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A Phase 2b/3 Double-Blind, Randomized, Placebo-Controlled Study to Evaluate the Efficacy and Safety of MK-1654 in Healthy Pre-Term and Full-Term Infants

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Trial Profile

A Phase 2b/3 Double-Blind, Randomized, Placebo-Controlled Study to Evaluate the Efficacy and Safety of MK-1654 in Healthy Pre-Term and Full-Term Infants

Status: Completed
Phase of Trial: Phase II/III

Latest Information Update: 15 Jun 2025

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At a glance

  • Drugs Clesrovimab (Primary)
  • Indications Respiratory syncytial virus infections
  • Focus Adverse reactions
  • Acronyms CLEVER
  • Sponsors Merck Sharp & Dohme; Merck Sharp & Dohme Corp.

Most Recent Events

  • 09 Jun 2025 According to a Merck and Co media release, based on the data from this study and the Phase 3 SMART trial (MK-1654-007), 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.
  • 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
  • 17 Oct 2024 According to a Merck AG media release, data from this trial were presented during IDWeek 2024, held October 16-19 in Los Angeles, California.

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