Trial Profile

A Phase 3, Randomized, Triple-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of VYD2311 for the Prevention of COVID-19 in Adults and Adolescents

Status: Recruiting

Phase of Trial: Phase III

Latest Information Update: 29 Jan 2026

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At a glance

08 Jan 2026 According to an Invivyd media release, the company is capable of supporting DECLARATION pivotal clinical trial and the potential commercial launch of VYD2311, if approved, and looks forward to trial enrollment during the anticipated upcoming peak season of COVID infections. Total expected enrollment is 1,770 participants across all three study arms.
23 Dec 2025 Status changed from not yet recruiting to recruiting, according to Invivyd media release.
23 Dec 2025 According to Invivyd media release, company announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation for VYD2311.

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