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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 days 1, 28 days after dose 1, 28 days after dose 2, 6 months after dose 2, and 1 year after dose 2
Awards & highlights
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 weeks3 visits
Treatment ~ Varies
Follow Up ~ 28 days after dose 3, 6 months after dose 3, and 1 year after dose 3
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~28 days after dose 3, 6 months after dose 3, and 1 year after dose 3
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Part A: GMC of SARS-CoV-2-Specific nAb 28 Days After Dose 3
Part A: Geometric Mean Concentration (GMC) of Serum SARS-CoV-2-Specific Neutralizing Antibody (nAb) After the Second Dose in Unvaccinated Participants
Part B: GMC of SARS-CoV-2-Specific nAb 28 Days After the BD in SOT Participants Who Received the Moderna Primary Series and Non-Moderna Primary Series
+14 moreSecondary study objectives
Part A: GM Value of Anti-SARS-CoV-2 S-specific bAb for Unvaccinated and Previously Vaccinated Participants Receiving the 3-Dose Regimen
Part A: GMC of SARS-CoV-2-Specific nAb for Unvaccinated Participants Receiving the 2-Dose Regimen
Part A: GMC of SARS-CoV-2-Specific nAb for Unvaccinated and Previously Vaccinated Participants Receiving the 3-Dose Regimen
+12 moreSide effects data
From 2022 Phase 4 trial • 41 Patients • NCT0479256724%
COVID-19
18%
Lymphopenia
18%
Injection site pain
12%
Liver function test increased
12%
Pain in extremity
12%
Multiple sclerosis relapse
6%
Escherichia urinary tract infection
6%
Visual impairment
6%
Fatigue
6%
Pyrexia
6%
Injection site pustule
6%
Rhinitis
6%
Urinary tract infection
6%
Upper limb fracture
6%
Back pain
6%
Myalgia
6%
Dizziness
6%
Headache
6%
VIth nerve paralysis
6%
Menstrual disorder
6%
Cough
6%
Flushing
100%
80%
60%
40%
20%
0%
Study treatment Arm
Siponimod Continuous
Siponimod Interrupted
DMT or No MS Treatment
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
~58720
Find a Location
Who is running the clinical trial?
ModernaTX, Inc.Lead Sponsor
113 Previous Clinical Trials
61,461,730 Total Patients Enrolled
39 Trials studying COVID-19
61,261,066 Patients Enrolled for COVID-19
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I'm sorry, but the criterion you provided seems to be incomplete. Could you please provide more information or context so I can accurately summarize it for you?You are currently taking experimental drugs to prevent or treat COVID-19.You are medically stable, according to investigator's judgment, during the 3 months before signing consent.You have either received or plan to receive a vaccine for COVID-19, SARS, or MERS. If you have not been vaccinated yet, this applies to you.You have a medical condition that may affect the outcome of the study or put you at risk during the study.You understand the study procedures and are able to comply with themYou have received an organ transplant.You have a history of problems resulting from weakened immune system.You are currently receiving experimental medication to prevent or treat COVID-19.
Research Study Groups:
This trial has the following groups:- Group 1: mRNA-1273
Awards:
This trial has 2 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
COVID-19 Patient Testimony for trial: Trial Name: NCT04860297 — Phase 3
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