Study

Overview

Official Title: 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

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).

Study Type:

Interventional

Study Phase:

Phase 3

Enrollment:

1003

Study Start Date:

November 2021

Study Completion Date:

August 2025

Primary Completion Date:

April 2025

Eligibility

Ages Eligible for Study:

up to 1 years

Genders Eligible for Study:

All

Accepts Healthy Volunteers:

No

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.
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.

Locations

No Contacts or Locations in US/Canada Provided

Results

No Study Results Posted

Study Detail

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

Overview

Eligibility

CRITERIA

Locations

Results