Either you have JavaScript disabled or your browser does not support Javascript . To work properly, this page requires JavaScript to be enabled.
How to enable JavaScript in your browser?

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

Next Previous
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: 03 Sep 2025

Price :
$35 *
Note:
  • Adis is an information provider.
  • Final gross price and currency may vary according to local VAT and billing address.
  • Your purchase entitles you to full access to the information contained in our trial profile at the time of purchase.
  • A link to download a PDF version of the trial profile will be included in your email receipt.

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

  • 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.
  • 20 Mar 2025 Planned End Date changed from 27 Oct 2025 to 13 Aug 2025.

You need to be a logged in or subscribed to view this content

Request demo (opens in a new window)
If your organization or you do not have a subscription, try one of the following: If your organization has a subscription, there are several access options, even while working remotely:
  • Working within your organization’s network
  • with username/password or try to via your institution
  • Persisted access using your organization’s identifier stored in your user browser for 90 days
Back to top