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Um estudo da vacinação com vacina extraintestinal patogênica contra Escherichia Coli 9-valente (ExPEC9V) na prevenção da doença invasiva extraintestinal patogênica por Escherichia Coli em adultos com 60 anos ou mais com histórico de infecção do trato urinário nos últimos 2 anos

2 de setembro de 2026 atualizado por: Janssen Research & Development, LLC

Estudo randomizado, duplo-cego, controlado por placebo, multicêntrico de fase 3 para avaliar a eficácia, segurança e imunogenicidade da vacinação com ExPEC9V na prevenção da doença invasiva extraintestinal patogênica por Escherichia Coli em adultos com 60 anos ou mais com histórico de infecção do trato urinário nos últimos 2 anos

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.

Visão geral do estudo

Status

Status

Indica o status de recrutamento atual ou o status de acesso expandido.
Concluído

Condições

Condições

A doença, distúrbio, síndrome, doença ou lesão que está sendo estudada. Em ClinicalTrials.gov, as condições também podem incluir outros problemas relacionados à saúde, como expectativa de vida, qualidade de vida e riscos à saúde.

Intervenção / Tratamento

Intervenção / Tratamento

Um processo ou ação que é o foco de um estudo clínico. As intervenções incluem medicamentos, dispositivos médicos, procedimentos, vacinas e outros produtos em fase de investigação ou já disponíveis. As intervenções também podem incluir abordagens não invasivas, como educação ou modificação da dieta e exercícios.

Descrição detalhada

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.

Tipo de estudo

Tipo de estudo

Descreve a natureza de um estudo clínico. Os tipos de estudo incluem estudos intervencionais (também chamados de ensaios clínicos), estudos observacionais (incluindo registros de pacientes) e acesso expandido.
Intervencional

Inscrição (Real)

Inscrição

O número de participantes em um estudo clínico. A inscrição "antecipada" é o número alvo de participantes que os pesquisadores precisam para o estudo.
17797

Estágio

Estágio

A etapa de um ensaio clínico que estuda um medicamento ou produto biológico, com base nas definições desenvolvidas pela Food and Drug Administration (FDA) dos EUA. A fase é baseada no objetivo do estudo, no número de participantes e em outras características. Existem cinco fases: Fase Inicial 1 (anteriormente listada como Fase 0), Fase 1, Fase 2, Fase 3 e Fase 4. Não Aplicável é usado para descrever ensaios sem fases definidas pela FDA, incluindo ensaios de dispositivos ou intervenções comportamentais.
  • Fase 3

Contactos e Locais

Esta seção fornece os detalhes de contato para aqueles que conduzem o estudo e informações sobre onde este estudo está sendo realizado.

Locais de estudo

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

Critérios de participação

Os pesquisadores procuram pessoas que se encaixem em uma determinada descrição, chamada de critérios de elegibilidade. Alguns exemplos desses critérios são a condição geral de saúde de uma pessoa ou tratamentos anteriores.

Critérios de elegibilidade

Critérios de elegibilidade

Os principais requisitos que as pessoas que desejam participar de um estudo clínico devem atender ou as características que devem ter. Os critérios de elegibilidade consistem em critérios de inclusão (que são necessários para que uma pessoa participe do estudo) e critérios de exclusão (que impedem uma pessoa de participar). Tipos de critérios de elegibilidade incluem se um estudo aceita voluntários saudáveis, tem requisitos de idade ou faixa etária ou é limitado por sexo.

Idades elegíveis para estudo

60 anos e mais velhos (Adulto, Adulto mais velho)

Aceita Voluntários Saudáveis

Sim

Gêneros Elegíveis para o Estudo

Tudo

Descrição

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

Plano de estudo

Esta seção fornece detalhes do plano de estudo, incluindo como o estudo é projetado e o que o estudo está medindo.

Como o estudo é projetado?

Detalhes do projeto

  • Finalidade Principal: Prevenção
  • Alocação: Randomizado
  • Modelo Intervencional: Atribuição Paralela
  • Mascaramento: Dobro

Armas e Intervenções

Grupo de Participantes / Braço

Grupo de Participantes / Braço

Um grupo ou subgrupo de participantes em um estudo clínico que recebe uma intervenção/tratamento específico, ou nenhuma intervenção, de acordo com o protocolo do estudo.
Intervenção / Tratamento

Intervenção / Tratamento

Um processo ou ação que é o foco de um estudo clínico. As intervenções incluem medicamentos, dispositivos médicos, procedimentos, vacinas e outros produtos em fase de investigação ou já disponíveis. As intervenções também podem incluir abordagens não invasivas, como educação ou modificação da dieta e exercícios.
Experimental: ExPEC9V

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

ExPEC9V will be administered as an IM injection.

Outros nomes:
  • VAC52416,
  • JNJ-78901563
Comparador de Placebo: Placebo

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

Matching placebo will be administered as an IM injection.

O que o estudo está medindo?

Medidas de resultados primários

Medidas de resultados primários

No protocolo de um estudo clínico, a medida de resultado planejada que é a mais importante para avaliar o efeito de uma intervenção/tratamento. A maioria dos estudos clínicos tem uma medida de desfecho primário, mas alguns têm mais de uma.
Medida de resultado
Descrição da medida
Prazo
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
Prazo: 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)

Medidas de resultados secundários

Medidas de resultados secundários

No protocolo de um estudo clínico, uma medida de resultado planejada que não é tão importante quanto a medida de resultado primária para avaliar o efeito de uma intervenção, mas ainda é de interesse. A maioria dos estudos clínicos tem mais de uma medida de desfecho secundário.
Medida de resultado
Descrição da medida
Prazo
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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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)
Prazo: 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)
Prazo: 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
Prazo: 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
Prazo: 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)
Prazo: 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
Prazo: 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
Prazo: 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)
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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)

Colaboradores e Investigadores

É aqui que você encontrará pessoas e organizações envolvidas com este estudo.

Patrocinador

Patrocinador

A organização ou pessoa que inicia o estudo e que tem autoridade e controle sobre o estudo.
Janssen Research & Development, LLC

Investigadores

Investigadores

Um pesquisador envolvido em um estudo clínico. Os termos relacionados incluem investigador principal do centro, subinvestigador do centro, coordenador do estudo, diretor do estudo e investigador principal do estudo.
  • Diretor de estudo: Janssen Research & Development, LLC Clinical Trial, Janssen Research & Development, LLC

Publicações e links úteis

A pessoa responsável por inserir informações sobre o estudo fornece voluntariamente essas publicações. Estes podem ser sobre qualquer coisa relacionada ao estudo.

Publicações Gerais

Datas de registro do estudo

Essas datas acompanham o progresso do registro do estudo e os envios de resumo dos resultados para ClinicalTrials.gov. Os registros do estudo e os resultados relatados são revisados ​​pela National Library of Medicine (NLM) para garantir que atendam aos padrões específicos de controle de qualidade antes de serem publicados no site público.

Datas Principais do Estudo

Início do estudo (Real)

Início do estudo

A data real em que o primeiro participante foi inscrito em um estudo clínico. A data de início do estudo "antecipada" é a data que os pesquisadores acham que será a data de início do estudo.
30 de junho de 2021

Conclusão Primária (Real)

Conclusão Primária

A data em que o último participante de um estudo clínico foi examinado ou recebeu uma intervenção para coletar dados finais para a medida de resultado primário. Se o estudo clínico terminou de acordo com o protocolo ou foi encerrado, não afeta esta data. Para estudos clínicos com mais de uma medida de resultado primário com diferentes datas de conclusão, este termo refere-se à data em que a coleta de dados é concluída para todas as medidas de resultado primário. A data de conclusão primária "antecipada" é a data que os pesquisadores acham que será a data de conclusão primária do estudo.
27 de agosto de 2025

Conclusão do estudo (Real)

Conclusão do estudo

A data em que o último participante de um estudo clínico foi examinado ou recebeu uma intervenção/tratamento para coletar dados finais para as medidas de resultado primário, medidas de resultado secundário e eventos adversos (ou seja, a última visita do último participante). A data "prevista" de conclusão do estudo é a data que os pesquisadores acham que será a data de conclusão do estudo.
27 de agosto de 2025

Datas de inscrição no estudo

Enviado pela primeira vez

Enviado pela primeira vez

A data em que o patrocinador ou investigador do estudo enviou pela primeira vez um registro do estudo para ClinicalTrials.gov. Normalmente, há um atraso de alguns dias entre a primeira data de envio e a disponibilidade do registro em ClinicalTrials.gov (a primeira data publicada).
21 de maio de 2021

Enviado pela primeira vez que atendeu aos critérios de CQ

Enviado pela primeira vez que atendeu aos critérios de CQ

A data em que o patrocinador ou investigador do estudo envia pela primeira vez um registro do estudo que seja consistente com os critérios de revisão do controle de qualidade (QC) da National Library of Medicine (NLM). O patrocinador ou investigador pode precisar revisar e enviar um registro de estudo uma ou mais vezes antes que os critérios de revisão de QC do NLM sejam atendidos. É responsabilidade do patrocinador ou investigador garantir que o registro do estudo seja consistente com os critérios de revisão do NLM QC.
21 de maio de 2021

Primeira postagem (Real)

Primeira postagem

A data em que o registro do estudo foi disponibilizado pela primeira vez em ClinicalTrials.gov após a conclusão da revisão do controle de qualidade (QC) da National Library of Medicine (NLM). Normalmente, há um atraso de alguns dias entre a data em que o patrocinador ou investigador do estudo enviou o registro do estudo e a primeira data publicada.
24 de maio de 2021

Atualizações de registro de estudo

Última Atualização Postada (Real)

Última Atualização Postada

A data mais recente em que as alterações em um registro de estudo foram disponibilizadas em ClinicalTrials.gov. Pode haver um atraso entre o momento em que as alterações foram enviadas ao ClinicalTrials.gov pelo patrocinador ou investigador do estudo (a última data de envio de atualização) e a data de publicação da última atualização.
28 de setembro de 2026

Última atualização enviada que atendeu aos critérios de controle de qualidade

Última atualização enviada que atendeu aos critérios de controle de qualidade

A data mais recente em que o patrocinador ou investigador do estudo enviou alterações em um registro do estudo que são consistentes com os critérios de revisão do controle de qualidade (QC) da National Library of Medicine (NLM). É responsabilidade do patrocinador ou investigador garantir que o registro do estudo seja consistente com os critérios de revisão do NLM QC.
2 de setembro de 2026

Última verificação

Última verificação

A data mais recente em que o patrocinador ou investigador do estudo confirmou as informações sobre um estudo clínico no ClinicalTrials.gov como precisas e atuais. Se um estudo com status de recrutamento de recrutamento; ainda não está recrutando; ou ativo, não recrutando não foi confirmado nos últimos 2 anos, o status de recrutamento do estudo é mostrado como desconhecido.
1 de setembro de 2026

Mais Informações

Termos relacionados a este estudo

Outros números de identificação do estudo

Outros números de identificação do estudo

Identificadores ou números de identificação diferentes do número NCT que são atribuídos a um estudo clínico pelo patrocinador, financiadores ou outros do estudo. Esses números podem incluir identificadores exclusivos de outros registros de ensaios e números de concessão do National Institutes of Health.
  • CR109000
  • 2020-005273-27 (Número EudraCT)
  • VAC52416BAC3001 (Outro identificador: Janssen Research & Development, LLC)
  • 2023-506589-30-00 (Identificador de registro: EUCT number)
  • 2023 (Concessão/Contrato do NIH dos EUA)

Plano para dados de participantes individuais (IPD)

Planeja compartilhar dados de participantes individuais (IPD)?

SIM

Descrição do plano 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

Informações sobre medicamentos e dispositivos, documentos de estudo

Estuda um medicamento regulamentado pela FDA dos EUA

Sim

Estuda um produto de dispositivo regulamentado pela FDA dos EUA

Não

Essas informações foram obtidas diretamente do site clinicaltrials.gov sem nenhuma alteração. Se você tiver alguma solicitação para alterar, remover ou atualizar os detalhes do seu estudo, entre em contato com register@clinicaltrials.gov. Assim que uma alteração for implementada em clinicaltrials.gov, ela também será atualizada automaticamente em nosso site .

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