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A Phase IIb/3 Randomized, Multi-Center, Placebo-Controlled Noninferiority Study to Evaluate the Safety, Immunogenicity and Potential Efficacy of an rVSV-SARS-CoV-2-S Vaccine (IIBR-100) in Adults Compared to an Approved COVID-19 Vaccine

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Trial Profile

A Phase IIb/3 Randomized, Multi-Center, Placebo-Controlled Noninferiority Study to Evaluate the Safety, Immunogenicity and Potential Efficacy of an rVSV-SARS-CoV-2-S Vaccine (IIBR-100) in Adults Compared to an Approved COVID-19 Vaccine

Status: Withdrawn prior to enrolment
Phase of Trial: Phase II/III

Latest Information Update: 23 Jan 2024

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At a glance

  • Drugs IIBR-100 (Primary)
  • Indications COVID 2019 infections
  • Focus Registrational; Therapeutic Use
  • Acronyms BRILIFE001
  • Sponsors NeuroRX; NRx Pharmaceuticals
  • Most Recent Events

    • 17 Jan 2024 Status changed from recruiting to withdrawn prior to enrolment.
    • 09 Dec 2021 According to a NRx Pharmaceuticals media release, Hungary will be a clinical trial site for this trial. In addition to the already-developed trial protocol, NRx has been invited to submit a pediatric trial protocol that may include both injected and nasal spray administration of the vaccine. The NRx initiative in Hungary will be led by senior regulatory and academic medical leaders. Regulatory clearance for this trial is expected by the
    • 06 Dec 2021 According to a NRx Pharmaceuticals media release, Independent Data Safety Monitoring Board review has been completed and formal report is expected in the coming days. The company expected to commence trial in Israel and the Nation of Georgia, with European and North American countries to be added once the initial phase 2b volunteers have been vaccinated. The company has received the guidance in design of the trial from the European Medicines Agency and the World Health Organization.
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