Study of a Recombinant Spike COVID-19 Vaccine With Matrix-M in Older Adults and People at Increased Risk of Severe COVID-19
Public ClinicalTrials.gov record NCT07861542. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
A Phase 4 Open-label, Single-arm Study to Evaluate the Safety and Immunogenicity of an Omicron Subvariant-based SARS-CoV-2 Recombinant Spike (rS) Vaccine Adjuvanted With Matrix-M in Participants ≥ 65 Years of Age and Participants 12 Through 64 Years of Age Who Are at Increased Risk for Severe COVID-19 Illness
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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).
Study identification
- NCT ID
- NCT07861542
- Recruitment status
- Recruiting
- Study type
- Interventional
- Phase
- Phase 4
- Enrollment
- 660 participants
Conditions and interventions
Conditions
Interventions
Biological
Eligibility (public fields only)
- Age range
- 12 Years and older
- Sex
- All
- Healthy volunteers
- Accepts healthy volunteers
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Oct 1, 2026 (Actual)
- Primary completion
- Nov 26, 2026 (Estimated)
- Completion
- Jan 27, 2027 (Estimated)
- Last update posted
- Oct 15, 2026
2026 – 2027
United States locations
- U.S. sites
- 20
- U.S. states
- 14
- U.S. cities
- 19
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Site #: 8400005 | Fair Oaks | California | 95628 | Recruiting |
| Site #: 8400002 | Doral | Florida | 33172 | Recruiting |
| Site #: 8400008 | Atlanta | Georgia | 30329 | Recruiting |
| Site #: 8400015 | Decatur | Georgia | 30030 | Recruiting |
| Site #: 8400011 | Melrose Park | Illinois | 60160 | Recruiting |
| Site #: 8400019 | Sioux City | Iowa | 51106 | Recruiting |
| Site #: 8400009 | Lenexa | Kansas | 66219 | Recruiting |
| Site #: 8400001 | Lafayette | Louisiana | 70508 | Recruiting |
| Site #: 8400003 | New Orleans | Louisiana | 70115 | Recruiting |
| Site #: 8400024 | Rockville | Maryland | 20854 | Recruiting |
| Site #: 8400012 | Southfield | Michigan | 48076 | Recruiting |
| Site #: 8400023 | Grand Island | Nebraska | 68803 | Recruiting |
| Site #: 8400004 | Omaha | Nebraska | 68114 | Recruiting |
| Site #: 8400021 | Omaha | Nebraska | 68134 | Recruiting |
| Site #: 8400016 | Cincinnati | Ohio | 45219 | Recruiting |
| Site #: 8400007 | Philadelphia | Pennsylvania | 19107 | Recruiting |
| Site #: 8400018 | Austin | Texas | 78750 | Recruiting |
| Site #: 8400017 | Frisco | Texas | 75033 | Recruiting |
| Site #: 8400014 | Houston | Texas | 77065 | Recruiting |
| Site #: 8400013 | Richmond | Virginia | 23226 | Recruiting |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT07861542, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Oct 15, 2026 · Synced Oct 15, 2026
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Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT07861542 live on ClinicalTrials.gov.