Clinical Trial of SARS-CoV-2 Vaccine (Vero Cells), Inactivated in Healthy Population Aged 3 to 17 Years(COVID-19)
NCT05003479 · Status: UNKNOWN · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 84
Last updated 2021-08-18
Summary
This study is a randomized, double-blinded, and placebo controlled phase Ⅰ clinical trial of the SARS-CoV-2 inactivated vaccine to evaluate the safety and immunogenicity of the experimental vaccine in healthy population aged 3 to 17 years.
Conditions
Interventions
- BIOLOGICAL
-
SARS-CoV-2 Vaccine (Vero Cells), Inactivated
2 doses of SARS-CoV-2 Vaccine (Vero Cells), Inactivated should be administered as an intramuscular injection into the lateral deltoid of the upper arm with a 28-day interval.
- BIOLOGICAL
-
2 doses of Placebo should be administered as an intramuscular injection into the lateral deltoid of the upper arm with a 28-day interval.
Sponsors & Collaborators
-
Beijing Minhai Biotechnology Co., Ltd
collaborator INDUSTRY -
Hunan Provincial Center for Disease Control and Prevention
collaborator OTHER -
Shenzhen Kangtai Biological Products Co., LTD
lead INDUSTRY
Study Design
- Allocation
- RANDOMIZED
- Purpose
- PREVENTION
- Masking
- DOUBLE
- Model
- PARALLEL
Eligibility
- Min Age
- 3 Years
- Max Age
- 17 Years
- Sex
- ALL
- Healthy Volunteers
- Yes
Timeline & Regulatory
- Start
- 2021-08-31
- Primary Completion
- 2022-09-30
- Completion
- 2022-10-31
Countries
- China
Study Locations
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