Study of DS-5670a (COVID-19 Vaccine) in Japanese Healthy Adults and Elderly Subjects
NCT04821674 · Status: COMPLETED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 142
Last updated 2022-08-30
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.
Conditions
- Covid19
Interventions
- BIOLOGICAL
-
DS-5670a
DS-5670a (10, 30, 60 or 100 µg) administered as an intramuscular injection into the deltoid muscle of the upper arm; 2 injections total
- BIOLOGICAL
-
Placebo administered as an intramuscular injection into the deltoid muscle of the upper arm; 2 injections total
Sponsors & Collaborators
-
Daiichi Sankyo Co., Ltd.
lead INDUSTRY
Principal Investigators
-
Global Clinical Leader · Daiichi Sankyo
Study Design
- Allocation
- RANDOMIZED
- Purpose
- PREVENTION
- Masking
- TRIPLE
- Model
- PARALLEL
Eligibility
- Min Age
- 20 Years
- Max Age
- 74 Years
- Sex
- ALL
- Healthy Volunteers
- Yes
Timeline & Regulatory
- Start
- 2021-03-15
- Primary Completion
- 2021-08-13
- Completion
- 2022-07-14
Countries
- Japan
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