COVID-19 trials registries data warehouse

https://jrct.niph.go.jp/latest-detail/jRCT2031210383

Corporate Communications Department -

shionogiclintrials-admin@shionogi.co.jp

2021-10-20

Not recruiting

nonRCT

Non-randomized

Single group assignment

Open label

unclear

Prevention

Participant must be >= 20 years of age inclusive, at the time of signing the informed consent.Male and femaleCapable of giving signed informed consent which includes compliance with the requirements and restrictions listed in the ICF and in this protocol.

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 efficacyImmunosuppressed 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.

1

Nagata Tsutae

20

100

Japan

Healthy volunteers

N/A

3100

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

Phase 2/Phase 3

[{"arm_notes": "", "treatment_id": 1139, "treatment_name": "S-268019", "treatment_type": "Protein subunit", "pharmacological_treatment": "Vaccine"}]