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A PHASE 3 MASTER PROTOCOL TO EVALUATE THE SAFETY, TOLERABILITY, AND IMMUNOGENICITY OF RESPIRATORY SYNCYTIAL VIRUS (RSV) PREFUSION F SUBUNIT VACCINE IN ADULTS AT HIGH RISK OF SEVERE RSV DISEASE

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Trial Profile

A PHASE 3 MASTER PROTOCOL TO EVALUATE THE SAFETY, TOLERABILITY, AND IMMUNOGENICITY OF RESPIRATORY SYNCYTIAL VIRUS (RSV) PREFUSION F SUBUNIT VACCINE IN ADULTS AT HIGH RISK OF SEVERE RSV DISEASE

Status: Completed
Phase of Trial: Phase III

Latest Information Update: 07 Apr 2025

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At a glance

Most Recent Events

  • 01 Apr 2025 According to a Pfizer media release, the company announced that the European Commission (EC) has issued a decision amending the marketing authorization for ABRYSVO, this approval is based on results from this study.
  • 22 Oct 2024 According to a Pfizer media release, the company intends to submit results from MONeT for publication in a peer-reviewed scientific journal and for presentation at an upcoming scientific conference.
  • 22 Oct 2024 According to a Pfizer media release, based on results from this trial the U.S. Food and Drug Administration (FDA) has approved ABRYSVO (Respiratory Syncytial Virus Vaccine), the bivalent RSV prefusion F (RSVpreF) vaccine, for the prevention of lower respiratory tract disease (LRTD) caused by RSV in individuals 18 through 59 years of age who are at increased risk for LRTD caused by RSV.

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