Summary

Eligibility
for people ages 60 years and up (full criteria)
Healthy Volunteers
healthy people welcome
Location
at UC Davis
Dates
study started
completion around

Description

Summary

The 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.

Official Title

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

Details

Keywords

Invasive Extraintestinal Pathogenic Escherichia Coli Disease (IED) Prevention, Urinary Tract Infections, Escherichia coli Infections, ExPEC9V

Eligibility

Locations

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Janssen Research & Development, LLC
ID
NCT04899336
Phase
Phase 3 research study
Study Type
Interventional
Participants
Expecting 19800 study participants
Last Updated