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Phase I, Open-Label, Dose-Ranging Study of the Safety and Immunogenicity of 2019-nCoV Vaccine (mRNA-1273) in Healthy Adults

Trial Profile

Phase I, Open-Label, Dose-Ranging Study of the Safety and Immunogenicity of 2019-nCoV Vaccine (mRNA-1273) in Healthy Adults

Status: Completed
Phase of Trial: Phase I

Latest Information Update: 05 Jan 2024

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At a glance

  • Drugs Elasomeran (Primary)
  • Indications COVID 2019 infections
  • Focus Adverse reactions; First in man
  • Acronyms NIH-Led

Most Recent Events

  • 03 Jul 2023 According to a Moderna Therapeutics media release, the company has has submitted a regulatory application to the European Medicines Agency (EMA) for its updated COVID-19 vaccine encoding the spike protein for the XBB.1.5 sublineage of SARS-CoV-2.
  • 29 Jun 2023 According to a Moderna Therapeutics media release, the company has initiated the filing a rolling New Drug Submission (NDS) to Health Canada for its updated monovalent COVID-19 vaccine, SPIKEVAX XBB.1.5 (mRNA-1273.815) targeting the omicron subvariant XBB.1.5 of SARS-CoV-2. This follows Modernas submission to the U.S. Food and Drug Administration for authorization
  • 08 Dec 2022 Status changed from active, no longer recruiting to completed.

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