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A Multicenter, Randomized, Observer-Blinded, Active-Controlled Phase II Study to Evaluate the Immunogenicity and Safety of One Dose Booster by Recombinant Two-Component COVID-19 Vaccine (CHO Cell) in Adults Aged 18 Years and Older

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A Multicenter, Randomized, Observer-Blinded, Active-Controlled Phase II Study to Evaluate the Immunogenicity and Safety of One Dose Booster by Recombinant Two-Component COVID-19 Vaccine (CHO Cell) in Adults Aged 18 Years and Older

Status: Completed
Phase of Trial: Phase II

Latest Information Update: 27 Apr 2023

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At a glance

  • Drugs Recombinant two component COVID 19 vaccine Jiangsu Rec Biotechnology (Primary) ; Aluminium hydroxide; COVID-19 vaccine; Squalene
  • Indications COVID 2019 infections
  • Focus Adverse reactions; Pharmacodynamics
  • Sponsors Jiangsu Rec-Biotechnology

    • Most Recent Events

    • 24 Apr 2023 Number of treatment arms increased from 2 to 3 by the addition of one more experimental arm with 40 microgram dose of the study vaccine. Phase changed from phase 2/3 to phase 2 and all primary end-points related to phase 3 were removed.
    • 24 Apr 2023 Status changed from recruiting to completed.
    • 29 Sep 2022 Planned number of patients changed from 1950 to 300.

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