Prevention of infectious disease caused by SARS-CoV-2
Conditions
Interventions
S-268019 0.5 mL or Placebo, intramuscular injection in the upper arm for a total of two doses.
Of the participants assigned to the S-268019 group, S-268019 0.5 mL is injected intramuscularly once to
Sponsors
Nagata Tsutae
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: A person with Japanese parents. Apparently healthy as determined by medical assessment. Participant must be 20 to 64 years of age inclusive, at the time of signing the informed consent form (ICF).
Exclusion criteria
Exclusion criteria: Positive SARS-CoV-2 antigen test result at Screening or before the first vaccination on Visit 1 (Day 1) . 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 Body temperature higher than 37.5 degree Celsius on Day 1 before the vaccination. Positive SARS-CoV-2 antibody test result at Screening or a known history of SARS-CoV-2 infection by medical consultation on Day 1 before the vaccination Past use of vaccines approved or under development related to SARS-CoV-2 prior to the first vaccination. Past use of immunosuppressive drug within 6 months prior to the first vaccination. 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).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The incidence of adverse events (AEs), adverse reactions, serious AEs (SAEs), solicited AEs, vital signs, laboratory tests, ECG | — |
Contacts
Public ContactCorporate Communications Department
Shionogi & Co., Ltd.
Outcome results
None listed