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A Phase 3 Randomized, Double-blind, Placebo-controlled Study to Evaluate the Safety and Efficacy of MEDI8897, a Monoclonal Antibody With an Extended Half-life Against Respiratory Syncytial Virus, in Healthy Late Preterm and Term Infants (MELODY)

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Trial Profile

A Phase 3 Randomized, Double-blind, Placebo-controlled Study to Evaluate the Safety and Efficacy of MEDI8897, a Monoclonal Antibody With an Extended Half-life Against Respiratory Syncytial Virus, in Healthy Late Preterm and Term Infants (MELODY)

Status: Completed
Phase of Trial: Phase III

Latest Information Update: 04 Apr 2024

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At a glance

  • Drugs Nirsevimab (Primary)
  • Indications Respiratory syncytial virus infections
  • Focus Registrational; Therapeutic Use
  • Acronyms MELODY; Trial 04
  • Sponsors AstraZeneca; MedImmune

    • Most Recent Events

    • 27 Mar 2024 According to an AstraZeneca media release, Nirsevimab has been approved in Japan by the Japanese Ministry of Health, Labour and Welfare for the prophylaxis of lower respiratory tract disease (LRTD) caused by respiratory syncytial virus (RSV) in all neonates, infants and children entering their first RSV season, and the prevention of RSV LRTD in neonates, infants and children at risk of serious RSV infection entering their first or second RSV season.
    • 02 Jan 2024 According to an AstraZeneca media release, based on three Beyfortus pivotal late-stage clinical trials MELODY, MEDLEY and Phase IIb trial (Trial 03) the nirsevimab has been approved in China by National Medical Products Administration (NMPA) for the prevention of respiratory syncytial virus (RSV) lower respiratory tract infection (LRTI) in neonates and infants entering or during their first RSV season. Regulatory applications are also currently under review in Japan and several other countries.
    • 03 Aug 2023 According to a Sanofi media release, the U.S. Centers for Disease Control and Prevention's (CDC) Advisory Committee on Immunization Practices (ACIP) voted unanimously 10 to 0 to recommend routine use of Beyfortus (nirsevimab-alip) for the prevention of respiratory syncytial virus (RSV) lower respiratory tract disease for newborns and infants below 8 months of age born during or entering their first RSV season.

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