Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
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: Completed Phase 3 study of SARS-CoV-2, sponsored by ModernaTX.
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 3,447-participant average among 34 other SARS-CoV-2 trials with a reported enrollment target (93% lower). The trial reports 15 study locations across 12 states. According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
An unsolicited AE was any AE reported by the participant that was not specified as a solicited adverse reaction (AR) or was specified as a solicited AR but started outside the protocol-defined period for reporting solicited ARs (that is, for the 7 days after each dose of vaccine). A summary of serious adverse events (SAEs) and all nonserious AEs ("Other") reported up to the end of the study (up to Day 419), regardless of causality, is located in the Reported "Adverse Events" section.
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 |
What the finished NCT04860297 record still lists
NCT04860297 is an interventional study that assigns participants to a tested intervention. The registered 234 participants enrollment target is mid-sized for trials with a published cap, below the 3,447-participant average among 34 other SARS-CoV-2 trials with a reported enrollment target (93% lower).
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 lists 15 locations in 12 states (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.
Learn More About Clinical Trials
Similar trials for SARS-CoV-2
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 NCT04860297's enrollment target sits among peer trials
234 19th of 34 higher than 16 of 34 other SARS-CoV-2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other SARS-CoV-2 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.
Source ClinicalTrials.gov registry export · 2026-08-08
-
Phase III Double-blind, Placebo-controlled Study of AZD1222 for the Prevention of COVID-19 in Adults
COMPLETED · Phase 3
-
Inpatient Treatment of COVID-19 With Anti-Coronavirus Immunoglobulin (ITAC)
COMPLETED · Phase 3
-
A Study to Evaluate Efficacy, Safety, and Immunogenicity of mRNA-1273 Vaccine in Adults Aged 18 Years and Older to Prevent COVID-19
COMPLETED · Phase 3
-
A Study of LY3819253 (LY-CoV555) and LY3832479 (LY-CoV016) in Preventing SARS-CoV-2 Infection and COVID-19 in Nursing Home Residents and Staff
COMPLETED · Phase 3
-
A Study to Investigate the Immunogenicity and Safety of mRNA COVID-19 Variant-containing Vaccine Formulations
RECRUITING · Phase 4
-
A Study to Evaluate the Efficacy and Safety of mRNA-1283 and mRNA-1273 in Participants 50 to 64 Years of Age Without High-Risk Conditions for Severe Coronavirus Disease 2019 (COVID-19)
RECRUITING · Phase 4
Nationwide trials with similar profiles
Cross-condition peers matched on enrollment target and registry start date, not the same-condition list above.
Similar enrollment target
- NCT04942717 · 234 participants · NA
Adapting for Latinx Populations an Intervention That Involves Discussing and Sharing Patients' Health-Related Values
- NCT05208671 · 234 participants · NA
Nutrition to Optimize, Understand, and Restore Insulin Sensitivity in HIV for Oklahoma
- NCT05444465 · 234 participants · NA
Use of the REGENETEN™ Bioinductive Implant System in High Grade Partial-thickness Tears
- NCT05720338 · 234 participants · Phase 3
Is Intraperitoneal Drainage Necessary Following Distal Pancreatectomy?
Similar registry start date
- NCT05962346 · started 2026-12 · NA
Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia
- NCT07125183 · started 2026-12 · Phase 2
Study on Efficacy and Tolerability of Weekly Doxorubicin in Elderly Patients With Advanced or Metastatic Leiomyosarcoma
- NCT07292298 · started 2026-11 · Phase 2
Phase 2 Single-Arm Rectal Cancer Brachytherapy for Patients With Low-Lying Residual Adenocarcinoma After Total Neoadjuvant Therapy to Improve Organ Preservation Rates
- NCT04263285 · started 2026-10 · NA
Treatment of Depression Post-SCI