seasonal (2018-2019, 2019-2020,2020-2021, 2021-2022) influenza vaccination.
  4. Able to speak English and able to provide informed consent
  5. Able to receive and respond to texts and/or emails, or a military recruit

Exclusion Criteria:

  1. Adults intending to receive or who have received the current seasons FluMist Vaccine (LAIV)
  2. Adults who have already received a flu vaccine within the current season
  3. Individual who cannot receive a flu vaccine or standard dosing due to another medical condition
  4. Allergic to gentamicin, polymyxin and/or neomycin
  5. Individuals who fail to meet the inclusion criteria

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Egg based influenza vaccines
Quadrivalent egg-based vaccines, which contain an inactivated form of the virus. Vaccines will be given to the participant in accordance with standard clinical practices for those in the US military. All egg-based vaccines are FDA licensed for use in the United States.
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.
Active Comparator: Recombinant influenza vaccines
FluBlok, recombinant HA influenza vaccine. Vaccines will be given to the participant in accordance with standard clinical practices for those in the US military. Flublok Quadrivalent is a quadrivalent recombinant influenza vaccine that has been licensed by the FDA 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.
Active Comparator: Cell-culture based influenza vaccines
Flucelvax, Madin-Darby canine kidney (MDCK)-cell-culture based inactivated influenza vaccine. Vaccines will be given to the participant in accordance with standard clinical practices for those in the US military. Flucelvax quadrivalent, the only cell-based flu vaccine 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of Participants With Laboratory Confirmed Influenza
Time Frame: Onset > 13 days after vaccination up to 1 year
Laboratory-confirmed influenza as ascertained by a sensitive and specific assay.
Onset > 13 days after vaccination up to 1 year

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Hemagglutination Inhibition (HI) Titer Responses to Influenza Vaccine Strains.
Time Frame: Baseline to 21-35 days post vaccine
Strain-specific seroconversion rate determined by reference hemagglutination inhibition assay.
Baseline to 21-35 days post vaccine
Pseudovirion Neutralization (PVN) Responses to Influenza Vaccine.
Time Frame: Baseline to 21-35 days post vaccine
Neutralizing antibody responses (4-fold rise) to HA-psuedoviruses corresponding to vaccine-matched viruses, recently circulating influenza virus, and emerging influenza strain.
Baseline to 21-35 days post vaccine
Anti-Neuraminidase (Anti-NA) Titer Responses to Influenza Vaccine.
Time Frame: Baseline to 21-35 days post vaccine
Anti-Neuraminidase (Anti-NA) titer responses determined by enzyme linked immuno-assay.
Baseline to 21-35 days post vaccine
Number of Participants With Influenza-Like Illness
Time Frame: Onset > 13 days after vaccination up to 1 year
Rate of protocol defined influenza-like illness ascertained by participant response to active surveillance.
Onset > 13 days after vaccination up to 1 year

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of Participants With SARS-CoV-2 and Influenza Co-Infection
Time Frame: Onset > 13 days after influenza vaccination up until one year
Laboratory-confirmed SARS CoV2, and SARS CoV2 plus influenza co-infection, as ascertained by nasal swab PCR.
Onset > 13 days after influenza vaccination up until one year
Symptom Severity of SARS CoV2
Time Frame: onset >13 days after Influenza vaccination up to 1 year
Symptom severity scores were reported by participants using FLU-PRO Plus (Influenza Patient Reported Outcomes), a standardized instrument developed to measure the intensity and frequency of viral respiratory tract symptoms. FluPRO Plus symptom scores range from 0 ("not at all") to 4 ("very much"), with higher scores indicating greater severity.
onset >13 days after Influenza vaccination up to 1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Henry M. Jackson Foundation for the Advancement of Military Medicine

Collaborators

National Institute of Allergy and Infectious Diseases (NIAID)
Food and Drug Administration (FDA)
Uniformed Services University of the Health Sciences
Naval Health Research Center
United States Air Force School of Aerospace Medicine
US Department of Defense Armed Forces Health Surveillance Center
Defense Health Agency

Investigators

  • Principal Investigator: Timothy Burgess, MD, Uniformed Services University of the Health Sciences
  • Study Director: Rhonda Colombo, MD, Infectious Diseases Clinical Research Program

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 6, 2018

Primary Completion (Actual)

July 7, 2022

Study Completion (Estimated)

June 30, 2026

Study Registration Dates

First Submitted

November 2, 2018

First Submitted That Met QC Criteria

November 6, 2018

First Posted (Actual)

November 7, 2018

Study Record Updates

Last Update Posted (Actual)

April 2, 2026

Last Update Submitted That Met QC Criteria

March 13, 2026

Last Verified

March 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IDCRP-120
  • AAI1201200007000 (Other Grant/Funding Number: NIAID)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

Investigative team members with knowledge and experience with statistical and scientific procedures will de-identify PHI and prepare the data set to be shared.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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