Study of a Recombinant Spike COVID-19 Vaccine With Matrix-M in Older Adults and People at Increased Risk of Severe COVID-19
Condition(s) studied
Investigational drug(s) / intervention(s)
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
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)
| Facility | City | Region | Status |
|---|---|---|---|
| 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 |
More Sanofi trials in the USA
Other trials for the same condition
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