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
Trial Phone: 321.843.5278 ; 321.843.5279 ; 321.841.7619
-
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
ClinicalTrials.gov 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.
