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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: 04 Mar 2026

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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

  • 20 Feb 2026 According to a Merck and Co media release, Results from this study support extrapolation of efficacy to children under 2 years of age at increased risk for severe RSV disease through RSV season 2.The second season results will be shared with the FDA and global regulatory authorities for evaluation for an expanded indication in children at increased risk for severe RSV disease through their second RSV season.
  • 20 Feb 2026 According to a Merck and Co media release,The data from this study were presented during an oral session at RSVVW 26, the 9th conference of the Respiratory Syncytial Virus Foundation (ReSViNET) in Rome, Italy.
  • 19 Feb 2026 Results presented at Merck media release.

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