New mRNA vaccines aim to outsmart evolving COVID variants
NCT ID NCT06585241
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study tests several updated mRNA COVID-19 vaccines designed to target new variants of the virus. About 1,100 adults and children with certain risk factors will receive one of the vaccines to see how well it boosts immunity and how safe it is. The goal is to ensure vaccines remain effective as the virus changes.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 4
Runs after approval, following long-term safety and how well the treatment works in everyday use.
- Participants
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About 1,144 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Sep 2024
- Expected to finish
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Dec 2026
An estimate. End dates often move.
- Lead sponsor
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A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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6 months and older
- Sex
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Anyone
- Healthy volunteers
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Accepted
You do not need to have the condition being studied to take part.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Key Inclusion Criteria: * mRNA-1273.167 and mRNA-1273.712: Previously vaccinated adults aged ≥18 years * mRNA-1273.251: Participants ≥65 years of age, ≥12 to \<65 years of age, or ≥6 months to \<12 years of age with at least 1 risk factor for severe outcomes from COVID-19. * mRNA-1273.261: ≥65 years of age at the time of signing the informed consent or ≥18 to \<65 years of age at the time of signing the informed consent with at least 1 risk factor for severe outcomes from COVID-19. * Able to comply with study procedures based on the assessment of the Investigator. * Female participants of childbearing potential may be enrolled in the study if the participant fulfills all the following criteria: * Has a negative pregnancy test at the Screening Visit and on the day of vaccination prior to vaccine dose being administered on Day 1. * Has practiced adequate contraception or has abstained from all activities that could result in pregnancy for at least 28 days prior to the first dose. * Has agreed to continue adequate contraception through 28 days following vaccine administration. Key Exclusion Criteria: * History of SARS-CoV-2 infection within 3 months prior to enrollment for mRNA-1273.167 and mRNA-1273.712 or within up to 6 months prior to enrollment for mRNA-1273.251 and mRNA-1273.261. * Is acutely ill or febrile (temperature 38.0°Celsius/100.4°Fahrenheit) less than 72 hours prior to or at the Screening Visit or Day 1. Participants meeting this criterion may be rescheduled within the Screening window. * History of a diagnosis or condition that, in the judgment of the Investigator, is clinically unstable, or may affect participant safety, assessment of study endpoints, assessment of immune response, or adherence to study procedures. * History of anaphylaxis or severe hypersensitivity reaction requiring medical intervention after receipt of any mRNA vaccine or therapeutic or any components of an mRNA vaccine or therapeutic. * Receipt of COVID-19 vaccine within 3 months prior to enrollment for mRNA-1273.167 and mRNA-1273.712 or within 6 months prior to enrollment for mRNA-1273.251 and mRNA-1273.261. * Receipt of any licensed non-COVID-19 vaccine within 14 days (inactivated vaccine, pediatric) or 28 days before or planned receipt within 14 days (pediatric) or 28 days after the study intervention, except an influenza vaccine, which may be given at least 7 days before (pediatric) or 14 days before or after receipt of the study intervention. * Receipt of systemic immunosuppressants or immune-modifying drugs for \>14 days total (within 6 months prior to Screening for mRNA-1273.167 and mRNA-1273.712 or within 180 days prior to Screening for mRNA-1273.251 and mRNA-1273.261) or is anticipating the need for immunosuppressive treatment at any time during participation in the study. * Receipt of systemic immunoglobulins, long-acting biological therapies that affect immune (pediatric) responses, or blood products (within 3 months prior to Screening for mRNA-1273.167 and mRNA-1273.712 or within 90 days prior to the Screening for mRNA-1273.251 and mRNA-1273.261) or plans for receipt during the study. * Has donated ≥450 milliliters of blood products within 28 days prior to the Screening Visit or plans to donate blood products during the study. Other protocol-defined inclusion/exclusion criteria may apply.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
6 sites. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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CenExel
RECRUITINGAtlanta, Georgia, 30331, United States
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CenExel
RECRUITINGDecatur, Georgia, 30030, United States
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Richard Bennett - Clinical Research Partners
RECRUITINGRichmond, Virginia, 23226, United States
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Velocity Clinical Research
RECRUITINGBaton Rouge, Louisiana, 70809, United States
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Velocity Clinical Research
RECRUITINGGulfport, Mississippi, 39503, United States
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Velocity Clinical Research
RECRUITINGOmaha, Nebraska, 68134, United States
More trials for these conditions
Other studies related to the condition(s) this trial covers.
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- Can an old malaria drug help fight severe COVID-19?
- Can a new pill keep High-Risk COVID-19 patients out of the hospital?
- Could a five-day pill course cut COVID-19 deaths? czech nationwide data puts molnupiravir to the test.
- Millions of vaccine records scoured for rare side effects
- Scientists probe why lung disease raises COVID-19 risk