Clinical Research and Clinical Trial in Vaccines

  • This study is a randomized, double-blinded, and placebo controlled phase III clinical trial of the SARS-CoV-2 inactivated vaccine manufactured by Pvt. Ltd Company. The purpose of this study is to evaluate the efficacy, safety and immunogenicity of the experimental vaccine in healthy adults aged 18~59 Years.

     

    Primary Outcome Measures:

    ·         Protection Indexes of Two Vaccine Doses for Symptomatic COVID-19 (Time Frame: 2 weeks after the second dose of vaccination)

    ·         The protection rate of a two-dose of SARS-CoV-2 (Vero Cell) vaccine against RT-PCR confirmed symptomatic COVID-19

     

    Secondary Outcome Measures:

  1. Protection Indexes of One Vaccine Dose For Symptomatic COVID-19 (Time Frame: 2 weeks after the second dose of vaccination)

  • The protection rate of, at least, one dose of SARS-CoV-2 (Vero Cell) vaccine against RT-PCR confirmed symptomatic COVID-19 Two weeks after the last dose vaccination.

      2.Protection Indexes of Second Vaccine Dose For Hospitalization, Disease Severity/and Death                           (Time Frame: 2 weeks after the second dose of vaccination)

  • The protection rate of a two-dose of SARS-CoV-2 (Vero Cell) vaccine against rates of hospitalization, disease severity/and death two weeks after the second dose of vaccination

      3.Protection Indexes of Two Vaccine Doses For SARS-CoV-2 infection  (Time Frame: 2 weeks after the             second dose of vaccination)

  • The protection rate of a two dose of SARS-CoV-2 (Vero Cell) vaccine against RT-PCR confirmed SARS-CoV-2 infection two weeks after the second dose of vaccination

      4.Safety indexes of adverse reactions in 28 days  (Time Frame: 28 days after the second dose of                          vaccination)

  • The incidence of adverse reactions from the day of first vaccination to 28 days after the second dose of vaccination.

  • This Phase III study is a global multicenter, randomized, double-blind,placebo controlled clinical trial to evaluate the efficacy, safety, and immunogenicity of therecombinant COVID-19 vaccine (Sf9 cells) in 40,000 participants aged 18 years and older who

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