Study 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 (COVID-19 Vaccine) in Japanese Healthy Adults and Elderly Subjects

This study will assess the safety, tolerability and immunogenicity of DS-5670a (COVID-19 Vaccine) and determine the recommended dose in Japanese healthy adults and elderly participants.

Inclusion Criteria:

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

Exclusion Criteria:

• Have a history of immunodeficiency or having a close relative with congenital immunodeficiency.
• Have a history of SARS-CoV-2 infection.
• Have previously participated in an investigational study of SARS-Cov-2 vaccine or involving LNPs.
• Have a history of anaphylaxis or severe allergies due to food, cosmetics, medicines, or vaccination
• Have alcohol or drug dependence.
• Have a fever of ≥39.0°C or symptoms of suspected allergies such as systemic rash within 2 days after past vaccination, etc.