Clesrovimab (MK-1654) in Infants and Children at Increased Risk for Severe Respiratory Syncytial Virus (RSV) Disease (MK-1654-007)

Completed · Phase 3 · Has a placebo group

Conditions studied: RSV Infection

In brief

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

Key facts

Study ID

NCT04938830

Run by

Merck Sharp & Dohme LLC

People needed

1003

Starts

2021-11-30

Expected to finish

2025-08-01

Last updated by the study team

2026-05-08

Who can join

Age: any, up to 1. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Participants at increased risk for severe RSV infection recommended to receive palivizumab in accordance with national or local guidelines or professional society recommendations and meet defined criteria for the Early or Moderate Pre-term Group or the chronic lung disease (CLD)/congenital heart disease (CHD) Group.
• Is available to complete the follow-up period.
• Additional inclusion criteria for participation in RSV Season 2:
• RSV Season 2 participants enrolled in the CLD/CHD Group in RSV Season 1. Participants with CHD must also have the following:
• Hemodynamically significant CHD at the beginning of RSV Season 2, or
• If the participant has had surgically repaired hemodynamically significant CHD that did not include extracorporeal membrane oxygenation (ECMO) or cardiopulmonary bypass: 1) continues to require medications to manage CHD, or 2) any additional medical intervention related to their CHD.
• RSV Season 2 participants enrolled in the Early or Moderate Pre-term Group in RSV Season 1, with the following:
• Neuromuscular disease or congenital pulmonary anomaly that impairs the ability to clear secretions from the upper airway because of ineffective cough
• Down Syndrome (trisomy of chromosome 21)
• Cystic fibrosis with nutritional compromise
• Native Americans and Alaskan Indians or other indigenous populations at high risk for severe RSV disease

You may not qualify if…

• Requires mechanical ventilation at time of enrollment.
• Has a life expectancy <6 months.
• Has known hepatic or renal dysfunction, or chronic seizure disorder.
• Is hospitalized at the time of randomization unless discharge is expected within 7 days after randomization.
• Has severe immunodeficiency or is severely immunocompromised.
• Has known hypersensitivity to any component of clesrovimab or palivizumab.
• Additional exclusion criteria for participation in RSV Season 2:
• Had 1) ECMO or 2) surgical intervention during the RSV season for CHD and required cardiopulmonary bypass during the procedure in RSV Season 1.

Where it is running

• Children's Hospital of Orange County ( Site 0047) — Orange, California, United States
• Children's Hospital Colorado ( Site 0011) — Aurora, Colorado, United States
• Children's National Medical Center ( Site 0020) — Washington D.C., District of Columbia, United States
• Orlando Health - Arnold Palmer Hospital-Orlando Health-Arnold Palmer Hospital Pulmonary and Sleep M ( Site 0022) — Orlando, Florida, United States
• Nemours Children's Health, Lake Nona Medical City ( Site 0032) — Orlando, Florida, United States
• University of South Florida-Department of Pediatrics ( Site 0045) — Tampa, Florida, United States
• Morehouse School Of Medicine ( Site 0049) — Atlanta, Georgia, United States
• Clinical Research Prime ( Site 0046) — Idaho Falls, Idaho, United States
• University of Kentucky HealthCare - Turfland ( Site 0044) — Lexington, Kentucky, United States
• Our Lady of the Lake Children's Hospital ( Site 0031) — Baton Rouge, Louisiana, United States
• Tulane University School of Medicine ( Site 0010) — New Orleans, Louisiana, United States
• M Health Fairview University of Minnesota Masonic Children's Hospital, West Bank-Peds Research ( Site 0037) — Minneapolis, Minnesota, United States
• Rutgers University-Pediatric Clinical Research Center ( Site 0007) — New Brunswick, New Jersey, United States
• NYU Langone Hospital - Long Island-Pediatrics ( Site 0028) — Mineola, New York, United States
• University of Rochester Medical Center ( Site 0017) — Rochester, New York, United States
• The University of North Carolina at Chapel Hill ( Site 0035) — Chapel Hill, North Carolina, United States
• Duke University ( Site 0021) — Durham, North Carolina, United States
• Dayton Children's Hospital ( Site 0053) — Dayton, Ohio, United States
• Tribe Clinical Research, LLC ( Site 0002) — Greenville, South Carolina, United States
• Driscoll Children's Hospital ( Site 0025) — Corpus Christi, Texas, United States
• DHR Health Institute for Research and Development ( Site 0029) — Edinburg, Texas, United States
• Christus Children's-Clinical Research Center ( Site 0038) — San Antonio, Texas, United States
• University Hospital-Pediatrics ( Site 0019) — San Antonio, Texas, United States
• Road Runner Research, Ltd ( Site 0052) — San Antonio, Texas, United States
• Miller Children's & Women's Hospital Long Beach ( Site 0001) — Long Beach, California, United States

Full record on ClinicalTrials.gov

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