Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Merck Sharp & Dohme LLC
Age
0–1
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible 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.
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 be 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.
Had 1) ECMO or 2) surgical intervention during the RSV season for CHD and required cardiopulmonary bypass during the procedure in RSV Season 1.
Clareo Health | Clesrovimab (MK-1654) in Infants and Children at Increased Risk for Severe Respiratory Syncytial Virus (RSV) Disease (MK-1654-007)
