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A Multi-Centre, Prospective, Observational Post-Marketing Surveillance to Investigate the Long-Term Safety of SPIKEVAX BIVALENT and SPIKEVAX X Injection Under Routine Clinical Care in Korea

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Trial Profile

A Multi-Centre, Prospective, Observational Post-Marketing Surveillance to Investigate the Long-Term Safety of SPIKEVAX BIVALENT and SPIKEVAX X Injection Under Routine Clinical Care in Korea

Status: Recruiting
Phase of Trial: Phase IV

Latest Information Update: 24 Mar 2025

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At a glance

  • Drugs Elasomeran (Primary) ; Elasomeran/davesomeran (Primary)
  • Indications COVID 2019 infections
  • Focus Adverse reactions
  • Sponsors Moderna Therapeutics

Most Recent Events

  • 19 Mar 2025 Planned number of patients changed from 3300 to 4206.
  • 19 Mar 2025 Planned End Date changed from 7 Dec 2026 to 10 Dec 2028.
  • 19 Mar 2025 Planned primary completion date changed from 7 Dec 2026 to 10 Dec 2028.

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