COVID-19 trials registries data warehouse

https://jrct.niph.go.jp/latest-detail/jRCT2031210269

Corporate Communications Department

shionogiclintrials-admin@shionogi.co.jp

2021-08-23

Not recruiting

RCT

Randomized

Parallel

Blind label

unclear

Prevention

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).

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 efficacyBody 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 vaccinationPast 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).

2

Nagata Tsutae

20

64

Japan

Healthy volunteers

N/A

60

The incidence of adverse events (AEs); adverse reactions; serious AEs (SAEs); solicited AEs; vital signs; laboratory tests; ECG

Phase 1/Phase 2

[{"arm_notes": "No information on doses", "treatment_id": 1139, "treatment_name": "S-268019", "treatment_type": "Protein subunit", "pharmacological_treatment": "Vaccine"}, {"arm_notes": "", "treatment_id": 2187, "treatment_name": "Placebo", "treatment_type": "Placebo", "pharmacological_treatment": "Placebo"}]