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Recruiting Phase 4

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

NCT07861542 · tracked via the Priya Life Science USA tracker
Sponsor
Phase
Phase 4
Started
2026-10-01
Last updated
2026-10-15

Condition(s) studied

COVID-19

Investigational drug(s) / intervention(s)

Omicron Subvariant-Based SARS-CoV-2 Recombinant Spike Vaccine Adjuvanted With Matrix-M

Omicron Subvariant-Based SARS-CoV-2 Recombinant Spike Vaccine Adjuvanted With Matrix-M: Pharmaceutical form: Sterile suspension for injection Route of administration: Intramuscular injection

Study summary

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).

Eligibility

Sex
ALL
Min age
12 Years
Max age
—
Healthy volunteers
Accepted
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.

Primary outcome measure(s)

  • Geometric Mean Fold Rise (GMFR) in pseudovirus neutralizing antibody titers (ID50) against the Omicron subvariant included in the vaccine formulation from pre-vaccination to 28 days post-vaccination. — Day 1 (pre-vaccination) and Day 29 (28 days after vaccination)
    Superior neutralizing antibody response is defined as a GMFR with a lower bound of the two-sided 95% confidence interval greater than 4.0 within each age cohort.

Trial sites (20)

FacilityCityRegionStatus
Site #: 8400005 Fair Oaks California Recruiting
Site #: 8400002 Doral Florida Recruiting
Site #: 8400008 Atlanta Georgia Recruiting
Site #: 8400015 Decatur Georgia Recruiting
Site #: 8400011 Melrose Park Illinois Recruiting
Site #: 8400019 Sioux City Iowa Recruiting
Site #: 8400009 Lenexa Kansas Recruiting
Site #: 8400001 Lafayette Louisiana Recruiting
Site #: 8400003 New Orleans Louisiana Recruiting
Site #: 8400024 Rockville Maryland Recruiting
Site #: 8400012 Southfield Michigan Recruiting
Site #: 8400023 Grand Island Nebraska Recruiting
Site #: 8400004 Omaha Nebraska Recruiting
Site #: 8400021 Omaha Nebraska Recruiting
Site #: 8400016 Cincinnati Ohio Recruiting
Site #: 8400007 Philadelphia Pennsylvania Recruiting
Site #: 8400018 Austin Texas Recruiting
Site #: 8400017 Frisco Texas Recruiting
Site #: 8400014 Houston Texas Recruiting
Site #: 8400013 Richmond Virginia Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07861542 on ClinicalTrials.gov ↗ ← All trials in the USA