Evaluation of Immunogenicity, Safety and Antibody Persistence of COVID-19 Booster Vaccine (Produced in Beijing) in Patients With Hypertension and/or Diabetes
NCT05104333 · Status: UNKNOWN · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 1440
Last updated 2021-11-03
Summary
To evaluate the post-marketing immunogenicity, safety and antibody persistence of the third dose (booster) of Covid-19 vaccine in patients aged 60 years or older with hypertension and/or diabetes.
Conditions
Interventions
- BIOLOGICAL
-
Covid-19 vaccine (0-1-4 schedule)
Subjects receive the booster vaccine 3 months after the second dose.
- BIOLOGICAL
-
Covid-19 vaccine (0-1-6 schedule)
Subjects receive the booster vaccine 5 months after the second dose.
Sponsors & Collaborators
-
Guizhou Center for Disease Control and Prevention
collaborator OTHER -
Hunan Provincial Center for Disease Control and Prevention
collaborator OTHER -
Center for Disease Control and Prevention, Fujian
collaborator OTHER -
Beijing Institute of Biological Products Co Ltd.
collaborator INDUSTRY -
China National Biotec Group Company Limited
lead INDUSTRY
Study Design
- Allocation
- NON_RANDOMIZED
- Purpose
- PREVENTION
- Masking
- SINGLE
- Model
- PARALLEL
Eligibility
- Min Age
- 60 Years
- Sex
- ALL
- Healthy Volunteers
- Yes
Timeline & Regulatory
- Start
- 2021-11-30
- Primary Completion
- 2022-11-30
- Completion
- 2022-12-31
Countries
- China
Study Locations
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