A Global Study to find out the Effects of a Test Vaccine on prevention of harmful diseases caused by E.Coli spreading outside of the gut in Adults who are 60 Years And Older with a History of Urinary Tract Infection in the Past 2 Years.

Recruitment & Eligibility

Status: ot Yet Recruiting

Sex: Not specified

Target Recruitment: 0

Inclusion Criteria

1- 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.

2- 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.

3- Before randomization, participants who were born female must be either postmenopausal or permanently sterile, and not intending to conceive by any methods.

4- Participant must be willing to provide verifiable identification, has means to be contacted and to contact the investigator during the study.

Exclusion Criteria

1- Participant has end stage renal disease for which dialysis is required.

2- Participant has a contraindication to intramuscular (IM) injections and blood draws example, due to bleeding disorders or a history of difficult blood draws.

3- 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.

4- Participant has a history of acute polyneuropathy (for example, Guillain barre syndrome) or chronic inflammatory demyelinating polyneuropathy.

5- Participant has received any Escherichia coli (E. coli) or extraintestinal pathogenic Escherichia coli (ExPEC) vaccine

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
1-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 <br/ ><br>2-Number of Participants with First IED Event with Microbiological Confirmation in Blood or Other Sterile Sites Caused by ExPEC9V O serotypesTimepoint: Up to 3 years

Secondary Outcome Measures