May. 07, 2021 |
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Jan. 08, 2022 |
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jRCT2031210069 |
A Phase 1 study to assess the safety, tolerability, and immunogenicity of VN-0200 after intramuscular injection in Japanese healthy adults and elderly subjects |
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A Phase 1 study to assess the safety, tolerability, and immunogenicity of VN-0200 after intramuscular injection in Japanese healthy adults and elderly subjects |
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 |
May. 20, 2021 |
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June. 11, 2021 | ||
48 | ||
Interventional |
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randomized controlled trial |
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double blind |
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placebo control |
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parallel assignment |
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prevention purpose |
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1. Japanese healthy subjects. |
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1. Subjects with a history of anaphylaxis or severe allergies due to food, medicine, insect bites, cosmetics, or vaccination |
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20age old over | ||
80age old under | ||
Both |
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Prevention of respiratory syncytial virus |
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VN-0200 (antigen: VAGA-9001a, adjuvant: MABH-9002b) or placebo 0.5 mL is administered twice on Day 1 and Day 29. |
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Safety:Adverse events, specific adverse events, Potential Immune-Mediated Disease, laboratory data, body weight, vital signs and 12-lead ECGs, |
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Geometric Mean Fold Rise (GMFR) of Anti-RSV Specific Neutralizing activity, Geometric Mean Titer (GMT) of anti-VAGA-9001a IgG, GMT of anti-RSV G IgG, VAGA-9001a-specific IFN-gamma production |
DAIICHI SANKYO Co.,Ltd. |
Japan Science and Technology Agency | |
Not applicable |
Institutional Review Board of Medical Corporation Shinanokai, Shinanozaka Clinic | |
20 Samoncho, Shinjyuku-ku, Tokyo | |
+81-3-5366-3006 |
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Approval | |
No |
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none |