Invasive extraintestinal pathogenic Escherichia coli disease (IED) preventionprevention
Conditions
Interventions
ExPEC9V : Participants will receive a single intramuscular (IM) injection of 9-valent extraintestinal pathogenic Escherichia coli vaccine (ExPEC9V) on Day 1.
Placebo : Participants will receive a sing
Sponsors
Kawahara Kensaku
Eligibility
Sex/Gender
All
Inclusion 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, 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
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 - Chronic systemic prophylactic use of antibacterials (including antibiotics and urinary tract antiseptics). Repeated courses administered for recurrent UTIs preceding randomization will not be referred to as 'chronic'. In case of chronic prophylactic use of antibacterials, the last dose must have been administered > 60 days prior to randomization - 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Number of Participants with First Invasive Extraintestinal Pathogenic E. coli Disease (IED) Event with Microbiological Confirmation in Blood, Other Sterile Sites,or Urine, Caused by 9-valent Extraintestinal Pathogenic E. coli Vaccine (ExPEC9V) O-serotypes:Up to 3 years:Number of participants with first IED event, with microbiological confirmation in blood, other sterile sites, or urine, caused by ExPEC9V O-serotypes will be reported. Number of Participants with First IED Event with Microbiological Confirmation in Blood or Other Sterile Sites Caused by ExPEC9V O-serotypes:Up to 3 years:Number of participants with first IED event with microbiological confirmation in blood or other sterile sites, excluding IED cases with microbiological confirmation from urine only, caused by ExPEC9V O-serotypes will be reported. | — |
Secondary
| Measure | Time frame |
|---|---|
| Number of Participants with All IEDs (Including Multiple IEDs per Participant) Caused by ExPEC9V O-serotypes: Up to 3 years: Number of participants with all IEDs(including multiple IEDs per participant)caused by ExPEC9V O-serotypes will be reported. Number of Participants with First Hospitalized IED Event Caused by ExPEC9V O-serotypes: Up to 3 years: Number of participants with first hospitalized IED event caused by ExPEC9V O-serotypes will be reported. Number of Participants with First IED Event Meeting Criteria for Sepsis Caused by ExPEC9V O-serotypes: Up to 3 years: Number of participants with first IED event meeting criteria for sepsis caused by ExPEC9V O-serotypes will be reported. Number of Participants with First Bacteremic IED Event Caused by ExPEC9V O-serotypes: Up to 3 years: Number of participants with first bacteremic IED event caused by ExPEC9V O-serotypes will be reported. Number of Participants with First Pyelonephritis Event Caused by ExPEC9V O-serotypes: Up to 3 years: Number of participants with first pyelonephritis event caused by ExPEC9V O-serotypes will be reported. Number of Participants with First Urinary Tract Infection (UTI) Event Caused by ExPEC9V O-serotypes: Up to 3 years: Number of participants with first UTI event caused by ExPEC9V O-serotypes will be reported. Number of Participants with All UTIs (Including Multiple UTIs per Participant) Caused by ExPEC9V O-serotypes: Up to 3 years: Number of participants with all UTIs (including multiple UTIs per participant) caused by ExPEC9V O-serotypes will be reported. Number of Participants with First IED Event Caused by Any ExPEC O-serotype: Up to 3 years: Number of participants with first IED event caused by any ExPEC O-serotype will be reported. Number of Participants with First Pyelonephritis Event caused By Any ExPEC O-serotype: Up to 3 years: Number of participants with first pyelonephritis event caused by any ExPEC O-serotype will be reported. Number of Participants with First UTI Event ca | — |
Countries
Australia, Canada, China, Colombia, Czechia, Denmark, France, Germany, India, Israel, Italy, Japan, Korea, Netherlands, New Zealand, Spain, Sweden, Taiwan, Thailand, United Kingdom Of Great Britain, United States Of America
Contacts
Public ContactMedical Information Center
Janssen Pharmaceutical K.K.
Outcome results
None listed