← Back to Search

Virus Vaccine

mRNA-1273 for COVID-19

Phase 3
Waitlist Available
Research Sponsored by ModernaTX, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to approximately 1 year
Awards & highlights

Study Summary

This trial is testing a vaccine for safety in adults who have had a kidney or liver transplant, as well as in healthy adults. The goal is to see if the vaccine is safe and if it produces an immune response.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to approximately 1 year
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to approximately 1 year for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
GMT of SARS-CoV-2 Specific nAB for Participants in Part B
Geometric Mean Titer (GMT) of SARS-CoV-2 Specific Neutralizing Antibody (nAb) for Participants in Part A
Number of Participants with AEs Leading to Withdrawal
+8 more
Secondary outcome measures
GM of SARS-CoV-2 bAb for Previously Vaccinated SOT Participants
GM of SARS-CoV-2 bAb for Unvaccinated SOT Participants Receiving 3-Dose Regimen
GMFR of bAb Relative to Day 1 for Previously Vaccinated SOT Participants
+13 more

Side effects data

From 2022 Phase 3 trial • 30415 Patients • NCT04470427
7%
Headache
7%
Fatigue
2%
Upper respiratory tract infection
2%
Injection site pain
1%
COVID-19
100%
80%
60%
40%
20%
0%
Study treatment Arm
Part A (Blinded): Placebo
Part A (Blinded): mRNA-1273
Part B (Open-label): Placebo
Part B (Open-label): Placebo/mRNA-1273
Part B (Open-label): mRNA-1273
Part C: mRNA-1273 Booster

Trial Design

1Treatment groups
Experimental Treatment
Group I: mRNA-1273Experimental Treatment1 Intervention
Part A: All participants (healthy participants and SOT participants) who were unvaccinated prior to enrollment will receive 2 intramuscular (IM) injections of 100 microgram (µg) mRNA-1273 on Day 1 and Day 29. All SOT participants who were unvaccinated prior to enrollment will be offered the opportunity to receive a third primary dose of mRNA-1273 at Day 85 as per the emergency use authorization (EUA) Fact Sheet available at the time of protocol finalization. SOT participants who were previously vaccinated with 2 doses of Moderna COVID-19 vaccine under the EUA prior to enrollment will receive Dose 3 on Day 1. Part B: All eligible participants from Part A will be offered to receive a 100 µg booster dose of mRNA-1273 who are at least 4 months from the last dose. SOT recipients who completed primary COVID-19 vaccination series under EUA (outside of the mRNA-1273-P304 study) will receive a 100 µg booster dose on booster dose Day 1.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
mRNA-1273
2021
Completed Phase 4
~58700

Find a Location

Who is running the clinical trial?

ModernaTX, Inc.Lead Sponsor
107 Previous Clinical Trials
61,377,891 Total Patients Enrolled
37 Trials studying COVID-19
61,260,332 Patients Enrolled for COVID-19

Media Library

mRNA-1273 (Virus Vaccine) Clinical Trial Eligibility Overview. Trial Name: NCT04860297 — Phase 3
COVID-19 Research Study Groups: mRNA-1273
COVID-19 Clinical Trial 2023: mRNA-1273 Highlights & Side Effects. Trial Name: NCT04860297 — Phase 3
mRNA-1273 (Virus Vaccine) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04860297 — Phase 3
COVID-19 Patient Testimony for trial: Trial Name: NCT04860297 — Phase 3

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What other mRNA-1273 research has been conducted in the past?

"The first published study on mRNA-1273 was in 2020 at Kaiser Permanente Washington Health Research Institute - Vaccines and Infectious Diseases. Since that time, there have been a total of 8 completed clinical trials with 28 more recruiting patients as we speak. Most of the active studies are based out of Worcester, Massachusetts."

Answered by AI

How many people are participating in this research project?

"This research is not currently looking for volunteers. The study was originally posted on April 16th, 2021 and updated as recently as August 31st, 2022. There are 1119 other clinical trials related to covid-19 actively recruiting patients and 28 studies for mRNA-1273 that are also searching for participants."

Answered by AI

Does mRNA-1273 have a high potential for patient harm?

"mRNA-1273 is in Phase 3 of clinical trials, so it has received a score of 3 for safety. This is due to the existence of data supporting both efficacy and multiple rounds of safety testing."

Answered by AI

At how many hospitals is this research project being conducted?

"Presently, this trial is recruiting patients from a total of 15 sites. 3 of these locations are in Worcester, Mesa and Tampa with the remaining 12 situated elsewhere. To cut down on travel-related stresses, it is advised that you select a clinic closest to your location."

Answered by AI

Is this an innovative clinical trial?

"Since 2020, mRNA-1273 has been the focus of various medical studies. In fact, the first clinical trial occurred in 2020 and was sponsored by ModernaTX, Inc.. After this initial study involving just 120 people, Phase 1 drug approval was granted. As it stands today, there are 28 live studies being conducted in 219 cities across 22 countries."

Answered by AI

Are there any available positions for participants in this trial?

"This particular trial, as seen on clinicaltrials.gov, is not looking for new patients at the moment. The study was originally posted on April 16th 2021 and updated last on August 31st 2022. There are 1147 other trials that are open for recruitment currently though."

Answered by AI

Who else is applying?

What state do they live in?
Georgia
What site did they apply to?
Piedmont Transplant Institute
What portion of applicants met pre-screening criteria?
Did not meet criteria
Met criteria
How many prior treatments have patients received?
2

Why did patients apply to this trial?

I worked and the medical field , And I like to see what is new.
PatientReceived 1 prior treatment
Recent research and studies
clinicaltrials.govStudy
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
2021. "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". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04860297.
~58 spots leftby Apr 2025
Unbiased ResultsWe believe in providing patients with all the options.
Your Data Stays Your DataWe only share your information with the clinical trials you're trying to access.
Verified Trials OnlyAll of our trials are run by licensed doctors, researchers, and healthcare companies.
Back to top