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

NCT04938830

CompletedPhase 3

Sponsor: Merck Sharp & Dohme LLC

Conditions: RSV Infection

Interventions: Clesrovimab, Palivizumab, Placebo

Countries: United States, Australia, Canada, Chile, Colombia, Czechia, Finland, France

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).

Eligibility overview

Sex: ALL

Age: — to 1 Year

Healthy volunteers: No

Study type: INTERVENTIONAL

Eligibility criteria

Inclusion Criteria:

* 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

Exclusion Criteria:

* 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.

Locations (146)

Long Beach, California, United States
Orange, California, United States
Aurora, Colorado, United States
Washington D.C., District of Columbia, United States
Orlando, Florida, United States
Orlando, Florida, United States
Tampa, Florida, United States
Atlanta, Georgia, United States
Idaho Falls, Idaho, United States
Lexington, Kentucky, United States
Baton Rouge, Louisiana, United States
New Orleans, Louisiana, United States
Minneapolis, Minnesota, United States
New Brunswick, New Jersey, United States
Mineola, New York, United States
Rochester, New York, United States
Chapel Hill, North Carolina, United States
Durham, North Carolina, United States
Dayton, Ohio, United States
Greenville, South Carolina, United States
Corpus Christi, Texas, United States
Edinburg, Texas, United States
San Antonio, Texas, United States
San Antonio, Texas, United States
San Antonio, Texas, United States
Salt Lake City, Utah, United States
Spokane, Washington, United States
Spokane, Washington, United States
Tacoma, Washington, United States
Brisbane, Queensland, Australia
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