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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: 25 Jul 2024

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At a glance

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

    • Most Recent Events

    • 23 Jul 2024 According to Merck media release,company announced clesrovimab met its primary safety and efficacy endpoints, including reducing medically attended lower respiratory infections (MALRI) caused by RSV through Day 150. Detailed findings of the study will be presented at an upcoming scientific congress and Merck plans to file these data with global regulatory authorities.
    • 23 Jul 2024 According to Merck media release,Primary endpoint (Percentage of participants with RSV-associated MALRI) has been met.
    • 23 Jul 2024 According to Merck media release, announced positive topline results from its Phase 2b/3 clinical trial (MK-1654-004) evaluating clesrovimab (MK-1654), the companys investigational prophylactic monoclonal antibody designed to protect infants from respiratory syncytial virus (RSV) disease.

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