MedTrace Logo

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

NCT04899336 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 17935

Last updated 2026-05-11

No results posted yet for this study

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.

Conditions

  • Invasive Extraintestinal Pathogenic Escherichia Coli Disease (IED) Prevention

Interventions

BIOLOGICAL

ExPEC9V

ExPEC9V will be administered as an IM injection.

OTHER

Placebo

Matching placebo will be administered as an IM injection.

Sponsors & Collaborators

  • Janssen Research & Development, LLC

    lead INDUSTRY

Principal Investigators

  • Janssen Research & Development, LLC Clinical Trial · Janssen Research & Development, LLC

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
60 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2021-06-30
Primary Completion
2025-08-27
Completion
2025-08-27
FDA Drug
Yes

Countries

  • United States
  • Australia
  • Canada
  • China
  • Colombia
  • Czechia
  • Denmark
  • France
  • Germany
  • India
  • Israel
  • Italy
  • Japan
  • Netherlands
  • New Zealand
  • South Korea
  • Spain
  • Sweden
  • Taiwan
  • Thailand
  • United Kingdom

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04899336 on ClinicalTrials.gov