NCT04767373

Efficacy and Safety of Clesrovimab (MK-1654) in Infants (MK-1654-004)

A Phase 2b/3 Double-Blind, Randomized, Placebo-Controlled Study to Evaluate the Efficacy and Safety of MK-1654 in Healthy Pre-Term and Full-Term Infants

• Status: Completed
• Phase: Phase 2 / Phase 3
• Study type: Interventional
• Enrollment: 3,632 (actual)
• Sponsor: Merck Sharp & Dohme LLC · Industry
• Sex: All
• Age: 1 Year
• Healthy volunteers: Accepted

Summary

The primary objectives of this phase 2b/3 double-blind, randomized, placebo-controlled study are to evaluate the efficacy and safety of clesrovimab in healthy pre-term and full-term infants. It is hypothesized that clesrovimab will reduce the incidence of respiratory syncytial virus (RSV)-associated medically attended lower respiratory infection (MALRI) from Days 1 through 150 postdose compared to placebo.

Conditions

• Respiratory Syncytial Virus Infection

Interventions

Type	Name	Description
BIOLOGICAL	Clesrovimab	Clesrovimab solution
DRUG	Placebo	Placebo (0.9% sodium chloride \[NaCL\]) solution

Timeline

• Start date: 2021-04-07
• Primary completion: 2024-07-09
• Completion: 2024-07-09
• First posted: 2021-02-23
• Last updated: 2026-02-11
• Results posted: 2025-02-04

Locations

217 sites across 24 countries: United States, Argentina, Belgium, Canada, Chile, China, Colombia, Denmark, Finland, France, Israel, Italy, Japan, Malaysia, Mexico, Peru, Philippines, Poland, Romania, South Africa, South Korea, Thailand, Turkey (Türkiye), United Kingdom

Regulatory

• FDA-regulated drug study