過去 2 年間に尿路感染症の既往がある 60 歳以上の成人における侵襲性腸管外病原性大腸菌疾患の予防における 9 価の腸管外病原性大腸菌ワクチン (ExPEC9V) によるワクチン接種の研究
尿路感染症の既往のある60歳以上の成人における侵襲性腸管外病原性大腸菌疾患の予防におけるExPEC9Vワクチン接種の有効性、安全性および免疫原性を評価するための無作為化、二重盲検、プラセボ対照、多施設第3相試験過去2年間
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.
調査の概要
状態
状態
条件
条件
介入・治療
介入・治療
詳細な説明
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.
研究の種類
研究の種類
入学 (実際)
入学
段階
段階
- フェーズ 3
連絡先と場所
研究場所
-
-
Alabama
-
Guntersville、Alabama、アメリカ、35976
- Lakeview Clinical Research
-
-
Arizona
-
Phoenix、Arizona、アメリカ、85018
- Hope Research Institute
-
Phoenix、Arizona、アメリカ、85108
- Hope Research Institute
-
Sun City West、Arizona、アメリカ、85357
- Interspond-Clinical Research Institute of AZ
-
-
Arkansas
-
Little Rock、Arkansas、アメリカ、72205
- Baptist Health Center For Clinical Research
-
-
California
-
Buena Park、California、アメリカ、90621
- Sun Urology - Buena Park Office
-
Canoga Park、California、アメリカ、91303
- Hope clinical Research LLC
-
Chula Vista、California、アメリカ、91911
- Velocity Clinical Research, Inc.
-
Huntington Beach、California、アメリカ、92647
- Marvel Clinical Research
-
La Mesa、California、アメリカ、91942
- California Adult Circumcision - Alvarado La Mesa Urology Center
-
Lancaster、California、アメリカ、93534
- Om Research LLC
-
Long Beach、California、アメリカ、90806
- Long Beach Clinical Trials, LLC
-
Long Beach、California、アメリカ、90806-2766
- Atlantic Urology Medical Group
-
Los Angeles、California、アメリカ、90027
- Kaiser Permanente Los Angeles Medical Center
-
Los Angeles、California、アメリカ、90027
- Southern California Permanente Medical Group
-
Los Angeles、California、アメリカ、90017
- American Institute of Research
-
Los Angeles、California、アメリカ、90048
- Comprehensive Urology
-
Los Angeles、California、アメリカ、90073
- Veterans Affairs Greater Los Angeles HCS
-
Mather、California、アメリカ、95655
- VA Sacramento Medical Center
-
Newport Beach、California、アメリカ、92663
- Hoag Medical Group
-
Oakland、California、アメリカ、94612
- Kaiser Permanente Vaccine Study Center
-
Pomona、California、アメリカ、91767
- Empire Clinical Research, LLC
-
Pomona、California、アメリカ、91767
- Inland Urology Medical Group
-
Sacramento、California、アメリカ、95821
- Northern California Research
-
Sacramento、California、アメリカ、92647
- UC Davis Health System
-
San Diego、California、アメリカ、92123
- Medical Associates Research Group, Inc.
-
San Diego、California、アメリカ、92120
- San Diego Sports Medicine & Family Health Center
-
San Dimas、California、アメリカ、91773
- California Kidney Specialists
-
Santa Ana、California、アメリカ、92705
- Prestige Medical Group
-
Simi Valley、California、アメリカ、93065
- Millennium Clinical Trials LLC
-
Upland、California、アメリカ、91786
- San Antonio Regional Hospital
-
-
Connecticut
-
New Haven、Connecticut、アメリカ、06510
- Yale University
-
-
Florida
-
Adventura、Florida、アメリカ、33180
- Ideal Clinical Research
-
Bay Pines、Florida、アメリカ、33744
- Bay Pines VA Healthcare System
-
Bradenton、Florida、アメリカ、34209
- Nova Clinical Research, LLC
-
Brandon、Florida、アメリカ、33511
- Clinical Research of Brandon
-
Brandon、Florida、アメリカ、33511
- Moore Clinical Reseach - Brandon Clinic
-
Clearwater、Florida、アメリカ、33756
- Innovative Research of West Florida, Incorporated
-
Clearwater、Florida、アメリカ、33755
- Florida Medical Center of Clearwater
-
Coral Gables、Florida、アメリカ、33134
- Advanced Clinical Research Network
-
Coral Gables、Florida、アメリカ、33134
- Prestige Clinical Research Center, Inc.
-
DeLand、Florida、アメリカ、32720
- Accel Research Sites
-
Doral、Florida、アメリカ、33166
- Doral Medical Research
-
Doral、Florida、アメリカ、33166
- Universal Axon Clinical Research
-
Gainesville、Florida、アメリカ、32607
- Florida Medical Research Institute
-
Hialeah、Florida、アメリカ、33012
- Indago Research & Health Center Inc
-
Homestead、Florida、アメリカ、33030
- Prestige Clinical Research
-
Lake City、Florida、アメリカ、32055
- Multi Specialty Research Associates Inc
-
Maitland、Florida、アメリカ、32751
- ClinCloud Clinical Research
-
Miami、Florida、アメリカ、33126
- Finlay Medical Research
-
Miami、Florida、アメリカ、33135
- Suncoast Research Group
-
Miami、Florida、アメリカ、33155
- Florida International Medical Research
-
Miami、Florida、アメリカ、33144
- Dynamic Medical Research, LLC
-
Miami、Florida、アメリカ、33185
- Felicidad Medical Research
-
Miami、Florida、アメリカ、33124
- Nova Clinical Research Center
-
Miami、Florida、アメリカ、33133
- Royal Care Medical Research Corporation
-
Miami、Florida、アメリカ、33135
- Retreat Medical Research LLC
-
Miami、Florida、アメリカ、33144-4273
- Continental Research
-
Miami、Florida、アメリカ、33155
- Health- Life Research Inst
-
Miami、Florida、アメリカ、33155
- Office of Dr. Marisela Gonzalez
-
Miami、Florida、アメリカ、33186
- A and R Research Group
-
Miami、Florida、アメリカ、33186
- Alpha Science Research
-
Orlando、Florida、アメリカ、32808
- Omega Research Consultants
-
Orlando、Florida、アメリカ、32801
- Clinical NeuroScience Solutions Inc
-
Pembroke Pines、Florida、アメリカ、33024
- Pines Care Research Center Inc
-
Plant City、Florida、アメリカ、33563
- Clinical Research of Central Florida
-
Spring Hill、Florida、アメリカ、34609
- Care Access Research
-
Tampa、Florida、アメリカ、33615
- Santos Research Center
-
Tampa、Florida、アメリカ、33614
- St. Joseph's Comprehensive Research Institute
-
Tampa、Florida、アメリカ、33603
- Tampa General Hospital
-
Tampa、Florida、アメリカ、33613
- Theia Clincial Research, LLC
-
Tampa、Florida、アメリカ、33614
- Precision Research Institute
-
Tampa、Florida、アメリカ、33625
- Care Access Research
-
-
Georgia
-
Atlanta、Georgia、アメリカ、30328
- Agile Clinical Research Trials, LLC
-
Columbus、Georgia、アメリカ、31904
- Columbus Regional Research Institute
-
Decatur、Georgia、アメリカ、30033
- Atlanta VA Medical Center
-
-
Idaho
-
Idaho Falls、Idaho、アメリカ、83404
- Clinical Research Prime
-
Idaho Falls、Idaho、アメリカ、83404
- Snake River Research, PLLC
-
-
Illinois
-
Chicago、Illinois、アメリカ、60612
- Jesse Brown VAMC Department of Surgery
-
Chicago、Illinois、アメリカ、60611
- Northwestern Medicine - Northwestern Memorial Hospital Galter Pavilion
-
Chicago、Illinois、アメリカ、60612
- University Of Illinois
-
-
Indiana
-
Evansville、Indiana、アメリカ、47714
- Medisphere Medical Research Center, Llc
-
Hammond、Indiana、アメリカ、46324
- Asha Clinical Research-Munster Llc
-
Mishawaka、Indiana、アメリカ、46544
- Mishawaka Osteopathic Clinic/MOC Research
-
-
Kansas
-
Wichita、Kansas、アメリカ、67226
- Cypress Medical Research Center
-
-
Louisiana
-
Marrero、Louisiana、アメリカ、70072
- Tandem Clinical Research
-
Natchitoches、Louisiana、アメリカ、71457
- KAMP Medical Research, Inc
-
New Orleans、Louisiana、アメリカ、70121
- Ochsner Medical Center
-
-
Maryland
-
Rockville、Maryland、アメリカ、20852
- Kaiser Permanente
-
-
Massachusetts
-
Boston、Massachusetts、アメリカ、02111
- Floating Hospital For Children at Tufts Medical Center
-
West Roxbury、Massachusetts、アメリカ、02132-4927
- West Roxbury Veterans Affairs Medical Center
-
-
Michigan
-
Detroit、Michigan、アメリカ、48202
- Henry Ford Hospital
-
Royal Oak、Michigan、アメリカ、48073
- William Beaumont Hospital
-
-
Mississippi
-
Petal、Mississippi、アメリカ、39465
- MediSync Clinical Research
-
-
Nebraska
-
Grand Island、Nebraska、アメリカ、68803
- Meridian Clinical Research, LLC
-
Lincoln、Nebraska、アメリカ、68516
- Be Well Clinical Studies
-
Norfolk、Nebraska、アメリカ、68701
- Meridian Clinical Research, LLC
-
-
Nevada
-
Las Vegas、Nevada、アメリカ、89106
- Sierra Clinical Research
-
Las Vegas、Nevada、アメリカ、89109
- Excel Clinical Research
-
Las Vegas、Nevada、アメリカ、89106
- Hope Research Institute
-
Reno、Nevada、アメリカ、89509
- VA Sierra Nevada Health Care System
-
-
New Jersey
-
Hillsborough、New Jersey、アメリカ、08844
- I.D. Care, Inc.
-
Teaneck、New Jersey、アメリカ、07666
- Holy Name Medical Center
-
-
New York
-
Binghamton、New York、アメリカ、13901
- Meridian Clinical Research, LLC
-
Endwell、New York、アメリカ、13760
- Meridian Clinical Research, LLC
-
New York、New York、アメリカ、10016
- Manhattan Medical Research
-
The Bronx、New York、アメリカ、10467
- Montefiore Medical Center
-
-
North Carolina
-
Durham、North Carolina、アメリカ、27705
- Durham VAMC
-
Fayetteville、North Carolina、アメリカ、28303
- Carolina Institute for Clinical Research
-
Greenville、North Carolina、アメリカ、27834
- ECU Health Vidant Medical Center
-
-
North Dakota
-
Fargo、North Dakota、アメリカ、58104
- Plains Clinical Research
-
-
Ohio
-
Centerville、Ohio、アメリカ、45458
- Kroger Health
-
Cleveland、Ohio、アメリカ、44106
- University Hospitals Cleveland Medical Center
-
Columbus、Ohio、アメリカ、43215
- Remington Davis Inc
-
Englewood、Ohio、アメリカ、45322
- Kroger Health
-
Englewood、Ohio、アメリカ、45322
- The Little Clinic
-
Wooster、Ohio、アメリカ、44691
- Comprehensive Internal Medicine
-
-
Oklahoma
-
Yukon、Oklahoma、アメリカ、73099
- Tekton Research Inc.
-
-
Oregon
-
Portland、Oregon、アメリカ、97227
- Kaiser Permanente
-
-
Pennsylvania
-
Camp Hill、Pennsylvania、アメリカ、17011
- Capital Area Research
-
West Reading、Pennsylvania、アメリカ、19611
- Reading Hospital
-
-
South Carolina
-
Charleston、South Carolina、アメリカ、29412
- Hugh D. Durrence, MD, PC
-
Little River、South Carolina、アメリカ、29566
- Waterway Familiy Medicine
-
-
Texas
-
Bellaire、Texas、アメリカ、77401
- Novel Research LLC
-
Dallas、Texas、アメリカ、75246
- North Texas Infectious Diseases Consultants
-
Dallas、Texas、アメリカ、75230
- Medical City Dallas
-
Dallas、Texas、アメリカ、75224
- Global Medical Research - Dallas
-
Houston、Texas、アメリカ、77024
- Digestive Health Associates
-
Lewisville、Texas、アメリカ、75057
- EPIC Clinical Research
-
Mesquite、Texas、アメリカ、75149
- SMS Clinical Research LLC
-
Round Rock、Texas、アメリカ、78681
- Be Well Clinical Studies
-
San Antonio、Texas、アメリカ、78229
- Audie L Murphy Memorial Va Ho
-
Sherman、Texas、アメリカ、75092
- Sherman Clinical Research
-
-
Utah
-
Draper、Utah、アメリカ、84020
- Lone Peak Family Medicine
-
-
Virginia
-
Annandale、Virginia、アメリカ、22003-7347
- Clinical Alliance for Research and Education
-
Charlottesville、Virginia、アメリカ、22911
- Charlottesville Medical Research Center, LLC
-
Lynchburg、Virginia、アメリカ、24501
- Infectious Disease Associates of Central Virginia
-
Suffolk、Virginia、アメリカ、23435
- IACT - Suffolk Multispecialty Research
-
Winchester、Virginia、アメリカ、22601
- Selma Medical Associates
-
-
Washington
-
Cheney、Washington、アメリカ、99004
- Multicare Institute For Research & Innovation - Rockwood Clinic - Cheney
-
-
West Virginia
-
Morgantown、West Virginia、アメリカ、26505
- Exemplar Research, Inc
-
-
Wisconsin
-
Marshfield、Wisconsin、アメリカ、54449
- Marshfield Clinic
-
-
-
-
-
Aberdeen、イギリス、AB25 2ZN
- Aberdeen Royal Infirmary
-
Atherstone、イギリス、CV9 1EU
- Atherstone Surgery
-
Banbury、イギリス、OX16 9AD
- Banbury Cross Health Center
-
Birkenhead、イギリス、CH62 6EE
- FutureMeds Bridle Clinic
-
Birmingham、イギリス、B21 0RY
- FutureMeds-Soho UK
-
Blackpool、イギリス、FY3 8NR
- Blackpool Teaching Hospitals NHS Foundation Trust
-
Bournemouth、イギリス、BH7 7DW
- Royal Bournemouth Hospital
-
Bristol、イギリス、BS10 5NB
- North Bristol NHS Trust
-
Bristol、イギリス、BS2 8BJ
- University Hospitals Bristol NHS Trust
-
Exeter、イギリス、EX2 5DW
- Royal Devon & Exeter NHS Foundation Trust
-
Eynsham、イギリス、OX29 4QB
- Eynsham Medical Centre
-
Guisborough、イギリス、TS14 7DJ
- The Garth Surgery
-
Leicester、イギリス、LE1 5WW
- University Hospitals Of Leicester Nhs Trust
-
London、イギリス、SE5 9RS
- King's College Hospital NHS Foundation Trust
-
Manchester、イギリス、M13 9WL
- Manchester Royal Infirmary
-
Manchester、イギリス、M23 9LT
- The NIHR Manchester Clinical Research Facility
-
Middlesbrough、イギリス、TS4 3BW
- South Tees Hospitals NHS Foundation Trust
-
Nottingham、イギリス、NG7 2UH
- Nottingham University Hospitals NHS Trust
-
Plymouth、イギリス、PL6 8DH
- Plymouth University Hospitals Trust
-
Pontypridd、イギリス、CF37 2DR
- Ashgrove Surgery
-
Poole、イギリス、BH15 4JQ
- The Adam Practice
-
Sheffield、イギリス、S10 2 JF
- Sheffield Teaching Hospitals NHS Foundation Trust
-
Stafford、イギリス、ST16 3SR
- Midlands Partnership NHS Foundation Trust
-
Stockton-on-Tees、イギリス、TS19 8PE
- North Tees Furturemeds
-
Wakefield、イギリス、WF1 4DG
- Mid Yorkshire Hospital NHS Trust- Pinderfields Hospital
-
Wantage、イギリス、OX12 9BN
- Church Street Practice
-
Witney、イギリス、OX28 6JS
- Windrush Medical Practice
-
-
-
-
-
Ashdod、イスラエル、7747629
- Samson Assuta Ashdod University Hospital
-
Jerusalem、イスラエル、9112001
- Hadassah Medical Center
-
Kfar Saba、イスラエル、44281
- Meir Medical Center
-
Ramat Gan、イスラエル、52621
- The Chaim Sheba Medical Center
-
Tel Aviv、イスラエル、6423906
- Tel Aviv Sourasky Medical Center
-
-
-
-
-
Chieti、イタリア、66100
- ASL2 Lanciano - Vasto - Chieti - Ospedale 'SS Annunziata' di Chieti
-
Roma、イタリア、00144
- Istituto Nazionale Tumori Regina Elena
-
Rome、イタリア、00189
- Azienda Ospedaliera Sant Andrea
-
-
-
-
-
Belagavi、インド、590010
- KLE's Dr. Prabhakar Kore Hospital & Medical Research Centre (MRC)
-
Jaipur、インド、302006
- S. R. Kalla Memorial General Hospital
-
Kolkata、インド、700014
- Nil Ratan Sircar Medical College and Hospital
-
Lucknow、インド、226022
- Regency health super specialty hospital
-
Mumbai、インド、421203
- Asian Institute Of Medical Science
-
Mysuru、インド、570015
- Jagadguru Sri Shivarathreeshwara Academy of Higher Education and Research
-
New Delhi、インド、1100776
- Indraprastha Apollo Hospital
-
Rajkot、インド、360004
- Shree Giriraj Multispeciality Hospital
-
Surat、インド、395009
- BAPS Pramukhswami Hospital
-
Surat、インド、395002
- Nirmal Hospital Pvt. Ltd.
-
-
-
-
-
Leiden、オランダ、2333 ZA
- Leiden University Medical Center
-
Uden、オランダ、5406 PT
- Ziekenhuis
-
Utrecht、オランダ、3508 GA
- The Julius Center - Utrecht Science Park - Stratenum
-
-
-
-
-
Brisbane、オーストラリア、4001
- Saint Andrew's War Memorial Hospital
-
Campbelltown、オーストラリア、5074
- GP Surgery - Campbelltown
-
Geelong、オーストラリア、3220
- Barwon Health - University Hospital Geelong
-
Melbourne、オーストラリア、5000
- CMAX Clinical Research
-
New Lambton、オーストラリア、2305
- John Hunter Hospital
-
Palmyra DC、オーストラリア、6961
- Fiona Stanley Hospital
-
Para Hills West、オーストラリア、5096
- McIntyre Medical Center
-
Salisbury、オーストラリア、5108
- North West Medical Center
-
South Brisbane、オーストラリア、4101
- Mater Medical Centre South Brisbane
-
St Agnes、オーストラリア、5097
- Bene Aged Care - Italian Village
-
Sydney、オーストラリア、2145
- Westmead Hospital
-
Taringa、オーストラリア、4068
- AusTrials Pty Ltd
-
Tarragindi、オーストラリア、4121
- AusTrials Pty Ltd
-
Woodville、オーストラリア、5011
- Adelaide Medical Solutions
-
-
-
-
Alberta
-
Calgary、Alberta、カナダ、T4P 1K4
- CARe Clinical Ltd
-
Edmonton、Alberta、カナダ、T6G121
- University of Alberta
-
Red Deer、Alberta、カナダ、T4P 1K4
- CARe Clinical Ltd
-
-
British Columbia
-
Vancouver、British Columbia、カナダ、V6Z2C7
- Vancouver ID Research and Care Centre Society
-
-
Ontario
-
Greater Sudbury、Ontario、カナダ、P3E 5J1
- Health Sciences North
-
Guelph、Ontario、カナダ、N1H 1B1
- Dawson Road Family Health Team
-
Sarnia、Ontario、カナダ、N7T 4X3
- Bluewater Clinical Research Group Inc.
-
Winchester、Ontario、カナダ、K0C2K0
- Winchester District Memorial Hospital
-
-
Quebec
-
Québec、Quebec、カナダ、G2J 0C4
- Alpha Recherche Clinique
-
Québec、Quebec、カナダ、G3K 2P8
- Alpha Recherche Clinique
-
-
-
-
-
Barranquilla、コロンビア
- Centro de Investigaciones y Proyectos en Neurociencias CIPNA
-
Barranquilla、コロンビア、080001
- Clinica de la Costa
-
Barranquilla、コロンビア、80020
- IPS Centro Cientifico Asisitencial Jose Luis Accini S.A.S.
-
Casanare、コロンビア、856010
- Centro de Atencion e Investigacion Medica S.A. - CAIMED
-
Floridablanca、コロンビア
- Fundacion Cardiovascular de Colombia
-
Girardot、コロンビア、252432
- Centro de Atencion e Investigacion Medica S.A. - CAIMED
-
Helechos、コロンビア
- Centro de Atencion e Investigacion Medica S.A. - CAIMED
-
Manizales、コロンビア、170001
- Asociacion IPS Medicos Internistas de Caldas
-
Meta、コロンビア、507001
- CAIMED Acacias
-
Pereira、コロンビア、660003
- Fundacion Centro de Investigaciones Clinicas IPS Cardiomet
-
Villavicencio、コロンビア、500001
- Corporación Clínica Universidad Cooperativa De Colombia Clínica Ucc
-
-
-
-
-
Helsingborg、スウェーデン、25187
- Helsingborgs lasarett
-
Karlskrona、スウェーデン、37179
- BTH Research & Development Clinic
-
Linkoaping、スウェーデン、582 13
- CTC Ebbepark
-
Malmö、スウェーデン、21428
- Skanes universitetssjukhus
-
Mölndal、スウェーデン、43153
- CTC GoCo
-
Solna、スウェーデン、171 64
- ClinSmart Sweden AB
-
Uppsala、スウェーデン、752 37
- ClinSmart Sweden AB
-
Örebro、スウェーデン、70362
- Universitetssjukhuset Orebro
-
-
-
-
-
Alicante、スペイン、3010
- Hosp. Gral. Univ. Dr. Balmis
-
Barcelona、スペイン、8003
- Hosp. Del Mar
-
Barcelona、スペイン、08907
- Hosp. Univ. de Bellvitge
-
Barcelona、スペイン、08036
- Hosp Clinic de Barcelona
-
Barcelona、スペイン、8028
- Consorci D'Atenció Primària de Salut Barcelona Esquerra
-
Córdoba、スペイン、14004
- Hosp Reina Sofia
-
Girona、スペイン、17007
- Hosp. Univ. Dr. Josep Trueta
-
Jerez de la Frontera、スペイン、11407
- Hosp. de Jerez de La Frontera
-
La Roca del Vallès、スペイン、8430
- CAP Dr. Vicenç Papaceit ABS LA ROCA
-
Madrid、スペイン、28046
- Hosp. Univ. La Paz
-
Madrid、スペイン、28006
- Hosp. Univ. de La Princesa
-
Madrid、スペイン、28660
- Hosp. Univ. Hm Monteprincipe
-
Madrid、スペイン、28050
- Hospital Sanitas La Moraleja
-
Málaga、スペイン、29004
- Hosp. Quirónsalud Málaga
-
Ourense、スペイン、32005
- Complexo Hosp. Univ. de Ourense
-
Palma de Mallorca、スペイン、07120
- Hosp. Univ. Son Espases
-
Sabadell、スペイン、08208
- Corporacio Sanitari Parc Tauli
-
Seville、スペイン、41009
- Hosp. Virgen Macarena
-
Vigo、スペイン、36312
- Hosp. Alvaro Cunqueiro
-
-
-
-
-
Bangkok、タイ、10330
- King Chulalongkorn Memorial Hospital
-
Bangkok、タイ、10700
- Siriraj Hospital
-
Bangkok、タイ、10400
- Ramathibodi Hospital
-
Bangkok、タイ、10400
- Tropical Medicine Hospital, Mahidol University
-
Bangkok、タイ、10330
- Thai Red Cross Aids Research Centre
-
-
-
-
-
Brno、チェコ、61500
- Uromeda
-
Dolní Břežany、チェコ、252 41
- Aesculap Ambulance sro - Zdravotni Stredisko Centrum Zdravi
-
Hradec Králové、チェコ、50002
- Centrum Ockovani a Cestovi Mediciny
-
Nový Knín、チェコ、262 03
- Res Medica
-
Olomouc、チェコ、77900
- PreventaMed, s.r.o.
-
Ostrava-Proskovice、チェコ、72400
- GYNURO s.r.o
-
Pilsen、チェコ、30100
- Ambulance name: Gynekologická ordinace MUDr
-
Pilsen、チェコ、323 00
- MUDr. Mita Rosenberg
-
Prague、チェコ、13000
- Gona s.R.o- Orfinace Harov
-
Protivín、チェコ、39811
- Zdravi-fit, s.r.o.
-
Slaný、チェコ、274 01
- Nemocnice Slany
-
Vysoké Mýto、チェコ、56601
- Progerint s.r.o.
-
České Budějovice、チェコ、37001
- Ordinace Hradebni s.r.o.
-
-
-
-
-
Hellerup、デンマーク、2900
- Aalborg Universitetshospital Nord
-
Herlev、デンマーク、2730
- Gentofte Hospital
-
Hilleroed、デンマーク、3400
- Nordsjaellands Hospital - Hillerod
-
Hvidovre、デンマーク、2650
- Hvidovre Hospital
-
Odense M、デンマーク、5230
- Odense Universitetshospital
-
Roskilde、デンマーク、4000
- Sjællands University hospital
-
-
-
-
-
Frankfurt、ドイツ、60590
- Universitatsklinikum Frankfurt
-
Jena、ドイツ、07747
- Universitatsklinikum Jena
-
Leipzig、ドイツ、04179
- Familienmedizinisches Zentrum Radowsky
-
Leipzig、ドイツ、4103
- SIBAmed GmbH & Co. KG
-
Marburg、ドイツ、35037
- Universitaetsklinikum Giessen und Marburg GmbH
-
Oldenburg in Holstein、ドイツ、23758
- Red-Institut für medizinische Forschung und Fortbildung
-
Reinfeld、ドイツ、23858
- Praxis Dr. Weimer
-
Rostock、ドイツ、18057
- Universitaetsmedizin Rostock
-
-
-
-
-
Auckland、ニュージーランド、0600
- Southern Clinical Trials Totara Clinical Research
-
Auckland、ニュージーランド、0626
- Southern Clinical Trials Ltd
-
Auckland、ニュージーランド、1011
- Optimal Clinical Trials
-
Bay of Plenty、ニュージーランド、3112
- Tauranga Urology Research Limited
-
Christchurch、ニュージーランド、8013
- Canterbury Urology Research Trust
-
Christchurch Central、ニュージーランド、8013
- Southern Clinical Trials Ltd
-
Dunedin、ニュージーランド、9016
- P3 Research Ltd
-
Hamilton、ニュージーランド、3200
- Lakeland Clinical Trials
-
Hastings、ニュージーランド、4122
- P3 Research Ltd
-
Lower Hutt、ニュージーランド、5010
- P3 Research - Lower Hutt
-
Nelson、ニュージーランド、7011
- Southern Clinical Trials Ltd
-
Palmerston North、ニュージーランド、4414
- P3 Research Ltd
-
Papamoa、ニュージーランド、3118
- Culloden Research Ltd
-
Papatoetoe、ニュージーランド、2025
- Middlemore Clinical Trials
-
Rosedale、ニュージーランド、632
- Optimal Clinical Trials
-
Rotorua、ニュージーランド、3010
- Lakeland Clinical Trials
-
Tauranga、ニュージーランド、3110
- P3 Research Ltd
-
Upper Hutt、ニュージーランド、5018
- Lakeland Clinical Trials
-
Wellington、ニュージーランド、5032
- P3 Research Limited Kapiti
-
Wellington、ニュージーランド、6242
- Capatial & Coast District Health Board
-
-
-
-
-
Annecy、フランス、74370
- Centre Hospitalier Annecy Genevois
-
Dijon、フランス、21000
- CHU Dijon Bourgogne - Hopital Francois Mitterrand
-
Limousis、フランス、87042
- CHU de Limoges
-
Lyon、フランス、69004
- Hopital de La Croix Rousse
-
Nîmes、フランス、30029
- CHU Nimes Hopital Caremeau
-
Pierre-Bénite、フランス、69495
- Centre hospitalier Lyon-Sud
-
Saint-Priest-en-Jarez、フランス、42270
- CHU Saint Etienne Hopital Nord
-
-
-
-
-
Chengdu、中国、610041
- West China School of Medicine/West China Hospital, Sichuan University
-
Fuyang、中国、236399
- Funan Center for Disease Control and Prevention
-
Guangzhou、中国、510120
- The First Affiliated Hospital of Guangzhou Medical University
-
Guangzhou、中国、510260
- The Second Affiliated Hospital of Guangzhou Medical University
-
Hangzhou、中国、310003
- 1st Affiliated Hospital of Zhejiang University Medical College
-
Hefei、中国、230601
- Anhui Provincial Center for Disease Control and Prevention
-
Liuan、中国、237400
- Huoqiu County Center For Disease Control and Prevention
-
Nanjing、中国、210009
- Jiangsu Provincial Center for Disease Control and Prevention
-
Nanjing、中国、211112
- Nanjing Medical University
-
Shanghai、中国、200040
- Huashan Hospital affiliated to Fudan University
-
Suzhou、中国、215002
- Suzhou Municipal Hospital
-
Taizhou、中国、225300
- Taizhou Peoples Hospital
-
Wuxi、中国、214200
- Yixing People's Hospital
-
-
-
-
-
Kaohsiung City、台湾、813
- Kaohsiung Veterans General Hospital
-
Tainan、台湾、704
- National Cheng Kung University Hospital
-
Taoyuan、台湾、333
- Chang Gung Memorial Hospital Linkou Branch
-
-
-
-
-
Akashi Shi、日本、674 0063
- Akashi Medical Center
-
Fukuoka、日本、811-0213
- Fukuoka Wajiro Hospital
-
Fukuoka、日本、807-0051
- Fukuoka Shinmizumaki Hospital
-
Hakodate、日本、040 8611
- Hakodate Goryoukaku Hospital
-
Hashima-gun、日本、5016062
- Matsunami General Hospital
-
Hokkaido、日本、006-8555
- Teine Keijinkai Hospital
-
Iizuka、日本、820-8501
- Aso Co.,Ltd Iizuka Hospital
-
Itoshima、日本、8191104
- Inoue Hospital
-
Kasuya-gun、日本、811-3112
- Kano Hospital
-
Kawasaki、日本、211-8510
- Kanto Rosai Hospital
-
Kitakyushu、日本、800-0057
- Shinkomonji hospital
-
Kitakyushu、日本、8000295
- Japan Community Health care Organization Kyushu Hospital
-
Nagasaki、日本、852-8511
- JRC Nagasaki Genbaku Hospital
-
Neyagawa、日本、572-8567
- Kyoujinkai Clinic Komatsu
-
Omuta-Shi、日本、836-0861
- Omuta City Hospital
-
Osaka、日本、5340024
- Kyobashi Sugimoto Clinic
-
Osaka、日本、5530003
- Japan Community Health Care Organization Osaka Hospital
-
Sanuki、日本、7692393
- National Hospital Organization Shikoku Cancer Center
-
Sapporo、日本、006-0812
- Teine Maeda Urology Clinic
-
Sapporo、日本、0060816
- Teine Urological Clinic
-
Shimajiri-Gun、日本、9010493
- Nanbu Tokushukai Hospital
-
Shimonoseki-shi、日本、7500061
- Shimonoseki City Hospital
-
Shinagawa City、日本、1408522
- Tokyo Shinagawa Hospital
-
Suita-Shi、日本、5650814
- Suita Tokushukai Hospital
-
Suwa-Shi、日本、3928510
- Japanese Red Cross Society Suwa Hospital
-
Yahatanishi-ku、日本、806-8501
- Japan Community Health care Organization Kyushu Hospital
-
Yamaguchi、日本、750-0041
- Shimonoseki City Hospital
-
Yokohama、日本、222-0036
- Yokohama Rosai Hospital
-
Yokohama、日本、245-8575
- National Hospital Organization Yokohama Medical Center
-
Ōita、日本、8700039
- Abe Diabetes Clinic
-
Ōita、日本、8701195
- Almeida Memorial Hospital
-
Ōmura、日本、856-8562
- National Hospital Organization Nagasaki Medical Center
-
-
-
-
-
Busan、韓国、602 812
- Dong-A University Hospital
-
Chuncheon、韓国、24253
- Hallym University Chuncehon Medical Center
-
Daejeon、韓国、35015
- Chungnam National University Hospital
-
Gwangju、韓国、501-757
- Chunnam National University Hospital
-
Gyeonggi-do、韓国、15355
- Korea University Ansan Hospital
-
Incheon、韓国、22322
- Inha University Hospital
-
Seongnam-si、韓国、13620
- Seoul National University Bundang Hospital
-
Seoul、韓国、05505
- Asan Medical Center
-
Seoul、韓国、06351
- Samsung Medical Center
-
Seoul、韓国、03181
- Kangbuk Samsung Hospital
-
Seoul、韓国、07985
- Ewha Womans University Mokdong Hospital
-
Seoul、韓国、8308
- Korea University Guro Hospital
-
Seoul、韓国、07441
- Hallym University Sacred Heart Hospital
-
Suwon、韓国、16247
- The Catholic university of Korea, St. Vincent's Hospital
-
Wŏnju、韓国、220-701
- WonJu Severance Christian Hospital
-
-
参加基準
適格基準
適格基準
就学可能な年齢
健康ボランティアの受け入れ
受講資格のある性別
説明
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
研究計画
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：防止
- 割り当て：ランダム化
- 介入モデル：並列代入
- マスキング：ダブル
アーム数
武器と介入
参加者グループ / アーム参加者グループ / アーム |
介入・治療介入・治療 |
|---|---|
|
実験的：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.
他の名前：
|
|
プラセボコンパレーター：Placebo
Participants will receive a single IM injection of matching placebo on Day 1. |
Matching placebo will be administered as an IM injection. |
この研究は何を測定していますか？
主要な結果の測定
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
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
時間枠：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)
|
二次結果の測定
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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)
時間枠：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)
時間枠：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
時間枠：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
時間枠：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
|
|
Number of Participants With Serious Adverse Events (SAEs)
時間枠：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
|
|
Change From Baseline in Short Form-36 Health Survey
時間枠：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
|
|
Change From Baseline in 5-level EuroQol 5-Dimension (EQ-5D-5L) Descriptive System Score: Index Score
時間枠：Baseline, Day 15, Day 30, Day 181, Year 1, Year 2, and Year 3
|
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
|
|
Change From Baseline in 5-level EuroQol 5-Dimension (EQ-5D-5L) Score: Visual Analog Scale (VAS)
時間枠：Baseline, Day 15, Day 30, Day 181, Year 1, Year 2, and Year 3
|
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
|
|
Number of Participants With Frailty Index
時間枠：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
|
|
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
時間枠：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)
|
|
Number of Participants With MRU Related to First Occurrence of UTI, or Acute Bacterial Prostatitis (ABP) Events Per CCD Caused by ExPEC9V O-Serotype
時間枠：From Day 1 up to Day 1296 (Day of futility announcement)
|
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)
|
|
Number of Participants With Invasive Escherichia Coli Disease (IED) Events Per CCD That Required Hospitalization Caused by ExPEC9V O-Serotype
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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)
|
協力者と研究者
捜査官
捜査官
- スタディディレクター：Janssen Research & Development, LLC Clinical Trial、Janssen Research & Development, LLC
出版物と役立つリンク
一般刊行物
- 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.
研究記録日
主要日程の研究
研究開始 (実際)
研究開始
一次修了 (実際)
一次修了
研究の完了 (実際)
研究の完了
試験登録日
最初に提出
最初に提出
QC基準を満たした最初の提出物
QC基準を満たした最初の提出物
最初の投稿 (実際)
最初の投稿
学習記録の更新
投稿された最後の更新 (実際)
投稿された最後の更新
QC基準を満たした最後の更新が送信されました
QC基準を満たした最後の更新が送信されました
最終確認日
最終確認日
詳しくは
本研究に関する用語
その他の研究ID番号
その他の研究ID番号
- CR109000
- 2020-005273-27 (EudraCT番号)
- VAC52416BAC3001 (その他の識別子：Janssen Research & Development, LLC)
- 2023-506589-30-00 (レジストリ識別子：EUCT number)
- 2023 (米国 NIH グラント/契約)
個々の参加者データ (IPD) の計画
個々の参加者データ (IPD) を共有する予定はありますか?
IPD プランの説明
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
医薬品およびデバイス情報、研究文書
米国FDA規制医薬品の研究
米国FDA規制機器製品の研究
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