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A Phase 2a, Randomized, Observer-Blind, Placebo Controlled, Dose-Confirmation Study to Evaluate the Safety, Reactogenicity, and Immunogenicity of mRNA-1273 SARS-COV-2 Vaccine in Adults Aged 18 Years and Older

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Trial Profile

A Phase 2a, Randomized, Observer-Blind, Placebo Controlled, Dose-Confirmation Study to Evaluate the Safety, Reactogenicity, and Immunogenicity of mRNA-1273 SARS-COV-2 Vaccine in Adults Aged 18 Years and Older

Status: Completed
Phase of Trial: Phase II

Latest Information Update: 02 Jan 2023

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At a glance

  • Drugs Elasomeran (Primary) ; MRNA 1273 351 (Primary)
  • Indications COVID 2019 infections
  • Focus Adverse reactions; Pharmacodynamics; Proof of concept; Registrational
  • Sponsors Moderna Therapeutics

    • Most Recent Events

    • 15 Nov 2022 Results (n=593) assessing the combined utility of the Elecsys Anti-SARS-CoV-2 S (ACOV2S) and the Elecsys Anti-SARS-CoV-2 (ACOV2N) assays using samples from the mRNA-1273 (Spikevax), published in the Infectious Diseases and Therapy.
    • 01 May 2022 Results (n=344) from the part B of the study evaluating the safety and immunogenicity of a booster injection of 50 microg mRNA-1273 vaccine, published in the Nature Medicine.
    • 07 Jan 2022 According to a Moderna Therapeutics media release, the U.S. Food and Drug Administration amended the emergency use authorization (EUA) for the Moderna COVID-19 Vaccine to shorten the time between the completion of a primary series of the vaccine and a booster dose to at least five months for individuals 18 years of age and older.
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