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Virus Vaccine
mRNA Vaccine Boosters for COVID-19
Phase 2 & 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 days 1, 15, 181, and 366
Awards & highlights
Study Summary
This trial will test how well different doses of a new COVID-19 vaccine work in people, as well as how safe it is.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ days 1, 15, 181, and 366
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~days 1, 15, 181, and 366
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
GMT of Omicron-Specific Antibody (For Part J only) at Day 15
GMT of Omicron-Specific Antibody (For Parts F, G, H and J only) at Day 29
GMT of Omicron-Specific Antibody at Day 91 (For Part G only)
+9 moreSecondary outcome measures
GMT of SARS-CoV-2-Specific Antibody
Seroresponse Rate of Vaccine Recipients
Trial Design
14Treatment groups
Experimental Treatment
Group I: Part J: mRNA-1273.815 or mRNA-1273.231Experimental Treatment2 Interventions
Participants will receive 1 intramuscular booster dose of 50 μg of mRNA-1273.815 or 50 ug of mRNA-1273.231 on Day 1.
Group II: Part H: mRNA-1273.222 50 μgExperimental Treatment1 Intervention
Participants will receive 1 intramuscular second booster dose of 50 μg of mRNA-1273.222 on Day 1.
Group III: Part G: mRNA-1273.214 50 μgExperimental Treatment1 Intervention
Participants will receive 1 intramuscular second booster dose of mRNA-1273.214 50 μg on Day 1.
Group IV: Part F Cohort 2: mRNA-1273.529 50 μg and mRNA-1273 50 μgExperimental Treatment2 Interventions
Participants will receive 1 intramuscular second booster dose of 50 μg of mRNA-1273.529 or mRNA-1273 enrolled sequentially (after receiving a primary series of mRNA-1273 and a single booster dose of mRNA-1273 50 μg) on Day 1.
Group V: Part F Cohort 1: mRNA-1273.529 50 μgExperimental Treatment1 Intervention
Participants will receive 1 intramuscular first booster dose of 50 μg of mRNA-1273.529 on Day 1.
Group VI: Part E: mRNA-1273.213 100 μgExperimental Treatment1 Intervention
Participants will receive 1 intramuscular booster dose of 100 μg of mRNA-1273.213 on Day 1.
Group VII: Part D: mRNA-1273.213 50 μgExperimental Treatment1 Intervention
Participants will receive 1 intramuscular booster dose of 50 μg of mRNA-1273.213 on Day 1.
Group VIII: Part D: mRNA-1273.213 100 μgExperimental Treatment1 Intervention
Participants will receive 1 intramuscular booster dose of 100 μg of mRNA-1273.213 on Day 1.
Group IX: Part C: mRNA-1273.617.2 50 μgExperimental Treatment1 Intervention
Participants will receive 1 intramuscular booster dose of 50 μg of mRNA-1273.617.2 on Day 1.
Group X: Part C: mRNA-1273.617.2 100 μgExperimental Treatment1 Intervention
Participants will receive 1 intramuscular booster dose of 100 μg of mRNA-1273.617.2 on Day 1.
Group XI: Part B: mRNA-1273 100 μgExperimental Treatment1 Intervention
Participants will receive 1 intramuscular booster dose of 100 μg of mRNA-1273 on Day 1.
Group XII: Part A.2: mRNA-1273.214 50 μgExperimental Treatment1 Intervention
Participants will receive 1 intramuscular booster dose of 50 μg of mRNA-1273.214 on Day 1.
Group XIII: Part A.1: mRNA-1273.211 50 μgExperimental Treatment1 Intervention
Participants will receive 1 intramuscular booster dose of 50 micrograms (μg) of mRNA-1273.211 on Day 1.
Group XIV: Part A.1: mRNA-1273.211 100 μgExperimental Treatment1 Intervention
Participants will receive 1 intramuscular booster dose of 100 μg of mRNA-1273.211 on Day 1.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
mRNA-1273.213
2021
Completed Phase 3
~5410
mRNA-1273.529
2021
Completed Phase 3
~10240
mRNA-1273.214
2021
Completed Phase 3
~20920
mRNA-1273.222
2021
Completed Phase 3
~6280
mRNA-1273.815
2021
Completed Phase 3
~5410
mRNA-1273.231
2021
Completed Phase 3
~5410
mRNA-1273.211
2021
Completed Phase 3
~6280
mRNA-1273
2021
Completed Phase 4
~58700
mRNA-1273.617.2
2021
Completed Phase 3
~6680
Find a Location
Who is running the clinical trial?
ModernaTX, Inc.Lead Sponsor
107 Previous Clinical Trials
61,372,721 Total Patients Enrolled
37 Trials studying COVID-19
61,255,162 Patients Enrolled for COVID-19
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I'm sorry, I cannot provide a summary for this criterion as it appears to be incomplete. Can you please provide more context or information?You are currently experiencing a serious adverse event in another study called mRNA-1273-P301 (COVE) at the time of screening for this study.You have had inflammation of the heart or the sac around the heart within the past two months.You have experienced severe allergic reactions in the past to the vaccine or its ingredients.
Research Study Groups:
This trial has the following groups:- Group 1: Part A.2: mRNA-1273.214 50 μg
- Group 2: Part D: mRNA-1273.213 100 μg
- Group 3: Part E: mRNA-1273.213 100 μg
- Group 4: Part F Cohort 1: mRNA-1273.529 50 μg
- Group 5: Part F Cohort 2: mRNA-1273.529 50 μg and mRNA-1273 50 μg
- Group 6: Part J: mRNA-1273.815 or mRNA-1273.231
- Group 7: Part G: mRNA-1273.214 50 μg
- Group 8: Part H: mRNA-1273.222 50 μg
- Group 9: Part A.1: mRNA-1273.211 50 μg
- Group 10: Part A.1: mRNA-1273.211 100 μg
- Group 11: Part B: mRNA-1273 100 μg
- Group 12: Part C: mRNA-1273.617.2 100 μg
- Group 13: Part C: mRNA-1273.617.2 50 μg
- Group 14: Part D: mRNA-1273.213 50 μg
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
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: NCT04927065 — Phase 2 & 3
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Is this medical study taking place in more than one facility within the state?
"Presently, this trial is enrolling patients from 22 clinical sites. Some of these locations include Sacramento, Norfolk and Grand Island. To cut down on travel-related stressors, try to select the location nearest you."
Answered by AI
How many people are participating in the research project?
"This specific trial is not enrolling patients at the moment, however this may change in the future. Last updated on November 16th, 2022, this study was originally posted on May 28th, 2021. There are 1119 other trials actively searching for participants with covid-19 and 28 trials for mRNA-1273.211 that are still enrolling patients."
Answered by AI
How does mRNA-1273.211 compare to other similar treatments?
"The first study of mRNA-1273.211 took place in 2020 at Kaiser Permanente Washington Health Research Institute - Vaccines and Infectious Diseases. There have been a total of 8 completed clinical trials since then, with 28 more currently underway across the globe; many of these are being conducted out of Sacramento, California."
Answered by AI
Are people with the relevant medical condition still able to sign up for this experiment?
"The clinical trial in question is not presently seeking participants, as per the information available on clinicaltrials.gov. This specific study was first posted on 5/28/2021 and was last edited on 11/16/2022; however, there are 1147 other clinical trials that are actively recruiting patients right now."
Answered by AI
Is this a unique or innovative clinical trial?
"A search of available data reveals that there are 28 ongoing studies for mRNA-1273.211 in 219 cities across 22 countries. The first trial was sponsored by ModernaTX, Inc. and completed its Phase 1 drug approval stage in 2020 after involving 120 patients. In the two years since the initial study, 8 more trials have been conducted."
Answered by AI
Who else is applying?
What state do they live in?
Nebraska
California
Texas
How old are they?
18 - 65
What site did they apply to?
Benchmark Research (California)
Meridian Clinical Research-(Omaha Nebraska)
Benchmark Research - Austin - HyperCore
What portion of applicants met pre-screening criteria?
Did not meet criteria
Met criteria
How many prior treatments have patients received?
0
Why did patients apply to this trial?
I am worried about the long term effects of repeated covid infections and would love to see a more effective vaccine be available.
PatientReceived 2+ prior treatments
Recent research and studies
New England Journal of MedicineJournal
A Bivalent Omicron-containing Booster Vaccine Against Covid-19Other Trials to Consider
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