Study of mRNA COVID-19 Variant Vaccines
This study is looking at new versions of the mRNA COVID-19 vaccine (mRNA-1273 Variant-containing Formulation) to see how well they protect against different types of the COVID-19 virus and if they are safe. Researchers will measure the amount of protective antibodies (immune proteins that fight off infection) your body makes against various COVID-19 variants. The study is open to adults who have already been vaccinated, and to people aged 6 months and older, including those with risk factors for severe COVID-19. The goal is to find out if these updated vaccines can create a strong immune response. The study plans to enroll 1144 people, but its current status is unclear.
- Study design
- This study is an interventional study, meaning participants will receive a specific treatment. It plans to enroll 1144 participants.
- What's involved
- Not specified in the trial record.
- Compensation
- Not stated in the trial record.
- Follow-up
- Researchers will measure antibody levels up to 29 days after vaccination and up to 28 days after the last dose of the study intervention.
AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.
NCT06585241
A Study to Investigate the Immunogenicity and Safety of mRNA COVID-19 Variant-containing Vaccine Formulations
Recruiting
PHASE4Ages 6+InterventionalPreventionModernaTX, Inc.
~1,144 participants
Updated 2026-03-27 on ClinicalTrials.gov
What's tested:mRNA-1273 Variant-containing Formulation
At a glance
Recruiting sites
6 of 6 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
mRNA-1273.167, mRNA-1273.712, mRNA-1273.251, and mRNA-1273.261: Geometric Mean Value of Neutralizing Antibody Against COVID-19 Variants
Measured over Up to Day 29
+2 more outcomes measured
Conditions
Where it's being run
6 sites across 5 statesGeorgia2
Louisiana1
Mississippi1
Nebraska1
Virginia1
Who to contact
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Do you actually qualify for this trial?
Add a private profile and we'll compare every criterion below against your situation — and tell you which ones are met, uncertain, or excluding.
Eligibility criteria
Inclusion
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.
Exclusion
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.
What this trial measures
- mRNA-1273.167, mRNA-1273.712, mRNA-1273.251, and mRNA-1273.261: Geometric Mean Value of Neutralizing Antibody Against COVID-19 VariantsUp to Day 29
- mRNA-1273.167, mRNA-1273.712, mRNA-1273.251, and mRNA-1273.261: Geometric Mean Fold Rise of Neutralizing Antibody Against COVID-19 VariantsUp to 28 days after last dose of study intervention
- mRNA-1273.251 and mRNA-1273.261: Seroresponse RateUp to Day 29