A Study of SARS-CoV-2 mRNA Vaccine (SYS6006) in Chinese Healthy Older Adults.
NCT05354063 · Status: UNKNOWN · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 40
Last updated 2023-05-24
Summary
This is a phase I, randomized, observer-blinded, placebo-controlled and dose-escalation clinical trial to evaluate the safety and preliminary immunogenicity of SARS-CoV-2 mRNA Vaccine (SYS6006) in Chinese healthy adults aged 60 years and over.
Conditions
Interventions
- BIOLOGICAL
-
20 μg dose of SYS6006
20 μg dose of SYS6006 vaccine IM on day 0 and day 21.
- BIOLOGICAL
-
30 μg dose of SYS6006
30 μg dose of SYS6006 vaccine IM on day 0 and day 21.
- DRUG
-
Placebo IM on day 0 and day 21.
Sponsors & Collaborators
-
CSPC ZhongQi Pharmaceutical Technology Co., Ltd.
lead INDUSTRY
Principal Investigators
-
Lanjuan Li · Shulan (Hangzhou) Hospital
-
Guiling Chen · Shulan (Hangzhou) Hospital
-
Xiang Lu · Sir Run Run Hosipital Nanjing Medical University
-
Yuwen Su · Sir Run Run Hosipital Nanjing Medical University
Study Design
- Allocation
- RANDOMIZED
- Purpose
- PREVENTION
- Masking
- TRIPLE
- Model
- PARALLEL
Eligibility
- Min Age
- 60 Years
- Sex
- ALL
- Healthy Volunteers
- Yes
Timeline & Regulatory
- Start
- 2022-06-01
- Primary Completion
- 2022-09-05
- Completion
- 2023-10-01
Countries
- China
Study Locations
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