Actively Recruiting
A Study to Investigate the Immunogenicity and Safety of mRNA COVID-19 Variant-containing Vaccine Formulations
Led by ModernaTX, Inc. · Updated on 2026-03-27
1144
Participants Needed
6
Research Sites
120 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
Official Title
A Study to Investigate the Immunogenicity and Safety of mRNA COVID-19 Variant-containing Vaccine Formulations
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adults aged 18 years or older for mRNA-1273.167 and mRNA-1273.712
- Participants aged 65 years or older, 12 to under 65 years, or 6 months to under 12 years with at least one risk factor for severe COVID-19 for mRNA-1273.251
- Participants aged 65 years or older or 18 to under 65 years with at least one risk factor for severe COVID-19 for mRNA-1273.261
- Ability to comply with study procedures as determined by the Investigator
- Female participants of childbearing potential must have a negative pregnancy test at screening and on vaccination day
- Female participants of childbearing potential must practice adequate contraception or abstain from pregnancy-risk activities for at least 28 days before first dose and continue contraception through 28 days after vaccination
You will not qualify if you...
- History of SARS-CoV-2 infection within 3 months prior to enrollment for mRNA-1273.167 and mRNA-1273.712
- History of SARS-CoV-2 infection within 6 months prior to enrollment for mRNA-1273.251 and mRNA-1273.261
- Being acutely ill or febrile (38.0°C/100.4°F or higher) within 72 hours before screening or vaccination day
- Clinically unstable conditions or diagnoses that may affect safety or study assessments
- History of anaphylaxis or severe hypersensitivity to any mRNA vaccine or components
- Receipt of a COVID-19 vaccine within 3 months for mRNA-1273.167 and mRNA-1273.712 or within 6 months for mRNA-1273.251 and mRNA-1273.261
- Receipt of any licensed non-COVID-19 vaccine within 14 days (inactivated or pediatric) or 28 days before or planned within 14 or 28 days after study intervention, except influenza vaccine with specific timing
- Use of systemic immunosuppressants or immune-modifying drugs for more than 14 days within 6 months prior to screening or anticipated during study
- Receipt of systemic immunoglobulins, long-acting biological therapies affecting immune responses, or blood products within 3 months prior to screening or planned during study
- Donated 450 milliliters or more of blood products within 28 days before screening or plans to donate during study
- Other protocol-defined inclusion/exclusion criteria may apply
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 6 locations
1
CenExel
Atlanta, Georgia, United States, 30331
Actively Recruiting
2
CenExel
Decatur, Georgia, United States, 30030
Actively Recruiting
3
Velocity Clinical Research
Baton Rouge, Louisiana, United States, 70809
Actively Recruiting
4
Velocity Clinical Research
Gulfport, Mississippi, United States, 39503
Actively Recruiting
5
Velocity Clinical Research
Omaha, Nebraska, United States, 68134
Actively Recruiting
6
Richard Bennett - Clinical Research Partners
Richmond, Virginia, United States, 23226
Actively Recruiting
Research Team
M
Moderna WeCare Team
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
PREVENTION
Number of Arms
1
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