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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

Testing a vaccine to prevent E. coli infections in older adults.

Recruiting
60 years and older
All
Phase 3

This study is testing a new vaccine called ExPEC9V to help prevent a serious illness caused by a bacteria named Escherichia coli (E. coli). This illness, called invasive extraintestinal pathogenic E. coli disease (IED), happens when E. coli enters the blood or other parts of the body, causing a bad infection. People aged 60 and older who have had a urinary tract infection (UTI) in the past two years can join the study.

Participants will be randomly assigned to receive either the ExPEC9V vaccine or a placebo, which is a harmless substance that does not affect the body. The study will last up to 6 years and 9 months, with follow-ups for 4 years after getting the vaccine.

Key points to consider:

  • The study involves a vaccination phase and a long follow-up period.
  • Participants must have had a UTI in the past two years and be willing to share medical information.
  • Participants should not have certain medical conditions like end-stage kidney disease or a history of certain nerve disorders.

Participants may experience side effects like serious adverse events (SAEs) or other reactions. If interested, it's important to discuss with a doctor to ensure eligibility.

Study details
    Invasive Extraintestinal Pathogenic Escherichia Coli Disease (IED) Prevention

NCT04899336

Janssen Research & Development, LLC

8 March 2025

Step 1 Get in touch with the nearest study center
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  • You can expect the study team to contact you via email or phone in the next few days.
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A clinical trial is a study designed to test specific interventions or treatments' effectiveness and safety, paving the way for new, innovative healthcare solutions.

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Participating in a clinical trial provides early access to potentially effective treatments and directly contributes to the healthcare advancements that benefit us all.

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The duration of clinical trials varies. Some trials last weeks, some years, depending on the phase and intention of the trial.

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Compensation varies per trial. Some offer payment or reimbursement for time and travel, while others may not.

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Clinical trials follow strict ethical guidelines and protocols to safeguard participants' health. They are closely monitored and safety reviewed regularly.
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