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) PreventionThe 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.
null
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 LtdCalgary, Alberta
Canada
Contact Study Team
Dawson Road Family Health Team
Dawson Road Family Health TeamGuelph, Ontario
Canada
Contact Study Team
Vancouver ID Research and Care Centre Society
Vancouver ID Research and Care Centre SocietyVancouver, British Columbia
Canada
Contact Study Team
Winchester District Memorial Hospital
Winchester District Memorial HospitalWinchester, Ontario
Canada
Contact Study Team
University of Alberta
University of AlbertaEdmonton, Alberta
Canada
Contact Study Team
Bluewater Clinical Research Group Inc.
Bluewater Clinical Research Group Inc.Sarnia, Ontario
Canada
Contact Study Team
CARe Clinical Ltd
CARe Clinical LtdRed Deer, Alberta
Canada
Contact Study Team
Health Sciences North
Health Sciences NorthSudbury, Ontario
Canada
Contact Study Team
- Study Sponsored By
- Janssen Research & Development, LLC
- Participants Required
- More Information
- Study ID:
NCT04899336