Recruiting
Phase 4

Nuvaxovid

Sponsor:

Sanofi

Code:

NCT07861542

Conditions

COVID-19

Eligibility Criteria

Sex: All

Age: 12+

Healthy Volunteers: Accepted

Interventions

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

Study Details

Brief 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).

Conditions

COVID-19

Study ID

NCT07861542

Start date

Oct 1, 2026

Status verified date

Oct, 2026

Completion date

Jan 27, 2027

Anticipated

Primary completion date

Nov 26, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 12+

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.

Study Design

Enrollment

660 participants

Anticipated

Intervention Model

Single group

Primary purpose

Prevention

Interventions and Outcome Measures

Arms

experimental: Nuvaxovid

Participants will receive a single intramuscular injection of Nuvaxovid on Day 1

Interventions

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

Pharmaceutical form: Sterile suspension for injection Route of administration: Intramuscular injection

Primary outcome measure

  • 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. [ Time Frame: Day 1 (pre-vaccination) and Day 29 (28 days after vaccination) ]

Central Contacts and Locations

Central contacts

Trial Transparency email recommended (Toll free number for US & Canada)

800-633-1610contact-us@sanofi.com

Locations

Site #: 8400005

Recruiting

Fair Oaks, California, United States, 95628

Site #: 8400002

Recruiting

Doral, Florida, United States, 33172

Site #: 8400008

Recruiting

Atlanta, Georgia, United States, 30329

Site #: 8400015

Recruiting

Decatur, Georgia, United States, 30030

Site #: 8400011

Recruiting

Melrose Park, Illinois, United States, 60160

Site #: 8400019

Recruiting

Sioux City, Iowa, United States, 51106

Site #: 8400009

Recruiting

Lenexa, Kansas, United States, 66219

Site #: 8400001

Recruiting

Lafayette, Louisiana, United States, 70508

Site #: 8400003

Recruiting

New Orleans, Louisiana, United States, 70115

Site #: 8400024

Recruiting

Rockville, Maryland, United States, 20854

Site #: 8400012

Recruiting

Southfield, Michigan, United States, 48076

Site #: 8400023

Recruiting

Grand Island, Nebraska, United States, 68803

Site #: 8400004

Recruiting

Omaha, Nebraska, United States, 68114

Site #: 8400021

Recruiting

Omaha, Nebraska, United States, 68134

Site #: 8400016

Recruiting

Cincinnati, Ohio, United States, 45219

Site #: 8400007

Recruiting

Philadelphia, Pennsylvania, United States, 19107

Site #: 8400018

Recruiting

Austin, Texas, United States, 78750

Site #: 8400017

Recruiting

Frisco, Texas, United States, 75033

Site #: 8400014

Recruiting

Houston, Texas, United States, 77065

Site #: 8400013

Recruiting

Richmond, Virginia, United States, 23226

More Information

Sponsor

Sanofi

Last update posted

Oct 15, 2026

Last verified

Oct, 2026

Keywords

  • NUVAXOVID
  • COVID-19
  • SARS-CoV-2 Infection

Trial information was received from ClinicalTrials.gov and was last updated on 2026-10-16. This information was provided to ClinicalTrials.gov by Sanofi on 2026-10-15. Recruitment status is synced daily from ClinicalTrials.gov and may not reflect the sponsor's current status. Confirm during your call.