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

NCT04938830 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 1003

Last updated 2026-05-08

Study results available
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Summary

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).

Conditions

  • RSV Infection

Interventions

BIOLOGICAL

Clesrovimab

IM injection

BIOLOGICAL

Palivizumab

IM injection

BIOLOGICAL

Placebo

IM injection

Sponsors & Collaborators

Principal Investigators

  • Medical Director · Merck Sharp & Dohme LLC

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
TRIPLE
Model
PARALLEL

Eligibility

Max Age
1 Year
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-11-30
Primary Completion
2025-04-28
Completion
2025-08-01
FDA Drug
Yes

Countries

  • United States
  • Australia
  • Canada
  • Chile
  • Colombia
  • Czechia
  • Finland
  • France
  • Germany
  • Greece
  • Hong Kong
  • Hungary
  • Italy
  • Japan
  • Malaysia
  • Mexico
  • New Zealand
  • Norway
  • Peru
  • Puerto Rico
  • Singapore
  • South Africa
  • Spain
  • Taiwan
  • 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 NCT04938830 on ClinicalTrials.gov