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NCT04938830 · ClinicalTrials.gov registry record · Phase 3
Clesrovimab (MK-1654) in Infants and Children at Increased Risk for Severe Respiratory Syncytial Virus (RSV) Disease (MK-1654-007)
A Phase 3 study of RSV Infection, sponsored by Merck Sharp & Dohme.
- Completed
- Registry status
- Phase 3
- Development phase
- 1,003
- Enrollment target
- 20
- Study locations
NCT04938830: Completed Phase 3 study of RSV Infection, sponsored by Merck Sharp & Dohme.
NCT04938830 is a Phase 3 study of RSV Infection that has completed, run by Merck Sharp & Dohme. The registered enrollment target is 1,003 participants, above the 622-participant average among 8 other RSV Infection trials with a reported enrollment target (61% higher). The trial reports 20 study locations across 14 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04938830, a Phase 3 study of RSV Infection, has completed, sponsored by Merck Sharp & Dohme.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 1,003 participants
- Enrollment target
- 20
- Study locations
Study 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).
Primary Outcome
An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. Solicited injection-site AEs included erythema, pain, and swelling. The number of participants with solicited injection-site AEs in RSV Season 1 is reported.
Conditions Studied
Interventions
- BIOLOGICAL Placebo
- BIOLOGICAL Clesrovimab
- BIOLOGICAL Palivizumab
Study Locations (20)
Florida
- Orlando Health - Arnold Palmer Hospital-Orlando Health-Arnold Palmer Hospital Pulmonary and Sleep M ( Site 0022) - Orlando
- Nemours Children's Health, Lake Nona Medical City ( Site 0032) - Orlando
- University of South Florida-Department of Pediatrics ( Site 0045) - Tampa
California
- Miller Children's & Women's Hospital Long Beach ( Site 0001) - Long Beach
- Children's Hospital of Orange County ( Site 0047) - Orange
Louisiana
- Our Lady of the Lake Children's Hospital ( Site 0031) - Baton Rouge
- Tulane University School of Medicine ( Site 0010) - New Orleans
New York
- NYU Langone Hospital - Long Island-Pediatrics ( Site 0028) - Mineola
- University of Rochester Medical Center ( Site 0017) - Rochester
North Carolina
- The University of North Carolina at Chapel Hill ( Site 0035) - Chapel Hill
- Duke University ( Site 0021) - Durham
Colorado
- Children's Hospital Colorado ( Site 0011) - Aurora
District of Columbia
- Children's National Medical Center ( Site 0020) - Washington D.C.
Georgia
- Morehouse School Of Medicine ( Site 0049) - Atlanta
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 1,003 participants |
| Start Date | 2021-11-30 |
| Est. Completion | 2025-08-01 |
| Phase | Phase 3 |
What the finished NCT04938830 record still lists
NCT04938830 is an interventional study that assigns participants to a tested intervention. Its 1,003 participants enrollment target places it among the larger protocols in the corpus, above the 622-participant average among 8 other RSV Infection trials with a reported enrollment target (61% higher).
The record links to 1 condition, with RSV Infection appearing as the primary indexed condition, and to 3 interventions - of which Placebo is the first listed.
NCT04938830 names 20 study sites across 14 states, led by Florida, California, Louisiana.
Frequently Asked Questions
What is clinical trial NCT04938830 about?
NCT04938830 is a clinical study titled "Clesrovimab (MK-1654) in Infants and Children at Increased Risk for Severe Respiratory Syncytial Virus (RSV) Disease (MK-1654-007)". 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).
What is the current status of trial NCT04938830?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 1,003 participants. The study started on 2021-11-30. Estimated completion is 2025-08-01.
What conditions does trial NCT04938830 study?
This clinical trial studies the following conditions: RSV Infection.
What interventions are being tested in trial NCT04938830?
The interventions under investigation include: Placebo (BIOLOGICAL), Clesrovimab (BIOLOGICAL), Palivizumab (BIOLOGICAL).
Who is sponsoring clinical trial NCT04938830?
This trial is sponsored by Merck Sharp & Dohme, which has 558 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04938830 being conducted?
This trial has 20 study locations across California, Colorado, District of Columbia, Florida, Georgia. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for RSV Infection
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT04938830's enrollment target sits among peer trials
1,003 2nd of 8 the highest of 8 other RSV Infection trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other RSV Infection trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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