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).
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.
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.
Single group
Omicron Subvariant-Based SARS-CoV-2 Recombinant Spike Vaccine Adjuvanted With Matrix-M
Biological/VaccinePharmaceutical form: Sterile suspension for injection Route of administration: Intramuscular injection
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.
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.
Geometric Mean Titers (GMTs) of Pseudovirus Neutralizing Antibodies Against the Omicron Subvariant Included in the Vaccine Formulation
Pseudovirus neutralizing antibody responses against the Omicron subvariant included in the vaccine formulation will be measured as geometric mean titers (GMTs).
Seroresponse Rate (SRR) in Pseudovirus Neutralizing Antibody Titers Against the Omicron Subvariant Used in the Vaccine Formulation
Seroresponse is defined as a pre-vaccination antibody titer below the lower limit of quantitation (LLOQ) and a post-vaccination antibody titer ≥ 4 × LLOQ; at least a 4-fold rise when the pre-vaccination titer is ≥ LLOQ and \< 4 × LLOQ; or at least a 2-fold rise when the pre-vaccination titer is ≥ 4 × LLOQ.
Presence of Immediate Adverse Events (AEs)
Number of participants reporting immediate adverse events within 30 minutes following study vaccination.
Presence of Solicited Injection Site Reactions
Number of participants reporting solicited injection site reactions during the 8-day period including the day of vaccination.
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