Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT04899336 · ClinicalTrials.gov registry record · Phase 3
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
A Phase 3 study, sponsored by Janssen Research & Development.
- Completed
- Registry status
- Phase 3
- Development phase
- 17,797
- Enrollment target
NCT04899336: Completed Phase 3 study, sponsored by Janssen Research & Development.
NCT04899336 is a Phase 3 study that has completed, run by Janssen Research & Development. The registered enrollment target is 17,797 participants, above the 771-participant average among 15,282 other Phase 3 trials with a reported enrollment target (2208% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04899336, a Phase 3 study, has completed, sponsored by Janssen Research & Development.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 17,797 participants
- Enrollment target
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.
Primary Outcome
Number of participants with first IED event with microbiological confirmation in blood or other sterile sites, excluding IED cases with microbiological confirmation from urine only, caused by ExPEC9V O-serotypes will be reported.
Interventions
- OTHER Placebo
- BIOLOGICAL ExPEC9V
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 17,797 participants |
| Start Date | 2021-06-30 |
| Est. Completion | 2025-08-27 |
| Phase | Phase 3 |
What the finished NCT04899336 record still lists
NCT04899336 is an interventional study that assigns participants to a tested intervention. Its 17,797 participants enrollment target places it among the larger protocols in the corpus, above the 771-participant average among 15,282 other Phase 3 trials with a reported enrollment target (2208% higher).
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT04899336 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT04899336 about?
NCT04899336 is a clinical study titled "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". 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.
What is the current status of trial NCT04899336?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 17,797 participants. The study started on 2021-06-30. Estimated completion is 2025-08-27.
What interventions are being tested in trial NCT04899336?
The interventions under investigation include: Placebo (OTHER), ExPEC9V (BIOLOGICAL).
Who is sponsoring clinical trial NCT04899336?
This trial is sponsored by Janssen Research & Development, which has 593 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT04899336's enrollment target sits among peer trials
17,797 11th of 2000 higher than 1,990 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
Nationwide trials with similar profiles
Cross-condition peers matched on enrollment target and registry start date, not the same-condition list above.
Similar enrollment target
- NCT07108660 · 17,800 participants · NA
Machine Learning Prediction of Possible Central Line Associated Blood Stream Infections and Rate of Reduction
- NCT04110522 · 18,000 participants · NA
Psoriatic Arthritis D2P Screening
- NCT05513833 · 18,000 participants · NA
School Screening and Telemedicine Specialty Referral to Address Childhood Hearing Loss in Rural Kentucky
- NCT06802224 · 18,000 participants · Phase 4
The Choice of Vasopressor to Prevent Postoperative Acute Kidney Injury After Major Non-Cardiac Surgery
Similar registry start date
- NCT05962346 · started 2026-12 · NA
Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia
- NCT07125183 · started 2026-12 · Phase 2
Study on Efficacy and Tolerability of Weekly Doxorubicin in Elderly Patients With Advanced or Metastatic Leiomyosarcoma
- NCT07292298 · started 2026-11 · Phase 2
Phase 2 Single-Arm Rectal Cancer Brachytherapy for Patients With Low-Lying Residual Adenocarcinoma After Total Neoadjuvant Therapy to Improve Organ Preservation Rates
- NCT04263285 · started 2026-10 · NA
Treatment of Depression Post-SCI