Randomized, Double-blind, Placebo-controlled, Multicenter Phase 3 Study to Assess the Efficacy, Safety And Immunogenicity of Vaccination With 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 - Embrace

Janssen Vaccines & Prevention B.V.0 个研究点目标入组 0 人开始时间: 待定最近更新: 2023年11月13日

试验速览

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•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.

•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

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