Vaccine formulations containing mRNA-1273 and mRNA-1283 to see if they boost immunity and remain safe

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This interventional phase 4 trial compares the immunogenicity and safety of variant-containing mRNA-1273 and mRNA-1283 vaccines in the current epidemiological setting. Eligible participants include adults 65 and older or adults 12–64 with one or more risk factors for severe COVID-19 outcomes. Key safety considerations exclude recent SARS-CoV-2 infection, acute illness, or conditions that could affect safety or immune response. The study is sponsored by ModernaTX, Inc. with multiple U.S. sites. Participants will receive either mRNA-1273 or mRNA-1283 and will be monitored for immune response and adverse events. The trial aims to inform whether these variant-form formulations can provide meaningful protection in real-world settings.

Why it matters

Who can join: the full rules

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 3 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 3 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 it's running

• Delricht Research @ Overland
  Overland Park, Kansas, United States Recruiting
• Delricht Research @ Louisville
  Louisville, Kentucky, United States Recruiting
• Delricht Research @ Charlotte
  Charlotte, North Carolina, United States Recruiting
• Delricht Research @ Magnolia Family Medicine
  Hendersonville, Tennessee, United States Recruiting
• Delricht Research @ Zomnir Family Medicine
  Prosper, Texas, United States Recruiting

Study contacts

• Study coordinator: Moderna WeCareTeam
• Email: WeCareClinicalTrials@modernatx.com
• Phone: +1-866-663-3762

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.