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Randomized, Double-blind, Placebo-controlled, Multicenter Phase 3 Study to Assess the Efficacy, Safety And Immunogenicity of Vaccination With ExPEC9V in the Prevention of Invasive Extraintestinal Pathogenic Escherichia Coli Disease in Adults Aged 60 Years And Older With a History of Urinary Tract Infection in the Past 2 Years

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Trial Profile

Randomized, Double-blind, Placebo-controlled, Multicenter Phase 3 Study to Assess the Efficacy, Safety And Immunogenicity of Vaccination With ExPEC9V in the Prevention of Invasive Extraintestinal Pathogenic Escherichia Coli Disease in Adults Aged 60 Years And Older With a History of Urinary Tract Infection in the Past 2 Years

Status: Recruiting
Phase of Trial: Phase III

Latest Information Update: 14 Oct 2024

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At a glance

  • Drugs JNJ-78901563 (Primary)
  • Indications Escherichia coli infections
  • Focus Registrational; Therapeutic Use
  • Acronyms E.mbrace
  • Sponsors Janssen Research & Development; Janssen Vaccines and Prevention B.V

    • Most Recent Events

    • 08 Oct 2024 Planned End Date changed from 29 Mar 2028 to 29 Jun 2029.
    • 19 Sep 2024 Planned number of patients changed from 18556 to 19800.
    • 19 Sep 2024 Planned End Date changed from 22 Nov 2027 to 29 Mar 2028.

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