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NCT04767373 · ClinicalTrials.gov registry record · Phase 2
Efficacy and Safety of Clesrovimab (MK-1654) in Infants (MK-1654-004)
A Phase 2 study of Respiratory Syncytial Virus Infection, sponsored by Merck Sharp & Dohme.
- Completed
- Registry status
- Phase 2
- Development phase
- 3,632
- Enrollment target
- 20
- Study locations
NCT04767373 is a Phase 2 study of Respiratory Syncytial Virus Infection that has completed, run by Merck Sharp & Dohme. The registered enrollment target is 3,632 participants, above the 100-participant average among 4 other Respiratory Syncytial Virus Infection trials with a reported enrollment target (3532% higher). The trial reports 20 study locations across 11 states.
The verdict
NCT04767373, a Phase 2 study of Respiratory Syncytial Virus Infection, has completed, sponsored by Merck Sharp & Dohme.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 3,632 participants
- Enrollment target
- 20
- Study locations
Study 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.
Conditions Studied
Interventions
- DRUG Placebo
- BIOLOGICAL Clesrovimab
Study Locations (20)
California
- Long Beach Memorial Medical Center ( Site 0014) - Long Beach
- Madera Family Medical Group ( Site 0046) - Madera
- Orange County Research Institute ( Site 0057) - Ontario
Arkansas
- Northwest Arkansas Pediatric Clinic ( Site 0050) - Fayetteville
- Children's Clinic of Jonesboro, PA ( Site 0058) - Jonesboro
Colorado
- Children's Hospital Colorado ( Site 0066) - Aurora
- Optumcare Colorado Springs, LLC ( Site 0022) - Colorado Springs
District of Columbia
- Children's National Hospital ( Site 0076) - Washington D.C.
- MedStar Georgetown Pediatrics ( Site 0047) - Washington D.C.
Florida
- Next Phase Research Alliance, LLC ( Site 0071) - Homestead
- Acevedo Clinical Research Associates ( Site 0002) - Miami
Georgia
- Tekton Research ( Site 0080) - Chamblee
- Meridian Clinical Research, LLC ( Site 0083) - Macon
Idaho
- Clinical Research Prime ( Site 0075) - Idaho Falls
- Saltzer Medical Group ( Site 0004) - Nampa
Nebraska
- Meridian Clinical Research, LLC ( Site 0082) - Hastings
- Midwest Children's Health Research Institute, LLC ( Site 0044) - Lincoln
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 3,632 participants |
| Start Date | 2021-04-07 |
| Est. Completion | 2024-07-09 |
| Phase | Phase 2 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04767373
The ClinicalTrials.gov registry entry for NCT04767373 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 3,632 participants, a figure that helps gauge the scale of data the investigators plan to collect, above the 100-participant average among 4 other Respiratory Syncytial Virus Infection trials with a reported enrollment target (3532% 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 Respiratory Syncytial Virus Infection appearing as the primary indexed condition, and to 2 interventions - of which Placebo is the first listed.
NCT04767373 reports 20 study locations spanning 11 distinct geographic areas - top geographies include California, Arkansas, Colorado.
Frequently Asked Questions
What is clinical trial NCT04767373 about?
NCT04767373 is a clinical study titled "Efficacy and Safety of Clesrovimab (MK-1654) in Infants (MK-1654-004)". 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...
What is the current status of trial NCT04767373?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 3,632 participants. The study started on 2021-04-07. Estimated completion is 2024-07-09.
What conditions does trial NCT04767373 study?
This clinical trial studies the following conditions: Respiratory Syncytial Virus Infection.
What interventions are being tested in trial NCT04767373?
The interventions under investigation include: Placebo (DRUG), Clesrovimab (BIOLOGICAL).
Who is sponsoring clinical trial NCT04767373?
This trial is sponsored by Merck Sharp & Dohme, which has 558 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04767373 being conducted?
This trial has 20 study locations across Alabama, Arkansas, California, Colorado, District of Columbia. 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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