The Efficacy, Safety and Immunogenicity Study of Inactivated SARS-CoV-2 Vaccine for Preventing Against COVID-19
NCT04659239 · Status: UNKNOWN · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 34020
Last updated 2021-02-10
Summary
This is a randomized, double-blinded, placebo controlled phase III clinical trial to evaluate the efficacy, safety and immunogenicity of SARS-CoV-2 Vaccine, Inactivated (Vero Cell) in adults aged 18 years and above after 2-dose schedule.
Conditions
Interventions
- BIOLOGICAL
-
Inactivated SARS-CoV-2 Vaccine (Vero cell)
The inactivated SARS-CoV-2 vaccine (vero cell) was manufactured by IMBCAMS. Each dose of 0.5ml is for per person per time use.
- BIOLOGICAL
-
The placebo was manufactured by IMBCAMS. Each dose of 0.5ml is for per person per time use.
Sponsors & Collaborators
-
Chinese Academy of Medical Sciences
lead OTHER
Principal Investigators
-
Yasmin binti Mohamed Gani, PhD · Hospital Sungai Buloh
-
Adilson JW Cavalcante, PhD · CEMEC Pesquisa Clinica
Study Design
- Allocation
- RANDOMIZED
- Purpose
- PREVENTION
- Masking
- QUADRUPLE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- Yes
Timeline & Regulatory
- Start
- 2021-01-28
- Primary Completion
- 2021-09-30
- Completion
- 2022-07-31
Countries
- Brazil
- Malaysia
Study Locations
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