COVID-19 trials registries data warehouse

https://jrct.niph.go.jp/latest-detail/jRCT2031220063

Corporate Communications Department -

shionogiclintrials-admin@shionogi.co.jp

2022-05-17

Recruiting

RCT

Randomized

Parallel

Blind label

unclear

Prevention

Participant aged 12 to 19 years, at the time of signing the informed consent form (ICF).Male and femaleCapable of giving signed ICF from participants, minor participants and parent(s) or legal guardian as stated in the protcol, which includes compliance with the requirements and restrictions listed in the ICF and in the protocol.

Tested positive SARS-CoV-2 infection (as determined by SARS-CoV-2 antigen test) at Screening.Determined in the interview prior to the study intervention to have a history of SARS-CoV-2 infection.Current history of poorly controlled 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.Immunosuppressed (immunocompromised, having acquired immunodeficiency syndrome [AIDS], having received steroids and having received systemic immunosuppressants within 6 months prior to the first dose of study intervention, being treated for malignant tumors, being on 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

12

19

Japan

Healthy volunteers

N/A

350

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

Phase 2/Phase 3

[{"arm_notes": "", "treatment_id": 222, "treatment_name": "Bnt162b2", "treatment_type": "Rna based vaccine", "pharmacological_treatment": "Vaccine"}, {"arm_notes": "", "treatment_id": 1139, "treatment_name": "S-268019", "treatment_type": "Protein subunit", "pharmacological_treatment": "Vaccine"}]