지난 2년 동안 요로 감염 병력이 있는 60세 이상 성인의 침습성 장외 병원성 대장균 질환 예방을 위한 9가 장외 병원성 대장균 백신(ExPEC9V) 백신 접종에 관한 연구
요로 감염 병력이 있는 60세 이상 성인의 침습성 장외 병원성 대장균 질환 예방에 ExPEC9V 백신 접종의 효능, 안전성 및 면역원성을 평가하기 위한 무작위, 이중 맹검, 위약 대조, 다기관 3상 연구 지난 2년 동안
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.
연구 개요
상태
상태
정황
정황
개입 / 치료
개입 / 치료
상세 설명
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.
연구 유형
연구 유형
등록 (실제)
등록
단계
단계
- 3단계
연락처 및 위치
연구 장소
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Leiden, 네덜란드, 2333 ZA
- Leiden University Medical Center
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Uden, 네덜란드, 5406 PT
- Ziekenhuis
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Utrecht, 네덜란드, 3508 GA
- The Julius Center - Utrecht Science Park - Stratenum
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Auckland, 뉴질랜드, 0600
- Southern Clinical Trials Totara Clinical Research
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Auckland, 뉴질랜드, 0626
- Southern Clinical Trials Ltd
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Auckland, 뉴질랜드, 1011
- Optimal Clinical Trials
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Bay of Plenty, 뉴질랜드, 3112
- Tauranga Urology Research Limited
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Christchurch, 뉴질랜드, 8013
- Canterbury Urology Research Trust
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Christchurch Central, 뉴질랜드, 8013
- Southern Clinical Trials Ltd
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Dunedin, 뉴질랜드, 9016
- P3 Research Ltd
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Hamilton, 뉴질랜드, 3200
- Lakeland Clinical Trials
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Hastings, 뉴질랜드, 4122
- P3 Research Ltd
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Lower Hutt, 뉴질랜드, 5010
- P3 Research - Lower Hutt
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Nelson, 뉴질랜드, 7011
- Southern Clinical Trials Ltd
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Palmerston North, 뉴질랜드, 4414
- P3 Research Ltd
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Papamoa, 뉴질랜드, 3118
- Culloden Research Ltd
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Papatoetoe, 뉴질랜드, 2025
- Middlemore Clinical Trials
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Rosedale, 뉴질랜드, 632
- Optimal Clinical Trials
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Rotorua, 뉴질랜드, 3010
- Lakeland Clinical Trials
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Tauranga, 뉴질랜드, 3110
- P3 Research Ltd
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Upper Hutt, 뉴질랜드, 5018
- Lakeland Clinical Trials
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Wellington, 뉴질랜드, 5032
- P3 Research Limited Kapiti
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Wellington, 뉴질랜드, 6242
- Capatial & Coast District Health Board
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-
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Kaohsiung City, 대만, 813
- Kaohsiung Veterans General Hospital
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Tainan, 대만, 704
- National Cheng Kung University Hospital
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Taoyuan, 대만, 333
- Chang Gung Memorial Hospital Linkou Branch
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Busan, 대한민국, 602 812
- Dong-A University Hospital
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Chuncheon, 대한민국, 24253
- Hallym University Chuncehon Medical Center
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Daejeon, 대한민국, 35015
- Chungnam National University Hospital
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Gwangju, 대한민국, 501-757
- Chunnam National University Hospital
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Gyeonggi-do, 대한민국, 15355
- Korea University Ansan Hospital
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Incheon, 대한민국, 22322
- Inha University Hospital
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Seongnam-si, 대한민국, 13620
- Seoul National University Bundang Hospital
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Seoul, 대한민국, 05505
- Asan Medical Center
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Seoul, 대한민국, 06351
- Samsung Medical Center
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Seoul, 대한민국, 03181
- Kangbuk Samsung Hospital
-
Seoul, 대한민국, 07985
- Ewha Womans University Mokdong Hospital
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Seoul, 대한민국, 8308
- Korea University Guro Hospital
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Seoul, 대한민국, 07441
- Hallym University Sacred Heart Hospital
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Suwon, 대한민국, 16247
- The Catholic university of Korea, St. Vincent's Hospital
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Wŏnju, 대한민국, 220-701
- WonJu Severance Christian Hospital
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-
-
-
-
Hellerup, 덴마크, 2900
- Aalborg Universitetshospital Nord
-
Herlev, 덴마크, 2730
- Gentofte Hospital
-
Hilleroed, 덴마크, 3400
- Nordsjaellands Hospital - Hillerod
-
Hvidovre, 덴마크, 2650
- Hvidovre Hospital
-
Odense M, 덴마크, 5230
- Odense Universitetshospital
-
Roskilde, 덴마크, 4000
- Sjællands University hospital
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-
-
-
-
Frankfurt, 독일, 60590
- Universitatsklinikum Frankfurt
-
Jena, 독일, 07747
- Universitatsklinikum Jena
-
Leipzig, 독일, 04179
- Familienmedizinisches Zentrum Radowsky
-
Leipzig, 독일, 4103
- SIBAmed GmbH & Co. KG
-
Marburg, 독일, 35037
- Universitaetsklinikum Giessen und Marburg GmbH
-
Oldenburg in Holstein, 독일, 23758
- Red-Institut für medizinische Forschung und Fortbildung
-
Reinfeld, 독일, 23858
- Praxis Dr. Weimer
-
Rostock, 독일, 18057
- Universitaetsmedizin Rostock
-
-
-
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Alabama
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Guntersville, Alabama, 미국, 35976
- Lakeview Clinical Research
-
-
Arizona
-
Phoenix, Arizona, 미국, 85018
- Hope Research Institute
-
Phoenix, Arizona, 미국, 85108
- Hope Research Institute
-
Sun City West, Arizona, 미국, 85357
- Interspond-Clinical Research Institute of AZ
-
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Arkansas
-
Little Rock, Arkansas, 미국, 72205
- Baptist Health Center For Clinical Research
-
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California
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Buena Park, California, 미국, 90621
- Sun Urology - Buena Park Office
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Canoga Park, California, 미국, 91303
- Hope clinical Research LLC
-
Chula Vista, California, 미국, 91911
- Velocity Clinical Research, Inc.
-
Huntington Beach, California, 미국, 92647
- Marvel Clinical Research
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La Mesa, California, 미국, 91942
- California Adult Circumcision - Alvarado La Mesa Urology Center
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Lancaster, California, 미국, 93534
- Om Research LLC
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Long Beach, California, 미국, 90806
- Long Beach Clinical Trials, LLC
-
Long Beach, California, 미국, 90806-2766
- Atlantic Urology Medical Group
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Los Angeles, California, 미국, 90027
- Kaiser Permanente Los Angeles Medical Center
-
Los Angeles, California, 미국, 90027
- Southern California Permanente Medical Group
-
Los Angeles, California, 미국, 90017
- American Institute of Research
-
Los Angeles, California, 미국, 90048
- Comprehensive Urology
-
Los Angeles, California, 미국, 90073
- Veterans Affairs Greater Los Angeles HCS
-
Mather, California, 미국, 95655
- VA Sacramento Medical Center
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Newport Beach, California, 미국, 92663
- Hoag Medical Group
-
Oakland, California, 미국, 94612
- Kaiser Permanente Vaccine Study Center
-
Pomona, California, 미국, 91767
- Empire Clinical Research, LLC
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Pomona, California, 미국, 91767
- Inland Urology Medical Group
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Sacramento, California, 미국, 95821
- Northern California Research
-
Sacramento, California, 미국, 92647
- UC Davis Health System
-
San Diego, California, 미국, 92123
- Medical Associates Research Group, Inc.
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San Diego, California, 미국, 92120
- San Diego Sports Medicine & Family Health Center
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San Dimas, California, 미국, 91773
- California Kidney Specialists
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Santa Ana, California, 미국, 92705
- Prestige Medical Group
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Simi Valley, California, 미국, 93065
- Millennium Clinical Trials LLC
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Upland, California, 미국, 91786
- San Antonio Regional Hospital
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Connecticut
-
New Haven, Connecticut, 미국, 06510
- Yale University
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Florida
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Adventura, Florida, 미국, 33180
- Ideal Clinical Research
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Bay Pines, Florida, 미국, 33744
- Bay Pines VA Healthcare System
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Bradenton, Florida, 미국, 34209
- Nova Clinical Research, LLC
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Brandon, Florida, 미국, 33511
- Clinical Research of Brandon
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Brandon, Florida, 미국, 33511
- Moore Clinical Reseach - Brandon Clinic
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Clearwater, Florida, 미국, 33756
- Innovative Research of West Florida, Incorporated
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Clearwater, Florida, 미국, 33755
- Florida Medical Center of Clearwater
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Coral Gables, Florida, 미국, 33134
- Advanced Clinical Research Network
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Coral Gables, Florida, 미국, 33134
- Prestige Clinical Research Center, Inc.
-
DeLand, Florida, 미국, 32720
- Accel Research Sites
-
Doral, Florida, 미국, 33166
- Doral Medical Research
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Doral, Florida, 미국, 33166
- Universal Axon Clinical Research
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Gainesville, Florida, 미국, 32607
- Florida Medical Research Institute
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Hialeah, Florida, 미국, 33012
- Indago Research & Health Center Inc
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Homestead, Florida, 미국, 33030
- Prestige Clinical Research
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Lake City, Florida, 미국, 32055
- Multi Specialty Research Associates Inc
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Maitland, Florida, 미국, 32751
- ClinCloud Clinical Research
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Miami, Florida, 미국, 33126
- Finlay Medical Research
-
Miami, Florida, 미국, 33135
- Suncoast Research Group
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Miami, Florida, 미국, 33155
- Florida International Medical Research
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Miami, Florida, 미국, 33144
- Dynamic Medical Research, LLC
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Miami, Florida, 미국, 33185
- Felicidad Medical Research
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Miami, Florida, 미국, 33124
- Nova Clinical Research Center
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Miami, Florida, 미국, 33133
- Royal Care Medical Research Corporation
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Miami, Florida, 미국, 33135
- Retreat Medical Research LLC
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Miami, Florida, 미국, 33144-4273
- Continental Research
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Miami, Florida, 미국, 33155
- Health- Life Research Inst
-
Miami, Florida, 미국, 33155
- Office of Dr. Marisela Gonzalez
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Miami, Florida, 미국, 33186
- A and R Research Group
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Miami, Florida, 미국, 33186
- Alpha Science Research
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Orlando, Florida, 미국, 32808
- Omega Research Consultants
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Orlando, Florida, 미국, 32801
- Clinical NeuroScience Solutions Inc
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Pembroke Pines, Florida, 미국, 33024
- Pines Care Research Center Inc
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Plant City, Florida, 미국, 33563
- Clinical Research of Central Florida
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Spring Hill, Florida, 미국, 34609
- Care Access Research
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Tampa, Florida, 미국, 33615
- Santos Research Center
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Tampa, Florida, 미국, 33614
- St. Joseph's Comprehensive Research Institute
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Tampa, Florida, 미국, 33603
- Tampa General Hospital
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Tampa, Florida, 미국, 33613
- Theia Clincial Research, LLC
-
Tampa, Florida, 미국, 33614
- Precision Research Institute
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Tampa, Florida, 미국, 33625
- Care Access Research
-
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Georgia
-
Atlanta, Georgia, 미국, 30328
- Agile Clinical Research Trials, LLC
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Columbus, Georgia, 미국, 31904
- Columbus Regional Research Institute
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Decatur, Georgia, 미국, 30033
- Atlanta VA Medical Center
-
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Idaho
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Idaho Falls, Idaho, 미국, 83404
- Clinical Research Prime
-
Idaho Falls, Idaho, 미국, 83404
- Snake River Research, PLLC
-
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Illinois
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Chicago, Illinois, 미국, 60612
- Jesse Brown VAMC Department of Surgery
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Chicago, Illinois, 미국, 60611
- Northwestern Medicine - Northwestern Memorial Hospital Galter Pavilion
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Chicago, Illinois, 미국, 60612
- University Of Illinois
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Indiana
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Evansville, Indiana, 미국, 47714
- Medisphere Medical Research Center, Llc
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Hammond, Indiana, 미국, 46324
- Asha Clinical Research-Munster Llc
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Mishawaka, Indiana, 미국, 46544
- Mishawaka Osteopathic Clinic/MOC Research
-
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Kansas
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Wichita, Kansas, 미국, 67226
- Cypress Medical Research Center
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-
Louisiana
-
Marrero, Louisiana, 미국, 70072
- Tandem Clinical Research
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Natchitoches, Louisiana, 미국, 71457
- KAMP Medical Research, Inc
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New Orleans, Louisiana, 미국, 70121
- Ochsner Medical Center
-
-
Maryland
-
Rockville, Maryland, 미국, 20852
- Kaiser Permanente
-
-
Massachusetts
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Boston, Massachusetts, 미국, 02111
- Floating Hospital For Children at Tufts Medical Center
-
West Roxbury, Massachusetts, 미국, 02132-4927
- West Roxbury Veterans Affairs Medical Center
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-
Michigan
-
Detroit, Michigan, 미국, 48202
- Henry Ford Hospital
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Royal Oak, Michigan, 미국, 48073
- William Beaumont Hospital
-
-
Mississippi
-
Petal, Mississippi, 미국, 39465
- MediSync Clinical Research
-
-
Nebraska
-
Grand Island, Nebraska, 미국, 68803
- Meridian Clinical Research, LLC
-
Lincoln, Nebraska, 미국, 68516
- Be Well Clinical Studies
-
Norfolk, Nebraska, 미국, 68701
- Meridian Clinical Research, LLC
-
-
Nevada
-
Las Vegas, Nevada, 미국, 89106
- Sierra Clinical Research
-
Las Vegas, Nevada, 미국, 89109
- Excel Clinical Research
-
Las Vegas, Nevada, 미국, 89106
- Hope Research Institute
-
Reno, Nevada, 미국, 89509
- VA Sierra Nevada Health Care System
-
-
New Jersey
-
Hillsborough, New Jersey, 미국, 08844
- I.D. Care, Inc.
-
Teaneck, New Jersey, 미국, 07666
- Holy Name Medical Center
-
-
New York
-
Binghamton, New York, 미국, 13901
- Meridian Clinical Research, LLC
-
Endwell, New York, 미국, 13760
- Meridian Clinical Research, LLC
-
New York, New York, 미국, 10016
- Manhattan Medical Research
-
The Bronx, New York, 미국, 10467
- Montefiore Medical Center
-
-
North Carolina
-
Durham, North Carolina, 미국, 27705
- Durham VAMC
-
Fayetteville, North Carolina, 미국, 28303
- Carolina Institute for Clinical Research
-
Greenville, North Carolina, 미국, 27834
- ECU Health Vidant Medical Center
-
-
North Dakota
-
Fargo, North Dakota, 미국, 58104
- Plains Clinical Research
-
-
Ohio
-
Centerville, Ohio, 미국, 45458
- Kroger Health
-
Cleveland, Ohio, 미국, 44106
- University Hospitals Cleveland Medical Center
-
Columbus, Ohio, 미국, 43215
- Remington Davis Inc
-
Englewood, Ohio, 미국, 45322
- Kroger Health
-
Englewood, Ohio, 미국, 45322
- The Little Clinic
-
Wooster, Ohio, 미국, 44691
- Comprehensive Internal Medicine
-
-
Oklahoma
-
Yukon, Oklahoma, 미국, 73099
- Tekton Research Inc.
-
-
Oregon
-
Portland, Oregon, 미국, 97227
- Kaiser Permanente
-
-
Pennsylvania
-
Camp Hill, Pennsylvania, 미국, 17011
- Capital Area Research
-
West Reading, Pennsylvania, 미국, 19611
- Reading Hospital
-
-
South Carolina
-
Charleston, South Carolina, 미국, 29412
- Hugh D. Durrence, MD, PC
-
Little River, South Carolina, 미국, 29566
- Waterway Familiy Medicine
-
-
Texas
-
Bellaire, Texas, 미국, 77401
- Novel Research LLC
-
Dallas, Texas, 미국, 75246
- North Texas Infectious Diseases Consultants
-
Dallas, Texas, 미국, 75230
- Medical City Dallas
-
Dallas, Texas, 미국, 75224
- Global Medical Research - Dallas
-
Houston, Texas, 미국, 77024
- Digestive Health Associates
-
Lewisville, Texas, 미국, 75057
- EPIC Clinical Research
-
Mesquite, Texas, 미국, 75149
- SMS Clinical Research LLC
-
Round Rock, Texas, 미국, 78681
- Be Well Clinical Studies
-
San Antonio, Texas, 미국, 78229
- Audie L Murphy Memorial Va Ho
-
Sherman, Texas, 미국, 75092
- Sherman Clinical Research
-
-
Utah
-
Draper, Utah, 미국, 84020
- Lone Peak Family Medicine
-
-
Virginia
-
Annandale, Virginia, 미국, 22003-7347
- Clinical Alliance for Research and Education
-
Charlottesville, Virginia, 미국, 22911
- Charlottesville Medical Research Center, LLC
-
Lynchburg, Virginia, 미국, 24501
- Infectious Disease Associates of Central Virginia
-
Suffolk, Virginia, 미국, 23435
- IACT - Suffolk Multispecialty Research
-
Winchester, Virginia, 미국, 22601
- Selma Medical Associates
-
-
Washington
-
Cheney, Washington, 미국, 99004
- Multicare Institute For Research & Innovation - Rockwood Clinic - Cheney
-
-
West Virginia
-
Morgantown, West Virginia, 미국, 26505
- Exemplar Research, Inc
-
-
Wisconsin
-
Marshfield, Wisconsin, 미국, 54449
- Marshfield Clinic
-
-
-
-
-
Helsingborg, 스웨덴, 25187
- Helsingborgs lasarett
-
Karlskrona, 스웨덴, 37179
- BTH Research & Development Clinic
-
Linkoaping, 스웨덴, 582 13
- CTC Ebbepark
-
Malmö, 스웨덴, 21428
- Skanes universitetssjukhus
-
Mölndal, 스웨덴, 43153
- CTC GoCo
-
Solna, 스웨덴, 171 64
- ClinSmart Sweden AB
-
Uppsala, 스웨덴, 752 37
- ClinSmart Sweden AB
-
Örebro, 스웨덴, 70362
- Universitetssjukhuset Orebro
-
-
-
-
-
Alicante, 스페인, 3010
- Hosp. Gral. Univ. Dr. Balmis
-
Barcelona, 스페인, 8003
- Hosp. Del Mar
-
Barcelona, 스페인, 08907
- Hosp. Univ. de Bellvitge
-
Barcelona, 스페인, 08036
- Hosp Clinic de Barcelona
-
Barcelona, 스페인, 8028
- Consorci D'Atenció Primària de Salut Barcelona Esquerra
-
Córdoba, 스페인, 14004
- Hosp Reina Sofia
-
Girona, 스페인, 17007
- Hosp. Univ. Dr. Josep Trueta
-
Jerez de la Frontera, 스페인, 11407
- Hosp. de Jerez de La Frontera
-
La Roca del Vallès, 스페인, 8430
- CAP Dr. Vicenç Papaceit ABS LA ROCA
-
Madrid, 스페인, 28046
- Hosp. Univ. La Paz
-
Madrid, 스페인, 28006
- Hosp. Univ. de La Princesa
-
Madrid, 스페인, 28660
- Hosp. Univ. Hm Monteprincipe
-
Madrid, 스페인, 28050
- Hospital Sanitas La Moraleja
-
Málaga, 스페인, 29004
- Hosp. Quirónsalud Málaga
-
Ourense, 스페인, 32005
- Complexo Hosp. Univ. de Ourense
-
Palma de Mallorca, 스페인, 07120
- Hosp. Univ. Son Espases
-
Sabadell, 스페인, 08208
- Corporacio Sanitari Parc Tauli
-
Seville, 스페인, 41009
- Hosp. Virgen Macarena
-
Vigo, 스페인, 36312
- Hosp. Alvaro Cunqueiro
-
-
-
-
-
Aberdeen, 영국, AB25 2ZN
- Aberdeen Royal Infirmary
-
Atherstone, 영국, CV9 1EU
- Atherstone Surgery
-
Banbury, 영국, OX16 9AD
- Banbury Cross Health Center
-
Birkenhead, 영국, CH62 6EE
- FutureMeds Bridle Clinic
-
Birmingham, 영국, B21 0RY
- FutureMeds-Soho UK
-
Blackpool, 영국, FY3 8NR
- Blackpool Teaching Hospitals NHS Foundation Trust
-
Bournemouth, 영국, BH7 7DW
- Royal Bournemouth Hospital
-
Bristol, 영국, BS10 5NB
- North Bristol NHS Trust
-
Bristol, 영국, BS2 8BJ
- University Hospitals Bristol NHS Trust
-
Exeter, 영국, EX2 5DW
- Royal Devon & Exeter NHS Foundation Trust
-
Eynsham, 영국, OX29 4QB
- Eynsham Medical Centre
-
Guisborough, 영국, TS14 7DJ
- The Garth Surgery
-
Leicester, 영국, LE1 5WW
- University Hospitals Of Leicester Nhs Trust
-
London, 영국, SE5 9RS
- King's College Hospital NHS Foundation Trust
-
Manchester, 영국, M13 9WL
- Manchester Royal Infirmary
-
Manchester, 영국, M23 9LT
- The NIHR Manchester Clinical Research Facility
-
Middlesbrough, 영국, TS4 3BW
- South Tees Hospitals NHS Foundation Trust
-
Nottingham, 영국, NG7 2UH
- Nottingham University Hospitals NHS Trust
-
Plymouth, 영국, PL6 8DH
- Plymouth University Hospitals Trust
-
Pontypridd, 영국, CF37 2DR
- Ashgrove Surgery
-
Poole, 영국, BH15 4JQ
- The Adam Practice
-
Sheffield, 영국, S10 2 JF
- Sheffield Teaching Hospitals NHS Foundation Trust
-
Stafford, 영국, ST16 3SR
- Midlands Partnership NHS Foundation Trust
-
Stockton-on-Tees, 영국, TS19 8PE
- North Tees Furturemeds
-
Wakefield, 영국, WF1 4DG
- Mid Yorkshire Hospital NHS Trust- Pinderfields Hospital
-
Wantage, 영국, OX12 9BN
- Church Street Practice
-
Witney, 영국, OX28 6JS
- Windrush Medical Practice
-
-
-
-
-
Ashdod, 이스라엘, 7747629
- Samson Assuta Ashdod University Hospital
-
Jerusalem, 이스라엘, 9112001
- Hadassah Medical Center
-
Kfar Saba, 이스라엘, 44281
- Meir Medical Center
-
Ramat Gan, 이스라엘, 52621
- The Chaim Sheba Medical Center
-
Tel Aviv, 이스라엘, 6423906
- Tel Aviv Sourasky Medical Center
-
-
-
-
-
Chieti, 이탈리아, 66100
- ASL2 Lanciano - Vasto - Chieti - Ospedale 'SS Annunziata' di Chieti
-
Roma, 이탈리아, 00144
- Istituto Nazionale Tumori Regina Elena
-
Rome, 이탈리아, 00189
- Azienda Ospedaliera Sant Andrea
-
-
-
-
-
Belagavi, 인도, 590010
- KLE's Dr. Prabhakar Kore Hospital & Medical Research Centre (MRC)
-
Jaipur, 인도, 302006
- S. R. Kalla Memorial General Hospital
-
Kolkata, 인도, 700014
- Nil Ratan Sircar Medical College and Hospital
-
Lucknow, 인도, 226022
- Regency health super specialty hospital
-
Mumbai, 인도, 421203
- Asian Institute Of Medical Science
-
Mysuru, 인도, 570015
- Jagadguru Sri Shivarathreeshwara Academy of Higher Education and Research
-
New Delhi, 인도, 1100776
- Indraprastha Apollo Hospital
-
Rajkot, 인도, 360004
- Shree Giriraj Multispeciality Hospital
-
Surat, 인도, 395009
- BAPS Pramukhswami Hospital
-
Surat, 인도, 395002
- Nirmal Hospital Pvt. Ltd.
-
-
-
-
-
Akashi Shi, 일본, 674 0063
- Akashi Medical Center
-
Fukuoka, 일본, 811-0213
- Fukuoka Wajiro Hospital
-
Fukuoka, 일본, 807-0051
- Fukuoka Shinmizumaki Hospital
-
Hakodate, 일본, 040 8611
- Hakodate Goryoukaku Hospital
-
Hashima-gun, 일본, 5016062
- Matsunami General Hospital
-
Hokkaido, 일본, 006-8555
- Teine Keijinkai Hospital
-
Iizuka, 일본, 820-8501
- Aso Co.,Ltd Iizuka Hospital
-
Itoshima, 일본, 8191104
- Inoue Hospital
-
Kasuya-gun, 일본, 811-3112
- Kano Hospital
-
Kawasaki, 일본, 211-8510
- Kanto Rosai Hospital
-
Kitakyushu, 일본, 800-0057
- Shinkomonji hospital
-
Kitakyushu, 일본, 8000295
- Japan Community Health care Organization Kyushu Hospital
-
Nagasaki, 일본, 852-8511
- JRC Nagasaki Genbaku Hospital
-
Neyagawa, 일본, 572-8567
- Kyoujinkai Clinic Komatsu
-
Omuta-Shi, 일본, 836-0861
- Omuta City Hospital
-
Osaka, 일본, 5340024
- Kyobashi Sugimoto Clinic
-
Osaka, 일본, 5530003
- Japan Community Health Care Organization Osaka Hospital
-
Sanuki, 일본, 7692393
- National Hospital Organization Shikoku Cancer Center
-
Sapporo, 일본, 006-0812
- Teine Maeda Urology Clinic
-
Sapporo, 일본, 0060816
- Teine Urological Clinic
-
Shimajiri-Gun, 일본, 9010493
- Nanbu Tokushukai Hospital
-
Shimonoseki-shi, 일본, 7500061
- Shimonoseki City Hospital
-
Shinagawa City, 일본, 1408522
- Tokyo Shinagawa Hospital
-
Suita-Shi, 일본, 5650814
- Suita Tokushukai Hospital
-
Suwa-Shi, 일본, 3928510
- Japanese Red Cross Society Suwa Hospital
-
Yahatanishi-ku, 일본, 806-8501
- Japan Community Health care Organization Kyushu Hospital
-
Yamaguchi, 일본, 750-0041
- Shimonoseki City Hospital
-
Yokohama, 일본, 222-0036
- Yokohama Rosai Hospital
-
Yokohama, 일본, 245-8575
- National Hospital Organization Yokohama Medical Center
-
Ōita, 일본, 8700039
- Abe Diabetes Clinic
-
Ōita, 일본, 8701195
- Almeida Memorial Hospital
-
Ōmura, 일본, 856-8562
- National Hospital Organization Nagasaki Medical Center
-
-
-
-
-
Chengdu, 중국, 610041
- West China School of Medicine/West China Hospital, Sichuan University
-
Fuyang, 중국, 236399
- Funan Center for Disease Control and Prevention
-
Guangzhou, 중국, 510120
- The First Affiliated Hospital of Guangzhou Medical University
-
Guangzhou, 중국, 510260
- The Second Affiliated Hospital of Guangzhou Medical University
-
Hangzhou, 중국, 310003
- 1st Affiliated Hospital of Zhejiang University Medical College
-
Hefei, 중국, 230601
- Anhui Provincial Center for Disease Control and Prevention
-
Liuan, 중국, 237400
- Huoqiu County Center For Disease Control and Prevention
-
Nanjing, 중국, 210009
- Jiangsu Provincial Center for Disease Control and Prevention
-
Nanjing, 중국, 211112
- Nanjing Medical University
-
Shanghai, 중국, 200040
- Huashan Hospital affiliated to Fudan University
-
Suzhou, 중국, 215002
- Suzhou Municipal Hospital
-
Taizhou, 중국, 225300
- Taizhou Peoples Hospital
-
Wuxi, 중국, 214200
- Yixing People's Hospital
-
-
-
-
-
Brno, 체코, 61500
- Uromeda
-
Dolní Břežany, 체코, 252 41
- Aesculap Ambulance sro - Zdravotni Stredisko Centrum Zdravi
-
Hradec Králové, 체코, 50002
- Centrum Ockovani a Cestovi Mediciny
-
Nový Knín, 체코, 262 03
- Res Medica
-
Olomouc, 체코, 77900
- PreventaMed, s.r.o.
-
Ostrava-Proskovice, 체코, 72400
- GYNURO s.r.o
-
Pilsen, 체코, 30100
- Ambulance name: Gynekologická ordinace MUDr
-
Pilsen, 체코, 323 00
- MUDr. Mita Rosenberg
-
Prague, 체코, 13000
- Gona s.R.o- Orfinace Harov
-
Protivín, 체코, 39811
- Zdravi-fit, s.r.o.
-
Slaný, 체코, 274 01
- Nemocnice Slany
-
Vysoké Mýto, 체코, 56601
- Progerint s.r.o.
-
České Budějovice, 체코, 37001
- Ordinace Hradebni s.r.o.
-
-
-
-
Alberta
-
Calgary, Alberta, 캐나다, T4P 1K4
- CARe Clinical Ltd
-
Edmonton, Alberta, 캐나다, T6G121
- University of Alberta
-
Red Deer, Alberta, 캐나다, T4P 1K4
- CARe Clinical Ltd
-
-
British Columbia
-
Vancouver, British Columbia, 캐나다, V6Z2C7
- Vancouver ID Research and Care Centre Society
-
-
Ontario
-
Greater Sudbury, Ontario, 캐나다, P3E 5J1
- Health Sciences North
-
Guelph, Ontario, 캐나다, N1H 1B1
- Dawson Road Family Health Team
-
Sarnia, Ontario, 캐나다, N7T 4X3
- Bluewater Clinical Research Group Inc.
-
Winchester, Ontario, 캐나다, K0C2K0
- Winchester District Memorial Hospital
-
-
Quebec
-
Québec, Quebec, 캐나다, G2J 0C4
- Alpha Recherche Clinique
-
Québec, Quebec, 캐나다, G3K 2P8
- Alpha Recherche Clinique
-
-
-
-
-
Barranquilla, 콜롬비아
- Centro de Investigaciones y Proyectos en Neurociencias CIPNA
-
Barranquilla, 콜롬비아, 080001
- Clinica de la Costa
-
Barranquilla, 콜롬비아, 80020
- IPS Centro Cientifico Asisitencial Jose Luis Accini S.A.S.
-
Casanare, 콜롬비아, 856010
- Centro de Atencion e Investigacion Medica S.A. - CAIMED
-
Floridablanca, 콜롬비아
- Fundacion Cardiovascular de Colombia
-
Girardot, 콜롬비아, 252432
- Centro de Atencion e Investigacion Medica S.A. - CAIMED
-
Helechos, 콜롬비아
- Centro de Atencion e Investigacion Medica S.A. - CAIMED
-
Manizales, 콜롬비아, 170001
- Asociacion IPS Medicos Internistas de Caldas
-
Meta, 콜롬비아, 507001
- CAIMED Acacias
-
Pereira, 콜롬비아, 660003
- Fundacion Centro de Investigaciones Clinicas IPS Cardiomet
-
Villavicencio, 콜롬비아, 500001
- Corporación Clínica Universidad Cooperativa De Colombia Clínica Ucc
-
-
-
-
-
Bangkok, 태국, 10330
- King Chulalongkorn Memorial Hospital
-
Bangkok, 태국, 10700
- Siriraj Hospital
-
Bangkok, 태국, 10400
- Ramathibodi Hospital
-
Bangkok, 태국, 10400
- Tropical Medicine Hospital, Mahidol University
-
Bangkok, 태국, 10330
- Thai Red Cross Aids Research Centre
-
-
-
-
-
Annecy, 프랑스, 74370
- Centre Hospitalier Annecy Genevois
-
Dijon, 프랑스, 21000
- CHU Dijon Bourgogne - Hopital Francois Mitterrand
-
Limousis, 프랑스, 87042
- CHU de Limoges
-
Lyon, 프랑스, 69004
- Hopital de La Croix Rousse
-
Nîmes, 프랑스, 30029
- CHU Nimes Hopital Caremeau
-
Pierre-Bénite, 프랑스, 69495
- Centre hospitalier Lyon-Sud
-
Saint-Priest-en-Jarez, 프랑스, 42270
- CHU Saint Etienne Hopital Nord
-
-
-
-
-
Brisbane, 호주, 4001
- Saint Andrew's War Memorial Hospital
-
Campbelltown, 호주, 5074
- GP Surgery - Campbelltown
-
Geelong, 호주, 3220
- Barwon Health - University Hospital Geelong
-
Melbourne, 호주, 5000
- CMAX Clinical Research
-
New Lambton, 호주, 2305
- John Hunter Hospital
-
Palmyra DC, 호주, 6961
- Fiona Stanley Hospital
-
Para Hills West, 호주, 5096
- McIntyre Medical Center
-
Salisbury, 호주, 5108
- North West Medical Center
-
South Brisbane, 호주, 4101
- Mater Medical Centre South Brisbane
-
St Agnes, 호주, 5097
- Bene Aged Care - Italian Village
-
Sydney, 호주, 2145
- Westmead Hospital
-
Taringa, 호주, 4068
- AusTrials Pty Ltd
-
Tarragindi, 호주, 4121
- AusTrials Pty Ltd
-
Woodville, 호주, 5011
- Adelaide Medical Solutions
-
-
참여기준
자격 기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
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
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 방지
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 더블
팔의 수
무기와 개입
참가자 그룹 / 팔참가자 그룹 / 팔 |
개입 / 치료개입 / 치료 |
|---|---|
|
실험적: 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.
다른 이름들:
|
|
위약 비교기: Placebo
Participants will receive a single IM injection of matching placebo on Day 1. |
Matching placebo will be administered as an IM injection. |
연구는 무엇을 측정합니까?
주요 결과 측정
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
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
기간: 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)
|
2차 결과 측정
2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: From 29 days after vaccination on Day 1 (Day 30) up to Day 1296 (Day of futility announcement)
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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)
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Number of Participants With First Occurrence of Pyelonephritis Event Per Adjudication Caused by E. Coli
기간: From 29 days after vaccination on Day 1 (Day 30) up to Day 1296 (Day of futility announcement)
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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)
|
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Number of Participants With First Occurrence of UTI Event Per CCD Caused by E. Coli
기간: From 29 days after vaccination on Day 1 (Day 30) up to Day 1296 (Day of futility announcement)
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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
기간: 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
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Geometric Mean Titers (GMTs) to Vaccine O-serotype Antigens as Determined by Multiplex Opsonophagocytic Killing Assay (MOPA)
기간: 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
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Number of Participants With Solicited Local Adverse Events (AEs)
기간: 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
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Number of Participants With Solicited Systemic Adverse Events
기간: 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
|
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Number of Participants With Unsolicited Adverse Events
기간: 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)
기간: From Day 1 (post vaccination) up to Day 181
|
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
기간: Baseline, Day 15, Day 30, Day 181, Year 1, Year 2, and Year 3
|
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
기간: 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)
기간: 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
기간: Day 1, Year 1, Year 2, and Year 3
|
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
기간: From Day 1 up to Day 1296 (Day of futility announcement)
|
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
기간: 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
기간: From Day 1 up to Day 1296 (Day of futility announcement)
|
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)
|
|
Number of Participants With UTI, or ABP Events Per CCD That Required Hospitalization Caused by ExPEC9V O-Serotype
기간: From Day 1 up to Day 1296 (Day of futility announcement)
|
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)
|
|
Duration of Stay in Hospital for Invasive Escherichia Coli Disease (IED) Events Per CCD Caused by ExPEC9V O-Serotype
기간: From Day 1 up to Day 1296 (Day of futility announcement)
|
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)
|
|
Duration of Stay in Hospital for UTI, or ABP Events Per CCD Caused by ExPEC9V O-Serotype
기간: From Day 1 up to Day 1296 (Day of futility announcement)
|
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)
|
|
Number of Participants With Invasive Escherichia Coli Disease (IED) Events Per CCD That Required Intensive Care Unit (ICU) Hospitalization Caused by ExPEC9V O-Serotype
기간: From Day 1 up to Day 1296 (Day of futility announcement)
|
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)
|
|
Number of Participants With UTI, or ABP Events Per CCD That Required Intensive Care Unit (ICU) Hospitalization Caused by ExPEC9V O-Serotype
기간: From Day 1 up to Day 1296 (Day of futility announcement)
|
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)
|
|
Duration of ICU Stay in Hospital for IED Events Per CCD Caused by ExPEC9V O-Serotype
기간: From Day 1 up to Day 1296 (Day of futility announcement)
|
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)
|
|
Duration of ICU Stay in Hospital for UTI, or ABP Events Per CCD Caused by ExPEC9V O-Serotype
기간: From Day 1 up to Day 1296 (Day of futility announcement)
|
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)
|
|
Number of Participants With IED-related Mortality
기간: 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)
|
|
Number of Participants With All-cause Mortality
기간: From Day 1 up to end of study (Up to 4 year 1 month)
|
Number of participants with all-cause mortality was reported. |
From Day 1 up to end of study (Up to 4 year 1 month)
|
공동 작업자 및 조사자
수사관
수사관
- 연구 책임자: Janssen Research & Development, LLC Clinical Trial, Janssen Research & Development, LLC
간행물 및 유용한 링크
일반 간행물
- 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.
연구 기록 날짜
연구 주요 날짜
연구 시작 (실제)
연구 시작
기본 완료 (실제)
기본 완료
연구 완료 (실제)
연구 완료
연구 등록 날짜
최초 제출
최초 제출
QC 기준을 충족하는 최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (실제)
처음 게시됨
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
마지막 업데이트 게시됨
QC 기준을 충족하는 마지막 업데이트 제출
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
마지막으로 확인됨
추가 정보
이 연구와 관련된 용어
기타 연구 ID 번호
기타 연구 ID 번호
- CR109000
- 2020-005273-27 (EudraCT 번호)
- VAC52416BAC3001 (기타 식별자: Janssen Research & Development, LLC)
- 2023-506589-30-00 (레지스트리 식별자: EUCT number)
- 2023 (미국 NIH 보조금/계약)
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
IPD 계획 설명
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
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
미국 FDA 규제 기기 제품 연구
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