Efficacy,Immunogenicity and Safety of COVID-19 Vaccine , Inactivated Booster Dose in Adults Aged 18 Years and Above
NCT05156632 · Status: WITHDRAWN · Phase: PHASE3 · Type: INTERVENTIONAL
Last updated 2023-02-08
Summary
This is a multi-center, case-driven, randomized, double-blinded, and placebo-controlled Phase Ⅲb clinical trial of COVID-19 Vaccine manufactured by Sinovac Research \& Development Co., Ltd.The purpose of this study is to evaluate the efficacy of the booster dose after two doses of CoronaVac® against RT-PCR confirmed symptomatic COVID-19 cases in participants aged 18 years and above.
Conditions
Interventions
- BIOLOGICAL
-
Medium-dosage COVID-19 Vaccine,Inactivated
The COVID-19 vaccine,inactivated was manufactured by Sinovac Research\& Development Co., Ltd..600SU Inactivated SARS-COV-2 virus in 0·5 mL of aluminium hydroxide solution per injection.
- BIOLOGICAL
-
High-dosage COVID-19 Vaccine,Inactivated
The COVID-19 vaccine,inactivated was manufactured by Sinovac Research\& Development Co., Ltd.1200SU inactivated virus in 0.5 mL of aluminium hydroxide solution per injection.
- BIOLOGICAL
-
Placebo-comparator group
The composition is aluminium hydroxide with no antigen ,0 SU/0.5 mL,The appearance of the placebo is consistent with the vaccine, which is a milky-white suspension.
Sponsors & Collaborators
-
Sinovac Research and Development Co., Ltd.
lead INDUSTRY
Principal Investigators
-
Javed Khan, Master · Rehman Medical Institute
Study Design
- Allocation
- RANDOMIZED
- Purpose
- PREVENTION
- Masking
- DOUBLE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- Yes
Timeline & Regulatory
- Start
- 2023-02-20
- Primary Completion
- 2023-02-20
- Completion
- 2023-02-20
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