CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 3,632 enrolled
Drug / intervention
Clesrovimab +1 morebiological
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT04767373
NCT04767373Phase 3Completed
CompareCT.gov

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

Merck Sharp & Dohme LLC·interventional·Posted Feb 23, 2021·Updated Feb 11, 2026

In Brief

A Phase 3 clinical trial evaluating Clesrovimab and Placebo for Respiratory Syncytial Virus Infection. Completed, enrolled 3,632 participants across 217 sites in 24 countries.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsRespiratory Syncytial Virus Infection
CountriesArgentina, 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, United States
Collaborators--

Timeline

Phase 3CompletedFinished
202120222023202420252026
First PostedFeb 23, 2021
Enrollment StartApr 7, 2021
Primary CompletionJul 9, 2024
TodayJul 2, 2026
Enrollment to primary: 3.3 yearsPosted 5.4 years ago

Interventions

Clesrovimabbiological

Clesrovimab solution

Placebodrug

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