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A Phase I/II, Two-Staged, Single-Center, Randomized, Double-Blind, Antibody Titer Study to Assess Immunogenicity and Safety of FluMist Intranasal Influenza Vaccine Administered With and Without a TLR-3 Agonist, Ampligen

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Trial Profile

A Phase I/II, Two-Staged, Single-Center, Randomized, Double-Blind, Antibody Titer Study to Assess Immunogenicity and Safety of FluMist Intranasal Influenza Vaccine Administered With and Without a TLR-3 Agonist, Ampligen

Status: Discontinued
Phase of Trial: Phase I/II

Latest Information Update: 23 Jan 2020

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At a glance

  • Drugs Influenza virus vaccine live (Primary) ; Rintatolimod (Primary)
  • Indications Influenza virus infections
  • Focus Adverse reactions
  • Sponsors AIM ImmunoTech

    • Most Recent Events

    • 31 Jan 2018 According to a Hemispherx Biopharma media release, the principal investigator of this Phase 1/2 trial was Edgar Turner Overton, MD.
    • 14 Aug 2017 According to a Hemispherx Biopharma media release, this trial was closed previously but full data analysis awaited the FDAs evaluation of preliminary reports of blinded study findings. That evaluation was completed after formal notification from the FDA on August 9, 2017.
    • 22 Feb 2017 Status changed from active, no longer recruiting to discontinued.
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