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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: Completed
Phase of Trial: Phase III

Latest Information Update: 31 Oct 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

  • 19 Sep 2025 According to a Merck and Co media release, based on the data from CLEVER and SMART trials, the CHMP of the European Medicines Agency recommended the approval of ENFLONSIA for the prevention of respiratory syncytial virus lower respiratory tract disease in neonates and infants during their first RSV season. The CHMP recommendation will now be reviewed by the EC for marketing authorization in the EU, Iceland, Liechtenstein and Norway, and a final decision is expected before the end of the year.
  • 13 Aug 2025 Status changed from active, no longer recruiting to completed.
  • 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.

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