RecruitingCOVID-19

Study of a Recombinant Spike COVID-19 Vaccine With Matrix-M in Older Adults and People at Increased Risk of Severe COVID-19

Eligible age

12+ yrs

Accepts

All genders

Locations

14 states

Healthy volunteers

Yes

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About this study

The purpose of this study is to evaluate the safety and immunogenicity of a single dose of Sanofi's Omicron subvariant-based Nuvaxovid in participants ≥ 65 years of age and participants 12 through 64 years of age who have at least one underlying condition that puts them at increased risk for severe outcomes of COVID-19 and who have been previously vaccinated with a COVID-19 vaccine ≥ 90 days prior to study vaccination. Study details include: * The study duration will be approximately 3 months per participant. * Study intervention will be administered via a single intramuscular (IM) injection into the deltoid muscle on Day 1. * The visit frequency will be Day 1, Day 9 telephone call, Day 29, and Day 91 telephone call (3-month safety follow-up).

Sponsor: Sanofi

You may qualify if…

✓ 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.

You may not qualify if…

✕ 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.