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A Pragmatic Assessment of Influenza Vaccine Effectiveness in the DoD

Study acronym: PAIVED
StatusActive, Not Recruiting
PhasePhase 4
Started
View on ClinicalTrials.gov ↗

Record History

See every version on ClinicalTrials.gov ↗

  1. Enrollment target: 15449 to 15448
    • Study completion date: May 31, 2024 to Jun 30, 2026
    • Collaborators revised (7)
    v12
  2. Results first posted: Nov 24, 2023v11
  3. Primary endpoint revised
    • Enrollment target: 16023 to 15449
    • Secondary endpoints revised (4)
    v10
  4. Secondary endpoints: 7 to 4
    • Primary endpoint revised
    v9
  5. Re-verified, no change to tracked fieldsv8
Show 6 earlier versionsHide 6 earlier versions
  1. Trial status: Recruiting to Active, Not Recruitingv7 Show 4 more changesShow less
    • Enrollment target: estimated 18000 to confirmed 16023
    • Primary completion date changed from estimate of May 31, 2022 to Jul 7, 2022
    • Study completion date: May 31, 2022 to May 31, 2024
    • Site details revised at 9 of 9 sites
  2. Enrollment target: 15000 to 18000
    • Study sites: 10 to 9
    • Study description revised
    • Eligibility criteria expanded, about 1 word
    v6
  3. Primary completion date: May 31, 2020 to May 31, 2022v5 Show 5 more changesShow less
    • Enrollment target: 10650 to 15000
    • Study sites: 6 to 10
    • Study completion date: Sep 30, 2021 to May 31, 2022
    • Eligibility criteria expanded, about 11 words
    • Study description shortened, about 10 words
  4. Re-verified, no change to tracked fieldsv4
  5. Study description expanded, about 2 words
    • Study title expanded, about 2 words
    v3
  6. Trial status: Not Yet Recruiting to Recruiting
    • Site details revised at 6 of 6 sites
    v2
  1. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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).
Trial Details
NCT Number NCT03734237
Lead 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), US Department of Defense Armed Forces Health Surveillance Center, Naval Health Research Center, United States Air Force School of Aerospace Medicine, Uniformed Services University of the Health Sciences, Defense Health Agency
Conditions
(from sponsor)		 Influenza, Influenza-like Illness, Influenza Vaccines
Related terms Influenza, Human
Enrollment 15,448 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov