JRCT ID: jRCT2031220063
Registered date:17/05/2022
A Phase 2/3 Study of S-268019 in Participants Aged 12 to 19 Years(COVID-19)
Basic Information
Recruitment status | Not Recruiting |
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Health condition(s) or Problem(s) studied | Prevention of COVID-19 |
Date of first enrollment | 14/05/2022 |
Target sample size | 350 |
Countries of recruitment | |
Study type | Interventional |
Intervention(s) | S-268019 or COMIRNATY (intramuscular injection) |
Outcome(s)
Primary Outcome | Priming vaccination part SARS-CoV-2 neutralizing antibody (NAb) titer at 28 days following the second vaccination Booster vaccination part SARS-CoV-2 neutralizing antibody (NAb) titer at 28 days following the third vaccination |
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Secondary Outcome |
Key inclusion & exclusion criteria
Age minimum | >= 12age old |
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Age maximum | < 20age old |
Gender | Both |
Include criteria | Participant aged 12 to 19 years, at the time of signing the informed consent form (ICF). Male and female Capable 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. |
Exclude criteria | 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. |
Related Information
Primary Sponsor | Nagata Tsutae |
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Secondary Sponsor | |
Source(s) of Monetary Support | Ministry of Health, Labour and Welfare |
Secondary ID(s) |
Contact
Public contact | |
Name | Corporate Communications Department - - |
Address | 1-8, Doshomachi 3-chome, Chuo-ku, Osaka, Osaka Osaka Japan 541-0045 |
Telephone | +81-6-6209-7885 |
shionogiclintrials-admin@shionogi.co.jp | |
Affiliation | Shionogi & Co., Ltd. |
Scientific contact | |
Name | Tsutae Nagata |
Address | 1-8, Doshomachi 3-chome, Chuo-ku, Osaka, Osaka Osaka Japan 541-0045 |
Telephone | +81-6-6209-7885 |
shionogiclintrials-admin@shionogi.co.jp | |
Affiliation | Shionogi & Co., Ltd. |