COVID-19
Conditions
Interventions
S-268019 (intramuscular injection), Placebo (intramuscular injection)
Sponsors
Nagata Tsutae
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: "Phase 1 Part-A: -A person with Japanese nationality. -Participant must be 20 to 64 years of age inclusive, at the time of signing the informed consent form (ICF). -Apparently healthy as determined by medical assessment. -Body mass index (BMI) within the range 18.5 to 25.0 (inclusive) at Screening. Phase 1 Part-B: -A person with Japanese nationality. -Participant must be 65 years of age or above, at the time of signing the ICF. -BMI within the range 18.5 to 30.0 (inclusive) at Screening. Phase 1 Part-C: -A person with Japanese nationality. -Participant must be 20 to 64 years of age inclusive, at the time of signing the informed consent form (ICF). -Apparently healthy as determined by medical assessment. -BMI within the range 18.5 to 30.0 (inclusive) at Screening. Phase 2 Part: -A person with Japanese nationality. -Participant must be 20 to 64 years of age inclusive, at the time of signing the ICF. -BMI within the range 18.5 to 30.0 (inclusive) at Screening. et, al."
Exclusion criteria
Exclusion criteria: Common to Phase 1 Part-A, Phase 1 Part-B, Phase 1 Part-C, and Phase 2 Part: -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 -Body temperature higher than 37.5 degree Celsius on Day 1 before the vaccination. -Past use of vaccines related to SARS-CoV-2 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). Phase 1 Part-A and Phase 1 Part-C: -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 immunosuppressive drug within 6 months prior to the first vaccination. The following applies to Phase 1 Part-B and Phase 2 Part: -Immunosuppressed state [immunocompromised, with acquired immunodeficiency syndrome (AIDS), receiving systemic steroid or immunosuppressive drugs, being treated for malignancy or receiving other immunosuppressive therapy]. et, al.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Phase 1 Part-A, Phase 1 Part-B, and Phase 1 Part-C: -The incidence of adverse events (AEs), adverse reactions, serious AEs (SAEs), solicited local reactogenicity AEs, and solicited systemic reactogenicity AEs Phase 2 Part: -Geometric mean titer (GMT) of SARS-CoV-2 neutralizing antibody titer | — |
Contacts
Public ContactCorporate Communications Department
Shionogi & Co., Ltd.
Outcome results
None listed