At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 1,003 enrolled
Drug / intervention
Clesrovimab +2 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.
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
In Brief
A Phase 3 clinical trial evaluating Clesrovimab, Palivizumab, and 1 other intervention for RSV Infection. Completed, enrolled 1,003 participants across 146 sites in 27 countries.
Detailed 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).
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsRSV Infection
CountriesAustralia, 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, United States
Collaborators--
Timeline
Phase 3CompletedFinished
20222023202420252026
First PostedJun 2021
Enrollment StartNov 2021
Primary CompletionApr 2025
Study CompletionAug 2025
TodayJul 2026
First PostedJun 24, 2021
Enrollment StartNov 30, 2021
Primary CompletionApr 28, 2025
Study CompletionAug 1, 2025
TodayJul 2, 2026
Enrollment to primary: 3.4 yearsPosted 5.0 years ago
Interventions
Clesrovimabbiological
IM injection
Palivizumabbiological
IM injection
Placebobiological
IM injection