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NCT04860297 · ClinicalTrials.gov registry record · Phase 3
A Study to Evaluate Safety and Immunogenicity of mRNA-1273 Vaccine to Prevent COVID-19 in Adult Organ Transplant Recipients and in Healthy Adult Participants
A Phase 3 study of SARS-CoV-2, sponsored by ModernaTX.
- Completed
- Registry status
- Phase 3
- Development phase
- 234
- Enrollment target
- 15
- Study locations
NCT04860297 is a Phase 3 study of SARS-CoV-2 that has completed, run by ModernaTX. The registered enrollment target is 234 participants, below the 3,761-participant average among 28 other SARS-CoV-2 trials with a reported enrollment target (94% lower). The trial reports 15 study locations across 12 states.
The verdict
NCT04860297, a Phase 3 study of SARS-CoV-2, has completed, sponsored by ModernaTX.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 234 participants
- Enrollment target
- 15
- Study locations
Study Summary
This is an open-label study to evaluate the safety, reactogenicity, and immunogenicity of mRNA-1273 Severe Acute Respiratory Syndrome coronavirus (SARS-CoV-2) vaccine in adults with a kidney or liver solid organ transplant (SOT) and in healthy adult participants. The primary goal of the study is to evaluate the safety of mRNA-1273 and the serum antibody (Ab) responses obtained 28 days after the last dose of mRNA-1273.
Conditions Studied
Interventions
- BIOLOGICAL mRNA-1273
Study Locations (15)
Massachusetts
- Brigham and Women's Hospital - Boston
- University of Massachusetts Medical School - Worcester
New York
- Northwell Health - Manhasset
- Colombia University Medical Center - New York
Ohio
- University of Cincinnati - Cincinnati
- Cleveland Clinic Hospital - Cleveland
Arizona
- Aventiv Research Inc - Mesa
California
- California Institute of Renal Research - San Diego
Connecticut
- Yale University School of Medicine - New Haven
Florida
- Tampa General Medical Group - Tampa
Georgia
- Piedmont Transplant Institute - Atlanta
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 234 participants |
| Start Date | 2021-04-16 |
| Est. Completion | 2023-05-22 |
| Phase | Phase 3 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04860297
The ClinicalTrials.gov registry entry for NCT04860297 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 234 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 3,761-participant average among 28 other SARS-CoV-2 trials with a reported enrollment target (94% lower). The listed sponsor is ModernaTX, which has 90 total studies on file at ClinicalTrials.gov.
The record links to 1 condition, with SARS-CoV-2 appearing as the primary indexed condition, and to 1 intervention - of which mRNA-1273 is the first listed.
NCT04860297 reports 15 study locations spanning 12 distinct geographic areas - top geographies include Massachusetts, New York, Ohio.
Frequently Asked Questions
What is clinical trial NCT04860297 about?
NCT04860297 is a clinical study titled "A Study to Evaluate Safety and Immunogenicity of mRNA-1273 Vaccine to Prevent COVID-19 in Adult Organ Transplant Recipients and in Healthy Adult Participants". This is an open-label study to evaluate the safety, reactogenicity, and immunogenicity of mRNA-1273 Severe Acute Respiratory Syndrome coronavirus (SARS-CoV-2) vaccine in adults with a kidney or liver solid organ transplant (SOT) and in healthy adult participants. The primary goal of the study is to ...
What is the current status of trial NCT04860297?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 234 participants. The study started on 2021-04-16. Estimated completion is 2023-05-22.
What conditions does trial NCT04860297 study?
This clinical trial studies the following conditions: SARS-CoV-2.
What interventions are being tested in trial NCT04860297?
The interventions under investigation include: mRNA-1273 (BIOLOGICAL).
Who is sponsoring clinical trial NCT04860297?
This trial is sponsored by ModernaTX, which has 90 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04860297 being conducted?
This trial has 15 study locations across Arizona, California, Connecticut, 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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