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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 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.
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).
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 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04938830
The ClinicalTrials.gov registry entry for NCT04938830 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 1,003 participants, a figure that helps gauge the scale of data the investigators plan to collect, above the 622-participant average among 8 other RSV Infection trials with a reported enrollment target (61% higher). The listed sponsor is Merck Sharp & Dohme, which has 558 total studies on file at ClinicalTrials.gov.
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 reports 20 study locations spanning 14 distinct geographic areas - top geographies include 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.
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Read our methodology - how this data is sourced, computed, and verified.
Related
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