Trials / Completed
CompletedNCT04938830
Clesrovimab (MK-1654) in Infants and Children at Increased Risk for Severe Respiratory Syncytial Virus (RSV) Disease (MK-1654-007)
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
- Status
- Completed
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 1,003 (actual)
- Sponsor
- Merck Sharp & Dohme LLC · Industry
- Sex
- All
- Age
- 1 Year
- Healthy volunteers
- Not accepted
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
Interventions
| Type | Name | Description |
|---|---|---|
| BIOLOGICAL | Clesrovimab | IM injection |
| BIOLOGICAL | Palivizumab | IM injection |
| BIOLOGICAL | Placebo | IM injection |
Timeline
- Start date
- 2021-11-30
- Primary completion
- 2025-04-28
- Completion
- 2025-08-01
- First posted
- 2021-06-24
- Last updated
- 2025-10-29
Locations
146 sites across 27 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
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT04938830. Inclusion in this directory is not an endorsement.