Status:
COMPLETED
Study of DS-5670a (COVID-19 Vaccine) in Japanese Healthy Adults and Elderly Subjects
Lead Sponsor:
Daiichi Sankyo Co., Ltd.
Conditions:
Covid19
Eligibility:
All Genders
20-74 years
Phase:
PHASE1
PHASE2
Brief Summary
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.
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
March 15 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 14 2022
Estimated Enrollment :
142 Patients enrolled
Trial Details
Trial ID
NCT04821674
Start Date
March 15 2021
End Date
July 14 2022
Last Update
August 30 2022
Active Locations (1)
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1
SOUSEIKAI Hakata Clinic
Hakata, Fukuoka, Japan, 812-0025