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Исследование вакцинации 9-валентной внекишечной патогенной вакциной против кишечной палочки (ExPEC9V) в профилактике инвазивной внекишечной патогенной кишечной палочки у взрослых в возрасте 60 лет и старше с историей инфекции мочевыводящих путей в течение последних 2 лет

2 сентября 2026 г. обновлено: Janssen Research & Development, LLC

Рандомизированное, двойное слепое, плацебо-контролируемое, многоцентровое исследование фазы 3 по оценке эффективности, безопасности и иммуногенности вакцинации ExPEC9V в профилактике инвазивной внекишечной патогенной кишечной палочки у взрослых в возрасте 60 лет и старше с историей инфекции мочевыводящих путей за последние 2 года

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.

Обзор исследования

Статус

Завершенный

Условия

Вмешательство/лечение

Подробное описание

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.

Тип исследования

Интервенционный

Регистрация (Действительный)

17797

Фаза

  • Фаза 3

Контакты и местонахождение

В этом разделе приведены контактные данные лиц, проводящих исследование, и информация о том, где проводится это исследование.

Места учебы

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

Критерии участия

Исследователи ищут людей, которые соответствуют определенному описанию, называемому критериям приемлемости. Некоторыми примерами этих критериев являются общее состояние здоровья человека или предшествующее лечение.

Критерии приемлемости

Возраст, подходящий для обучения

60 лет и старше (Взрослый, Пожилой взрослый)

Принимает здоровых добровольцев

Да

Полы, имеющие право на обучение

Все

Описание

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

Учебный план

В этом разделе представлена ​​подробная информация о плане исследования, в том числе о том, как планируется исследование и что оно измеряет.

Как устроено исследование?

Детали дизайна

  • Основная цель: Профилактика
  • Распределение: Рандомизированный
  • Интервенционная модель: Параллельное назначение
  • Маскировка: Двойной

Оружие и интервенции

Группа участников / Армия
Вмешательство/лечение
Экспериментальный: ExPEC9V

Participants will receive a single intramuscular (IM) injection of 9-valent extraintestinal pathogenic Escherichia coli vaccine (ExPEC9V) on Day 1.
Биологический: ExPEC9V

ExPEC9V will be administered as an IM injection.

Другие имена:
  • ВАК52416,
  • JNJ-78901563
Плацебо Компаратор: Placebo

Participants will receive a single IM injection of matching placebo on Day 1.
Другой: Placebo

Matching placebo will be administered as an IM injection.

Что измеряет исследование?

Первичные показатели результатов

Мера результата
Мера Описание
Временное ограничение
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
Временное ограничение: 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)

Вторичные показатели результатов

Мера результата
Мера Описание
Временное ограничение
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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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)
Временное ограничение: 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)
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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)
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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)
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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)

Соавторы и исследователи

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Спонсор

Janssen Research & Development, LLC

Следователи

  • Директор по исследованиям: Janssen Research & Development, LLC Clinical Trial, Janssen Research & Development, LLC

Публикации и полезные ссылки

Лицо, ответственное за внесение сведений об исследовании, добровольно предоставляет эти публикации. Это может быть что угодно, связанное с исследованием.

Общие публикации

Даты записи исследования

Эти даты отслеживают ход отправки отчетов об исследованиях и сводных результатов на сайт ClinicalTrials.gov. Записи исследований и сообщаемые результаты проверяются Национальной медицинской библиотекой (NLM), чтобы убедиться, что они соответствуют определенным стандартам контроля качества, прежде чем публиковать их на общедоступном веб-сайте.

Изучение основных дат

Начало исследования (Действительный)

30 июня 2021 г.

Первичное завершение (Действительный)

27 августа 2025 г.

Завершение исследования (Действительный)

27 августа 2025 г.

Даты регистрации исследования

Первый отправленный

21 мая 2021 г.

Впервые представлено, что соответствует критериям контроля качества

21 мая 2021 г.

Первый опубликованный (Действительный)

24 мая 2021 г.

Обновления учебных записей

Последнее опубликованное обновление (Действительный)

28 сентября 2026 г.

Последнее отправленное обновление, отвечающее критериям контроля качества

2 сентября 2026 г.

Последняя проверка

1 сентября 2026 г.

Дополнительная информация

Термины, связанные с этим исследованием

Другие идентификационные номера исследования

  • CR109000
  • 2020-005273-27 (Номер EudraCT)
  • VAC52416BAC3001 (Другой идентификатор: Janssen Research & Development, LLC)
  • 2023-506589-30-00 (Идентификатор реестра: EUCT number)
  • 2023 (Грант/контракт NIH США)

Планирование данных отдельных участников (IPD)

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ДА

Описание плана IPD

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

Информация о лекарствах и устройствах, исследовательские документы

Изучает лекарственный продукт, регулируемый FDA США.

Да

Изучает продукт устройства, регулируемый Управлением по санитарному надзору за качеством пищевых продуктов и медикаментов США.

Нет

Эта информация была получена непосредственно с веб-сайта clinicaltrials.gov без каких-либо изменений. Если у вас есть запросы на изменение, удаление или обновление сведений об исследовании, обращайтесь по адресу register@clinicaltrials.gov. Как только изменение будет реализовано на clinicaltrials.gov, оно будет автоматически обновлено и на нашем веб-сайте. .

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