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ClinicalTrials.gov record
Completed Phase 3 Interventional Accepts healthy volunteers Results available

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

ClinicalTrials.gov ID: NCT04899336

Public ClinicalTrials.gov record NCT04899336. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.

ClinicalTrials.gov public records Last synced Oct 23, 2026, 11:47 PM EDT

Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.

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

Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

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.

Study identification

NCT ID
NCT04899336
Recruitment status
Completed
Study type
Interventional
Phase
Phase 3
Enrollment
17,797 participants

Conditions and interventions

Eligibility (public fields only)

Age range
60 Years and older
Sex
All
Healthy volunteers
Accepts healthy volunteers

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date
Jun 30, 2021 (Actual)
Primary completion
Aug 27, 2025 (Actual)
Completion
Aug 27, 2025 (Actual)
Last update posted
Sep 28, 2026

2021 – 2025

United States locations

U.S. sites
142
U.S. states
33
U.S. cities
103
Facility City State ZIP Site status
Lakeview Clinical Research Guntersville Alabama 35976 —
Hope Research Institute Phoenix Arizona 85018 —
Hope Research Institute Phoenix Arizona 85108 —
Interspond-Clinical Research Institute of AZ Sun City West Arizona 85357 —
Baptist Health Center For Clinical Research Little Rock Arkansas 72205 —
Sun Urology - Buena Park Office Buena Park California 90621 —
Hope clinical Research LLC Canoga Park California 91303 —
Velocity Clinical Research, Inc. Chula Vista California 91911 —
Marvel Clinical Research Huntington Beach California 92647 —
California Adult Circumcision - Alvarado La Mesa Urology Center La Mesa California 91942 —
Om Research LLC Lancaster California 93534 —
Atlantic Urology Medical Group Long Beach California 90806-2766 —
Long Beach Clinical Trials, LLC Long Beach California 90806 —
American Institute of Research Los Angeles California 90017 —
Kaiser Permanente Los Angeles Medical Center Los Angeles California 90027 —
Southern California Permanente Medical Group Los Angeles California 90027 —
Comprehensive Urology Los Angeles California 90048 —
Veterans Affairs Greater Los Angeles HCS Los Angeles California 90073 —
VA Sacramento Medical Center Mather California 95655 —
Hoag Medical Group Newport Beach California 92663 —
Kaiser Permanente Vaccine Study Center Oakland California 94612 —
Empire Clinical Research, LLC Pomona California 91767 —
Inland Urology Medical Group Pomona California 91767 —
UC Davis Health System Sacramento California 92647 —
Northern California Research Sacramento California 95821 —
San Diego Sports Medicine & Family Health Center San Diego California 92120 —
Medical Associates Research Group, Inc. San Diego California 92123 —
California Kidney Specialists San Dimas California 91773 —
Prestige Medical Group Santa Ana California 92705 —
Millennium Clinical Trials LLC Simi Valley California 93065 —
San Antonio Regional Hospital Upland California 91786 —
Yale University New Haven Connecticut 06510 —
Ideal Clinical Research Adventura Florida 33180 —
Bay Pines VA Healthcare System Bay Pines Florida 33744 —
Nova Clinical Research, LLC Bradenton Florida 34209 —
Clinical Research of Brandon Brandon Florida 33511 —
Moore Clinical Reseach - Brandon Clinic Brandon Florida 33511 —
Florida Medical Center of Clearwater Clearwater Florida 33755 —
Innovative Research of West Florida, Incorporated Clearwater Florida 33756 —
Advanced Clinical Research Network Coral Gables Florida 33134 —
Prestige Clinical Research Center, Inc. Coral Gables Florida 33134 —
Accel Research Sites DeLand Florida 32720 —
Doral Medical Research Doral Florida 33166 —
Universal Axon Clinical Research Doral Florida 33166 —
Florida Medical Research Institute Gainesville Florida 32607 —
Indago Research & Health Center Inc Hialeah Florida 33012 —
Prestige Clinical Research Homestead Florida 33030 —
Multi Specialty Research Associates Inc Lake City Florida 32055 —
ClinCloud Clinical Research Maitland Florida 32751 —
Nova Clinical Research Center Miami Florida 33124 —
Finlay Medical Research Miami Florida 33126 —
Royal Care Medical Research Corporation Miami Florida 33133 —
Retreat Medical Research LLC Miami Florida 33135 —
Suncoast Research Group Miami Florida 33135 —
Continental Research Miami Florida 33144-4273 —
Dynamic Medical Research, LLC Miami Florida 33144 —
Florida International Medical Research Miami Florida 33155 —
Health- Life Research Inst Miami Florida 33155 —
Office of Dr. Marisela Gonzalez Miami Florida 33155 —
Felicidad Medical Research Miami Florida 33185 —
A and R Research Group Miami Florida 33186 —
Alpha Science Research Miami Florida 33186 —
Clinical NeuroScience Solutions Inc Orlando Florida 32801 —
Omega Research Consultants Orlando Florida 32808 —
Pines Care Research Center Inc Pembroke Pines Florida 33024 —
Clinical Research of Central Florida Plant City Florida 33563 —
Care Access Research Spring Hill Florida 34609 —
Tampa General Hospital Tampa Florida 33603 —
Theia Clincial Research, LLC Tampa Florida 33613 —
Precision Research Institute Tampa Florida 33614 —
St. Joseph's Comprehensive Research Institute Tampa Florida 33614 —
Santos Research Center Tampa Florida 33615 —
Care Access Research Tampa Florida 33625 —
Agile Clinical Research Trials, LLC Atlanta Georgia 30328 —
Columbus Regional Research Institute Columbus Georgia 31904 —
Atlanta VA Medical Center Decatur Georgia 30033 —
Clinical Research Prime Idaho Falls Idaho 83404 —
Snake River Research, PLLC Idaho Falls Idaho 83404 —
Northwestern Medicine - Northwestern Memorial Hospital Galter Pavilion Chicago Illinois 60611 —
Jesse Brown VAMC Department of Surgery Chicago Illinois 60612 —
University Of Illinois Chicago Illinois 60612 —
Medisphere Medical Research Center, Llc Evansville Indiana 47714 —
Asha Clinical Research-Munster Llc Hammond Indiana 46324 —
Mishawaka Osteopathic Clinic/MOC Research Mishawaka Indiana 46544 —
Cypress Medical Research Center Wichita Kansas 67226 —
Tandem Clinical Research Marrero Louisiana 70072 —
KAMP Medical Research, Inc Natchitoches Louisiana 71457 —
Ochsner Medical Center New Orleans Louisiana 70121 —
Kaiser Permanente Rockville Maryland 20852 —
Floating Hospital For Children at Tufts Medical Center Boston Massachusetts 02111 —
West Roxbury Veterans Affairs Medical Center West Roxbury Massachusetts 02132-4927 —
Henry Ford Hospital Detroit Michigan 48202 —
William Beaumont Hospital Royal Oak Michigan 48073 —
MediSync Clinical Research Petal Mississippi 39465 —
Meridian Clinical Research, LLC Grand Island Nebraska 68803 —
Be Well Clinical Studies Lincoln Nebraska 68516 —
Meridian Clinical Research, LLC Norfolk Nebraska 68701 —
Hope Research Institute Las Vegas Nevada 89106 —
Sierra Clinical Research Las Vegas Nevada 89106 —
Excel Clinical Research Las Vegas Nevada 89109 —
VA Sierra Nevada Health Care System Reno Nevada 89509 —
I.D. Care, Inc. Hillsborough New Jersey 08844 —
Holy Name Medical Center Teaneck New Jersey 07666 —
Meridian Clinical Research, LLC Binghamton New York 13901 —
Meridian Clinical Research, LLC Endwell New York 13760 —
Manhattan Medical Research New York New York 10016 —
Montefiore Medical Center The Bronx New York 10467 —
Durham VAMC Durham North Carolina 27705 —
Carolina Institute for Clinical Research Fayetteville North Carolina 28303 —
ECU Health Vidant Medical Center Greenville North Carolina 27834 —
Plains Clinical Research Fargo North Dakota 58104 —
Kroger Health Centerville Ohio 45458 —
University Hospitals Cleveland Medical Center Cleveland Ohio 44106 —
Remington Davis Inc Columbus Ohio 43215 —
Kroger Health Englewood Ohio 45322 —
The Little Clinic Englewood Ohio 45322 —
Comprehensive Internal Medicine Wooster Ohio 44691 —
Tekton Research Inc. Yukon Oklahoma 73099 —
Kaiser Permanente Portland Oregon 97227 —
Capital Area Research Camp Hill Pennsylvania 17011 —
Reading Hospital West Reading Pennsylvania 19611 —
Hugh D. Durrence, MD, PC Charleston South Carolina 29412 —
Waterway Familiy Medicine Little River South Carolina 29566 —
Novel Research LLC Bellaire Texas 77401 —
Global Medical Research - Dallas Dallas Texas 75224 —
Medical City Dallas Dallas Texas 75230 —
North Texas Infectious Diseases Consultants Dallas Texas 75246 —
Digestive Health Associates Houston Texas 77024 —
EPIC Clinical Research Lewisville Texas 75057 —
SMS Clinical Research LLC Mesquite Texas 75149 —
Be Well Clinical Studies Round Rock Texas 78681 —
Audie L Murphy Memorial Va Ho San Antonio Texas 78229 —
Sherman Clinical Research Sherman Texas 75092 —
Lone Peak Family Medicine Draper Utah 84020 —
Clinical Alliance for Research and Education Annandale Virginia 22003-7347 —
Charlottesville Medical Research Center, LLC Charlottesville Virginia 22911 —
Infectious Disease Associates of Central Virginia Lynchburg Virginia 24501 —
IACT - Suffolk Multispecialty Research Suffolk Virginia 23435 —
Selma Medical Associates Winchester Virginia 22601 —
Multicare Institute For Research & Innovation - Rockwood Clinic - Cheney Cheney Washington 99004 —
Exemplar Research, Inc Morgantown West Virginia 26505 —
Marshfield Clinic Marshfield Wisconsin 54449 —

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

Non-U.S. locations

This page focuses on the U.S. directory. The official record also lists 232 non-U.S. sites.

About this trial record page

What this page shows
Public field values for ClinicalTrials.gov record NCT04899336, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do
No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from
Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh
Last update posted Sep 28, 2026 · Synced Oct 23, 2026

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Open the official record

The complete public registry record, listed eligibility criteria, and available contact information for NCT04899336 live on ClinicalTrials.gov.

View official ClinicalTrials.gov record →