Studie očkování 9valentní extraintestinální patogenní vakcínou Escherichia Coli (ExPEC9V) v prevenci invazivního extraintestinálního patogenního onemocnění Escherichia coli u dospělých ve věku 60 let a starších s anamnézou infekce močových cest v posledních 2 letech
Randomizovaná, dvojitě zaslepená, placebem kontrolovaná, multicentrická studie fáze 3 k posouzení účinnosti, bezpečnosti a imunogenicity očkování s ExPEC9V v prevenci invazivní extraintestinální patogenní Escherichia coli u dospělých ve věku 60 let a starších s anamnézou infekce močových cest v posledních 2 letech
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.
Přehled studie
Postavení
Postavení
Podmínky
Podmínky
Intervence / Léčba
Intervence / Léčba
Detailní popis
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.
Typ studie
Typ studie
Zápis (Aktuální)
Zápis
Fáze
Fáze
- Fáze 3
Kontakty a umístění
Studijní místa
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Brisbane, Austrálie, 4001
- Saint Andrew's War Memorial Hospital
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Campbelltown, Austrálie, 5074
- GP Surgery - Campbelltown
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Geelong, Austrálie, 3220
- Barwon Health - University Hospital Geelong
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Melbourne, Austrálie, 5000
- CMAX Clinical Research
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New Lambton, Austrálie, 2305
- John Hunter Hospital
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Palmyra DC, Austrálie, 6961
- Fiona Stanley Hospital
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Para Hills West, Austrálie, 5096
- McIntyre Medical Center
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Salisbury, Austrálie, 5108
- North West Medical Center
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South Brisbane, Austrálie, 4101
- Mater Medical Centre South Brisbane
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St Agnes, Austrálie, 5097
- Bene Aged Care - Italian Village
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Sydney, Austrálie, 2145
- Westmead Hospital
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Taringa, Austrálie, 4068
- AusTrials Pty Ltd
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Tarragindi, Austrálie, 4121
- AusTrials Pty Ltd
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Woodville, Austrálie, 5011
- Adelaide Medical Solutions
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Hellerup, Dánsko, 2900
- Aalborg Universitetshospital Nord
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Herlev, Dánsko, 2730
- Gentofte Hospital
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Hilleroed, Dánsko, 3400
- Nordsjaellands Hospital - Hillerod
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Hvidovre, Dánsko, 2650
- Hvidovre Hospital
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Odense M, Dánsko, 5230
- Odense Universitetshospital
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Roskilde, Dánsko, 4000
- Sjællands University hospital
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Annecy, Francie, 74370
- Centre Hospitalier Annecy Genevois
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Dijon, Francie, 21000
- CHU Dijon Bourgogne - Hopital Francois Mitterrand
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Limousis, Francie, 87042
- CHU de Limoges
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Lyon, Francie, 69004
- Hopital de La Croix Rousse
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Nîmes, Francie, 30029
- CHU Nimes Hopital Caremeau
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Pierre-Bénite, Francie, 69495
- Centre hospitalier Lyon-Sud
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Saint-Priest-en-Jarez, Francie, 42270
- CHU Saint Etienne Hopital Nord
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Leiden, Holandsko, 2333 ZA
- Leiden University Medical Center
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Uden, Holandsko, 5406 PT
- Ziekenhuis
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Utrecht, Holandsko, 3508 GA
- The Julius Center - Utrecht Science Park - Stratenum
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Belagavi, Indie, 590010
- KLE's Dr. Prabhakar Kore Hospital & Medical Research Centre (MRC)
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Jaipur, Indie, 302006
- S. R. Kalla Memorial General Hospital
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Kolkata, Indie, 700014
- Nil Ratan Sircar Medical College and Hospital
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Lucknow, Indie, 226022
- Regency health super specialty hospital
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Mumbai, Indie, 421203
- Asian Institute Of Medical Science
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Mysuru, Indie, 570015
- Jagadguru Sri Shivarathreeshwara Academy of Higher Education and Research
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New Delhi, Indie, 1100776
- Indraprastha Apollo Hospital
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Rajkot, Indie, 360004
- Shree Giriraj Multispeciality Hospital
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Surat, Indie, 395009
- BAPS Pramukhswami Hospital
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Surat, Indie, 395002
- Nirmal Hospital Pvt. Ltd.
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Chieti, Itálie, 66100
- ASL2 Lanciano - Vasto - Chieti - Ospedale 'SS Annunziata' di Chieti
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Roma, Itálie, 00144
- Istituto Nazionale Tumori Regina Elena
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Rome, Itálie, 00189
- Azienda Ospedaliera Sant Andrea
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Ashdod, Izrael, 7747629
- Samson Assuta Ashdod University Hospital
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Jerusalem, Izrael, 9112001
- Hadassah Medical Center
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Kfar Saba, Izrael, 44281
- Meir Medical Center
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Ramat Gan, Izrael, 52621
- The Chaim Sheba Medical Center
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Tel Aviv, Izrael, 6423906
- Tel Aviv Sourasky Medical Center
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Akashi Shi, Japonsko, 674 0063
- Akashi Medical Center
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Fukuoka, Japonsko, 811-0213
- Fukuoka Wajiro Hospital
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Fukuoka, Japonsko, 807-0051
- Fukuoka Shinmizumaki Hospital
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Hakodate, Japonsko, 040 8611
- Hakodate Goryoukaku Hospital
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Hashima-gun, Japonsko, 5016062
- Matsunami General Hospital
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Hokkaido, Japonsko, 006-8555
- Teine Keijinkai Hospital
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Iizuka, Japonsko, 820-8501
- Aso Co.,Ltd Iizuka Hospital
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Itoshima, Japonsko, 8191104
- Inoue Hospital
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Kasuya-gun, Japonsko, 811-3112
- Kano Hospital
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Kawasaki, Japonsko, 211-8510
- Kanto Rosai Hospital
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Kitakyushu, Japonsko, 800-0057
- Shinkomonji hospital
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Kitakyushu, Japonsko, 8000295
- Japan Community Health care Organization Kyushu Hospital
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Nagasaki, Japonsko, 852-8511
- JRC Nagasaki Genbaku Hospital
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Neyagawa, Japonsko, 572-8567
- Kyoujinkai Clinic Komatsu
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Omuta-Shi, Japonsko, 836-0861
- Omuta City Hospital
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Osaka, Japonsko, 5340024
- Kyobashi Sugimoto Clinic
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Osaka, Japonsko, 5530003
- Japan Community Health Care Organization Osaka Hospital
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Sanuki, Japonsko, 7692393
- National Hospital Organization Shikoku Cancer Center
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Sapporo, Japonsko, 006-0812
- Teine Maeda Urology Clinic
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Sapporo, Japonsko, 0060816
- Teine Urological Clinic
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Shimajiri-Gun, Japonsko, 9010493
- Nanbu Tokushukai Hospital
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Shimonoseki-shi, Japonsko, 7500061
- Shimonoseki City Hospital
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Shinagawa City, Japonsko, 1408522
- Tokyo Shinagawa Hospital
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Suita-Shi, Japonsko, 5650814
- Suita Tokushukai Hospital
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Suwa-Shi, Japonsko, 3928510
- Japanese Red Cross Society Suwa Hospital
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Yahatanishi-ku, Japonsko, 806-8501
- Japan Community Health care Organization Kyushu Hospital
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Yamaguchi, Japonsko, 750-0041
- Shimonoseki City Hospital
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Yokohama, Japonsko, 222-0036
- Yokohama Rosai Hospital
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Yokohama, Japonsko, 245-8575
- National Hospital Organization Yokohama Medical Center
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Ōita, Japonsko, 8700039
- Abe Diabetes Clinic
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Ōita, Japonsko, 8701195
- Almeida Memorial Hospital
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Ōmura, Japonsko, 856-8562
- National Hospital Organization Nagasaki Medical Center
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Busan, Jižní Korea, 602 812
- Dong-A University Hospital
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Chuncheon, Jižní Korea, 24253
- Hallym University Chuncehon Medical Center
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Daejeon, Jižní Korea, 35015
- Chungnam National University Hospital
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Gwangju, Jižní Korea, 501-757
- Chunnam National University Hospital
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Gyeonggi-do, Jižní Korea, 15355
- Korea University Ansan Hospital
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Incheon, Jižní Korea, 22322
- Inha University Hospital
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Seongnam-si, Jižní Korea, 13620
- Seoul National University Bundang Hospital
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Seoul, Jižní Korea, 05505
- Asan Medical Center
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Seoul, Jižní Korea, 06351
- Samsung Medical Center
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Seoul, Jižní Korea, 03181
- Kangbuk Samsung Hospital
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Seoul, Jižní Korea, 07985
- Ewha Womans University Mokdong Hospital
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Seoul, Jižní Korea, 8308
- Korea University Guro Hospital
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Seoul, Jižní Korea, 07441
- Hallym University Sacred Heart Hospital
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Suwon, Jižní Korea, 16247
- The Catholic university of Korea, St. Vincent's Hospital
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Wŏnju, Jižní Korea, 220-701
- WonJu Severance Christian Hospital
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Alberta
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Calgary, Alberta, Kanada, T4P 1K4
- CARe Clinical Ltd
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Edmonton, Alberta, Kanada, T6G121
- University of Alberta
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Red Deer, Alberta, Kanada, T4P 1K4
- CARe Clinical Ltd
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British Columbia
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Vancouver, British Columbia, Kanada, V6Z2C7
- Vancouver ID Research and Care Centre Society
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Ontario
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Greater Sudbury, Ontario, Kanada, P3E 5J1
- Health Sciences North
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Guelph, Ontario, Kanada, N1H 1B1
- Dawson Road Family Health Team
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Sarnia, Ontario, Kanada, N7T 4X3
- Bluewater Clinical Research Group Inc.
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Winchester, Ontario, Kanada, K0C2K0
- Winchester District Memorial Hospital
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Quebec
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Québec, Quebec, Kanada, G2J 0C4
- Alpha Recherche Clinique
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Québec, Quebec, Kanada, G3K 2P8
- Alpha Recherche Clinique
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Barranquilla, Kolumbie
- Centro de Investigaciones y Proyectos en Neurociencias CIPNA
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Barranquilla, Kolumbie, 080001
- Clinica de la Costa
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Barranquilla, Kolumbie, 80020
- IPS Centro Cientifico Asisitencial Jose Luis Accini S.A.S.
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Casanare, Kolumbie, 856010
- Centro de Atencion e Investigacion Medica S.A. - CAIMED
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Floridablanca, Kolumbie
- Fundacion Cardiovascular de Colombia
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Girardot, Kolumbie, 252432
- Centro de Atencion e Investigacion Medica S.A. - CAIMED
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Helechos, Kolumbie
- Centro de Atencion e Investigacion Medica S.A. - CAIMED
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Manizales, Kolumbie, 170001
- Asociacion IPS Medicos Internistas de Caldas
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Meta, Kolumbie, 507001
- CAIMED Acacias
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Pereira, Kolumbie, 660003
- Fundacion Centro de Investigaciones Clinicas IPS Cardiomet
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Villavicencio, Kolumbie, 500001
- Corporación Clínica Universidad Cooperativa De Colombia Clínica Ucc
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Auckland, Nový Zéland, 0600
- Southern Clinical Trials Totara Clinical Research
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Auckland, Nový Zéland, 0626
- Southern Clinical Trials Ltd
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Auckland, Nový Zéland, 1011
- Optimal Clinical Trials
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Bay of Plenty, Nový Zéland, 3112
- Tauranga Urology Research Limited
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Christchurch, Nový Zéland, 8013
- Canterbury Urology Research Trust
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Christchurch Central, Nový Zéland, 8013
- Southern Clinical Trials Ltd
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Dunedin, Nový Zéland, 9016
- P3 Research Ltd
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Hamilton, Nový Zéland, 3200
- Lakeland Clinical Trials
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Hastings, Nový Zéland, 4122
- P3 Research Ltd
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Lower Hutt, Nový Zéland, 5010
- P3 Research - Lower Hutt
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Nelson, Nový Zéland, 7011
- Southern Clinical Trials Ltd
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Palmerston North, Nový Zéland, 4414
- P3 Research Ltd
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Papamoa, Nový Zéland, 3118
- Culloden Research Ltd
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Papatoetoe, Nový Zéland, 2025
- Middlemore Clinical Trials
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Rosedale, Nový Zéland, 632
- Optimal Clinical Trials
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Rotorua, Nový Zéland, 3010
- Lakeland Clinical Trials
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Tauranga, Nový Zéland, 3110
- P3 Research Ltd
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Upper Hutt, Nový Zéland, 5018
- Lakeland Clinical Trials
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Wellington, Nový Zéland, 5032
- P3 Research Limited Kapiti
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Wellington, Nový Zéland, 6242
- Capatial & Coast District Health Board
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Frankfurt, Německo, 60590
- Universitatsklinikum Frankfurt
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Jena, Německo, 07747
- Universitatsklinikum Jena
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Leipzig, Německo, 04179
- Familienmedizinisches Zentrum Radowsky
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Leipzig, Německo, 4103
- SIBAmed GmbH & Co. KG
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Marburg, Německo, 35037
- Universitaetsklinikum Giessen und Marburg GmbH
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Oldenburg in Holstein, Německo, 23758
- Red-Institut für medizinische Forschung und Fortbildung
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Reinfeld, Německo, 23858
- Praxis Dr. Weimer
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Rostock, Německo, 18057
- Universitaetsmedizin Rostock
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Aberdeen, Spojené království, AB25 2ZN
- Aberdeen Royal Infirmary
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Atherstone, Spojené království, CV9 1EU
- Atherstone Surgery
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Banbury, Spojené království, OX16 9AD
- Banbury Cross Health Center
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Birkenhead, Spojené království, CH62 6EE
- FutureMeds Bridle Clinic
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Birmingham, Spojené království, B21 0RY
- FutureMeds-Soho UK
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Blackpool, Spojené království, FY3 8NR
- Blackpool Teaching Hospitals NHS Foundation Trust
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Bournemouth, Spojené království, BH7 7DW
- Royal Bournemouth Hospital
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Bristol, Spojené království, BS10 5NB
- North Bristol NHS Trust
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Bristol, Spojené království, BS2 8BJ
- University Hospitals Bristol NHS Trust
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Exeter, Spojené království, EX2 5DW
- Royal Devon & Exeter NHS Foundation Trust
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Eynsham, Spojené království, OX29 4QB
- Eynsham Medical Centre
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Guisborough, Spojené království, TS14 7DJ
- The Garth Surgery
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Leicester, Spojené království, LE1 5WW
- University Hospitals Of Leicester Nhs Trust
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London, Spojené království, SE5 9RS
- King's College Hospital NHS Foundation Trust
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Manchester, Spojené království, M13 9WL
- Manchester Royal Infirmary
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Manchester, Spojené království, M23 9LT
- The NIHR Manchester Clinical Research Facility
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Middlesbrough, Spojené království, TS4 3BW
- South Tees Hospitals NHS Foundation Trust
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Nottingham, Spojené království, NG7 2UH
- Nottingham University Hospitals NHS Trust
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Plymouth, Spojené království, PL6 8DH
- Plymouth University Hospitals Trust
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Pontypridd, Spojené království, CF37 2DR
- Ashgrove Surgery
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Poole, Spojené království, BH15 4JQ
- The Adam Practice
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Sheffield, Spojené království, S10 2 JF
- Sheffield Teaching Hospitals NHS Foundation Trust
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Stafford, Spojené království, ST16 3SR
- Midlands Partnership NHS Foundation Trust
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Stockton-on-Tees, Spojené království, TS19 8PE
- North Tees Furturemeds
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Wakefield, Spojené království, WF1 4DG
- Mid Yorkshire Hospital NHS Trust- Pinderfields Hospital
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Wantage, Spojené království, OX12 9BN
- Church Street Practice
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Witney, Spojené království, OX28 6JS
- Windrush Medical Practice
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Alabama
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Guntersville, Alabama, Spojené státy, 35976
- Lakeview Clinical Research
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Arizona
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Phoenix, Arizona, Spojené státy, 85018
- Hope Research Institute
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Phoenix, Arizona, Spojené státy, 85108
- Hope Research Institute
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Sun City West, Arizona, Spojené státy, 85357
- Interspond-Clinical Research Institute of AZ
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Arkansas
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Little Rock, Arkansas, Spojené státy, 72205
- Baptist Health Center For Clinical Research
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California
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Buena Park, California, Spojené státy, 90621
- Sun Urology - Buena Park Office
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Canoga Park, California, Spojené státy, 91303
- Hope clinical Research LLC
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Chula Vista, California, Spojené státy, 91911
- Velocity Clinical Research, Inc.
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Huntington Beach, California, Spojené státy, 92647
- Marvel Clinical Research
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La Mesa, California, Spojené státy, 91942
- California Adult Circumcision - Alvarado La Mesa Urology Center
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Lancaster, California, Spojené státy, 93534
- Om Research LLC
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Long Beach, California, Spojené státy, 90806
- Long Beach Clinical Trials, LLC
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Long Beach, California, Spojené státy, 90806-2766
- Atlantic Urology Medical Group
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Los Angeles, California, Spojené státy, 90027
- Kaiser Permanente Los Angeles Medical Center
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Los Angeles, California, Spojené státy, 90027
- Southern California Permanente Medical Group
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Los Angeles, California, Spojené státy, 90017
- American Institute of Research
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Los Angeles, California, Spojené státy, 90048
- Comprehensive Urology
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Los Angeles, California, Spojené státy, 90073
- Veterans Affairs Greater Los Angeles HCS
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Mather, California, Spojené státy, 95655
- VA Sacramento Medical Center
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Newport Beach, California, Spojené státy, 92663
- Hoag Medical Group
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Oakland, California, Spojené státy, 94612
- Kaiser Permanente Vaccine Study Center
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Pomona, California, Spojené státy, 91767
- Empire Clinical Research, LLC
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Pomona, California, Spojené státy, 91767
- Inland Urology Medical Group
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Sacramento, California, Spojené státy, 95821
- Northern California Research
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Sacramento, California, Spojené státy, 92647
- UC Davis Health System
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San Diego, California, Spojené státy, 92123
- Medical Associates Research Group, Inc.
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San Diego, California, Spojené státy, 92120
- San Diego Sports Medicine & Family Health Center
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San Dimas, California, Spojené státy, 91773
- California Kidney Specialists
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Santa Ana, California, Spojené státy, 92705
- Prestige Medical Group
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Simi Valley, California, Spojené státy, 93065
- Millennium Clinical Trials LLC
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Upland, California, Spojené státy, 91786
- San Antonio Regional Hospital
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Connecticut
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New Haven, Connecticut, Spojené státy, 06510
- Yale University
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Florida
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Adventura, Florida, Spojené státy, 33180
- Ideal Clinical Research
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Bay Pines, Florida, Spojené státy, 33744
- Bay Pines VA Healthcare System
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Bradenton, Florida, Spojené státy, 34209
- Nova Clinical Research, LLC
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Brandon, Florida, Spojené státy, 33511
- Clinical Research of Brandon
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Brandon, Florida, Spojené státy, 33511
- Moore Clinical Reseach - Brandon Clinic
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Clearwater, Florida, Spojené státy, 33756
- Innovative Research of West Florida, Incorporated
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Clearwater, Florida, Spojené státy, 33755
- Florida Medical Center of Clearwater
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Coral Gables, Florida, Spojené státy, 33134
- Advanced Clinical Research Network
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Coral Gables, Florida, Spojené státy, 33134
- Prestige Clinical Research Center, Inc.
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DeLand, Florida, Spojené státy, 32720
- Accel Research Sites
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Doral, Florida, Spojené státy, 33166
- Doral Medical Research
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Doral, Florida, Spojené státy, 33166
- Universal Axon Clinical Research
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Gainesville, Florida, Spojené státy, 32607
- Florida Medical Research Institute
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Hialeah, Florida, Spojené státy, 33012
- Indago Research & Health Center Inc
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Homestead, Florida, Spojené státy, 33030
- Prestige Clinical Research
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Lake City, Florida, Spojené státy, 32055
- Multi Specialty Research Associates Inc
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Maitland, Florida, Spojené státy, 32751
- ClinCloud Clinical Research
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Miami, Florida, Spojené státy, 33126
- Finlay Medical Research
-
Miami, Florida, Spojené státy, 33135
- Suncoast Research Group
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Miami, Florida, Spojené státy, 33155
- Florida International Medical Research
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Miami, Florida, Spojené státy, 33144
- Dynamic Medical Research, LLC
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Miami, Florida, Spojené státy, 33185
- Felicidad Medical Research
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Miami, Florida, Spojené státy, 33124
- Nova Clinical Research Center
-
Miami, Florida, Spojené státy, 33133
- Royal Care Medical Research Corporation
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Miami, Florida, Spojené státy, 33135
- Retreat Medical Research LLC
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Miami, Florida, Spojené státy, 33144-4273
- Continental Research
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Miami, Florida, Spojené státy, 33155
- Health- Life Research Inst
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Miami, Florida, Spojené státy, 33155
- Office of Dr. Marisela Gonzalez
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Miami, Florida, Spojené státy, 33186
- A and R Research Group
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Miami, Florida, Spojené státy, 33186
- Alpha Science Research
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Orlando, Florida, Spojené státy, 32808
- Omega Research Consultants
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Orlando, Florida, Spojené státy, 32801
- Clinical NeuroScience Solutions Inc
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Pembroke Pines, Florida, Spojené státy, 33024
- Pines Care Research Center Inc
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Plant City, Florida, Spojené státy, 33563
- Clinical Research of Central Florida
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Spring Hill, Florida, Spojené státy, 34609
- Care Access Research
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Tampa, Florida, Spojené státy, 33615
- Santos Research Center
-
Tampa, Florida, Spojené státy, 33614
- St. Joseph's Comprehensive Research Institute
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Tampa, Florida, Spojené státy, 33603
- Tampa General Hospital
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Tampa, Florida, Spojené státy, 33613
- Theia Clincial Research, LLC
-
Tampa, Florida, Spojené státy, 33614
- Precision Research Institute
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Tampa, Florida, Spojené státy, 33625
- Care Access Research
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Georgia
-
Atlanta, Georgia, Spojené státy, 30328
- Agile Clinical Research Trials, LLC
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Columbus, Georgia, Spojené státy, 31904
- Columbus Regional Research Institute
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Decatur, Georgia, Spojené státy, 30033
- Atlanta VA Medical Center
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Idaho
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Idaho Falls, Idaho, Spojené státy, 83404
- Clinical Research Prime
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Idaho Falls, Idaho, Spojené státy, 83404
- Snake River Research, PLLC
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Illinois
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Chicago, Illinois, Spojené státy, 60612
- Jesse Brown VAMC Department of Surgery
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Chicago, Illinois, Spojené státy, 60611
- Northwestern Medicine - Northwestern Memorial Hospital Galter Pavilion
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Chicago, Illinois, Spojené státy, 60612
- University Of Illinois
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Indiana
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Evansville, Indiana, Spojené státy, 47714
- Medisphere Medical Research Center, Llc
-
Hammond, Indiana, Spojené státy, 46324
- Asha Clinical Research-Munster Llc
-
Mishawaka, Indiana, Spojené státy, 46544
- Mishawaka Osteopathic Clinic/MOC Research
-
-
Kansas
-
Wichita, Kansas, Spojené státy, 67226
- Cypress Medical Research Center
-
-
Louisiana
-
Marrero, Louisiana, Spojené státy, 70072
- Tandem Clinical Research
-
Natchitoches, Louisiana, Spojené státy, 71457
- KAMP Medical Research, Inc
-
New Orleans, Louisiana, Spojené státy, 70121
- Ochsner Medical Center
-
-
Maryland
-
Rockville, Maryland, Spojené státy, 20852
- Kaiser Permanente
-
-
Massachusetts
-
Boston, Massachusetts, Spojené státy, 02111
- Floating Hospital For Children at Tufts Medical Center
-
West Roxbury, Massachusetts, Spojené státy, 02132-4927
- West Roxbury Veterans Affairs Medical Center
-
-
Michigan
-
Detroit, Michigan, Spojené státy, 48202
- Henry Ford Hospital
-
Royal Oak, Michigan, Spojené státy, 48073
- William Beaumont Hospital
-
-
Mississippi
-
Petal, Mississippi, Spojené státy, 39465
- MediSync Clinical Research
-
-
Nebraska
-
Grand Island, Nebraska, Spojené státy, 68803
- Meridian Clinical Research, LLC
-
Lincoln, Nebraska, Spojené státy, 68516
- Be Well Clinical Studies
-
Norfolk, Nebraska, Spojené státy, 68701
- Meridian Clinical Research, LLC
-
-
Nevada
-
Las Vegas, Nevada, Spojené státy, 89106
- Sierra Clinical Research
-
Las Vegas, Nevada, Spojené státy, 89109
- Excel Clinical Research
-
Las Vegas, Nevada, Spojené státy, 89106
- Hope Research Institute
-
Reno, Nevada, Spojené státy, 89509
- VA Sierra Nevada Health Care System
-
-
New Jersey
-
Hillsborough, New Jersey, Spojené státy, 08844
- I.D. Care, Inc.
-
Teaneck, New Jersey, Spojené státy, 07666
- Holy Name Medical Center
-
-
New York
-
Binghamton, New York, Spojené státy, 13901
- Meridian Clinical Research, LLC
-
Endwell, New York, Spojené státy, 13760
- Meridian Clinical Research, LLC
-
New York, New York, Spojené státy, 10016
- Manhattan Medical Research
-
The Bronx, New York, Spojené státy, 10467
- Montefiore Medical Center
-
-
North Carolina
-
Durham, North Carolina, Spojené státy, 27705
- Durham VAMC
-
Fayetteville, North Carolina, Spojené státy, 28303
- Carolina Institute for Clinical Research
-
Greenville, North Carolina, Spojené státy, 27834
- ECU Health Vidant Medical Center
-
-
North Dakota
-
Fargo, North Dakota, Spojené státy, 58104
- Plains Clinical Research
-
-
Ohio
-
Centerville, Ohio, Spojené státy, 45458
- Kroger Health
-
Cleveland, Ohio, Spojené státy, 44106
- University Hospitals Cleveland Medical Center
-
Columbus, Ohio, Spojené státy, 43215
- Remington Davis Inc
-
Englewood, Ohio, Spojené státy, 45322
- Kroger Health
-
Englewood, Ohio, Spojené státy, 45322
- The Little Clinic
-
Wooster, Ohio, Spojené státy, 44691
- Comprehensive Internal Medicine
-
-
Oklahoma
-
Yukon, Oklahoma, Spojené státy, 73099
- Tekton Research Inc.
-
-
Oregon
-
Portland, Oregon, Spojené státy, 97227
- Kaiser Permanente
-
-
Pennsylvania
-
Camp Hill, Pennsylvania, Spojené státy, 17011
- Capital Area Research
-
West Reading, Pennsylvania, Spojené státy, 19611
- Reading Hospital
-
-
South Carolina
-
Charleston, South Carolina, Spojené státy, 29412
- Hugh D. Durrence, MD, PC
-
Little River, South Carolina, Spojené státy, 29566
- Waterway Familiy Medicine
-
-
Texas
-
Bellaire, Texas, Spojené státy, 77401
- Novel Research LLC
-
Dallas, Texas, Spojené státy, 75246
- North Texas Infectious Diseases Consultants
-
Dallas, Texas, Spojené státy, 75230
- Medical City Dallas
-
Dallas, Texas, Spojené státy, 75224
- Global Medical Research - Dallas
-
Houston, Texas, Spojené státy, 77024
- Digestive Health Associates
-
Lewisville, Texas, Spojené státy, 75057
- EPIC Clinical Research
-
Mesquite, Texas, Spojené státy, 75149
- SMS Clinical Research LLC
-
Round Rock, Texas, Spojené státy, 78681
- Be Well Clinical Studies
-
San Antonio, Texas, Spojené státy, 78229
- Audie L Murphy Memorial Va Ho
-
Sherman, Texas, Spojené státy, 75092
- Sherman Clinical Research
-
-
Utah
-
Draper, Utah, Spojené státy, 84020
- Lone Peak Family Medicine
-
-
Virginia
-
Annandale, Virginia, Spojené státy, 22003-7347
- Clinical Alliance for Research and Education
-
Charlottesville, Virginia, Spojené státy, 22911
- Charlottesville Medical Research Center, LLC
-
Lynchburg, Virginia, Spojené státy, 24501
- Infectious Disease Associates of Central Virginia
-
Suffolk, Virginia, Spojené státy, 23435
- IACT - Suffolk Multispecialty Research
-
Winchester, Virginia, Spojené státy, 22601
- Selma Medical Associates
-
-
Washington
-
Cheney, Washington, Spojené státy, 99004
- Multicare Institute For Research & Innovation - Rockwood Clinic - Cheney
-
-
West Virginia
-
Morgantown, West Virginia, Spojené státy, 26505
- Exemplar Research, Inc
-
-
Wisconsin
-
Marshfield, Wisconsin, Spojené státy, 54449
- Marshfield Clinic
-
-
-
-
-
Kaohsiung City, Tchaj-wan, 813
- Kaohsiung Veterans General Hospital
-
Tainan, Tchaj-wan, 704
- National Cheng Kung University Hospital
-
Taoyuan, Tchaj-wan, 333
- Chang Gung Memorial Hospital Linkou Branch
-
-
-
-
-
Bangkok, Thajsko, 10330
- King Chulalongkorn Memorial Hospital
-
Bangkok, Thajsko, 10700
- Siriraj Hospital
-
Bangkok, Thajsko, 10400
- Ramathibodi Hospital
-
Bangkok, Thajsko, 10400
- Tropical Medicine Hospital, Mahidol University
-
Bangkok, Thajsko, 10330
- Thai Red Cross Aids Research Centre
-
-
-
-
-
Brno, Česko, 61500
- Uromeda
-
Dolní Břežany, Česko, 252 41
- Aesculap Ambulance sro - Zdravotni Stredisko Centrum Zdravi
-
Hradec Králové, Česko, 50002
- Centrum Ockovani a Cestovi Mediciny
-
Nový Knín, Česko, 262 03
- Res Medica
-
Olomouc, Česko, 77900
- PreventaMed, s.r.o.
-
Ostrava-Proskovice, Česko, 72400
- GYNURO s.r.o
-
Pilsen, Česko, 30100
- Ambulance name: Gynekologická ordinace MUDr
-
Pilsen, Česko, 323 00
- MUDr. Mita Rosenberg
-
Prague, Česko, 13000
- Gona s.R.o- Orfinace Harov
-
Protivín, Česko, 39811
- Zdravi-fit, s.r.o.
-
Slaný, Česko, 274 01
- Nemocnice Slany
-
Vysoké Mýto, Česko, 56601
- Progerint s.r.o.
-
České Budějovice, Česko, 37001
- Ordinace Hradebni s.r.o.
-
-
-
-
-
Chengdu, Čína, 610041
- West China School of Medicine/West China Hospital, Sichuan University
-
Fuyang, Čína, 236399
- Funan Center for Disease Control and Prevention
-
Guangzhou, Čína, 510120
- The First Affiliated Hospital of Guangzhou Medical University
-
Guangzhou, Čína, 510260
- The Second Affiliated Hospital of Guangzhou Medical University
-
Hangzhou, Čína, 310003
- 1st Affiliated Hospital of Zhejiang University Medical College
-
Hefei, Čína, 230601
- Anhui Provincial Center for Disease Control and Prevention
-
Liuan, Čína, 237400
- Huoqiu County Center For Disease Control and Prevention
-
Nanjing, Čína, 210009
- Jiangsu Provincial Center for Disease Control and Prevention
-
Nanjing, Čína, 211112
- Nanjing Medical University
-
Shanghai, Čína, 200040
- Huashan Hospital affiliated to Fudan University
-
Suzhou, Čína, 215002
- Suzhou Municipal Hospital
-
Taizhou, Čína, 225300
- Taizhou Peoples Hospital
-
Wuxi, Čína, 214200
- Yixing People's Hospital
-
-
-
-
-
Alicante, Španělsko, 3010
- Hosp. Gral. Univ. Dr. Balmis
-
Barcelona, Španělsko, 8003
- Hosp. Del Mar
-
Barcelona, Španělsko, 08907
- Hosp. Univ. de Bellvitge
-
Barcelona, Španělsko, 08036
- Hosp Clinic de Barcelona
-
Barcelona, Španělsko, 8028
- Consorci D'Atenció Primària de Salut Barcelona Esquerra
-
Córdoba, Španělsko, 14004
- Hosp Reina Sofia
-
Girona, Španělsko, 17007
- Hosp. Univ. Dr. Josep Trueta
-
Jerez de la Frontera, Španělsko, 11407
- Hosp. de Jerez de La Frontera
-
La Roca del Vallès, Španělsko, 8430
- CAP Dr. Vicenç Papaceit ABS LA ROCA
-
Madrid, Španělsko, 28046
- Hosp. Univ. La Paz
-
Madrid, Španělsko, 28006
- Hosp. Univ. de La Princesa
-
Madrid, Španělsko, 28660
- Hosp. Univ. Hm Monteprincipe
-
Madrid, Španělsko, 28050
- Hospital Sanitas La Moraleja
-
Málaga, Španělsko, 29004
- Hosp. Quirónsalud Málaga
-
Ourense, Španělsko, 32005
- Complexo Hosp. Univ. de Ourense
-
Palma de Mallorca, Španělsko, 07120
- Hosp. Univ. Son Espases
-
Sabadell, Španělsko, 08208
- Corporacio Sanitari Parc Tauli
-
Seville, Španělsko, 41009
- Hosp. Virgen Macarena
-
Vigo, Španělsko, 36312
- Hosp. Alvaro Cunqueiro
-
-
-
-
-
Helsingborg, Švédsko, 25187
- Helsingborgs lasarett
-
Karlskrona, Švédsko, 37179
- BTH Research & Development Clinic
-
Linkoaping, Švédsko, 582 13
- CTC Ebbepark
-
Malmö, Švédsko, 21428
- Skanes universitetssjukhus
-
Mölndal, Švédsko, 43153
- CTC GoCo
-
Solna, Švédsko, 171 64
- ClinSmart Sweden AB
-
Uppsala, Švédsko, 752 37
- ClinSmart Sweden AB
-
Örebro, Švédsko, 70362
- Universitetssjukhuset Orebro
-
-
Kritéria účasti
Kritéria způsobilosti
Kritéria způsobilosti
Věk způsobilý ke studiu
Přijímá zdravé dobrovolníky
Pohlaví způsobilá ke studiu
Popis
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
Studijní plán
Jak je studie koncipována?
Detaily designu
- Primární účel: Prevence
- Přidělení: Randomizované
- Intervenční model: Paralelní přiřazení
- Maskování: Dvojnásobek
Počet zbraní
Zbraně a zásahy
Skupina účastníků / ArmSkupina účastníků / Arm |
Intervence / LéčbaIntervence / Léčba |
|---|---|
|
Experimentální: ExPEC9V
Participants will receive a single intramuscular (IM) injection of 9-valent extraintestinal pathogenic Escherichia coli vaccine (ExPEC9V) on Day 1. |
ExPEC9V will be administered as an IM injection.
Ostatní jména:
|
|
Komparátor placeba: Placebo
Participants will receive a single IM injection of matching placebo on Day 1. |
Matching placebo will be administered as an IM injection. |
Co je měření studie?
Primární výstupní opatření
Primární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
|
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
Časové okno: 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)
|
Sekundární výstupní opatření
Sekundární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
|
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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: Day 1 (pre-vaccination), Days 30, 181, 366, and 731
|
GMT to vaccine O-serotype antigen and EPA as measured by multiplex ECL based immunoassay was reported. GMTs for each antigen serotypes O1A, O2, O4, O6A, O15, O16, O18A, O25B, O75 and EPA were determined in serum from collected blood samples. |
Day 1 (pre-vaccination), Days 30, 181, 366, and 731
|
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Geometric Mean Titers (GMTs) to Vaccine O-serotype Antigens as Determined by Multiplex Opsonophagocytic Killing Assay (MOPA)
Časové okno: Day 1 (pre-vaccination) and Day 30
|
GMT to vaccine O-serotype antigen as determined by MOPA was reported. GMTs for each antigen serotypes O1A, O2, O4, O6, O15, O16, O18, O25, O75 were determined in serum from collected blood samples. The available immunogenicity data generated for MOPA assessments through Day 30 from the first 200 vaccinated participants were considered adequate for assessment of the post vaccination immune response. MOPA assessments beyond Day 30 were not performed per sponsor decision due to futility and is reflected in the changes to planned analysis. |
Day 1 (pre-vaccination) and Day 30
|
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Number of Participants With Solicited Local Adverse Events (AEs)
Časové okno: From Day 1 (post vaccination) up to Day 15
|
An AE is any untoward medical occurrence in a clinical study participant administered a medicinal (investigational or non-investigational) product. An AE does not necessarily have a causal relationship with the study vaccine. Solicited local AEs were precisely defined events that participants were specifically asked about and which were noted by participants in the e-diary. Solicited local (injection site) AEs included injection site pain/tenderness, erythema and swelling at the study vaccine injection site, were used to assess the reactogenicity of the study vaccine and were pre-defined local (injection site) event. All solicited AEs at the injection site (local) were considered related to the study vaccine administration. |
From Day 1 (post vaccination) up to Day 15
|
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Number of Participants With Solicited Systemic Adverse Events
Časové okno: From Day 1 (post vaccination) up to Day 15
|
An AE was any untoward medical occurrence in a clinical study administered a medicinal (investigational or non-investigational) product. An AE does not necessarily have a causal relationship with the study vaccine. Solicited AEs were precisely defined events that participants were specifically asked about and which were noted by participants in the e-diary. Solicited systemic AEs included fatigue, headache, nausea, fever and myalgia, used to assess the reactogenicity of the study vaccine and were predefined systemic events. |
From Day 1 (post vaccination) up to Day 15
|
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Number of Participants With Unsolicited Adverse Events
Časové okno: 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)
Časové okno: From Day 1 (post vaccination) up to Day 181
|
An AE was any untoward medical occurrence in a clinical study administered a medicinal (investigational or non-investigational) product. An AE does not necessarily have a causal relationship with the study vaccine. An SAE is an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly/birth defect; suspected transmission of any infectious agent via a medicinal product or medically important. |
From Day 1 (post vaccination) up to Day 181
|
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Change From Baseline in Short Form-36 Health Survey
Časové okno: Baseline, Day 15, Day 30, Day 181, Year 1, Year 2, and Year 3
|
The SF-36 determines participants' overall quality of life by assessing (1) limitations in physical functioning due to health problems (PF); (2) limitations in usual role because of physical health problems (RP); (3) bodily pain (BP); (4) general mental health (MH); (5) limitations in usual role due to emotional problems (RE); (6) limitations in social functioning due to physical or mental health problems (SF); (7) vitality, energy and fatigue (VT); and (8) general health perception (GH). Responses to all individual items are rated on a 3-, 5- or 6-point Likert scale and the 8 multi-item scales were scored from 0 to 100 with higher scores indicating better health. Scores on each item are summed and averaged (range: 0=worst to 100=best). Higher scores indicated better health. Baseline=value of last available assessment prior to vaccination on Day 1. |
Baseline, Day 15, Day 30, Day 181, Year 1, Year 2, and Year 3
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Change From Baseline in 5-level EuroQol 5-Dimension (EQ-5D-5L) Descriptive System Score: Index Score
Časové okno: 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
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Change From Baseline in 5-level EuroQol 5-Dimension (EQ-5D-5L) Score: Visual Analog Scale (VAS)
Časové okno: 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
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Number of Participants With Frailty Index
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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)
|
Spolupracovníci a vyšetřovatelé
Sponzor
Sponzor
Vyšetřovatelé
Vyšetřovatelé
- Ředitel studie: Janssen Research & Development, LLC Clinical Trial, Janssen Research & Development, LLC
Publikace a užitečné odkazy
Obecné publikace
- Doua J, Ekkelenkamp M, Verheij T, Go O, Ruhmel S, Leathers K, Spiessens B, van Rooij S, Fowler VG Jr, Geurtsen J, Dolor R, Sarnecki M, Chatterjee R, Poolman J, Bonten M; on behalf COMBACTE-NET consortium/EXPECT study group. Feasibility of tracking invasive Escherichia coli disease among older adults in a community setting: A prospective observational study. Eur J Clin Microbiol Infect Dis. 2024 Mar;43(3):541-550. doi: 10.1007/s10096-023-04738-y. Epub 2024 Jan 18.
- Doiron RC, Cotechini T, Nickel JC. It's Time to Embrace Vaccination as We Enter the Postantibiotic Era of Recurrent Urinary Tract Infection Management. J Urol. 2024 Jun;211(6):797-799. doi: 10.1097/JU.0000000000003969. Epub 2024 May 5. No abstract available.
- Bonten M, Butler CC, Edwards A, Gravenstein S, Ikeda H, Johansen IS, Lambregts MMC, Matsumoto T, Patterson DL, Rodriguez-Bano J, Saade E, Zingman BS, Day T, Geurtsen J, Hardt K, McLean C, Scheys I, Shukarev G, Guinazu JR, Sarnecki M, Spiessens B, Peeters M, Pau MG, Poolman J, Cohen KA; E.mbrace Study Team. Efficacy, safety, and immunogenicity of a nine-valent vaccine (ExPEC9V) for the prevention of invasive Escherichia coli disease in older adults: a phase 3, randomised, placebo-controlled trial (E.mbrace). Lancet Infect Dis. 2026 Oct 12:S1473-3099(26)00469-X. doi: 10.1016/S1473-3099(26)00469-X. Online ahead of print.
- Shastry R, Shang W, Janssen S, Tete S, Dominguez EG, van den Dobbelsteen G, Davies T, Morrow B. Development and validation of a high-throughput agglutination assay for O-serogrouping clinical Escherichia coli isolates. Microbiol Spectr. 2026 Aug 21:e0099126. doi: 10.1128/spectrum.00991-26. Online ahead of print.
Termíny studijních záznamů
Hlavní termíny studia
Začátek studia (Aktuální)
Začátek studia
Primární dokončení (Aktuální)
Primární dokončení
Dokončení studie (Aktuální)
Dokončení studie
Termíny zápisu do studia
První předloženo
První předloženo
První předloženo, které splnilo kritéria kontroly kvality
První předloženo, které splnilo kritéria kontroly kvality
První zveřejněno (Aktuální)
První zveřejněno
Aktualizace studijních záznamů
Poslední zveřejněná aktualizace (Aktuální)
Poslední zveřejněná aktualizace
Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality
Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality
Naposledy ověřeno
Naposledy ověřeno
Více informací
Termíny související s touto studií
Další identifikační čísla studie
Další identifikační čísla studie
- CR109000
- 2020-005273-27 (Číslo EudraCT)
- VAC52416BAC3001 (Jiný identifikátor: Janssen Research & Development, LLC)
- 2023-506589-30-00 (Identifikátor registru: EUCT number)
- 2023 (Grant/smlouva NIH USA)
Plán pro data jednotlivých účastníků (IPD)
Plánujete sdílet data jednotlivých účastníků (IPD)?
Popis plánu 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
Informace o lécích a zařízeních, studijní dokumenty
Studuje lékový produkt regulovaný americkým FDA
Studuje produkt zařízení regulovaný americkým úřadem FDA
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