Actively Recruiting
A Phase 3b/4, Open-label Study to Assess 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
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the immune response and safety of different mRNA COVID-19 vaccines that include formulations targeting various virus variants, including newly emerged types of SARS-CoV-2. This study follows a flexible master protocol that allows testing of different vaccine versions and age groups, with specific details outlined in subprotocols for each variant formulation. Participants will receive one or more intramuscular injections of one of the mRNA-1273 variant-containing vaccines, including mRNA-1273.167, mRNA-1273.712, mRNA-1273.251, or mRNA-1273.261. Each vaccine formulation is studied separately under subprotocols, and doses are administered according to the study schedule. The study is open-label and designed to assess multiple vaccine variants within the same framework. During the study, participants will undergo assessments of their immune response by measuring neutralizing antibodies against COVID-19 variants up to 29 days after vaccination. Safety will be monitored through recording adverse events, including serious events and reactions, for up to 209 days following the last dose. Participants will have visits and evaluations to track immune response, side effects, and overall health throughout the study period. Total participation duration varies with each vaccine formulation and age group under study.
CONDITIONS
Brief 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 vaccine groups
- Participants 6 months to under 12 years with at least 1 risk factor for severe COVID-19 for mRNA-1273.251 group
- Participants 12 to under 65 years and 65 years or older with or without risk factors depending on vaccine formulation
- Willingness and ability to comply with study procedures
- Female participants of childbearing potential must have negative pregnancy tests before vaccination and agree to use effective contraception during the study period
You will not qualify if you...
- History of COVID-19 infection within 3 months prior to enrollment for mRNA-1273.167 and mRNA-1273.712 groups or within 6 months for mRNA-1273.251 and mRNA-1273.261 groups
- Fever or acute illness within 72 hours prior to screening or vaccination
- Clinically unstable or unsafe medical conditions as judged by the investigator
- History of severe allergic reaction to any mRNA vaccine component
- Receipt of COVID-19 vaccine within 3 or 6 months depending on vaccine group
- Recent or planned receipt of other vaccines within 14 to 28 days around study vaccination, except influenza vaccine under specific timing
- Use of systemic immunosuppressive or immune-modifying drugs within defined recent periods or anticipated need during the study
- Receipt of blood products or immunoglobulins within specified recent periods
- Recent blood donation of 450 milliliters or more within 28 days prior to screening or planned during study participation
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 29 days
Participants receive intramuscular injections of an mRNA-1273 variant-containing COVID-19 vaccine formulation.
1 vaccination visit and follow-up visits up to Day 29
Duration - Up to 209 days
Participants are monitored for safety, including adverse events and immune response, for up to 209 days after vaccination.
Multiple follow-up visits over several months
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
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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