EXPECT-1: Pilot Study to Assess Success Factors and Barriers for Preparation of a Phase 3 Study with ExPEC10V in Adults Aged 60 Years or Older and in Stable Health
- Status:: Closed
E.coli bacteria are a leading cause of serious infections. To date, there is no vaccine available to prevent E.coli infections. To support the development of a vaccine, more information about E.coli infections is needed.
This study is being carried out by researchers at general practices and hospitals worldwide to collect more information to support the development of a vaccine to prevent serious E-coli infections. We are aiming to recruit 6,000 participants from eight different counties, and hope to recruit 750 participants in the United Kingdom. Participants will attend one appointment at their local GP practice to commence the study and be followed up for 12 months to monitor healthcare use and any development of Invasive Extra-intestinal Pathogenic Escherichia Coli Disease (IED).
Study Design: |
Prospective, multi-centre, observational study |
Sponsor: |
University Medical Centre Utrecht |
Ethical approval: |
REC Yorkshire & the Humber Leeds East 19/YH/0264 |
Contact Details |
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Trial Registration Details: |
ClinicalTrials.gov ID: NCT04087681 |