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May. 07, 2021

Jan. 08, 2022

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

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

DAIICHI SANKYO Co.,Ltd.

1-2-58, Hiromachi, Shinagawa-ku, Tokyo

+81-3-6225-1111

dsclinicaltrial@daiichisankyo.co.jp

Contact for Clinical Trial Information

DAIICHI SANKYO Co.,Ltd.

1-2-58, Hiromachi, Shinagawa-ku, Tokyo

+81-3-6225-1111

dsclinicaltrial@daiichisankyo.co.jp

Complete

May. 20, 2021

June. 11, 2021
48

Interventional

randomized controlled trial

double blind

placebo control

parallel assignment

prevention purpose

1. Japanese healthy subjects.
2. Age >=20 and <=50 years upon providing informed consent at step1 or Age >=65 and <=80 years upon providing informed consent at step2.
3. Body mass index (BMI) >=18.0 and <30.0 kg/m2 at screening.

1. Subjects with a history of anaphylaxis or severe allergies due to food, medicine, insect bites, cosmetics, or vaccination
2. Having alcohol or drug dependence etc.

20age old over
80age old under

Both

Prevention of respiratory syncytial virus

VN-0200 (antigen: VAGA-9001a, adjuvant: MABH-9002b) or placebo 0.5 mL is administered twice on Day 1 and Day 29.

Safety:Adverse events, specific adverse events, Potential Immune-Mediated Disease, laboratory data, body weight, vital signs and 12-lead ECGs,

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

Approval

No

none

History of Changes

No Publication date
4 Jan. 08, 2022 (this page) Changes
3 Nov. 01, 2021 Detail Changes
2 June. 22, 2021 Detail Changes
1 May. 07, 2021 Detail