Prevention of COVID-19
Conditions
Interventions
S-268019 0.5 mL, intramuscular injection in the upper arm for a total of two doses.
S-268019 0.5 mL is injected intramuscularly once to the participants who wish to receive the third vaccination.
Sponsors
Nagata Tsutae
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Participant must be >= 20 years of age inclusive, at the time of signing the informed consent. Male and female Capable of giving signed informed consent which includes compliance with the requirements and restrictions listed in the ICF and in this protocol.
Exclusion criteria
Exclusion criteria: Positive SARS-CoV-2 antigen test result at Screening. Presence of cardiovascular, respiratory, hepatic, renal, gastrointestinal, endocrinological, hematological, or neurological disorders that, in the opinion of the investigator/subinvestigator, will lead to a safety issue or interfere with the assessment of efficacy Immunosuppressed state [immunocompromised, with acquired immunodeficiency syndrome (AIDS), receiving systemic steroid or immunosuppressive drugs within 6 months prior to the first dose of study intervention, being treated for malignancy or receiving other immunosuppressive therapy]. Hypersensitivity to any of the study drugs, or components thereof, or drug or other allergy that, in the opinion of the investigator/subinvestigator, contraindicates participation in the study (except pollinosis and atopic dermatitis). Participant has a contraindication to IM injections or blood draws. et, al.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The incidence of adverse events/adverse reactions/serious adverse events/solicited adverse events/medically attended adverse events/adverse event of special interest. SARS-CoV-2 neutralizing antibody titer on Day 239 | — |
Contacts
Public ContactCorporate Communications Department -
Shionogi & Co., Ltd.
Outcome results
None listed