Clinical Trial on Sequential Immunization of Recombinant COVID-19 Vaccine (CHO Cells) and Inactivated COVID-19 Vaccine (Vero Cells) in Population Aged 18 Years and Above
NCT05033847 · Status: UNKNOWN · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 1800
Last updated 2023-02-02
Summary
This is randomized, blinded and controlled design. Among the randomly selected subjects who have been vaccinated with two doses of Inactivated COVID-19 vaccine (Vero cell), based on a step-wise approach, the subjects will receive one dose of recombinant COVID-19 vaccine sequentially at different shedules of 1-3 months, 3-6 months and ≥ 6 months after two doses of vaccination, and the subjects vaccinated at different schedules will be randomly assigned to different sequential immunization groups. At the same time, each sequential immunization group will be matched with a control group with the inactivated COVID-19 vaccine (vero cells) as the booster dose.
Conditions
- COVID-19 Pneumonia
- Coronavirus Infections
Interventions
- BIOLOGICAL
-
Recombinant COVID-19 Vaccine (CHO cell)
Intramuscular injection of Recombinant COVID-19 Vaccine (CHO cell) in the deltoid muscle of the upper arm
- BIOLOGICAL
-
COVID-19 vaccine (Vero cells)
Intramuscular injection of Recombinant COVID-19 vaccine (Vero cells) in the deltoid muscle of the upper arm
Sponsors & Collaborators
-
China National Biotec Group Company Limited
collaborator INDUSTRY -
Lanzhou Institute of Biological Products Co., Ltd
collaborator INDUSTRY -
National Vaccine and Serum Institute, China
lead INDUSTRY
Study Design
- Allocation
- RANDOMIZED
- Purpose
- PREVENTION
- Masking
- DOUBLE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- Yes
Timeline & Regulatory
- Start
- 2021-09-12
- Primary Completion
- 2023-11-30
- Completion
- 2024-01-31
Countries
- United Arab Emirates
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