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

Sanofi

Status and phase

Enrolling

Phase 4

Conditions

COVID-19

Treatments

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

Study type

Interventional

Funder types

Industry

Identifiers

NCT07861542

U1111-1339-2475 (Other Identifier)

VBV19172

Details and patient eligibility

About

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).

Enrollment

660 estimated patients

Sex

All

Ages

12+ years old

Volunteers

Accepts Healthy Volunteers

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.