Trial Profile

A Phase 3 Study to Evaluate the Immunogenicity and Safety of mRNA-1345, an mRNA Vaccine Targeting Respiratory Syncytial Virus, in High-Risk Adults

Status: Active, no longer recruiting

Phase of Trial: Phase III

Latest Information Update: 08 May 2025

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At a glance

01 May 2025 According to a Moderna Therapeutics media release, The FDA has assigned a PDUFA goal date of June 12, 2025.
12 Sep 2024 Results presented in the Moderna Therapeutics Media Release
12 Sep 2024 According to a Moderna Therapeutics media release, Company intends to file a supplemental Biologics License Application (sBLA) for U.S. approval in 2024 to extend the indicated age range of mRNA-1345 to high-risk adults 18 to 59 years old, and intends to use a Priority Review Voucher.

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