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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

NCT04899336

CompletedPhase 3

Sponsor: Janssen Research & Development, LLC

Conditions: Invasive Extraintestinal Pathogenic Escherichia Coli Disease (IED) Prevention

Interventions: ExPEC9V, Placebo

Countries: United States, Australia, Canada, China, Colombia, Czechia, Denmark, France

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.

Eligibility overview

Sex: ALL

Age: 60 Years to —

Healthy volunteers: Yes

Study type: INTERVENTIONAL

Eligibility 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

Locations (374)

Guntersville, Alabama, United States
Phoenix, Arizona, United States
Phoenix, Arizona, United States
Sun City West, Arizona, United States
Little Rock, Arkansas, United States
Buena Park, California, United States
Canoga Park, California, United States
Chula Vista, California, United States
Huntington Beach, California, United States
La Mesa, California, United States
Lancaster, California, United States
Long Beach, California, United States
Long Beach, California, United States
Los Angeles, California, United States
Los Angeles, California, United States
Los Angeles, California, United States
Los Angeles, California, United States
Los Angeles, California, United States
Mather, California, United States
Newport Beach, California, United States
Oakland, California, United States
Pomona, California, United States
Pomona, California, United States
Sacramento, California, United States
Sacramento, California, United States
San Diego, California, United States
San Diego, California, United States
San Dimas, California, United States
Santa Ana, California, United States
Simi Valley, California, United States
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