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

Study Overview
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Brief Summary
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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).

Official Title
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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

Conditions
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RSV Infection

Intervention / Treatment
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* Biological: Clesrovimab
* Biological: Palivizumab
* Biological: Placebo


Participation Criteria
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Eligibility Criteria
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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. Is available to complete the follow-up period. 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.

Ages Eligible for Study
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Maximum Age: 1 Year

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Clesrovimab<br>Participants will receive intramuscular (IM) injections of clesrovimab and placebo | Biological: Clesrovimab<br>* IM injection<br>* Other names: MK-1654;Biological: Placebo<br>* IM injection<br>|
| Active Comparator: Palivizumab<br>Participants will receive IM injections. | Biological: Palivizumab<br>* IM injection<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Participants with solicited injection-site Adverse Events (AEs) in RSV Season 1 | Percentage of participants with solicited injection-site AEs in RSV Season 1 | Up to 5 days | 
| Participants with solicited daily body temperature with fever in RSV Season 1 | Percentage of participants with solicited daily body temperature with fever in RSV Season 1 | Up to 5 days | 
| Participants with solicited systemic AEs in RSV Season 1 | Percentage of participants with solicited systemic AEs in RSV Season 1 | Up to 5 days | 
| Participants with anaphylaxis/hypersensitivity AEs of special interest (AESI) in RSV Season 1 | Percentage of participants with anaphylaxis/hypersensitivity AESI in RSV Season 1 | Up to 42 days | 
| Participants with rash AESI in RSV Season 1 | Percentage of participants with rash AESI in RSV Season 1 | Up to 42 days | 
| Participants with non-serious AEs in RSV Season 1 | Percentage of participants with non-serious AEs in RSV Season 1 | Up to 42 days | 
| Participants with serious AEs (SAEs) through the duration of participation in RSV Season 1 | Percentage of participants with serious AEs (SAEs) through the duration of participation in RSV Season 1 | Up to 365 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Participants with RSV-associated medically attended lower respiratory infection (MALRI) in RSV Season 1 | Percentage of participants with RSV-associated medically attended lower respiratory infection (MALRI) in RSV Season 1 | Up to 150 days | 
| Participants with RSV-associated hospitalization in RSV Season 1 | Percentage of participants with RSV-associated hospitalization in RSV Season 1 | Up to 150 days | 
| Participants with solicited injection-site AEs in RSV Season 2 | Percentage of participants with solicited injection-site AEs in RSV Season 2 | From approximately 393 days up to 400 days | 
| Participants with solicited daily body temperature with fever in RSV Season 2 | Percentage of participants with solicited daily body temperature with fever in RSV Season 2 | From approximately 393 days up to 400 days | 
| Participants with solicited systemic AEs in RSV Season 2 | Percentage of participants with solicited systemic AEs in RSV Season 2 | From approximately 393 days up to 400 days | 
| Participants with anaphylaxis/hypersensitivity AESI in RSV Season 2 | Percentage of participants with anaphylaxis/hypersensitivity AESI in RSV Season 2 | From approximately 393 days up to 440 days | 
| Participants with rash AESI in RSV Season 2 | Percentage of participants with rash AESI in RSV Season 2 | From approximately 393 days up to 440 days | 
| Participants with non-serious AEs in RSV Season 2 | Percentage of participants with non-serious AEs in RSV Season 2 | From approximately 393 days up to 440 days | 
| Participants with SAEs in RSV Season 2 | Percentage of participants with SAEs in RSV Season 2 | From approximately 393 days up to 575 days | 
| Concentration of clesrovimab in RSV Season 1 | Serum concentration of clesrovimab after dose of clesrovimab in RSV Season 1 | Up to 240 days | 
| Concentration of clesrovimab in RSV Season 2 | Serum concentration of clesrovimab after dose of clesrovimab in RSV Season 2 | From approximately 393 days up to 550 days |