Dec. 28, 2021 |
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Sept. 06, 2023 |
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jRCT2071210106 |
A Randomized, Active-comparator, Observer-blind, Phase I/II/III Study to Demonstrate the Immunogenicity of a Single Booster Dose of DS-5670a in Adults and Elderly Received a Primary Series of Approved COVID-19 Vaccine |
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A Randomized, Active-comparator, Observer-blind, Phase I/II/III Study to Demonstrate the Immunogenicity of a Single Booster Dose of DS-5670a in Adults and Elderly Received a Primary Series of Approved COVID-19 Vaccine |
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 |
Jan. 31, 2022 |
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Jan. 31, 2022 | ||
5028 | ||
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)Adults aged 18 to 64 years at the time of consent, or elderly subjects aged 65 years or older at the time of consent. |
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1)Subjects who have a history of seizure or epilepsy after vaccination. |
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18age old over | ||
No limit | ||
Both |
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Prevention of infectious disease by SARS-CoV-2 |
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A intramuscular injection of DS-5670a (10, 30 or 60 ug) , placebo, Comirnaty, or Spikevax once in total |
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Efficasy: Geometric mean fold rise (GMFR) of neutralizing antibody titer against SARS-CoV-2 in blood after 4 weeks (Day 29) of treatment with the study drug |
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Efficacy: |
DAIICHI SANKYO Co.,Ltd. |
Ministry of Health, Labour and Welfare | |
Not applicable |
Hakata Clinic Institutional Review Board | |
6-18, Tenyamachi, Hakata-ku, Fukuoka-shi, Fukuoka | |
+81-92-283-7701 |
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Approval | |
No |
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none |