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A Phase 3, Multicenter, Randomized, Partially Blinded, Palivizumab-Controlled Study to Evaluate the Safety, Efficacy, and Pharmacokinetics of MK-1654 in Infants and Children at Increased Risk for Severe RSV Disease

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Trial Profile

A Phase 3, Multicenter, Randomized, Partially Blinded, Palivizumab-Controlled Study to Evaluate the Safety, Efficacy, and Pharmacokinetics of MK-1654 in Infants and Children at Increased Risk for Severe RSV Disease

Status: Active, no longer recruiting
Phase of Trial: Phase III

Latest Information Update: 15 Jun 2025

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At a glance

  • Drugs Clesrovimab (Primary) ; Palivizumab
  • Indications Respiratory syncytial virus infections
  • Focus Adverse reactions; Registrational
  • Acronyms SMART
  • Sponsors Merck Sharp & Dohme; Merck Sharp & Dohme Corp.; MSD KK

Most Recent Events

  • 09 Jun 2025 According to a Merck and Co media release, based on the data from this study and the Phase 2b/3 CLEVER trial (MK-1654-004), the USFDA has approved ENFLONSIA (clesrovimab-cfor) for the prevention of RSVlower respiratory tract disease in newborns and infants who are born during or entering their first RSV season.
  • 20 Mar 2025 Planned End Date changed from 27 Oct 2025 to 13 Aug 2025.
  • 17 Dec 2024 According to a Merck and Co media release, company announced the U.S. Food and Drug Administration (FDA) has accepted the Biologics License Application (BLA) for clesrovimab designed to protect infants from respiratory syncytial virus (RSV) disease during their first RSV season. The FDA has set a Prescription Drug User Fee Act (PDUFA), or target action, date of June 10, 2025. The application is supported by results from the pivotal Phase 2b/3 CLEVER trial and interim results from the ongoing Pha

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