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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

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: Active, no longer recruiting
Phase of Trial: Phase III

Latest Information Update: 25 May 2025

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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

  • 09 Apr 2025 Status changed from discontinued to active, no longer recruiting.
  • 28 Mar 2025 Planned End Date changed from 31 Jul 2027 to 27 Aug 2025.
  • 28 Mar 2025 Planned primary completion date changed from 19 May 2025 to 27 Aug 2025.

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