Actively Recruiting
A Study to Evaluate the Immunogenicity and Safety of mRNA-1283 COVID-19 Variant-containing Formulations
Led by ModernaTX, Inc. · Updated on 2025-10-14
832
Participants Needed
5
Research Sites
42 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
The purpose of this study is to evaluate the immunogenicity and safety of the recommended variant-containing formulations of mRNA-1283 COVID-19 vaccine (mNEXSPIKE®) within the current epidemiological environment.
CONDITIONS
Official Title
A Study to Evaluate the Immunogenicity and Safety of mRNA-1283 COVID-19 Variant-containing Formulations
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 65 years or older at consent or age 12 to under 65 years with at least one risk factor for severe COVID-19 outcomes
- Willing and physically able to comply with all study procedures and follow-up
- Females who could become pregnant must have a negative pregnancy test at screening and Day 1
- Females who could become pregnant must have practiced adequate contraception or abstained from pregnancy-risk activities for at least 28 days before Day 1
- Females who could become pregnant must agree to continue contraception through 28 days after vaccination
You will not qualify if you...
- COVID-19 infection within 6 months before enrollment
- Acute illness or fever (≥38.0°C or 100.4°F) within 72 hours before screening or Day 1
- Clinically unstable conditions or diagnoses affecting safety or study assessments
- Receipt of any COVID-19 vaccine within 6 months before enrollment
- Receipt of any licensed non-COVID-19 vaccine within 28 days before or after study vaccine (except influenza vaccine within 14 days)
- Use of systemic immunosuppressants for more than 14 days within 180 days before screening or anticipated need during study
- Receipt of systemic immunoglobulins, long-acting biologics, or blood products within 90 days before screening or planned during study
- History of severe allergic reaction to any mRNA vaccine or its components
- Blood donation of 450 mL or more within 28 days before screening or planned within 28 days after vaccination
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 5 locations
1
DelRicht Research-Atlanta
Atlanta, Georgia, United States, 30329
Actively Recruiting
2
DelRicht Research-Baton Rouge
Baton Rouge, Louisiana, United States, 70769
Actively Recruiting
3
DelRicht Research-New Orleans
New Orleans, Louisiana, United States, 70115
Actively Recruiting
4
DelRicht Research-Gulfport
Gulfport, Mississippi, United States, 39503
Actively Recruiting
5
DelRicht Research-Tulsa
Tulsa, Oklahoma, United States, 74133
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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