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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

Invasive Extraintestinal Pathogenic Escherichia Coli Disease (IED) Prevention

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 extraintestinal pathogenic Escherichia coli disease (IED) event caused by ExPEC9V O-serotypes.

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Participation Requirements

  • Sex:

    ALL
  • Eligible Ages:

    60 and up

Participation Criteria

Inclusion Criteria:

* 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 Criteria:

* 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

Study Location

CARe Clinical Ltd
CARe Clinical Ltd
Calgary, Alberta
Canada

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Dawson Road Family Health Team
Dawson Road Family Health Team
Guelph, Ontario
Canada

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Vancouver ID Research and Care Centre Society
Vancouver ID Research and Care Centre Society
Vancouver, British Columbia
Canada

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Winchester District Memorial Hospital
Winchester District Memorial Hospital
Winchester, Ontario
Canada

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University of Alberta
University of Alberta
Edmonton, Alberta
Canada

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Bluewater Clinical Research Group Inc.
Bluewater Clinical Research Group Inc.
Sarnia, Ontario
Canada

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CARe Clinical Ltd
CARe Clinical Ltd
Red Deer, Alberta
Canada

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Health Sciences North
Health Sciences North
Sudbury, Ontario
Canada

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Study Sponsored By
Janssen Research & Development, LLC
Participants Required
More Information
Study ID: NCT04899336