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

Primary Objective

To evaluate the safety, tolerability, and efficacy of MK-1654 compared to palivizumab in infants at high risk for RSV

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This trial is testing a study medicine to learn if it can help prevent RSV infection in babies who are more likely to get severe RSV illness. Infants will be randomized to receive either Synagis or the study drug. There are approximately 3 blood draws per season, and participants will be asked to enter respiratory symptoms into an e-diary and return to the clinic for any respiratory illnesses.




- Recommended to receive Synagis in accordance with national guidelines - Under 1 year of age and under 6.0kg - Diagnosed with Chronic Lung Disease/BPD or Congenital Heart Disease - Not anticipated to have cardiac surgery within 2 months of enrollment - Does not have known hepatic or renal dysfunction

Contact study team for more information. Participants may be eligible for 2 seasons

Type of Study



Childrens Hospital Colorado

Principal Investigator
Photograph of Eric Simoes,  MD

Eric Simoes, MD

Study ID

Protocol Number: 21-4176

More information available at ClinicalTrials.gov: NCT04938830

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