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New mRNA vaccines aim to outsmart evolving COVID variants

NCT ID NCT06585241

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

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

Phase 4

Runs after approval, following long-term safety and how well the treatment works in everyday use.

Participants

About 1,144 people

The number the study aims to enrol. It can still change while the study runs.

Started

Sep 2024

Expected to finish

Dec 2026

An estimate. End dates often move.

Lead sponsor

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

6 months and older

Sex

Anyone

Healthy volunteers

Accepted

You do not need to have the condition being studied to take part.

Show 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.

  1. The places running it

    6 sites. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. 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

  • CenExel

    RECRUITING

    Atlanta, Georgia, 30331, United States

  • CenExel

    RECRUITING

    Decatur, Georgia, 30030, United States

  • Richard Bennett - Clinical Research Partners

    RECRUITING

    Richmond, Virginia, 23226, United States

  • Velocity Clinical Research

    RECRUITING

    Baton Rouge, Louisiana, 70809, United States

  • Velocity Clinical Research

    RECRUITING

    Gulfport, Mississippi, 39503, United States

  • Velocity Clinical Research

    RECRUITING

    Omaha, Nebraska, 68134, United States

More trials for these conditions

Other studies related to the condition(s) this trial covers.