NCT07863635 · ModernaTX, Inc.
A Study to Investigate the Immunogenicity and Safety of mRNA COVID-19 Variant-containing Formulations
What this study is about
The purpose of this study is to evaluate the immunogenicity and safety of mRNA-1283 and mRNA-1273 (variant formulations) within the current epidemiological environment
View original scientific description
The purpose of this study is to evaluate the immunogenicity and safety of mRNA-1283 and mRNA-1273 (variant formulations) within the current epidemiological environment
Interventions
BIOLOGICAL
mRNA-1273
Sterile liquid for injection
BIOLOGICAL
mRNA-1283
Sterile liquid for injection
Primary outcome measures
Geometric Mean Titer (GMT) on Neutralizing Antibody (nAb) Against Vaccine-matched Variant Formulation
Time frame: Day 29
Geometric Mean Fold Rise (GMFR) on Neutralizing Antibody (nAb) Against Vaccine-matched Variant Formulation
Time frame: Day 29
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- ≥65 years of age at the time of signing the informed consent OR ≥12 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.
- Female participants of childbearing potential may be enrolled in the study if not pregnant or breastfeeding, subject to other criteria specified in the study protocol.
Exclusion criteria
- History of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection within 6 months prior to enrollment.
- Acutely ill or febrile within 72 hours prior to or at Day 1.
- History of a diagnosis or conditions that in the Investigator's opinion could affect participant's safety, assessment of endpoints, assessment of immune response, or adherence to study procedures.
- Reported history of congenital or acquired immunodeficiency, immunosuppressive condition, asplenia, or recurrent severe infections.
- History of coagulopathy or bleeding disorder that is considered a contraindication to IM injection or phlebotomy.
- Receipt of any of the following:
- COVID-19 vaccine within 6 months prior to enrollment,
- Any licensed non COVID-19 vaccine within 28 days before or planned receipt within 28 days after the study intervention, except an influenza vaccine, which may be given 14 days before or after receipt of the study intervention,
- Systemic immunosuppressive treatment within 180 days prior to the Screening or is anticipating the need for systemic immunosuppressive treatment at any time during participation in the study,
- Systemic immunoglobulins, long-acting biological therapies that affect immune responses, or blood products within 90 days prior to the Day 1 Visit or plans for receipt during the study. Note: Additional protocol-defined inclusion/exclusion criteria may apply.
Where
- Overland Park, Kansas
- Louisville, Kentucky
- Charlotte, North Carolina
- Hendersonville, Tennessee
- Prosper, Texas
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Oct 27, 2026 · Source of record for eligibility and locations