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A Study to Evaluate The Efficacy, Safety and Immunogenicity of Inactivated SARS-CoV-2 Vaccines (Vero Cell) in Healthy Population Aged 18 Years Old and Above

    • China National Biotec Group Company Limited
    • G42 Healthcare
    • Wuhan Institute of Biological Products Co., Ltd.
    • Beijing Institute of Biological Products Co., Ltd.
    • Al Qarain Primary Health Care Centre

    Project: Clinical Trial

    Project Details

    Description

    This is a multicenter, randomized, double blind, parallel placebo controlled, phase 3 clinical trial to evaluate the protective efficacy, safety and immunogenicity of inactivated SARS-CoV-2 vaccines in healthy population 18 years old and above.

    Layman's description

    This is a multicenter, randomized, double-blind, placebo-controlled study to evaluate the protective efficacy, safety and immunogenicity of inactivated SARS-CoV-2 vaccines in healthy population 18 years old and above. The participants were randomized into three groups of investigational vaccine 1, investigational vaccine 2 and placebo in a 1:1:1 ratio.2 doses of the investigational vaccine or placebo are inoculated into the deltoid muscle of the either arm according to the vaccination schedule of D0 & D21 (+7 days).According to the immune durability results in Phase I/II study, and cross-neutralization assay results, a third dose (booster dose) generates a better immune response and is estimated to offer better protection, therefore, a booster dose will be given after 3 months.
    AcronymCOVID-19
    StatusFinished
    Effective start/end date16/07/2031/12/21

    Collaborative partners

    Keywords

    • SARS-CoV-2
    • SARS-CoV-2 Vaccine
    • Coronavirus
    • Immunologic Factors
    • Physiological Effects of Drugs
    • Vaccines

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