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Tutkimus rokottamisesta 9-valenttisella suoliston ulkopuolisella patogeenisellä Escherichia coli -rokotteella (ExPEC9V) invasiivisen suoliston ulkopuolisen patogeenisen Escherichia coli -taudin ehkäisyssä 60-vuotiailla ja sitä vanhemmilla aikuisilla, joilla on ollut virtsatieinfektio 2 vuoden aikana

keskiviikko 2. syyskuuta 2026 päivittänyt: Janssen Research & Development, LLC

Satunnaistettu, kaksoissokkoutettu, lumekontrolloitu, vaiheen 3 monikeskustutkimus ExPEC9V-rokotteen tehokkuuden, turvallisuuden ja immunogeenisyyden arvioimiseksi invasiivisen suoliston ulkopuolisen patogeenisen Escherichia coli -taudin ehkäisyssä yli 60-vuotiailla ja sitä vanhemmilla aikuisilla, joilla on ollut virtsaamishäiriö viimeisen 2 vuoden aikana

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.

Tutkimuksen yleiskatsaus

Tila

Valmis

Ehdot

Interventio / Hoito

Yksityiskohtainen kuvaus

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.

Opintotyyppi

Interventio

Ilmoittautuminen (Todellinen)

17797

Vaihe

  • Vaihe 3

Yhteystiedot ja paikat

Tässä osiossa on tutkimuksen suorittajien yhteystiedot ja tiedot siitä, missä tämä tutkimus suoritetaan.

Opiskelupaikat

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

Osallistumiskriteerit

Tutkijat etsivät ihmisiä, jotka sopivat tiettyyn kuvaukseen, jota kutsutaan kelpoisuuskriteereiksi. Joitakin esimerkkejä näistä kriteereistä ovat henkilön yleinen terveydentila tai aiemmat hoidot.

Kelpoisuusvaatimukset

Opintokelpoiset iät

60 vuotta ja vanhemmat (Aikuinen, Vanhempi Aikuinen)

Hyväksyy terveitä vapaaehtoisia

Joo

Sukupuolet, jotka voivat opiskella

Kaikki

Kuvaus

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

Opintosuunnitelma

Tässä osiossa on tietoja tutkimussuunnitelmasta, mukaan lukien kuinka tutkimus on suunniteltu ja mitä tutkimuksella mitataan.

Miten tutkimus on suunniteltu?

Suunnittelun yksityiskohdat

  • Ensisijainen käyttötarkoitus: Ennaltaehkäisy
  • Jako: Satunnaistettu
  • Inventiomalli: Rinnakkaistehtävä
  • Naamiointi: Kaksinkertainen

Aseet ja interventiot

Osallistujaryhmä / Arm
Interventio / Hoito
Kokeellinen: ExPEC9V

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

ExPEC9V will be administered as an IM injection.

Muut nimet:
  • VAC52416,
  • JNJ-78901563
Placebo Comparator: Placebo

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

Matching placebo will be administered as an IM injection.

Mitä tutkimuksessa mitataan?

Ensisijaiset tulostoimenpiteet

Tulosmittaus
Toimenpiteen kuvaus
Aikaikkuna
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
Aikaikkuna: 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)

Toissijaiset tulostoimenpiteet

Tulosmittaus
Toimenpiteen kuvaus
Aikaikkuna
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
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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)
Aikaikkuna: 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)
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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)
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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)
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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)

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Sponsori

Janssen Research & Development, LLC

Tutkijat

  • Opintojohtaja: Janssen Research & Development, LLC Clinical Trial, Janssen Research & Development, LLC

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Opiskelun aloitus (Todellinen)

Keskiviikko 30. kesäkuuta 2021

Ensisijainen valmistuminen (Todellinen)

Keskiviikko 27. elokuuta 2025

Opintojen valmistuminen (Todellinen)

Keskiviikko 27. elokuuta 2025

Opintoihin ilmoittautumispäivät

Ensimmäinen lähetetty

Perjantai 21. toukokuuta 2021

Ensimmäinen toimitettu, joka täytti QC-kriteerit

Perjantai 21. toukokuuta 2021

Ensimmäinen Lähetetty (Todellinen)

Maanantai 24. toukokuuta 2021

Tutkimustietojen päivitykset

Viimeisin päivitys julkaistu (Todellinen)

Maanantai 28. syyskuuta 2026

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Keskiviikko 2. syyskuuta 2026

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Tiistai 1. syyskuuta 2026

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Tähän tutkimukseen liittyvät termit

Muut tutkimustunnusnumerot

  • CR109000
  • 2020-005273-27 (EudraCT-numero)
  • VAC52416BAC3001 (Muu tunniste: Janssen Research & Development, LLC)
  • 2023-506589-30-00 (Rekisterin tunniste: EUCT number)
  • 2023 (Yhdysvaltain NIH-apuraha/sopimus)

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IPD-suunnitelman kuvaus

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

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