A Preliminary Exploratory Cohort Study of COVID-19 mRNA Vaccine, Bivalent in Participants Aged 18 Years and Over in China
NCT05547256 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 54
Last updated 2023-02-14
Summary
This is a preliminary exploratory cohort study to evaluate safety, tolerability and immunogenicity of COVID-19 mRNA Vaccine, Bivalent (LVRNA021) in participants Aged 18 years and over in China
Conditions
Interventions
- BIOLOGICAL
-
COVID-19 Variant (Omicron BA.5) mRNA Vaccine Low dose
50μg/dose
- BIOLOGICAL
-
COVID-19 Variant (Omicron BA.5) mRNA Vaccine High dose
100μg/dose
- DRUG
-
Saline solution
Sponsors & Collaborators
-
Ningbo Rongan Biological Pharmaceutical Co., Ltd.
collaborator INDUSTRY -
The First Affiliated Hospital of Bengbu Medical University
collaborator OTHER -
AIM Vaccine Co., Ltd.
lead INDUSTRY
Principal Investigators
-
Huan Zhou · The First Affiliated Hospital of Bengbu Medical University
-
Qiang Wu · The First Affiliated Hospital of Bengbu Medical University
Study Design
- Allocation
- RANDOMIZED
- Purpose
- PREVENTION
- Masking
- DOUBLE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- Yes
Timeline & Regulatory
- Start
- 2022-09-13
- Primary Completion
- 2022-12-05
- Completion
- 2024-03-31
Countries
- China
Study Locations
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