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A PHASE 3, RANDOMIZED, DOUBLE-BLINDED, PLACEBO-CONTROLLED TRIAL TO EVALUATE THE EFFICACY AND SAFETY OF A RESPIRATORY SYNCYTIAL VIRUS (RSV) PREFUSION F SUBUNIT VACCINE IN INFANTS BORN TO WOMEN VACCINATED DURING PREGNANCY

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Trial Profile

A PHASE 3, RANDOMIZED, DOUBLE-BLINDED, PLACEBO-CONTROLLED TRIAL TO EVALUATE THE EFFICACY AND SAFETY OF A RESPIRATORY SYNCYTIAL VIRUS (RSV) PREFUSION F SUBUNIT VACCINE IN INFANTS BORN TO WOMEN VACCINATED DURING PREGNANCY

Status: Completed
Phase of Trial: Phase III

Latest Information Update: 14 Feb 2025

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At a glance

  • Drugs Respiratory syncytial virus vaccine Pfizer (Primary)
  • Indications Respiratory syncytial virus infections; Respiratory tract infections
  • Focus Adverse reactions; Registrational; Therapeutic Use
  • Acronyms MATISSE
  • Sponsors Pfizer

Most Recent Events

  • 04 Jan 2024 According to a Pfizer media release, the Health Canada has approved ABRYSVOTM for the prevention of lower respiratory tract disease caused by RSV in individuals 60 years of age and older by active immunization, and the prevention of lower respiratory tract disease and severe lower respiratory tract disease caused by RSV in infants from birth through 6 months of age by active immunization of pregnant individuals.
  • 08 Nov 2023 Status changed from active, no longer recruiting to completed.
  • 26 Sep 2023 Planned End Date changed from 24 Nov 2023 to 30 Oct 2023.

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