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

Inoguchi Akihiro0 sites80 target enrollmentOctober 29, 2021

Overview

No summary available.

Registry

who.int

Start Date

October 29, 2021

End Date

TBD

Last Updated

2 years ago

Study Type

Interventional

Sex

All

Sponsor

Inoguchi Akihiro

•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.