Omicron-based COVID-19 vaccine with Matrix-M given as a single dose in older adults and high-risk individuals

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 randomized, interventional study evaluates safety and immunogenicity of a single intramuscular dose of an Omicron-subvariant–based SARS-CoV-2 recombinant spike vaccine adjuvanted with Matrix-M. Eligible participants are adults 65 years and older or 12–64 years with at least one risk condition for severe COVID-19, who had a prior COVID-19 vaccination more than 90 days before vaccination. The study involves follow-up through Day 91 to monitor safety and immune response, with visits on Day 1, Day 9 (phone), Day 29, and Day 91 (phone). The primary endpoints focus on safety and immune response after a one-time dose, conducted at three U.S. sites under Sanofi sponsorship.

Why it matters

Who can join: the full rules

Inclusion Criteria:

To be included in this study, each individual must satisfy all the following criteria:

* Participants ≥ 65 years of age, or participants 12 through 64 years of age who have at least 1 underlying condition that puts them at increased risk for severe outcomes from COVID-19 at the time of study vaccination.
* Previously vaccinated with a COVID-19 vaccine, with the last dose administered ≥ 90 days prior to study vaccination.
* Participants must not be pregnant or breastfeeding. Participants of childbearing potential must have a negative highly sensitive pregnancy test at enrollment and must agree to use an effective method of contraception or remain abstinent from ≥ 4 weeks before study vaccination through ≥ 4 weeks after vaccination.

Exclusion Criteria:

Participants are not eligible if any of the following criteria are met:

* Known or suspected congenital or acquired immunodeficiency; receipt of immunosuppressive therapy, such as anti-cancer chemotherapy or radiation therapy, within the past 6 months; or long-term use of systemic corticosteroids.
* History of virologically confirmed SARS-CoV-2 infection within 90 days before study vaccination.
* Known systemic hypersensitivity to any component of the study intervention or a history of a life-threatening reaction to the study intervention or to a product containing the same substances.
* Prior history of myocarditis, pericarditis, or myopericarditis.
* Receipt of any vaccine within 28 days before study vaccination, except for influenza vaccine, which may be administered at least 14 days before study vaccination.
* Receipt of an investigational or marketed COVID-19 vaccine within 90 days before study vaccination.

The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.

Where it's running

• Site #: 8400005
  Fair Oaks, California, United States Recruiting
• Site #: 8400002
  Doral, Florida, United States Recruiting
• Site #: 8400008
  Atlanta, Georgia, United States Recruiting
• Site #: 8400015
  Decatur, Georgia, United States Recruiting
• Site #: 8400011
  Melrose Park, Illinois, United States Recruiting
• Site #: 8400019
  Sioux City, Iowa, United States Recruiting

Study contacts

• Study coordinator: Trial Transparency email recommended (Toll free number for US & Canada)
• Email: contact-us@sanofi.com
• Phone: 800-633-1610

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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.