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

NCT04767373 · Status: COMPLETED · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL · Enrollment: 3632

Last updated 2026-02-11

Study results available
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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

BIOLOGICAL

Clesrovimab

Clesrovimab solution

DRUG

Placebo

Placebo (0.9% sodium chloride \[NaCL\]) solution

Sponsors & Collaborators

Principal Investigators

  • Medical Director · Merck Sharp & Dohme LLC

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Model
PARALLEL

Eligibility

Max Age
1 Year
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2021-04-07
Primary Completion
2024-07-09
Completion
2024-07-09
FDA Drug
Yes

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

Study Locations

More Related Trials

Entities

Drugs
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04767373 on ClinicalTrials.gov