En studie av vaksinering med 9-valent ekstratarm patogen Escherichia coli-vaksine (ExPEC9V) i forebygging av invasiv ekstraintestinal patogen Escherichia coli-sykdom hos voksne i alderen 60 år og eldre med en historie med urinveisinfeksjon i de siste 2 årene
Randomisert, dobbeltblind, placebokontrollert, multisenter fase 3-studie for å vurdere effektiviteten, sikkerheten og immunogenisiteten av vaksinasjon med ExPEC9V i forebygging av invasiv ekstraintestinal patogen Escherichia coli-sykdom hos voksne i alderen 60 år og eldre med en historie med urinveisinfeksjon i de siste 2 årene
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.
Studieoversikt
Status
Intervensjon / Behandling
Detaljert beskrivelse
Invasive extraintestinal pathogenic Escherichia coli disease (IED) is defined as an acute illness consistent with systemic bacterial infection, which is microbiologically confirmed either by the isolation and identification of Escherichia coli (E. coli) from blood or any other sterile body sites, or by the isolation and identification of E. coli from urine in a participant with urosepsis and no other identifiable source of infection. ExPEC9V (JNJ-78901563, primary compound number: VAC52416) is a 9-valent vaccine candidate in development for active immunization for the prevention of IED in adults 60 years of age and older. Although IED affects all ages, adults aged greater than or equal to (>=) 60 years have an increased risk of developing IED, including bacteremia and sepsis, which can be community-acquired, hospital-acquired or healthcare associated. As the mechanism of action of conjugate vaccines in the prevention of invasive disease is not expected to be affected by antibiotic resistance mechanisms, that is, resistance mechanisms are not linked to O-polysaccharide structures, the sponsor has no reason to expect a difference in outcome of efficacy between antimicrobial-resistant and susceptible O-serotypes. This study incorporates an inferentially seamless group-sequential design. This study consists of a Screening Phase (selected screening procedures may be performed up to 8 days prior to vaccination on Day 1), Randomization, Vaccination Phase (Day 1) and Follow-up Phase (up to 4 years post-vaccination). The total study duration is approximately up to 6 years 9 months. Key safety assessments include serious adverse events (SAEs), solicited and unsolicited adverse events (AEs), physical examination, and vital signs.
Studietype
Registrering (Faktiske)
Fase
- Fase 3
Kontakter og plasseringer
Studiesteder
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Brisbane, Australia, 4001
- Saint Andrew's War Memorial Hospital
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Campbelltown, Australia, 5074
- GP Surgery - Campbelltown
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Geelong, Australia, 3220
- Barwon Health - University Hospital Geelong
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Melbourne, Australia, 5000
- CMAX Clinical Research
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New Lambton, Australia, 2305
- John Hunter Hospital
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Palmyra DC, Australia, 6961
- Fiona Stanley Hospital
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Para Hills West, Australia, 5096
- McIntyre Medical Center
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Salisbury, Australia, 5108
- North West Medical Center
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South Brisbane, Australia, 4101
- Mater Medical Centre South Brisbane
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St Agnes, Australia, 5097
- Bene Aged Care - Italian Village
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Sydney, Australia, 2145
- Westmead Hospital
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Taringa, Australia, 4068
- AusTrials Pty Ltd
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Tarragindi, Australia, 4121
- AusTrials Pty Ltd
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Woodville, Australia, 5011
- Adelaide Medical Solutions
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Alberta
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Calgary, Alberta, Canada, T4P 1K4
- CARe Clinical Ltd
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Edmonton, Alberta, Canada, T6G121
- University of Alberta
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Red Deer, Alberta, Canada, T4P 1K4
- CARe Clinical Ltd
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British Columbia
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Vancouver, British Columbia, Canada, V6Z2C7
- Vancouver ID Research and Care Centre Society
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Ontario
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Greater Sudbury, Ontario, Canada, P3E 5J1
- Health Sciences North
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Guelph, Ontario, Canada, N1H 1B1
- Dawson Road Family Health Team
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Sarnia, Ontario, Canada, N7T 4X3
- Bluewater Clinical Research Group Inc.
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Winchester, Ontario, Canada, K0C2K0
- Winchester District Memorial Hospital
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Quebec
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Québec, Quebec, Canada, G2J 0C4
- Alpha Recherche Clinique
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Québec, Quebec, Canada, G3K 2P8
- Alpha Recherche Clinique
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Barranquilla, Colombia
- Centro de Investigaciones y Proyectos en Neurociencias CIPNA
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Barranquilla, Colombia, 080001
- Clinica de la Costa
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Barranquilla, Colombia, 80020
- IPS Centro Cientifico Asisitencial Jose Luis Accini S.A.S.
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Casanare, Colombia, 856010
- Centro de Atencion e Investigacion Medica S.A. - CAIMED
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Floridablanca, Colombia
- Fundacion Cardiovascular de Colombia
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Girardot, Colombia, 252432
- Centro de Atencion e Investigacion Medica S.A. - CAIMED
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Helechos, Colombia
- Centro de Atencion e Investigacion Medica S.A. - CAIMED
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Manizales, Colombia, 170001
- Asociacion IPS Medicos Internistas de Caldas
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Meta, Colombia, 507001
- CAIMED Acacias
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Pereira, Colombia, 660003
- Fundacion Centro de Investigaciones Clinicas IPS Cardiomet
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Villavicencio, Colombia, 500001
- Corporación Clínica Universidad Cooperativa De Colombia Clínica Ucc
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Hellerup, Danmark, 2900
- Aalborg Universitetshospital Nord
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Herlev, Danmark, 2730
- Gentofte Hospital
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Hilleroed, Danmark, 3400
- Nordsjaellands Hospital - Hillerod
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Hvidovre, Danmark, 2650
- Hvidovre Hospital
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Odense M, Danmark, 5230
- Odense Universitetshospital
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Roskilde, Danmark, 4000
- Sjællands University hospital
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Alabama
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Guntersville, Alabama, Forente stater, 35976
- Lakeview Clinical Research
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Arizona
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Phoenix, Arizona, Forente stater, 85018
- Hope Research Institute
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Phoenix, Arizona, Forente stater, 85108
- Hope Research Institute
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Sun City West, Arizona, Forente stater, 85357
- Interspond-Clinical Research Institute of AZ
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Arkansas
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Little Rock, Arkansas, Forente stater, 72205
- Baptist Health Center For Clinical Research
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California
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Buena Park, California, Forente stater, 90621
- Sun Urology - Buena Park Office
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Canoga Park, California, Forente stater, 91303
- Hope clinical Research LLC
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Chula Vista, California, Forente stater, 91911
- Velocity Clinical Research, Inc.
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Huntington Beach, California, Forente stater, 92647
- Marvel Clinical Research
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La Mesa, California, Forente stater, 91942
- California Adult Circumcision - Alvarado La Mesa Urology Center
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Lancaster, California, Forente stater, 93534
- Om Research LLC
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Long Beach, California, Forente stater, 90806
- Long Beach Clinical Trials, LLC
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Long Beach, California, Forente stater, 90806-2766
- Atlantic Urology Medical Group
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Los Angeles, California, Forente stater, 90027
- Kaiser Permanente Los Angeles Medical Center
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Los Angeles, California, Forente stater, 90027
- Southern California Permanente Medical Group
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Los Angeles, California, Forente stater, 90017
- American Institute of Research
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Los Angeles, California, Forente stater, 90048
- Comprehensive Urology
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Los Angeles, California, Forente stater, 90073
- Veterans Affairs Greater Los Angeles HCS
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Mather, California, Forente stater, 95655
- VA Sacramento Medical Center
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Newport Beach, California, Forente stater, 92663
- Hoag Medical Group
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Oakland, California, Forente stater, 94612
- Kaiser Permanente Vaccine Study Center
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Pomona, California, Forente stater, 91767
- Empire Clinical Research, LLC
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Pomona, California, Forente stater, 91767
- Inland Urology Medical Group
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Sacramento, California, Forente stater, 95821
- Northern California Research
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Sacramento, California, Forente stater, 92647
- UC Davis Health System
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San Diego, California, Forente stater, 92123
- Medical Associates Research Group, Inc.
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San Diego, California, Forente stater, 92120
- San Diego Sports Medicine & Family Health Center
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San Dimas, California, Forente stater, 91773
- California Kidney Specialists
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Santa Ana, California, Forente stater, 92705
- Prestige Medical Group
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Simi Valley, California, Forente stater, 93065
- Millennium Clinical Trials LLC
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Upland, California, Forente stater, 91786
- San Antonio Regional Hospital
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Connecticut
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New Haven, Connecticut, Forente stater, 06510
- Yale University
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Florida
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Adventura, Florida, Forente stater, 33180
- Ideal Clinical Research
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Bay Pines, Florida, Forente stater, 33744
- Bay Pines VA Healthcare System
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Bradenton, Florida, Forente stater, 34209
- Nova Clinical Research, LLC
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Brandon, Florida, Forente stater, 33511
- Clinical Research of Brandon
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Brandon, Florida, Forente stater, 33511
- Moore Clinical Reseach - Brandon Clinic
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Clearwater, Florida, Forente stater, 33756
- Innovative Research of West Florida, Incorporated
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Clearwater, Florida, Forente stater, 33755
- Florida Medical Center of Clearwater
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Coral Gables, Florida, Forente stater, 33134
- Advanced Clinical Research Network
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Coral Gables, Florida, Forente stater, 33134
- Prestige Clinical Research Center, Inc.
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DeLand, Florida, Forente stater, 32720
- Accel Research Sites
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Doral, Florida, Forente stater, 33166
- Doral Medical Research
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Doral, Florida, Forente stater, 33166
- Universal Axon Clinical Research
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Gainesville, Florida, Forente stater, 32607
- Florida Medical Research Institute
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Hialeah, Florida, Forente stater, 33012
- Indago Research & Health Center Inc
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Homestead, Florida, Forente stater, 33030
- Prestige Clinical Research
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Lake City, Florida, Forente stater, 32055
- Multi Specialty Research Associates Inc
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Maitland, Florida, Forente stater, 32751
- ClinCloud Clinical Research
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Miami, Florida, Forente stater, 33126
- Finlay Medical Research
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Miami, Florida, Forente stater, 33135
- Suncoast Research Group
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Miami, Florida, Forente stater, 33155
- Florida International Medical Research
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Miami, Florida, Forente stater, 33144
- Dynamic Medical Research, LLC
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Miami, Florida, Forente stater, 33185
- Felicidad Medical Research
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Miami, Florida, Forente stater, 33124
- Nova Clinical Research Center
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Miami, Florida, Forente stater, 33133
- Royal Care Medical Research Corporation
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Miami, Florida, Forente stater, 33135
- Retreat Medical Research LLC
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Miami, Florida, Forente stater, 33144-4273
- Continental Research
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Miami, Florida, Forente stater, 33155
- Health- Life Research Inst
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Miami, Florida, Forente stater, 33155
- Office of Dr. Marisela Gonzalez
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Miami, Florida, Forente stater, 33186
- A and R Research Group
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Miami, Florida, Forente stater, 33186
- Alpha Science Research
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Orlando, Florida, Forente stater, 32808
- Omega Research Consultants
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Orlando, Florida, Forente stater, 32801
- Clinical NeuroScience Solutions Inc
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Pembroke Pines, Florida, Forente stater, 33024
- Pines Care Research Center Inc
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Plant City, Florida, Forente stater, 33563
- Clinical Research of Central Florida
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Spring Hill, Florida, Forente stater, 34609
- Care Access Research
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Tampa, Florida, Forente stater, 33615
- Santos Research Center
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Tampa, Florida, Forente stater, 33614
- St. Joseph's Comprehensive Research Institute
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Tampa, Florida, Forente stater, 33603
- Tampa General Hospital
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Tampa, Florida, Forente stater, 33613
- Theia Clincial Research, LLC
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Tampa, Florida, Forente stater, 33614
- Precision Research Institute
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Tampa, Florida, Forente stater, 33625
- Care Access Research
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Georgia
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Atlanta, Georgia, Forente stater, 30328
- Agile Clinical Research Trials, LLC
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Columbus, Georgia, Forente stater, 31904
- Columbus Regional Research Institute
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Decatur, Georgia, Forente stater, 30033
- Atlanta VA Medical Center
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Idaho
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Idaho Falls, Idaho, Forente stater, 83404
- Clinical Research Prime
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Idaho Falls, Idaho, Forente stater, 83404
- Snake River Research, PLLC
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Illinois
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Chicago, Illinois, Forente stater, 60612
- Jesse Brown VAMC Department of Surgery
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Chicago, Illinois, Forente stater, 60611
- Northwestern Medicine - Northwestern Memorial Hospital Galter Pavilion
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Chicago, Illinois, Forente stater, 60612
- University Of Illinois
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Indiana
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Evansville, Indiana, Forente stater, 47714
- Medisphere Medical Research Center, Llc
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Hammond, Indiana, Forente stater, 46324
- Asha Clinical Research-Munster Llc
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Mishawaka, Indiana, Forente stater, 46544
- Mishawaka Osteopathic Clinic/MOC Research
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Kansas
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Wichita, Kansas, Forente stater, 67226
- Cypress Medical Research Center
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Louisiana
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Marrero, Louisiana, Forente stater, 70072
- Tandem Clinical Research
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Natchitoches, Louisiana, Forente stater, 71457
- KAMP Medical Research, Inc
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New Orleans, Louisiana, Forente stater, 70121
- Ochsner Medical Center
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Maryland
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Rockville, Maryland, Forente stater, 20852
- Kaiser Permanente
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Massachusetts
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Boston, Massachusetts, Forente stater, 02111
- Floating Hospital For Children at Tufts Medical Center
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West Roxbury, Massachusetts, Forente stater, 02132-4927
- West Roxbury Veterans Affairs Medical Center
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Michigan
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Detroit, Michigan, Forente stater, 48202
- Henry Ford Hospital
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Royal Oak, Michigan, Forente stater, 48073
- William Beaumont Hospital
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Mississippi
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Petal, Mississippi, Forente stater, 39465
- MediSync Clinical Research
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Nebraska
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Grand Island, Nebraska, Forente stater, 68803
- Meridian Clinical Research, LLC
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Lincoln, Nebraska, Forente stater, 68516
- Be Well Clinical Studies
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Norfolk, Nebraska, Forente stater, 68701
- Meridian Clinical Research, LLC
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Nevada
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Las Vegas, Nevada, Forente stater, 89106
- Sierra Clinical Research
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Las Vegas, Nevada, Forente stater, 89109
- Excel Clinical Research
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Las Vegas, Nevada, Forente stater, 89106
- Hope Research Institute
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Reno, Nevada, Forente stater, 89509
- VA Sierra Nevada Health Care System
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New Jersey
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Hillsborough, New Jersey, Forente stater, 08844
- I.D. Care, Inc.
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Teaneck, New Jersey, Forente stater, 07666
- Holy Name Medical Center
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New York
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Binghamton, New York, Forente stater, 13901
- Meridian Clinical Research, LLC
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Endwell, New York, Forente stater, 13760
- Meridian Clinical Research, LLC
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New York, New York, Forente stater, 10016
- Manhattan Medical Research
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The Bronx, New York, Forente stater, 10467
- Montefiore Medical Center
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North Carolina
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Durham, North Carolina, Forente stater, 27705
- Durham VAMC
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Fayetteville, North Carolina, Forente stater, 28303
- Carolina Institute for Clinical Research
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Greenville, North Carolina, Forente stater, 27834
- ECU Health Vidant Medical Center
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North Dakota
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Fargo, North Dakota, Forente stater, 58104
- Plains Clinical Research
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Ohio
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Centerville, Ohio, Forente stater, 45458
- Kroger Health
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Cleveland, Ohio, Forente stater, 44106
- University Hospitals Cleveland Medical Center
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Columbus, Ohio, Forente stater, 43215
- Remington Davis Inc
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Englewood, Ohio, Forente stater, 45322
- Kroger Health
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Englewood, Ohio, Forente stater, 45322
- The Little Clinic
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Wooster, Ohio, Forente stater, 44691
- Comprehensive Internal Medicine
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Oklahoma
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Yukon, Oklahoma, Forente stater, 73099
- Tekton Research Inc.
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Oregon
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Portland, Oregon, Forente stater, 97227
- Kaiser Permanente
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Pennsylvania
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Camp Hill, Pennsylvania, Forente stater, 17011
- Capital Area Research
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West Reading, Pennsylvania, Forente stater, 19611
- Reading Hospital
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South Carolina
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Charleston, South Carolina, Forente stater, 29412
- Hugh D. Durrence, MD, PC
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Little River, South Carolina, Forente stater, 29566
- Waterway Familiy Medicine
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Texas
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Bellaire, Texas, Forente stater, 77401
- Novel Research LLC
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Dallas, Texas, Forente stater, 75246
- North Texas Infectious Diseases Consultants
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Dallas, Texas, Forente stater, 75230
- Medical City Dallas
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Dallas, Texas, Forente stater, 75224
- Global Medical Research - Dallas
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Houston, Texas, Forente stater, 77024
- Digestive Health Associates
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Lewisville, Texas, Forente stater, 75057
- EPIC Clinical Research
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Mesquite, Texas, Forente stater, 75149
- SMS Clinical Research LLC
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Round Rock, Texas, Forente stater, 78681
- Be Well Clinical Studies
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San Antonio, Texas, Forente stater, 78229
- Audie L Murphy Memorial Va Ho
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Sherman, Texas, Forente stater, 75092
- Sherman Clinical Research
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Utah
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Draper, Utah, Forente stater, 84020
- Lone Peak Family Medicine
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Virginia
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Annandale, Virginia, Forente stater, 22003-7347
- Clinical Alliance for Research and Education
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Charlottesville, Virginia, Forente stater, 22911
- Charlottesville Medical Research Center, LLC
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Lynchburg, Virginia, Forente stater, 24501
- Infectious Disease Associates of Central Virginia
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Suffolk, Virginia, Forente stater, 23435
- IACT - Suffolk Multispecialty Research
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Winchester, Virginia, Forente stater, 22601
- Selma Medical Associates
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Washington
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Cheney, Washington, Forente stater, 99004
- Multicare Institute For Research & Innovation - Rockwood Clinic - Cheney
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West Virginia
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Morgantown, West Virginia, Forente stater, 26505
- Exemplar Research, Inc
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Wisconsin
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Marshfield, Wisconsin, Forente stater, 54449
- Marshfield Clinic
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-
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-
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Annecy, Frankrike, 74370
- Centre Hospitalier Annecy Genevois
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Dijon, Frankrike, 21000
- CHU Dijon Bourgogne - Hopital Francois Mitterrand
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Limousis, Frankrike, 87042
- CHU de Limoges
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Lyon, Frankrike, 69004
- Hopital de La Croix Rousse
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Nîmes, Frankrike, 30029
- CHU Nimes Hopital Caremeau
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Pierre-Bénite, Frankrike, 69495
- Centre hospitalier Lyon-Sud
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Saint-Priest-en-Jarez, Frankrike, 42270
- CHU Saint Etienne Hopital Nord
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Belagavi, India, 590010
- KLE's Dr. Prabhakar Kore Hospital & Medical Research Centre (MRC)
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Jaipur, India, 302006
- S. R. Kalla Memorial General Hospital
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Kolkata, India, 700014
- Nil Ratan Sircar Medical College and Hospital
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Lucknow, India, 226022
- Regency health super specialty hospital
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Mumbai, India, 421203
- Asian Institute Of Medical Science
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Mysuru, India, 570015
- Jagadguru Sri Shivarathreeshwara Academy of Higher Education and Research
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New Delhi, India, 1100776
- Indraprastha Apollo Hospital
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Rajkot, India, 360004
- Shree Giriraj Multispeciality Hospital
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Surat, India, 395009
- BAPS Pramukhswami Hospital
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Surat, India, 395002
- Nirmal Hospital Pvt. Ltd.
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Ashdod, Israel, 7747629
- Samson Assuta Ashdod University Hospital
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Jerusalem, Israel, 9112001
- Hadassah Medical Center
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Kfar Saba, Israel, 44281
- Meir Medical Center
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Ramat Gan, Israel, 52621
- The Chaim Sheba Medical Center
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Tel Aviv, Israel, 6423906
- Tel Aviv Sourasky Medical Center
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-
-
-
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Chieti, Italia, 66100
- ASL2 Lanciano - Vasto - Chieti - Ospedale 'SS Annunziata' di Chieti
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Roma, Italia, 00144
- Istituto Nazionale Tumori Regina Elena
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Rome, Italia, 00189
- Azienda Ospedaliera Sant Andrea
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-
-
-
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Akashi Shi, Japan, 674 0063
- Akashi Medical Center
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Fukuoka, Japan, 811-0213
- Fukuoka Wajiro Hospital
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Fukuoka, Japan, 807-0051
- Fukuoka Shinmizumaki Hospital
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Hakodate, Japan, 040 8611
- Hakodate Goryoukaku Hospital
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Hashima-gun, Japan, 5016062
- Matsunami General Hospital
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Hokkaido, Japan, 006-8555
- Teine Keijinkai Hospital
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Iizuka, Japan, 820-8501
- Aso Co.,Ltd Iizuka Hospital
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Itoshima, Japan, 8191104
- Inoue Hospital
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Kasuya-gun, Japan, 811-3112
- Kano Hospital
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Kawasaki, Japan, 211-8510
- Kanto Rosai Hospital
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Kitakyushu, Japan, 800-0057
- Shinkomonji hospital
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Kitakyushu, Japan, 8000295
- Japan Community Health care Organization Kyushu Hospital
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Nagasaki, Japan, 852-8511
- JRC Nagasaki Genbaku Hospital
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Neyagawa, Japan, 572-8567
- Kyoujinkai Clinic Komatsu
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Omuta-Shi, Japan, 836-0861
- Omuta City Hospital
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Osaka, Japan, 5340024
- Kyobashi Sugimoto Clinic
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Osaka, Japan, 5530003
- Japan Community Health Care Organization Osaka Hospital
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Sanuki, Japan, 7692393
- National Hospital Organization Shikoku Cancer Center
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Sapporo, Japan, 006-0812
- Teine Maeda Urology Clinic
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Sapporo, Japan, 0060816
- Teine Urological Clinic
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Shimajiri-Gun, Japan, 9010493
- Nanbu Tokushukai Hospital
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Shimonoseki-shi, Japan, 7500061
- Shimonoseki City Hospital
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Shinagawa City, Japan, 1408522
- Tokyo Shinagawa Hospital
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Suita-Shi, Japan, 5650814
- Suita Tokushukai Hospital
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Suwa-Shi, Japan, 3928510
- Japanese Red Cross Society Suwa Hospital
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Yahatanishi-ku, Japan, 806-8501
- Japan Community Health care Organization Kyushu Hospital
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Yamaguchi, Japan, 750-0041
- Shimonoseki City Hospital
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Yokohama, Japan, 222-0036
- Yokohama Rosai Hospital
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Yokohama, Japan, 245-8575
- National Hospital Organization Yokohama Medical Center
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Ōita, Japan, 8700039
- Abe Diabetes Clinic
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Ōita, Japan, 8701195
- Almeida Memorial Hospital
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Ōmura, Japan, 856-8562
- National Hospital Organization Nagasaki Medical Center
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Chengdu, Kina, 610041
- West China School of Medicine/West China Hospital, Sichuan University
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Fuyang, Kina, 236399
- Funan Center for Disease Control and Prevention
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Guangzhou, Kina, 510120
- The First Affiliated Hospital of Guangzhou Medical University
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Guangzhou, Kina, 510260
- The Second Affiliated Hospital of Guangzhou Medical University
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Hangzhou, Kina, 310003
- 1st Affiliated Hospital of Zhejiang University Medical College
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Hefei, Kina, 230601
- Anhui Provincial Center for Disease Control and Prevention
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Liuan, Kina, 237400
- Huoqiu County Center For Disease Control and Prevention
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Nanjing, Kina, 210009
- Jiangsu Provincial Center for Disease Control and Prevention
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Nanjing, Kina, 211112
- Nanjing Medical University
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Shanghai, Kina, 200040
- Huashan Hospital affiliated to Fudan University
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Suzhou, Kina, 215002
- Suzhou Municipal Hospital
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Taizhou, Kina, 225300
- Taizhou Peoples Hospital
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Wuxi, Kina, 214200
- Yixing People's Hospital
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-
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Leiden, Nederland, 2333 ZA
- Leiden University Medical Center
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Uden, Nederland, 5406 PT
- Ziekenhuis
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Utrecht, Nederland, 3508 GA
- The Julius Center - Utrecht Science Park - Stratenum
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Auckland, New Zealand, 0600
- Southern Clinical Trials Totara Clinical Research
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Auckland, New Zealand, 0626
- Southern Clinical Trials Ltd
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Auckland, New Zealand, 1011
- Optimal Clinical Trials
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Bay of Plenty, New Zealand, 3112
- Tauranga Urology Research Limited
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Christchurch, New Zealand, 8013
- Canterbury Urology Research Trust
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Christchurch Central, New Zealand, 8013
- Southern Clinical Trials Ltd
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Dunedin, New Zealand, 9016
- P3 Research Ltd
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Hamilton, New Zealand, 3200
- Lakeland Clinical Trials
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Hastings, New Zealand, 4122
- P3 Research Ltd
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Lower Hutt, New Zealand, 5010
- P3 Research - Lower Hutt
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Nelson, New Zealand, 7011
- Southern Clinical Trials Ltd
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Palmerston North, New Zealand, 4414
- P3 Research Ltd
-
Papamoa, New Zealand, 3118
- Culloden Research Ltd
-
Papatoetoe, New Zealand, 2025
- Middlemore Clinical Trials
-
Rosedale, New Zealand, 632
- Optimal Clinical Trials
-
Rotorua, New Zealand, 3010
- Lakeland Clinical Trials
-
Tauranga, New Zealand, 3110
- P3 Research Ltd
-
Upper Hutt, New Zealand, 5018
- Lakeland Clinical Trials
-
Wellington, New Zealand, 5032
- P3 Research Limited Kapiti
-
Wellington, New Zealand, 6242
- Capatial & Coast District Health Board
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-
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Alicante, Spania, 3010
- Hosp. Gral. Univ. Dr. Balmis
-
Barcelona, Spania, 8003
- Hosp. Del Mar
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Barcelona, Spania, 08907
- Hosp. Univ. de Bellvitge
-
Barcelona, Spania, 08036
- Hosp Clinic de Barcelona
-
Barcelona, Spania, 8028
- Consorci D'Atenció Primària de Salut Barcelona Esquerra
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Córdoba, Spania, 14004
- Hosp Reina Sofia
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Girona, Spania, 17007
- Hosp. Univ. Dr. Josep Trueta
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Jerez de la Frontera, Spania, 11407
- Hosp. de Jerez de La Frontera
-
La Roca del Vallès, Spania, 8430
- CAP Dr. Vicenç Papaceit ABS LA ROCA
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Madrid, Spania, 28046
- Hosp. Univ. La Paz
-
Madrid, Spania, 28006
- Hosp. Univ. de La Princesa
-
Madrid, Spania, 28660
- Hosp. Univ. Hm Monteprincipe
-
Madrid, Spania, 28050
- Hospital Sanitas La Moraleja
-
Málaga, Spania, 29004
- Hosp. Quirónsalud Málaga
-
Ourense, Spania, 32005
- Complexo Hosp. Univ. de Ourense
-
Palma de Mallorca, Spania, 07120
- Hosp. Univ. Son Espases
-
Sabadell, Spania, 08208
- Corporacio Sanitari Parc Tauli
-
Seville, Spania, 41009
- Hosp. Virgen Macarena
-
Vigo, Spania, 36312
- Hosp. Alvaro Cunqueiro
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-
-
-
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Aberdeen, Storbritannia, AB25 2ZN
- Aberdeen Royal Infirmary
-
Atherstone, Storbritannia, CV9 1EU
- Atherstone Surgery
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Banbury, Storbritannia, OX16 9AD
- Banbury Cross Health Center
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Birkenhead, Storbritannia, CH62 6EE
- FutureMeds Bridle Clinic
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Birmingham, Storbritannia, B21 0RY
- FutureMeds-Soho UK
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Blackpool, Storbritannia, FY3 8NR
- Blackpool Teaching Hospitals NHS Foundation Trust
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Bournemouth, Storbritannia, BH7 7DW
- Royal Bournemouth Hospital
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Bristol, Storbritannia, BS10 5NB
- North Bristol NHS Trust
-
Bristol, Storbritannia, BS2 8BJ
- University Hospitals Bristol NHS Trust
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Exeter, Storbritannia, EX2 5DW
- Royal Devon & Exeter NHS Foundation Trust
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Eynsham, Storbritannia, OX29 4QB
- Eynsham Medical Centre
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Guisborough, Storbritannia, TS14 7DJ
- The Garth Surgery
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Leicester, Storbritannia, LE1 5WW
- University Hospitals Of Leicester Nhs Trust
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London, Storbritannia, SE5 9RS
- King's College Hospital NHS Foundation Trust
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Manchester, Storbritannia, M13 9WL
- Manchester Royal Infirmary
-
Manchester, Storbritannia, M23 9LT
- The NIHR Manchester Clinical Research Facility
-
Middlesbrough, Storbritannia, TS4 3BW
- South Tees Hospitals NHS Foundation Trust
-
Nottingham, Storbritannia, NG7 2UH
- Nottingham University Hospitals NHS Trust
-
Plymouth, Storbritannia, PL6 8DH
- Plymouth University Hospitals Trust
-
Pontypridd, Storbritannia, CF37 2DR
- Ashgrove Surgery
-
Poole, Storbritannia, BH15 4JQ
- The Adam Practice
-
Sheffield, Storbritannia, S10 2 JF
- Sheffield Teaching Hospitals NHS Foundation Trust
-
Stafford, Storbritannia, ST16 3SR
- Midlands Partnership NHS Foundation Trust
-
Stockton-on-Tees, Storbritannia, TS19 8PE
- North Tees Furturemeds
-
Wakefield, Storbritannia, WF1 4DG
- Mid Yorkshire Hospital NHS Trust- Pinderfields Hospital
-
Wantage, Storbritannia, OX12 9BN
- Church Street Practice
-
Witney, Storbritannia, OX28 6JS
- Windrush Medical Practice
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-
-
-
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Helsingborg, Sverige, 25187
- Helsingborgs lasarett
-
Karlskrona, Sverige, 37179
- BTH Research & Development Clinic
-
Linkoaping, Sverige, 582 13
- CTC Ebbepark
-
Malmö, Sverige, 21428
- Skanes universitetssjukhus
-
Mölndal, Sverige, 43153
- CTC GoCo
-
Solna, Sverige, 171 64
- ClinSmart Sweden AB
-
Uppsala, Sverige, 752 37
- ClinSmart Sweden AB
-
Örebro, Sverige, 70362
- Universitetssjukhuset Orebro
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-
-
-
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Busan, Sør -Korea, 602 812
- Dong-A University Hospital
-
Chuncheon, Sør -Korea, 24253
- Hallym University Chuncehon Medical Center
-
Daejeon, Sør -Korea, 35015
- Chungnam National University Hospital
-
Gwangju, Sør -Korea, 501-757
- Chunnam National University Hospital
-
Gyeonggi-do, Sør -Korea, 15355
- Korea University Ansan Hospital
-
Incheon, Sør -Korea, 22322
- Inha University Hospital
-
Seongnam-si, Sør -Korea, 13620
- Seoul National University Bundang Hospital
-
Seoul, Sør -Korea, 05505
- Asan Medical Center
-
Seoul, Sør -Korea, 06351
- Samsung Medical Center
-
Seoul, Sør -Korea, 03181
- Kangbuk Samsung Hospital
-
Seoul, Sør -Korea, 07985
- Ewha Womans University Mokdong Hospital
-
Seoul, Sør -Korea, 8308
- Korea University Guro Hospital
-
Seoul, Sør -Korea, 07441
- Hallym University Sacred Heart Hospital
-
Suwon, Sør -Korea, 16247
- The Catholic university of Korea, St. Vincent's Hospital
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Wŏnju, Sør -Korea, 220-701
- WonJu Severance Christian Hospital
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-
-
-
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Kaohsiung City, Taiwan, 813
- Kaohsiung Veterans General Hospital
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Tainan, Taiwan, 704
- National Cheng Kung University Hospital
-
Taoyuan, Taiwan, 333
- Chang Gung Memorial Hospital Linkou Branch
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-
-
-
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Bangkok, Thailand, 10330
- King Chulalongkorn Memorial Hospital
-
Bangkok, Thailand, 10700
- Siriraj Hospital
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Bangkok, Thailand, 10400
- Ramathibodi Hospital
-
Bangkok, Thailand, 10400
- Tropical Medicine Hospital, Mahidol University
-
Bangkok, Thailand, 10330
- Thai Red Cross Aids Research Centre
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-
-
-
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Brno, Tsjekkia, 61500
- Uromeda
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Dolní Břežany, Tsjekkia, 252 41
- Aesculap Ambulance sro - Zdravotni Stredisko Centrum Zdravi
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Hradec Králové, Tsjekkia, 50002
- Centrum Ockovani a Cestovi Mediciny
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Nový Knín, Tsjekkia, 262 03
- Res Medica
-
Olomouc, Tsjekkia, 77900
- PreventaMed, s.r.o.
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Ostrava-Proskovice, Tsjekkia, 72400
- GYNURO s.r.o
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Pilsen, Tsjekkia, 30100
- Ambulance name: Gynekologická ordinace MUDr
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Pilsen, Tsjekkia, 323 00
- MUDr. Mita Rosenberg
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Prague, Tsjekkia, 13000
- Gona s.R.o- Orfinace Harov
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Protivín, Tsjekkia, 39811
- Zdravi-fit, s.r.o.
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Slaný, Tsjekkia, 274 01
- Nemocnice Slany
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Vysoké Mýto, Tsjekkia, 56601
- Progerint s.r.o.
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České Budějovice, Tsjekkia, 37001
- Ordinace Hradebni s.r.o.
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-
-
-
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Frankfurt, Tyskland, 60590
- Universitatsklinikum Frankfurt
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Jena, Tyskland, 07747
- Universitatsklinikum Jena
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Leipzig, Tyskland, 04179
- Familienmedizinisches Zentrum Radowsky
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Leipzig, Tyskland, 4103
- SIBAmed GmbH & Co. KG
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Marburg, Tyskland, 35037
- Universitaetsklinikum Giessen und Marburg GmbH
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Oldenburg in Holstein, Tyskland, 23758
- Red-Institut für medizinische Forschung und Fortbildung
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Reinfeld, Tyskland, 23858
- Praxis Dr. Weimer
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Rostock, Tyskland, 18057
- Universitaetsmedizin Rostock
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Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
Tar imot friske frivillige
Kjønn som er kvalifisert for studier
Beskrivelse
Inclusion Criteria:
- Participant must be willing to share relevant medical information pertaining to medical history and to share medical records relevant to the medical events identified as suspected cases of invasive extraintestinal pathogenic Escherichia coli disease (IED), urinary tract infections (UTI), or acute bacterial prostatitis (ABP) occurring during the study observation period
- Participant must have a history of UTI in the past 2 years for which evidence of diagnosis was verified by the investigator. In case of a recent history of UTI or ABP, the condition must have resolved greater than (>)14 days prior to randomization
- Before randomization, participants who were born female must be either postmenopausal or permanently sterile, and not intending to conceive by any methods
- Participant must be willing to provide verifiable identification, has means to be contacted and to contact the investigator during the study
Exclusion Criteria:
- Participant has end-stage renal disease for which dialysis is required
- Participant has a contraindication to intramuscular (IM) injections and blood draws example, due to bleeding disorders or a history of difficult blood draws
- Participant has a history of acute polyneuropathy (for example, Guillain-Barre syndrome) or chronic inflammatory demyelinating polyneuropathy
- Participant has received any Escherichia coli (E. coli) or extraintestinal pathogenic Escherichia coli (ExPEC) vaccine
Studieplan
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Forebygging
- Tildeling: Randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Dobbelt
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
|
Eksperimentell: ExPEC9V
Participants will receive a single intramuscular (IM) injection of 9-valent extraintestinal pathogenic Escherichia coli vaccine (ExPEC9V) on Day 1. |
ExPEC9V will be administered as an IM injection.
Andre navn:
|
|
Placebo komparator: Placebo
Participants will receive a single IM injection of matching placebo on Day 1. |
Matching placebo will be administered as an IM injection. |
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Number of Participants With First Occurrence of Invasive Escherichia Coli Disease (IED) Event Per Adjudication in Blood or Other Sterile Sites Caused by 9-valent Extraintestinal Pathogenic Escherichia Coli Vaccine (ExPEC9V) O-Serotypes
Tidsramme: From 29 days after vaccination on Day 1 (Day 30) up to Day 1296 (Day of Futility announcement)
|
Number of participants with first occurrence of IED event per adjudication in blood or other sterile sites, caused by ExPEC9V O-serotypes was reported. IED events were: (1) signs and symptoms of systemic bacterial infection as indicated by presence of any of following: temperature less than(<) 36.0 degree Celsius or greater than (>) 38.0 degree Celsius, tachycardia (HR) >90 beats per minute (bpm), tachypnea (RR) >20 bpm, white blood cell (WBC) count <4 or >12*10^9 cells/L or an acute change in total sequential organ failure assessment (SOFA) score of greater than or equal to (>=2) points from baseline; (2) microbiological confirmation by culture of E. coli in blood or in any other sterile site and/or in urine with urinary tract infection (UTI) symptoms and with no other identifiable site of infection and with an acute change in total SOFA score of >=2 points from baseline. Baseline=value of last available assessment prior to vaccination on Day 1. |
From 29 days after vaccination on Day 1 (Day 30) up to Day 1296 (Day of Futility announcement)
|
Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Number of Participants With First Occurrence of Invasive Escherichia Coli Disease (IED) Event Per Adjudication With Microbiological Confirmation in Blood or Other Sterile Sites or Urine Caused by ExPEC9V O-Serotypes
Tidsramme: From 29 days after vaccination on Day 1 (Day 30) up to Day 1296 (Day of futility announcement)
|
Number of participants with first occurrence of IED event per adjudication with microbiological confirmation in blood or other sterile sites or urine caused by ExPEC9V O-serotypes was reported. IED events were: (1) signs and symptoms of systemic bacterial infection as indicated by presence of any of following: temperature < 36.0 degree Celsius or >38.0 degree Celsius, tachycardia (HR) >90 bpm, tachypnea (RR) >20 bpm, WBC count <4 or >12*10^9 cells/L or an acute change in total SOFA score of >=2 points from baseline; (2) microbiological confirmation by culture of E. coli in blood or in any other sterile site and/or in urine with UTI symptoms and with no other identifiable site of infection and with an acute change in total SOFA score of >=2 points from baseline. Baseline=value of last available assessment prior to vaccination on Day 1. |
From 29 days after vaccination on Day 1 (Day 30) up to Day 1296 (Day of futility announcement)
|
|
Number of Participants With All Invasive Escherichia Coli Disease (IED) Events Per Adjudication With Microbiological Confirmation in Blood or Other Sterile Sites or Urine Caused by ExPEC9V O-Serotypes
Tidsramme: From 29 days after vaccination on Day 1 (Day 30) up to Day 1296 (Day of futility announcement)
|
Number of participants with all IED events per adjudication with microbiological confirmation in blood or other sterile sites or urine caused by ExPEC9V O-serotypes was reported. IED events were: (1) signs and symptoms of systemic bacterial infection as indicated by presence of any of following: temperature < 36.0 degree Celsius or >38.0 degree Celsius, tachycardia (HR) >90 bpm, tachypnea (RR) >20 bpm, WBC count <4 or >12*10^9 cells/L or an acute change in total SOFA score of >=2 points from baseline; (2) microbiological confirmation by culture of E. coli in blood or in any other sterile site and/or in urine with UTI symptoms and with no other identifiable site of infection and with an acute change in total SOFA score of >=2 points from baseline. Baseline=value of last available assessment prior to vaccination on Day 1. |
From 29 days after vaccination on Day 1 (Day 30) up to Day 1296 (Day of futility announcement)
|
|
Number of Participants With First Occurrence of Hospitalized Invasive Escherichia Coli Disease (IED) Event Per Adjudication Caused by ExPEC9V O-Serotypes
Tidsramme: From 29 days after vaccination on Day 1 (Day 30) up to Day 1296 (Day of futility announcement)
|
Number of participants with first occurrence of hospitalized IED event per adjudication caused by ExPEC9V O-serotypes was reported. IED events were: (1) signs and symptoms of systemic bacterial infection as indicated by presence of any of following: temperature < 36.0 degree Celsius or >38.0 degree Celsius, tachycardia (HR) >90 bpm, tachypnea (RR) >20 bpm, WBC count <4 or >12*10^9 cells/L or an acute change in total SOFA score of >=2 points from baseline; (2) microbiological confirmation by culture of E. coli in blood or in any other sterile site and/or in urine with UTI symptoms and with no other identifiable site of infection and with an acute change in total SOFA score of >=2 points from baseline. Baseline=value of last available assessment prior to vaccination on Day 1. |
From 29 days after vaccination on Day 1 (Day 30) up to Day 1296 (Day of futility announcement)
|
|
Number of Participants With First Occurrence of Invasive Escherichia Coli Disease (IED) Event Meeting Criteria for Sepsis Per Adjudication With Microbiological Confirmation in Blood, Other Sterile Sites or Urine Caused by ExPEC9V O-Serotypes
Tidsramme: From 29 days after vaccination on Day 1 (Day 30) up to Day 1296 (Day of futility announcement)
|
Number of participants with first occurrence of IED event meeting criteria for sepsis per adjudication with microbiological confirmation in blood, other sterile sites or urine caused by ExPEC9V O-serotypes was reported. Sepsis was defined as life-threatening organ dysfunction due to dysregulated host response to infection. A case of IED was defined as meeting criteria for sepsis if there is a documented acute change in total SOFA score of >=2 points from baseline and deemed secondary to the IED. Baseline=value of the last available assessment prior to the vaccination on Day 1. |
From 29 days after vaccination on Day 1 (Day 30) up to Day 1296 (Day of futility announcement)
|
|
Number of Participants With First Occurrence of Bacteremic Invasive Escherichia Coli Disease (IED) Events Per Adjudication Caused by ExPEC9V O-Serotypes
Tidsramme: From 29 days after vaccination on Day 1 (Day 30) up to Day 1296 (Day of futility announcement)
|
Number of participants with first occurrence of bacteremic IED events per adjudication caused by ExPEC9V O-serotypes was reported. IED events were: (1) signs and symptoms of systemic bacterial infection as indicated by presence of any of following: temperature < 36.0 degree Celsius or >38.0 degree Celsius, tachycardia (HR) >90 bpm, tachypnea (RR) >20 bpm, WBC count <4 or >12*10^9 cells/L or an acute change in total SOFA score of >=2 points from baseline; (2) microbiological confirmation by culture of E. coli in blood or in any other sterile site and/or in urine with UTI symptoms and with no other identifiable site of infection and with an acute change in total SOFA score of >=2 points from baseline. Baseline=value of last available assessment prior to vaccination on Day 1. |
From 29 days after vaccination on Day 1 (Day 30) up to Day 1296 (Day of futility announcement)
|
|
Number of Participants With First Occurrence of Pyelonephritis Events Per Adjudication Caused by ExPEC9V O-Serotypes
Tidsramme: From 29 days after vaccination on Day 1 (Day 30) up to Day 1296 (Day of futility announcement)
|
Number of participants with first occurrence of pyelonephritis events per adjudication caused by ExPEC9V O-serotypes was reported. An event was considered a confirmed pyelonephritis if an adult with documented pyuria (WBC count >=10 cells/cubic millimeter (mm^3) in a non-centrifuged urine or >=5 WBC per high-power field [400x enlargement] [WBC/HPF] in urine sediment) and microbiological confirmation by culture of E. coli in urine presents with at least 2 of the following signs and symptoms: fever (temperature >=38.0 degree Celsius), or chills, or rigors, or warmth (warmth only if associated with evidence of fever), flank pain, tenderness in the costovertebral angle on physical examination, nausea or vomiting. |
From 29 days after vaccination on Day 1 (Day 30) up to Day 1296 (Day of futility announcement)
|
|
Number of Participants With First Occurrence of Urinary Tract Infection (UTI) Event Per Clinical Case Definition (CCD) Caused by ExPEC9V O-Serotypes
Tidsramme: From 29 days after vaccination on Day 1 (Day 30) up to Day 1296 (Day of futility announcement)
|
Number of participants with first occurrence of UTI event per CCD caused by ExPEC9V O-serotypes was reported. An event was considered a confirmed UTI if an adult with documented pyuria (WBC count >=10 cells/mm^3 in a non-centrifuged urine or >=5 WBC per high-power field in urine sediment) and microbiological confirmation by culture of E. coli in urine presents with one of the following signs and symptoms: (1) uncomplicated UTI: dysuria, urinary frequency, urinary urgency, suprapubic pain; (2) complicated UTI: fever or chills, or rigors, or warmth (warmth only if associated with evidence of fever, dysuria, urinary frequency or urinary urgency, lower abdominal pain or pelvic pain, nausea or vomiting; (3) recurrent UTI: recurrence of symptomatic UTIs with a frequency of 2 UTIs in 6 months or at least 3 UTIs in 1 year; (4) recurrent uncomplicated UTI: recurrence of uncomplicated UTIs with a frequency of 2 UTIs in 6 months or at least 3 UTIs in 1 year. |
From 29 days after vaccination on Day 1 (Day 30) up to Day 1296 (Day of futility announcement)
|
|
Number of Participants With All UTI Event Per CCD Caused by ExPEC9V O-Serotypes
Tidsramme: From 29 days after vaccination on Day 1 (Day 30) up to Day 1296 (Day of futility announcement)
|
Number of participants with all UTI event per CCD caused by ExPEC9V O-serotypes was reported. An event was considered a confirmed UTI if an adult with documented pyuria (WBC count >=10 cells/mm^3 in a non-centrifuged urine or >=5 WBC per high-power field in urine sediment) and microbiological confirmation by culture of E. coli in urine presents with one of the following signs and symptoms: (1) uncomplicated UTI: dysuria, urinary frequency, urinary urgency, suprapubic pain; (2) complicated UTI: fever or chills, or rigors, or warmth (warmth only if associated with evidence of fever, dysuria, urinary frequency or urinary urgency, lower abdominal pain or pelvic pain, nausea or vomiting; (3) recurrent UTI: recurrence of symptomatic UTIs with a frequency of 2 UTIs in 6 months or at least 3 UTIs in 1 year; (4) recurrent uncomplicated UTI: recurrence of uncomplicated UTIs with a frequency of 2 UTIs in 6 months or at least 3 UTIs in 1 year. |
From 29 days after vaccination on Day 1 (Day 30) up to Day 1296 (Day of futility announcement)
|
|
Number of Participants With First Occurrence of Invasive Escherichia Coli Disease (IED) Event Per Adjudication With Microbiological Confirmation in Blood or Other Sterile Sites or Urine Caused by E. Coli
Tidsramme: From 29 days after vaccination on Day 1 (Day 30) up to Day 1296 (Day of futility announcement)
|
Number of participants with first occurrence of IED event per adjudication with microbiological confirmation in blood or other sterile sites or urine caused by E. coli was reported. IED events were: (1) signs and symptoms of systemic bacterial infection as indicated by presence of any of following: temperature < 36.0 degree Celsius or >38.0 degree Celsius, tachycardia (HR) >90 bpm, tachypnea (RR) >20 bpm, WBC count <4 or >12*10^9 cells/L or an acute change in total SOFA score of >=2 points from baseline; (2) microbiological confirmation by culture of E. coli in blood or in any other sterile site and/or in urine with UTI symptoms and with no other identifiable site of infection and with an acute change in total SOFA score of >=2 points from baseline. Baseline=value of last available assessment prior to vaccination on Day 1. |
From 29 days after vaccination on Day 1 (Day 30) up to Day 1296 (Day of futility announcement)
|
|
Number of Participants With First Occurrence of Pyelonephritis Event Per Adjudication Caused by E. Coli
Tidsramme: From 29 days after vaccination on Day 1 (Day 30) up to Day 1296 (Day of futility announcement)
|
Number of participants with first occurrence of pyelonephritis events per adjudication caused by E. coli was reported. An event was considered a confirmed pyelonephritis if an adult with documented pyuria (WBC count >=10 cells/mm^3 in a non-centrifuged urine or >=5 WBC per high-power field [400x enlargement] [WBC/HPF] in urine sediment) and microbiological confirmation by culture of E. coli in urine presents with at least 2 of the following signs and symptoms: fever (temperature >=38.0 degree Celsius), or chills, or rigors, or warmth (warmth only if associated with evidence of fever), flank pain, tenderness in the costovertebral angle on physical examination, nausea or vomiting. |
From 29 days after vaccination on Day 1 (Day 30) up to Day 1296 (Day of futility announcement)
|
|
Number of Participants With First Occurrence of UTI Event Per CCD Caused by E. Coli
Tidsramme: From 29 days after vaccination on Day 1 (Day 30) up to Day 1296 (Day of futility announcement)
|
Number of participants with first occurrence of UTI event per CCD caused by E. coli was reported. An event was considered a confirmed UTI if an adult with documented pyuria (WBC count >=10 cells/mm^3 in a non-centrifuged urine or >=5 WBC per high-power field in urine sediment) and microbiological confirmation by culture of E. coli in urine presents with one of the following signs and symptoms: (1) uncomplicated UTI: dysuria, urinary frequency, urinary urgency, suprapubic pain; (2) complicated UTI: fever or chills, or rigors, or warmth (warmth only if associated with evidence of fever, dysuria, urinary frequency or urinary urgency, lower abdominal pain or pelvic pain, nausea or vomiting; (3) recurrent UTI: recurrence of symptomatic UTIs with a frequency of 2 UTIs in 6 months or at least 3 UTIs in 1 year; (4) recurrent uncomplicated UTI: recurrence of uncomplicated UTIs with a frequency of 2 UTIs in 6 months or at least 3 UTIs in 1 year. |
From 29 days after vaccination on Day 1 (Day 30) up to Day 1296 (Day of futility announcement)
|
|
Geometric Mean Titers (GMT) to Vaccine O-serotype Antigens and Exotoxin Protein A (EPA) as Measured by Multiplex Electrochemiluminescent (ECL)-Based Immunoassay
Tidsramme: Day 1 (pre-vaccination), Days 30, 181, 366, and 731
|
GMT to vaccine O-serotype antigen and EPA as measured by multiplex ECL based immunoassay was reported. GMTs for each antigen serotypes O1A, O2, O4, O6A, O15, O16, O18A, O25B, O75 and EPA were determined in serum from collected blood samples. |
Day 1 (pre-vaccination), Days 30, 181, 366, and 731
|
|
Geometric Mean Titers (GMTs) to Vaccine O-serotype Antigens as Determined by Multiplex Opsonophagocytic Killing Assay (MOPA)
Tidsramme: Day 1 (pre-vaccination) and Day 30
|
GMT to vaccine O-serotype antigen as determined by MOPA was reported. GMTs for each antigen serotypes O1A, O2, O4, O6, O15, O16, O18, O25, O75 were determined in serum from collected blood samples. The available immunogenicity data generated for MOPA assessments through Day 30 from the first 200 vaccinated participants were considered adequate for assessment of the post vaccination immune response. MOPA assessments beyond Day 30 were not performed per sponsor decision due to futility and is reflected in the changes to planned analysis. |
Day 1 (pre-vaccination) and Day 30
|
|
Number of Participants With Solicited Local Adverse Events (AEs)
Tidsramme: From Day 1 (post vaccination) up to Day 15
|
An AE is any untoward medical occurrence in a clinical study participant administered a medicinal (investigational or non-investigational) product. An AE does not necessarily have a causal relationship with the study vaccine. Solicited local AEs were precisely defined events that participants were specifically asked about and which were noted by participants in the e-diary. Solicited local (injection site) AEs included injection site pain/tenderness, erythema and swelling at the study vaccine injection site, were used to assess the reactogenicity of the study vaccine and were pre-defined local (injection site) event. All solicited AEs at the injection site (local) were considered related to the study vaccine administration. |
From Day 1 (post vaccination) up to Day 15
|
|
Number of Participants With Solicited Systemic Adverse Events
Tidsramme: From Day 1 (post vaccination) up to Day 15
|
An AE was any untoward medical occurrence in a clinical study administered a medicinal (investigational or non-investigational) product. An AE does not necessarily have a causal relationship with the study vaccine. Solicited AEs were precisely defined events that participants were specifically asked about and which were noted by participants in the e-diary. Solicited systemic AEs included fatigue, headache, nausea, fever and myalgia, used to assess the reactogenicity of the study vaccine and were predefined systemic events. |
From Day 1 (post vaccination) up to Day 15
|
|
Number of Participants With Unsolicited Adverse Events
Tidsramme: From Day 1 (post vaccination) up to Day 30
|
An AE was any untoward medical occurrence in a clinical study administered a medicinal (investigational or non-investigational) product. An AE does not necessarily have a causal relationship with the study vaccine. Unsolicited AEs were all AEs for which the participant was not specifically questioned in the participant diary. |
From Day 1 (post vaccination) up to Day 30
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Number of Participants With Serious Adverse Events (SAEs)
Tidsramme: From Day 1 (post vaccination) up to Day 181
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An AE was any untoward medical occurrence in a clinical study administered a medicinal (investigational or non-investigational) product. An AE does not necessarily have a causal relationship with the study vaccine. An SAE is an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly/birth defect; suspected transmission of any infectious agent via a medicinal product or medically important. |
From Day 1 (post vaccination) up to Day 181
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Change From Baseline in Short Form-36 Health Survey
Tidsramme: Baseline, Day 15, Day 30, Day 181, Year 1, Year 2, and Year 3
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The SF-36 determines participants' overall quality of life by assessing (1) limitations in physical functioning due to health problems (PF); (2) limitations in usual role because of physical health problems (RP); (3) bodily pain (BP); (4) general mental health (MH); (5) limitations in usual role due to emotional problems (RE); (6) limitations in social functioning due to physical or mental health problems (SF); (7) vitality, energy and fatigue (VT); and (8) general health perception (GH). Responses to all individual items are rated on a 3-, 5- or 6-point Likert scale and the 8 multi-item scales were scored from 0 to 100 with higher scores indicating better health. Scores on each item are summed and averaged (range: 0=worst to 100=best). Higher scores indicated better health. Baseline=value of last available assessment prior to vaccination on Day 1. |
Baseline, Day 15, Day 30, Day 181, Year 1, Year 2, and Year 3
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Change From Baseline in 5-level EuroQol 5-Dimension (EQ-5D-5L) Descriptive System Score: Index Score
Tidsramme: Baseline, Day 15, Day 30, Day 181, Year 1, Year 2, and Year 3
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The EQ-5D-5L is a self-administered, standardized measure of health status in a wide range of health conditions and treatments. It essentially consists of the EQ-5D-5L descriptive system and the EQ Visual Analogue Scale (EQ-VAS). The EQ-5D-5L descriptive system comprises the following 5 dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each of the 5 dimensions is divided into 5 levels of perceived problems (Level 1 = no problem, Level 2 = slight problems, Level 3 = moderate problems, Level 4 = severe problems, and Level 5 = extreme problems). Participant selects answer for each of 5 dimensions considering response that best matches his/her health "today". The responses to 5 EQ-5D-5L dimensions were scored using a utility-weighted algorithm to derive an EQ-5D-5L health status index score between 0 (death) to 100 (full health). Higher score indicates improvement. Baseline=value of last available assessment prior to vaccination on Day 1. |
Baseline, Day 15, Day 30, Day 181, Year 1, Year 2, and Year 3
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Change From Baseline in 5-level EuroQol 5-Dimension (EQ-5D-5L) Score: Visual Analog Scale (VAS)
Tidsramme: Baseline, Day 15, Day 30, Day 181, Year 1, Year 2, and Year 3
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The EQ-5D-5L is a self-administered, standardized measure of health status in a wide range of health conditions and treatments. It essentially consists of the EQ-5D-5L descriptive system and the EQ-VAS. EQ-VAS self-rating records the respondent's own assessment of his/her overall health status at time of completion, on a scale of 0 (worst health you can imagine) to 100 (best health you can imagine). Positive change in score indicates improvement. Baseline=value of last available assessment prior to vaccination on Day 1. |
Baseline, Day 15, Day 30, Day 181, Year 1, Year 2, and Year 3
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Number of Participants With Frailty Index
Tidsramme: Day 1, Year 1, Year 2, and Year 3
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Frailty index was based on deficit accumulation. Frailty Index was calculated using participants self-reported information regarding health status and baseline health conditions collected through medical conditions of interest (including diabetes mellitus, history of myocardial infarction, congestive heart failure, hypertension, history of cerebrovascular disease, chronic obstructive pulmonary disease, cancer, osteoarthritis or rheumatoid arthritis, gastric or duodenal ulcer, long-term disability or handicap, hearing problems, migraine, cataract, and glaucoma). Summary score cut-offs was defined as: (1) frailty Index <=0.08: fit participant, normal; (2) Frailty Index 0.08 - <=0.25: pre-frail participant; (3) Frailty Index >0.25: frail participant. The frailty index score was calculated as the ratio of the number of deficits to the total number of deficits. The total range of the index is 0 to 1, with higher score indicating more frailty. |
Day 1, Year 1, Year 2, and Year 3
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Number of Participants With Medical Resource Utilization (MRU) Related to First Occurrence of Invasive Escherichia Coli Disease (IED) Events Per CCD in Blood, Sterile Sites or Urine Caused by ExPEC9V O-Serotype
Tidsramme: From Day 1 up to Day 1296 (Day of futility announcement)
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Number of participants with MRU related to first occurrence of IED events per CCD caused by ExPEC9V O-serotype was reported. IED events were: (1) signs and symptoms of systemic bacterial infection as indicated by presence of any of following: temperature < 36.0 degree Celsius or >38.0 degree Celsius, tachycardia (HR) >90 bpm, tachypnea (RR) >20 bpm, WBC count <4 or >12*10^9 cells/L or an acute change in total SOFA score of >=2 points from baseline; (2) microbiological confirmation by culture of E. coli in blood or in any other sterile site and/or in urine with UTI symptoms and with no other identifiable site of infection and with an acute change in total SOFA score of >=2 points from baseline. Baseline=value of last available assessment prior to vaccination on Day 1. |
From Day 1 up to Day 1296 (Day of futility announcement)
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Number of Participants With MRU Related to First Occurrence of UTI, or Acute Bacterial Prostatitis (ABP) Events Per CCD Caused by ExPEC9V O-Serotype
Tidsramme: From Day 1 up to Day 1296 (Day of futility announcement)
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Number of participants with MRU related to first occurrence of UTI or ABP events per CCD caused by ExPEC9V O-serotype was reported. ABP event=documented pyuria and microbiological confirmation in urine with fever(temperature >=38.0 degree Celsius) and an acute onset of irritative voiding symptoms (dysuria, frequency, urgency), obstructive symptoms (hesitancy, incomplete emptying, straining, weak stream), or suprapubic, rectal, or perineal pain. UTI event=documented pyuria(WBC count >=10 cells/mm^3 in a non-centrifuged urine or >=5 WBC per high-power field in urine sediment) and microbiological confirmation in urine presents with one of following symptoms: 1) uncomplicated UTI: dysuria, urinary frequency, suprapubic pain; 2) complicated UTI: fever; 3) recurrent UTI: symptomatic UTIs with a frequency of 2 UTIs in 6 months or at least 3 UTIs in 1 year; 4) recurrent uncomplicated UTI: recurrence of uncomplicated UTIs with a frequency of 2 UTIs in 6 months or at least 3 UTIs in 1 year. |
From Day 1 up to Day 1296 (Day of futility announcement)
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Number of Participants With Invasive Escherichia Coli Disease (IED) Events Per CCD That Required Hospitalization Caused by ExPEC9V O-Serotype
Tidsramme: From Day 1 up to Day 1296 (Day of futility announcement)
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Number of participants with IED events per CCD that required hospitalization caused by ExPEC9V O-serotypes was reported. IED events were: (1) signs and symptoms of systemic bacterial infection as indicated by presence of any of following: temperature < 36.0 degree Celsius or >38.0 degree Celsius, tachycardia(HR) >90 bpm, tachypnea(RR) >20 bpm, WBC count <4 or >12*10^9 cells/L or an acute change in total SOFA score of >=2 points from baseline; (2) microbiological confirmation by culture of E. coli in blood or in any other sterile site and/or in urine with UTI symptoms and with no other identifiable site of infection and with an acute change in total SOFA score of >=2 points from baseline. Baseline=value of last available assessment prior to vaccination on Day 1. |
From Day 1 up to Day 1296 (Day of futility announcement)
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Number of Participants With UTI, or ABP Events Per CCD That Required Hospitalization Caused by ExPEC9V O-Serotype
Tidsramme: From Day 1 up to Day 1296 (Day of futility announcement)
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Number of participants with UTI or ABP events per CCD that required hospitalization was reported. ABP event=documented pyuria and microbiological confirmation in urine with fever and an acute onset of following: irritative voiding symptoms(dysuria, urinary frequency and urgency), obstructive voiding symptoms(hesitancy, incomplete voiding, straining to urinate, weak stream) and suprapubic, rectal, or perineal pain. UTI event=documented pyuria (WBC count >=10 cells/mm^3 in a non-centrifuged urine or >=5 WBC per high-power field in urine sediment) and microbiological confirmation in urine presents with one of following symptoms: 1) uncomplicated UTI: dysuria, urinary frequency, suprapubic pain; 2) complicated UTI: fever, or warmth; 3) recurrent symptomatic UTIs with a frequency of 2 UTIs in 6 months or at least 3 UTIs in 1 year; 4) recurrent uncomplicated UTIs with a frequency of 2 UTIs in 6 months or at least 3 UTIs in 1 year. |
From Day 1 up to Day 1296 (Day of futility announcement)
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Duration of Stay in Hospital for Invasive Escherichia Coli Disease (IED) Events Per CCD Caused by ExPEC9V O-Serotype
Tidsramme: From Day 1 up to Day 1296 (Day of futility announcement)
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Duration of stay in hospital for IED events per CCD was reported. The duration of hospitalization stay was defined as discharge date minus (-) admission date plus 1. IED events were: (1) signs and symptoms of systemic bacterial infection as indicated by presence of any of following: temperature < 36.0 degree Celsius or >38.0 degree Celsius, tachycardia (HR) >90 bpm, tachypnea (RR) >20 bpm, WBC count <4 or >12*10^9 cells/L or an acute change in total SOFA score of >=2 points from baseline; (2) microbiological confirmation by culture of E. coli in blood or in any other sterile site and/or in UTI symptoms and with no other identifiable site of infection and with an acute change in total SOFA score of >=2 points from baseline. Baseline=value of last available assessment prior to vaccination on Day 1. |
From Day 1 up to Day 1296 (Day of futility announcement)
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Duration of Stay in Hospital for UTI, or ABP Events Per CCD Caused by ExPEC9V O-Serotype
Tidsramme: From Day 1 up to Day 1296 (Day of futility announcement)
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Duration of stay in hospital for UTI or ABP events per CCD was reported. Duration of hospitalization stay=discharge date minus(-) admission date plus 1. ABP event=documented pyuria and microbiological confirmation in urine with fever and an acute onset of following: irritative voiding symptoms(dysuria, urinary frequency and urgency), obstructive voiding symptoms(hesitancy, incomplete voiding, straining to urinate, weak stream) and suprapubic, rectal, or perineal pain. UTI event=documented pyuria(WBC count >=10 cells/mm^3 in a non-centrifuged urine or >=5 WBC per high-power field in urine sediment) and microbiological confirmation in urine presents with one of following symptoms: 1) uncomplicated UTI: dysuria, urinary frequency, suprapubic pain; 2) complicated UTI: fever, or warmth; 3) recurrent symptomatic UTIs with a frequency of 2 UTIs in 6 months or at least 3 UTIs in 1 year; 4) recurrent uncomplicated UTIs with a frequency of 2 UTIs in 6 months or at least 3 UTIs in 1 year. |
From Day 1 up to Day 1296 (Day of futility announcement)
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Number of Participants With Invasive Escherichia Coli Disease (IED) Events Per CCD That Required Intensive Care Unit (ICU) Hospitalization Caused by ExPEC9V O-Serotype
Tidsramme: From Day 1 up to Day 1296 (Day of futility announcement)
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Number of participants with IED events per CCD that required ICU hospitalization caused by ExPEC9V O-serotype was reported. IED events were: (1) signs and symptoms of systemic bacterial infection as indicated by presence of any of following: temperature < 36.0 degree Celsius or >38.0 degree Celsius, tachycardia (HR) >90 bpm, tachypnea (RR) >20 bpm, WBC count <4 or >12*10^9 cells/L or an acute change in total SOFA score of >=2 points from baseline; (2) microbiological confirmation by culture of E. coli in blood or in any other sterile site and/or in urine with UTI symptoms and with no other identifiable site of infection and with an acute change in total SOFA score of >=2 points from baseline. Baseline=value of last available assessment prior to vaccination on Day 1. |
From Day 1 up to Day 1296 (Day of futility announcement)
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Number of Participants With UTI, or ABP Events Per CCD That Required Intensive Care Unit (ICU) Hospitalization Caused by ExPEC9V O-Serotype
Tidsramme: From Day 1 up to Day 1296 (Day of futility announcement)
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Number of participants with UTI or ABP events per CCD that required ICU hospitalization caused by ExPEC9V O-serotype was reported. ABP event=documented pyuria and microbiological confirmation in urine with fever and an acute onset of following: irritative voiding symptoms(dysuria, urinary frequency and urgency), obstructive voiding symptoms(hesitancy, incomplete voiding, straining to urinate, weak stream) and suprapubic, rectal, or perineal pain. UTI event=documented pyuria(WBC count >=10 cells/mm^3 in a non-centrifuged urine or >=5 WBC per high-power field in urine sediment) and microbiological confirmation in urine presents with one of following symptoms: 1) uncomplicated UTI: dysuria, urinary frequency, suprapubic pain; 2) complicated UTI: fever, or warmth; 3) recurrent symptomatic UTIs with a frequency of 2 UTIs in 6 months or at least 3 UTIs in 1 year; 4) recurrent uncomplicated UTIs with a frequency of 2 UTIs in 6 months or at least 3 UTIs in 1 year. |
From Day 1 up to Day 1296 (Day of futility announcement)
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Duration of ICU Stay in Hospital for IED Events Per CCD Caused by ExPEC9V O-Serotype
Tidsramme: From Day 1 up to Day 1296 (Day of futility announcement)
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Duration of ICU stay in hospital for IED events per CCD was reported. IED events were: (1) signs and symptoms of systemic bacterial infection as indicated by presence of any of following: temperature < 36.0 degree Celsius or >38.0 degree Celsius, tachycardia(HR) >90 bpm, tachypnea (RR) >20 bpm, WBC count <4 or >12*10^9 cells/L or an acute change in total SOFA score of >=2 points from baseline; (2) microbiological confirmation by culture of E. coli in blood or in any other sterile site and/or in urine with UTI symptoms and with no other identifiable site of infection and with an acute change in total SOFA score of >=2 points from baseline. Baseline=value of last available assessment prior to vaccination on Day 1. |
From Day 1 up to Day 1296 (Day of futility announcement)
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Duration of ICU Stay in Hospital for UTI, or ABP Events Per CCD Caused by ExPEC9V O-Serotype
Tidsramme: From Day 1 up to Day 1296 (Day of futility announcement)
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Duration of ICU stay in hospital for UTI or ABP events per CCD was reported. ABP event=documented pyuria and microbiological confirmation in urine with fever and an acute onset of following: irritative voiding symptoms(dysuria, urinary frequency and urgency), obstructive voiding symptoms(hesitancy, incomplete voiding, straining to urinate, weak stream) and suprapubic, rectal, or perineal pain. UTI event=documented pyuria(WBC count >=10 cells/mm^3 in a non centrifuged urine or >=5 WBC per high-power field in urine sediment) and microbiological confirmation in urine presents with one of following symptoms: 1) uncomplicated UTI: dysuria, urinary frequency, suprapubic pain; 2) complicated UTI: fever, or warmth; 3) recurrent symptomatic UTIs with a frequency of 2 UTIs in 6 months or at least 3 UTIs in 1 year; 4) recurrent uncomplicated UTIs with a frequency of 2 UTIs in 6 months or at least 3 UTIs in 1 year. |
From Day 1 up to Day 1296 (Day of futility announcement)
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Number of Participants With IED-related Mortality
Tidsramme: From Day 1 (post vaccination) up to end of study (Up to 4 years 1 month)
|
Number of participants with IED-related mortality was reported. |
From Day 1 (post vaccination) up to end of study (Up to 4 years 1 month)
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Number of Participants With All-cause Mortality
Tidsramme: From Day 1 up to end of study (Up to 4 year 1 month)
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Number of participants with all-cause mortality was reported. |
From Day 1 up to end of study (Up to 4 year 1 month)
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Samarbeidspartnere og etterforskere
Etterforskere
- Studieleder: Janssen Research & Development, LLC Clinical Trial, Janssen Research & Development, LLC
Publikasjoner og nyttige lenker
Generelle publikasjoner
- Doua J, Ekkelenkamp M, Verheij T, Go O, Ruhmel S, Leathers K, Spiessens B, van Rooij S, Fowler VG Jr, Geurtsen J, Dolor R, Sarnecki M, Chatterjee R, Poolman J, Bonten M; on behalf COMBACTE-NET consortium/EXPECT study group. Feasibility of tracking invasive Escherichia coli disease among older adults in a community setting: A prospective observational study. Eur J Clin Microbiol Infect Dis. 2024 Mar;43(3):541-550. doi: 10.1007/s10096-023-04738-y. Epub 2024 Jan 18.
- Doiron RC, Cotechini T, Nickel JC. It's Time to Embrace Vaccination as We Enter the Postantibiotic Era of Recurrent Urinary Tract Infection Management. J Urol. 2024 Jun;211(6):797-799. doi: 10.1097/JU.0000000000003969. Epub 2024 May 5. No abstract available.
- Bonten M, Butler CC, Edwards A, Gravenstein S, Ikeda H, Johansen IS, Lambregts MMC, Matsumoto T, Patterson DL, Rodriguez-Bano J, Saade E, Zingman BS, Day T, Geurtsen J, Hardt K, McLean C, Scheys I, Shukarev G, Guinazu JR, Sarnecki M, Spiessens B, Peeters M, Pau MG, Poolman J, Cohen KA; E.mbrace Study Team. Efficacy, safety, and immunogenicity of a nine-valent vaccine (ExPEC9V) for the prevention of invasive Escherichia coli disease in older adults: a phase 3, randomised, placebo-controlled trial (E.mbrace). Lancet Infect Dis. 2026 Oct 12:S1473-3099(26)00469-X. doi: 10.1016/S1473-3099(26)00469-X. Online ahead of print.
- Shastry R, Shang W, Janssen S, Tete S, Dominguez EG, van den Dobbelsteen G, Davies T, Morrow B. Development and validation of a high-throughput agglutination assay for O-serogrouping clinical Escherichia coli isolates. Microbiol Spectr. 2026 Aug 21:e0099126. doi: 10.1128/spectrum.00991-26. Online ahead of print.
Studierekorddatoer
Studer hoveddatoer
Studiestart (Faktiske)
Primær fullføring (Faktiske)
Studiet fullført (Faktiske)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Faktiske)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Andre studie-ID-numre
- CR109000
- 2020-005273-27 (EudraCT-nummer)
- VAC52416BAC3001 (Annen identifikator: Janssen Research & Development, LLC)
- 2023-506589-30-00 (Registeridentifikator: EUCT number)
- 2023 (U.S. NIH-stipend/kontrakt)
Plan for individuelle deltakerdata (IPD)
Planlegger du å dele individuelle deltakerdata (IPD)?
IPD-planbeskrivelse
The data sharing policy of the Janssen Pharmaceutical Companies of Johnson & Johnson is available at www.janssen.com/clinical-trials/transparency. As noted on this site, requests for access to the study data can be submitted through Yale Open Data Access (YODA) Project site at yoda.yale.edu
Legemiddel- og utstyrsinformasjon, studiedokumenter
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