May. 17, 2022 |
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Dec. 25, 2022 |
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jRCT2031220063 |
A Phase 2/3, Randomized, Observer-Blind, Active-Controlled Study to Evaluate the Immunogenicity and Safety of S-268019 in Participants Aged 12 to 19 Years (COVID-19) |
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A Phase 2/3 Study of S-268019 in Participants Aged 12 to 19 Years(COVID-19) |
Nagata Tsutae |
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Shionogi & Co., Ltd. |
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1-8, Doshomachi 3-chome, Chuo-ku, Osaka, Osaka |
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+81-6-6209-7885 |
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shionogiclintrials-admin@shionogi.co.jp |
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- - Corporate Communications Department |
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Shionogi & Co., Ltd. |
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1-8, Doshomachi 3-chome, Chuo-ku, Osaka, Osaka |
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+81-6-6209-7885 |
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shionogiclintrials-admin@shionogi.co.jp |
Not Recruiting |
May. 14, 2022 |
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350 | ||
Interventional |
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randomized controlled trial |
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double blind |
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active control |
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parallel assignment |
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prevention purpose |
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Participant aged 12 to 19 years, at the time of signing the informed consent form (ICF). |
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Tested positive SARS-CoV-2 infection (as determined by SARS-CoV-2 antigen test) at Screening. |
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12age 0month 0week old over | ||
20age 0month 0week old not | ||
Both |
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Prevention of COVID-19 |
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S-268019 or COMIRNATY (intramuscular injection) |
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Priming vaccination part |
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Shionogi & Co., Ltd. |
Ministry of Health, Labour and Welfare | |
Not applicable |
Nihonbashi Sakura Clinic IRB | |
5F, Inamura Building, 1-9-2, Nihonbashikayabacho, Chuo-ku, Tokyo | |
+81-3-6661-9061 |
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c-irb_ug@neues.co.jp | |
Approval | |
No |
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none |