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

Inoguchi Akihiro0 个研究点目标入组 80 人开始时间: 2021年10月29日最近更新: 2023年10月17日

试验速览

暂无简介。

•1) Japanese
•2) Healthy adults aged >=20 and <65 years at the time of informed consent (Part 1 and Part 2)
•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
•5) Subjects who received DS-5670a 60 ug twice intramuscularly in Part 1 or Part 2 of this study and 6 months have passed (3rd administration part)

•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 anaphylaxis such as systemic rash within 2 days after past vaccination.

发起方

Inoguchi Akihiro