Recruiting

mRNA COVID-19 Vaccine

Sponsor:

Moderna

Code:

NCT06585241

Conditions

SARS-CoV-2

Eligibility Criteria

Sex: All

Age: 0+

Healthy Volunteers: Accepted

Interventions

mRNA-1273 Variant-containing Formulation

Study Details

Brief summary:

The purpose of this study is to investigate the immunogenicity and safety of mRNA COVID-19 variant-containing vaccine formulations against the vaccine-matched variants and newly emerged variants of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2).

Conditions

SARS-CoV-2

Study ID

NCT06585241

Start date

Sep 9, 2024

Status verified date

Mar, 2026

Completion date

Dec 31, 2026

Anticipated

Primary completion date

Dec 31, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 0+

Healthy Volunteers: Accepted

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.

Study Design

Enrollment

1144 participants

Anticipated

Intervention Model

Single group

Primary purpose

Prevention

Interventions and Outcome Measures

Arms

experimental: mRNA-1273 Variant-containing Formulation

Participants will receive intramuscular (IM) injection(s) of an mRNA-1273 variant-containing formulation (mRNA-1273.167, mRNA-1273.712, mRNA-1273.251, or mRNA-1273.261).

Interventions

mRNA-1273 Variant-containing Formulation

Sterile liquid for injection

Primary outcome measure

  • mRNA-1273.167, mRNA-1273.712, mRNA-1273.251, and mRNA-1273.261: Geometric Mean Value of Neutralizing Antibody Against COVID-19 Variants [ Time Frame: Up 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 Variants [ Time Frame: Up to 28 days after last dose of study intervention ]
  • mRNA-1273.251 and mRNA-1273.261: Seroresponse Rate [ Time Frame: Up to Day 29 ]

Central Contacts and Locations

Central contacts

Locations

CenExel

Recruiting

Atlanta, Georgia, United States, 30331

CenExel

Recruiting

Decatur, Georgia, United States, 30030

Velocity Clinical Research

Recruiting

Baton Rouge, Louisiana, United States, 70809

Velocity Clinical Research

Recruiting

Gulfport, Mississippi, United States, 39503

Velocity Clinical Research

Recruiting

Omaha, Nebraska, United States, 68134

Richard Bennett - Clinical Research Partners

Recruiting

Richmond, Virginia, United States, 23226

More Information

Sponsor

ModernaTX, Inc.

Last update posted

Mar 27, 2026

Last verified

Mar, 2026

Keywords

  • mRNA-1273
  • mRNA-1273 vaccine
  • SARS-CoV-2
  • SARS-CoV-2 Vaccine
  • Coronavirus
  • Virus Diseases
  • Messenger RNA
  • COVID-19
  • COVID-19 Vaccine
  • Variant
  • Moderna
  • Pediatric

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by ModernaTX, Inc. on 2026-03-27.