Status:
COMPLETED
A Study of Vaccination With 9-valent Extraintestinal Pathogenic Escherichia Coli Vaccine (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
Lead Sponsor:
Janssen Research & Development, LLC
Conditions:
Invasive Extraintestinal Pathogenic Escherichia Coli Disease (IED) Prevention
Eligibility:
All Genders
60+ years
Phase:
PHASE3
Brief Summary
The purpose of this study is to demonstrate the efficacy of 9-valent extraintestinal pathogenic Escherichia coli vaccine (ExPEC9V) compared to placebo in the prevention of the first invasive extrainte...
Detailed Description
Invasive extraintestinal pathogenic Escherichia coli disease (IED) is defined as an acute illness consistent with systemic bacterial infection, which is microbiologically confirmed either by the isola...
Eligibility Criteria
Inclusion
- Participant must be willing to share relevant medical information pertaining to medical history and to share medical records relevant to the medical events identified as suspected cases of invasive extraintestinal pathogenic Escherichia coli disease (IED), urinary tract infections (UTI), or acute bacterial prostatitis (ABP) occurring during the study observation period
- Participant must have a history of UTI in the past 2 years for which evidence of diagnosis was verified by the investigator. In case of a recent history of UTI or ABP, the condition must have resolved greater than (\>)14 days prior to randomization
- Before randomization, participants who were born female must be either postmenopausal or permanently sterile, and not intending to conceive by any methods
- Participant must be willing to provide verifiable identification, has means to be contacted and to contact the investigator during the study
Exclusion
- Participant has end-stage renal disease for which dialysis is required
- Participant has a contraindication to intramuscular (IM) injections and blood draws example, due to bleeding disorders or a history of difficult blood draws
- Participant has a history of acute polyneuropathy (for example, Guillain-Barre syndrome) or chronic inflammatory demyelinating polyneuropathy
- Participant has received any Escherichia coli (E. coli) or extraintestinal pathogenic Escherichia coli (ExPEC) vaccine
Key Trial Info
Start Date :
June 30 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 27 2025
Estimated Enrollment :
17935 Patients enrolled
Trial Details
Trial ID
NCT04899336
Start Date
June 30 2021
End Date
August 27 2025
Last Update
December 5 2025
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