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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.

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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

FieldValue
Enrollment Target 234 participants
Start Date 2021-04-16
Est. Completion 2023-05-22
Phase Phase 3

Sponsor

ModernaTX

90 total trials

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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Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

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