MK-1654 in Infants and Children at Increased Risk for Severe Respiratory Syncytial Virus (RSV) Disease

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

  • Clinical Trial Information

    Trial Contact: Tilme, Linda; Kern, Katelyn D; Beltran, Yajira

  • IRB No: 21.113.07

    Protocol Abbrev: MK-1654

    Principal Investigator: Carlos E. Sabogal, MD

    Phase: Drug: Phase III

    Age Group: Pediatric

    Secondary Protocol No: MK-1654

    Treatment: Experimental: MK-1654 Participants will receive an intramuscular (IM) injection Active Comparator: Palivizumab Participants will receive an IM injection.

    Therapies Involved: Medication ID: NCT04938830

  • Objective

    This study aims to evaluate the safety and tolerability of MK-1654 compared to palivizumab as assessed by the proportion of participants experiencing adverse events (AEs).

  • Key Eligibility

    Inclusion Criteria:
    up to 1 Year (Child)
    •  Participants at increased risk for severe RSV infection recommended to receive palivizumab in accordance with national or local guidelines or professional society recommendations.
    •  Is available to complete the follow-up period.