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Mar. 10, 2021

Sept. 02, 2022

jRCT2071200110

A Phase 1/2 study to assess the safety, immunogenicity and recommended dose of DS-5670a (COVID-19 Vaccine) in Japanese healthy adults and elderly subjects

A Phase 1/2 study to assess the safety, immunogenicity and recommended dose of DS-5670a 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

Mar. 12, 2021

Mar. 15, 2021
152

Interventional

randomized controlled trial

double blind

placebo control

parallel assignment

prevention purpose

1) Japanese
2) Healthy adults aged >=20 and <65 years, or healthy elderly aged >=65 and <75 years (at the time of informed consent)
3) Body Mass Index (BMI) is >=17.5 and <30.0 kg/m^2 (at screening )
4) Subjects who can follow the compliance requirements during clinical trials, undergo medical examinations and tests specified by the protocol, and report symptoms, etc.

1) Having a history of anaphylaxis or severe allergies due to food, cosmetics, medicines, or vaccination.
2) Having alcohol or drug dependence.
3) Having a history of immunodeficiency or having a close relative with congenital immunodeficiency.
4) Having a history of SARS-CoV-2 infection.
5) Having fever of >=39.0 C or symptoms of suspected allergies such as systemic rash within 2 days after past vaccination.
etc.

20age old over
75age old not

Both

Prevention of COVID-19

A intramuscular injection of DS-5670a (10, 30, 60 or 100 ug) or placebo twice in total.

- Safety: Adverse events, specific adverse events, laboratory data, weight, vital signs and 12-lead ECGs
- Immunogenicity: Neutralizing antibodies against SARS-CoV-2 levels in blood

- Immunogenicity: Anti-IgG levels in blood
- Pharmacokinetics: Plasma concentration of MAFB-7566a and constituent lipids of LNP

DAIICHI SANKYO Co.,Ltd.
Japan Agency for Medical Research and Development
Not applicable
Hakata Clinic Institutional Review Board
6-18, Tenyamachi, Hakata-ku, Fukuoka-shi, Fukuoka

+81-92-283-7701

Approval

No

none

History of Changes

No Publication date
4 Sept. 02, 2022 (this page) Changes
3 July. 09, 2021 Detail Changes
2 Mar. 26, 2021 Detail Changes
1 Mar. 10, 2021 Detail