Aug. 10, 2022 |
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July. 21, 2023 |
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jRCT2031220264 |
A Phase 3, Randomized, Active-Comparator, Observer-Blind, Non-Inferiority Study of DS-5670a (COVID-19 Vaccine) in Adults Aged 18 Years and Older |
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A Phase 3, Randomized, Active-Comparator, Observer-Blind, Non-Inferiority Study of DS-5670a in Adults Aged 18 Years and Older |
Inoguchi Akihiro |
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DAIICHI SANKYO Co.,Ltd. |
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1-2-58, Hiromachi, Shinagawa-ku, Tokyo |
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+81-3-6225-1111 |
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dsclinicaltrial@daiichisankyo.co.jp |
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Contact for Clinical Trial Information |
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DAIICHI SANKYO Co.,Ltd. |
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1-2-58, Hiromachi, Shinagawa-ku, Tokyo |
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+81-3-6225-1111 |
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dsclinicaltrial@daiichisankyo.co.jp |
Complete |
Sept. 01, 2022 |
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Sept. 01, 2022 | ||
420 | ||
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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1)Healthy adults >= 18 years of age at the time of consent |
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1)Known medical history of convulsion or seizure epilepsy due to vaccination. |
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18age old over | ||
No limit | ||
Both |
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Prevention of infectious disease by Severe acute respiratory syndrome coronavirus 2(SARS-CoV-2) |
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A intramuscular injection of DS-5670a or Comirnaty twice in total |
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Geometric mean titer (GMT) and seroconversion rate of serum neutralizing activity against SARS-CoV-2 4 weeks after the second dose of the study drug (Day 57) |
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Efficacy: |
DAIICHI SANKYO Co.,Ltd. |
Ministry of Health, Labour and Welfare | |
Not applicable |
Tokushukai Group Institutional Review Board | |
1-8-7, Koji-machi, Chiyoda-ku, Tokyo | |
+81-3-3263-4801 |
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irb@mirai-iryo.com | |
Approval | |
No |
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none |