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

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

Age range

12+ years

Sex

All

Healthy volunteers

Yes

Interventions

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

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

Locations (20)