COVID-19 trials registries data warehouse

https://jrct.niph.go.jp/latest-detail/jRCT2051210151

Corporate Communications Department

shionogiclintrials-admin@shionogi.co.jp

2022-01-13

Not recruiting

RCT

Randomized

Parallel

Blind label

unclear

Prevention

Participant must be >= 18 years of age, at the time of signing the informed consent form (ICF).Male and femaleCapable of giving signed ICF which includes compliance with the requirements and restrictions listed in the ICF and in this protocol.

Current or history of a laboratory-confirmed diagnosis of SARS-CoV-2 infection or COVID-19.Unstable current cardiovascular, respiratory, hepatic, renal, gastrointestinal, endocrine, hematological, or neurological disease that, in the opinion of the investigator or subinvestigator, would constitute a safety concern or confound data interpretation.Immunosuppression (immunodeficiency, acquired immunodeficiency syndrome [AIDS], use of systemic steroids, use of immunosuppressants within the past 6 months prior to the first dose of study intervention, treatment for malignant tumors, other immunosuppressive therapy). Individuals considered to have hypersensitivity to any of the study interventions,or components thereof, or drug or other allergy that, in the opinion of the investigator or subinvestigator, contraindicates participation in the study (except for pollinosis and atopic dermatitis).Participant has a contraindication to intramuscular(IM) injections or blood draws.

2

Nagata Tsutae

18

100

Japan

Healthy volunteers

N/A

1000

SARS-CoV-2 neutralizing antibody (NAb) titer at 28 days following the second vaccination

Phase 3

[{"arm_notes": " booster 13 weeks after the second dose", "treatment_id": 1139, "treatment_name": "S-268019", "treatment_type": "Protein subunit", "pharmacological_treatment": "Vaccine"}, {"arm_notes": " booster 26 weeks after the second dose", "treatment_id": 1139, "treatment_name": "S-268019", "treatment_type": "Protein subunit", "pharmacological_treatment": "Vaccine"}]