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A Phase 2a Randomized, Double-blind, Placebo-controlled Trial to Evaluate the Safety, Immunogenicity, and Efficacy of Bris10 M2SR (H3N2 A/Brisbane/10/2007) Vaccine Administered as a Single Intranasal Dose (Versus Placebo) in Healthy Adult Volunteers who are Subsequently Challenged with a Live, Antigenically Different Wild-type Influenza Type A Virus (A/Belgium/4217/2015 H3N2)

Trial Profile

A Phase 2a Randomized, Double-blind, Placebo-controlled Trial to Evaluate the Safety, Immunogenicity, and Efficacy of Bris10 M2SR (H3N2 A/Brisbane/10/2007) Vaccine Administered as a Single Intranasal Dose (Versus Placebo) in Healthy Adult Volunteers who are Subsequently Challenged with a Live, Antigenically Different Wild-type Influenza Type A Virus (A/Belgium/4217/2015 H3N2)

Recruiting
Phase of Trial: Phase II

Latest Information Update: 15 Oct 2018

At a glance

  • Drugs H3N2 M2SR influenza vaccine-FluGen (Primary)
  • Indications Influenza A virus infections
  • Focus Adverse reactions; Therapeutic Use
  • Sponsors FluGen
  • Most Recent Events

    • 15 Oct 2018 According to a FluGen media release, company announced all subjects have completed dosing in this study.
    • 16 May 2018 Planned number of patients changed from 100 to 96, as reported in a FluGen media release.
    • 16 May 2018 According to a FluGen media release, the first subject has been dosed in this trial. The study is being conducted by SGS. The study is supported by a grant from the Department of Defense. The U.S. Army Medical Research Acquisition Activity is the awarding and administering acquisition office and this work was supported by the Office of the Assistant Secretary of Defense for Health Affairs through the Peer Reviewed Medical Research Program under Award No. W81XWH-17-1-0430.
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