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

Purpose

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).

Condition

  • RSV Infection

Eligibility

Eligible Ages
Under 1 Year
Eligible Genders
All
Accepts Healthy Volunteers
No

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.

Study Design

Phase
Phase 3
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Prevention
Masking
Triple (Participant, Care Provider, Investigator)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
Clesrovimab 		Participants will receive intramuscular (IM) injections of clesrovimab and placebo
  • Biological: Clesrovimab
    IM injection
    Other names:
    • MK-1654
  • Biological: Placebo
    IM injection
Active Comparator
Palivizumab 		Participants will receive IM injections.
  • Biological: Palivizumab
    IM injection

More Details

Status
Active, not recruiting
Sponsor
Merck Sharp & Dohme LLC

Study Contact