Prevention of SARS-CoV and SARS-CoV-2 infections
Conditions
Interventions
Intramuscular injection of S-567123, placebo, COMIRNATY intramuscular injection (LP.8.1 variant) or NUVAXOVID intramuscular injection (LP.8.1 variant)
Sponsors
Gomez Juan Carlos
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: -Part 1 Participants aged 18 years or older and under 65 years, Part 2 Participants aged 65 years or older, at the time of signing the informed consent form. -Participant who was judged healthy by medical evaluation. -Participants who have completing the primary vaccination with an approved SARS-CoV-2 vaccine and have not received an approved SARS-CoV-2 vaccine since September 2025. -Participants with no infection history of SARS-CoV-2, or participants with infection history of SARS-CoV-2 who have not been infected since January 2025.
Exclusion criteria
Exclusion criteria: -Participants who had cardiovascular, respiratory, hepatic, renal, gastrointestinal, endocrine, hematological, or neurological disease that would be a risk when study interventions or confound data interpretation. -Participants who are positive SARS-CoV-2 infection (as determined by SARS-CoV-2 antigen test) before study administration on day1. -Participants who are positive for anti-SARS-CoV-2 N-protein antibody at the screening.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The incidence of adverse events (AEs), adverse reactions, serious AEs (SAEs), solicited AEs, medically attended adverse events (MAAEs), and AEs of special interest (AESIs), vital signs, laboratory evaluations, and electrocardiogram. | — |
Contacts
Public ContactCorporate Communications Department
Shionogi & Co., Ltd.
Outcome results
None listed