Badanie dotyczące szczepienia 9-walentną pozajelitową chorobotwórczą szczepionką Escherichia coli (ExPEC9V) w zapobieganiu inwazyjnej pozajelitowej patogennej chorobie Escherichia coli u dorosłych w wieku 60 lat i starszych z zakażeniem dróg moczowych w ciągu ostatnich 2 lat
Randomizowane, podwójnie ślepe, kontrolowane placebo, wieloośrodkowe badanie fazy 3 oceniające skuteczność, bezpieczeństwo i immunogenność szczepionki ExPEC9V w zapobieganiu inwazyjnej pozajelitowej patogennej chorobie Escherichia coli u dorosłych w wieku 60 lat i starszych z zakażeniem dróg moczowych w wywiadzie w ciągu ostatnich 2 lat
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.
Przegląd badań
Status
Status
Warunki
Warunki
Interwencja / Leczenie
Interwencja / Leczenie
Szczegółowy opis
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 studiów
Typ studiów
Zapisy (Rzeczywisty)
Zapisy
Faza
Faza
- Faza 3
Kontakty i lokalizacje
Lokalizacje studiów
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Brisbane, Australia, 4001
- Saint Andrew's War Memorial Hospital
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Campbelltown, Australia, 5074
- GP Surgery - Campbelltown
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Geelong, Australia, 3220
- Barwon Health - University Hospital Geelong
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Melbourne, Australia, 5000
- CMAX Clinical Research
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New Lambton, Australia, 2305
- John Hunter Hospital
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Palmyra DC, Australia, 6961
- Fiona Stanley Hospital
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Para Hills West, Australia, 5096
- McIntyre Medical Center
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Salisbury, Australia, 5108
- North West Medical Center
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South Brisbane, Australia, 4101
- Mater Medical Centre South Brisbane
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St Agnes, Australia, 5097
- Bene Aged Care - Italian Village
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Sydney, Australia, 2145
- Westmead Hospital
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Taringa, Australia, 4068
- AusTrials Pty Ltd
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Tarragindi, Australia, 4121
- AusTrials Pty Ltd
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Woodville, Australia, 5011
- Adelaide Medical Solutions
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Chengdu, Chiny, 610041
- West China School of Medicine/West China Hospital, Sichuan University
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Fuyang, Chiny, 236399
- Funan Center for Disease Control and Prevention
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Guangzhou, Chiny, 510120
- The First Affiliated Hospital of Guangzhou Medical University
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Guangzhou, Chiny, 510260
- The Second Affiliated Hospital of Guangzhou Medical University
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Hangzhou, Chiny, 310003
- 1st Affiliated Hospital of Zhejiang University Medical College
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Hefei, Chiny, 230601
- Anhui Provincial Center for Disease Control and Prevention
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Liuan, Chiny, 237400
- Huoqiu County Center For Disease Control and Prevention
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Nanjing, Chiny, 210009
- Jiangsu Provincial Center for Disease Control and Prevention
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Nanjing, Chiny, 211112
- Nanjing Medical University
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Shanghai, Chiny, 200040
- Huashan Hospital affiliated to Fudan University
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Suzhou, Chiny, 215002
- Suzhou Municipal Hospital
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Taizhou, Chiny, 225300
- Taizhou Peoples Hospital
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Wuxi, Chiny, 214200
- Yixing People's Hospital
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Brno, Czechy, 61500
- Uromeda
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Dolní Břežany, Czechy, 252 41
- Aesculap Ambulance sro - Zdravotni Stredisko Centrum Zdravi
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Hradec Králové, Czechy, 50002
- Centrum Ockovani a Cestovi Mediciny
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Nový Knín, Czechy, 262 03
- Res Medica
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Olomouc, Czechy, 77900
- PreventaMed, s.r.o.
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Ostrava-Proskovice, Czechy, 72400
- GYNURO s.r.o
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Pilsen, Czechy, 30100
- Ambulance name: Gynekologická ordinace MUDr
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Pilsen, Czechy, 323 00
- MUDr. Mita Rosenberg
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Prague, Czechy, 13000
- Gona s.R.o- Orfinace Harov
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Protivín, Czechy, 39811
- Zdravi-fit, s.r.o.
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Slaný, Czechy, 274 01
- Nemocnice Slany
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Vysoké Mýto, Czechy, 56601
- Progerint s.r.o.
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České Budějovice, Czechy, 37001
- Ordinace Hradebni s.r.o.
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Hellerup, Dania, 2900
- Aalborg Universitetshospital Nord
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Herlev, Dania, 2730
- Gentofte Hospital
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Hilleroed, Dania, 3400
- Nordsjaellands Hospital - Hillerod
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Hvidovre, Dania, 2650
- Hvidovre Hospital
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Odense M, Dania, 5230
- Odense Universitetshospital
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Roskilde, Dania, 4000
- Sjællands University hospital
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Annecy, Francja, 74370
- Centre Hospitalier Annecy Genevois
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Dijon, Francja, 21000
- CHU Dijon Bourgogne - Hopital Francois Mitterrand
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Limousis, Francja, 87042
- CHU de Limoges
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Lyon, Francja, 69004
- Hopital de La Croix Rousse
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Nîmes, Francja, 30029
- CHU Nimes Hopital Caremeau
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Pierre-Bénite, Francja, 69495
- Centre hospitalier Lyon-Sud
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Saint-Priest-en-Jarez, Francja, 42270
- CHU Saint Etienne Hopital Nord
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Alicante, Hiszpania, 3010
- Hosp. Gral. Univ. Dr. Balmis
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Barcelona, Hiszpania, 8003
- Hosp. Del Mar
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Barcelona, Hiszpania, 08907
- Hosp. Univ. de Bellvitge
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Barcelona, Hiszpania, 08036
- Hosp Clinic de Barcelona
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Barcelona, Hiszpania, 8028
- Consorci D'Atenció Primària de Salut Barcelona Esquerra
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Córdoba, Hiszpania, 14004
- Hosp Reina Sofia
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Girona, Hiszpania, 17007
- Hosp. Univ. Dr. Josep Trueta
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Jerez de la Frontera, Hiszpania, 11407
- Hosp. de Jerez de La Frontera
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La Roca del Vallès, Hiszpania, 8430
- CAP Dr. Vicenç Papaceit ABS LA ROCA
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Madrid, Hiszpania, 28046
- Hosp. Univ. La Paz
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Madrid, Hiszpania, 28006
- Hosp. Univ. de La Princesa
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Madrid, Hiszpania, 28660
- Hosp. Univ. Hm Monteprincipe
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Madrid, Hiszpania, 28050
- Hospital Sanitas La Moraleja
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Málaga, Hiszpania, 29004
- Hosp. Quirónsalud Málaga
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Ourense, Hiszpania, 32005
- Complexo Hosp. Univ. de Ourense
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Palma de Mallorca, Hiszpania, 07120
- Hosp. Univ. Son Espases
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Sabadell, Hiszpania, 08208
- Corporacio Sanitari Parc Tauli
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Seville, Hiszpania, 41009
- Hosp. Virgen Macarena
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Vigo, Hiszpania, 36312
- Hosp. Alvaro Cunqueiro
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Leiden, Holandia, 2333 ZA
- Leiden University Medical Center
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Uden, Holandia, 5406 PT
- Ziekenhuis
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Utrecht, Holandia, 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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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, Japonia, 674 0063
- Akashi Medical Center
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Fukuoka, Japonia, 811-0213
- Fukuoka Wajiro Hospital
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Fukuoka, Japonia, 807-0051
- Fukuoka Shinmizumaki Hospital
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Hakodate, Japonia, 040 8611
- Hakodate Goryoukaku Hospital
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Hashima-gun, Japonia, 5016062
- Matsunami General Hospital
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Hokkaido, Japonia, 006-8555
- Teine Keijinkai Hospital
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Iizuka, Japonia, 820-8501
- Aso Co.,Ltd Iizuka Hospital
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Itoshima, Japonia, 8191104
- Inoue Hospital
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Kasuya-gun, Japonia, 811-3112
- Kano Hospital
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Kawasaki, Japonia, 211-8510
- Kanto Rosai Hospital
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Kitakyushu, Japonia, 800-0057
- Shinkomonji hospital
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Kitakyushu, Japonia, 8000295
- Japan Community Health care Organization Kyushu Hospital
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Nagasaki, Japonia, 852-8511
- JRC Nagasaki Genbaku Hospital
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Neyagawa, Japonia, 572-8567
- Kyoujinkai Clinic Komatsu
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Omuta-Shi, Japonia, 836-0861
- Omuta City Hospital
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Osaka, Japonia, 5340024
- Kyobashi Sugimoto Clinic
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Osaka, Japonia, 5530003
- Japan Community Health Care Organization Osaka Hospital
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Sanuki, Japonia, 7692393
- National Hospital Organization Shikoku Cancer Center
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Sapporo, Japonia, 006-0812
- Teine Maeda Urology Clinic
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Sapporo, Japonia, 0060816
- Teine Urological Clinic
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Shimajiri-Gun, Japonia, 9010493
- Nanbu Tokushukai Hospital
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Shimonoseki-shi, Japonia, 7500061
- Shimonoseki City Hospital
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Shinagawa City, Japonia, 1408522
- Tokyo Shinagawa Hospital
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Suita-Shi, Japonia, 5650814
- Suita Tokushukai Hospital
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Suwa-Shi, Japonia, 3928510
- Japanese Red Cross Society Suwa Hospital
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Yahatanishi-ku, Japonia, 806-8501
- Japan Community Health care Organization Kyushu Hospital
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Yamaguchi, Japonia, 750-0041
- Shimonoseki City Hospital
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Yokohama, Japonia, 222-0036
- Yokohama Rosai Hospital
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Yokohama, Japonia, 245-8575
- National Hospital Organization Yokohama Medical Center
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Ōita, Japonia, 8700039
- Abe Diabetes Clinic
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Ōita, Japonia, 8701195
- Almeida Memorial Hospital
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Ōmura, Japonia, 856-8562
- National Hospital Organization Nagasaki Medical Center
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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, Kolumbia
- Centro de Investigaciones y Proyectos en Neurociencias CIPNA
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Barranquilla, Kolumbia, 080001
- Clinica de la Costa
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Barranquilla, Kolumbia, 80020
- IPS Centro Cientifico Asisitencial Jose Luis Accini S.A.S.
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Casanare, Kolumbia, 856010
- Centro de Atencion e Investigacion Medica S.A. - CAIMED
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Floridablanca, Kolumbia
- Fundacion Cardiovascular de Colombia
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Girardot, Kolumbia, 252432
- Centro de Atencion e Investigacion Medica S.A. - CAIMED
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Helechos, Kolumbia
- Centro de Atencion e Investigacion Medica S.A. - CAIMED
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Manizales, Kolumbia, 170001
- Asociacion IPS Medicos Internistas de Caldas
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Meta, Kolumbia, 507001
- CAIMED Acacias
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Pereira, Kolumbia, 660003
- Fundacion Centro de Investigaciones Clinicas IPS Cardiomet
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Villavicencio, Kolumbia, 500001
- Corporación Clínica Universidad Cooperativa De Colombia Clínica Ucc
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Busan, Korea Południowa, 602 812
- Dong-A University Hospital
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Chuncheon, Korea Południowa, 24253
- Hallym University Chuncehon Medical Center
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Daejeon, Korea Południowa, 35015
- Chungnam National University Hospital
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Gwangju, Korea Południowa, 501-757
- Chunnam National University Hospital
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Gyeonggi-do, Korea Południowa, 15355
- Korea University Ansan Hospital
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Incheon, Korea Południowa, 22322
- Inha University Hospital
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Seongnam-si, Korea Południowa, 13620
- Seoul National University Bundang Hospital
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Seoul, Korea Południowa, 05505
- Asan Medical Center
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Seoul, Korea Południowa, 06351
- Samsung Medical Center
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Seoul, Korea Południowa, 03181
- Kangbuk Samsung Hospital
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Seoul, Korea Południowa, 07985
- Ewha Womans University Mokdong Hospital
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Seoul, Korea Południowa, 8308
- Korea University Guro Hospital
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Seoul, Korea Południowa, 07441
- Hallym University Sacred Heart Hospital
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Suwon, Korea Południowa, 16247
- The Catholic university of Korea, St. Vincent's Hospital
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Wŏnju, Korea Południowa, 220-701
- WonJu Severance Christian Hospital
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Frankfurt, Niemcy, 60590
- Universitatsklinikum Frankfurt
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Jena, Niemcy, 07747
- Universitatsklinikum Jena
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Leipzig, Niemcy, 04179
- Familienmedizinisches Zentrum Radowsky
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Leipzig, Niemcy, 4103
- SIBAmed GmbH & Co. KG
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Marburg, Niemcy, 35037
- Universitaetsklinikum Giessen und Marburg GmbH
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Oldenburg in Holstein, Niemcy, 23758
- Red-Institut für medizinische Forschung und Fortbildung
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Reinfeld, Niemcy, 23858
- Praxis Dr. Weimer
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Rostock, Niemcy, 18057
- Universitaetsmedizin Rostock
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Auckland, Nowa Zelandia, 0600
- Southern Clinical Trials Totara Clinical Research
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Auckland, Nowa Zelandia, 0626
- Southern Clinical Trials Ltd
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Auckland, Nowa Zelandia, 1011
- Optimal Clinical Trials
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Bay of Plenty, Nowa Zelandia, 3112
- Tauranga Urology Research Limited
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Christchurch, Nowa Zelandia, 8013
- Canterbury Urology Research Trust
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Christchurch Central, Nowa Zelandia, 8013
- Southern Clinical Trials Ltd
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Dunedin, Nowa Zelandia, 9016
- P3 Research Ltd
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Hamilton, Nowa Zelandia, 3200
- Lakeland Clinical Trials
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Hastings, Nowa Zelandia, 4122
- P3 Research Ltd
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Lower Hutt, Nowa Zelandia, 5010
- P3 Research - Lower Hutt
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Nelson, Nowa Zelandia, 7011
- Southern Clinical Trials Ltd
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Palmerston North, Nowa Zelandia, 4414
- P3 Research Ltd
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Papamoa, Nowa Zelandia, 3118
- Culloden Research Ltd
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Papatoetoe, Nowa Zelandia, 2025
- Middlemore Clinical Trials
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Rosedale, Nowa Zelandia, 632
- Optimal Clinical Trials
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Rotorua, Nowa Zelandia, 3010
- Lakeland Clinical Trials
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Tauranga, Nowa Zelandia, 3110
- P3 Research Ltd
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Upper Hutt, Nowa Zelandia, 5018
- Lakeland Clinical Trials
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Wellington, Nowa Zelandia, 5032
- P3 Research Limited Kapiti
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Wellington, Nowa Zelandia, 6242
- Capatial & Coast District Health Board
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Alabama
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Guntersville, Alabama, Stany Zjednoczone, 35976
- Lakeview Clinical Research
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Arizona
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Phoenix, Arizona, Stany Zjednoczone, 85018
- Hope Research Institute
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Phoenix, Arizona, Stany Zjednoczone, 85108
- Hope Research Institute
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Sun City West, Arizona, Stany Zjednoczone, 85357
- Interspond-Clinical Research Institute of AZ
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Arkansas
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Little Rock, Arkansas, Stany Zjednoczone, 72205
- Baptist Health Center For Clinical Research
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California
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Buena Park, California, Stany Zjednoczone, 90621
- Sun Urology - Buena Park Office
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Canoga Park, California, Stany Zjednoczone, 91303
- Hope clinical Research LLC
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Chula Vista, California, Stany Zjednoczone, 91911
- Velocity Clinical Research, Inc.
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Huntington Beach, California, Stany Zjednoczone, 92647
- Marvel Clinical Research
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La Mesa, California, Stany Zjednoczone, 91942
- California Adult Circumcision - Alvarado La Mesa Urology Center
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Lancaster, California, Stany Zjednoczone, 93534
- Om Research LLC
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Long Beach, California, Stany Zjednoczone, 90806
- Long Beach Clinical Trials, LLC
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Long Beach, California, Stany Zjednoczone, 90806-2766
- Atlantic Urology Medical Group
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Los Angeles, California, Stany Zjednoczone, 90027
- Kaiser Permanente Los Angeles Medical Center
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Los Angeles, California, Stany Zjednoczone, 90027
- Southern California Permanente Medical Group
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Los Angeles, California, Stany Zjednoczone, 90017
- American Institute of Research
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Los Angeles, California, Stany Zjednoczone, 90048
- Comprehensive Urology
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Los Angeles, California, Stany Zjednoczone, 90073
- Veterans Affairs Greater Los Angeles HCS
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Mather, California, Stany Zjednoczone, 95655
- VA Sacramento Medical Center
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Newport Beach, California, Stany Zjednoczone, 92663
- Hoag Medical Group
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Oakland, California, Stany Zjednoczone, 94612
- Kaiser Permanente Vaccine Study Center
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Pomona, California, Stany Zjednoczone, 91767
- Empire Clinical Research, LLC
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Pomona, California, Stany Zjednoczone, 91767
- Inland Urology Medical Group
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Sacramento, California, Stany Zjednoczone, 95821
- Northern California Research
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Sacramento, California, Stany Zjednoczone, 92647
- UC Davis Health System
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San Diego, California, Stany Zjednoczone, 92123
- Medical Associates Research Group, Inc.
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San Diego, California, Stany Zjednoczone, 92120
- San Diego Sports Medicine & Family Health Center
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San Dimas, California, Stany Zjednoczone, 91773
- California Kidney Specialists
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Santa Ana, California, Stany Zjednoczone, 92705
- Prestige Medical Group
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Simi Valley, California, Stany Zjednoczone, 93065
- Millennium Clinical Trials LLC
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Upland, California, Stany Zjednoczone, 91786
- San Antonio Regional Hospital
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Connecticut
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New Haven, Connecticut, Stany Zjednoczone, 06510
- Yale University
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Florida
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Adventura, Florida, Stany Zjednoczone, 33180
- Ideal Clinical Research
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Bay Pines, Florida, Stany Zjednoczone, 33744
- Bay Pines VA Healthcare System
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Bradenton, Florida, Stany Zjednoczone, 34209
- Nova Clinical Research, LLC
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Brandon, Florida, Stany Zjednoczone, 33511
- Clinical Research of Brandon
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Brandon, Florida, Stany Zjednoczone, 33511
- Moore Clinical Reseach - Brandon Clinic
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Clearwater, Florida, Stany Zjednoczone, 33756
- Innovative Research of West Florida, Incorporated
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Clearwater, Florida, Stany Zjednoczone, 33755
- Florida Medical Center of Clearwater
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Coral Gables, Florida, Stany Zjednoczone, 33134
- Advanced Clinical Research Network
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Coral Gables, Florida, Stany Zjednoczone, 33134
- Prestige Clinical Research Center, Inc.
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DeLand, Florida, Stany Zjednoczone, 32720
- Accel Research Sites
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Doral, Florida, Stany Zjednoczone, 33166
- Doral Medical Research
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Doral, Florida, Stany Zjednoczone, 33166
- Universal Axon Clinical Research
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Gainesville, Florida, Stany Zjednoczone, 32607
- Florida Medical Research Institute
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Hialeah, Florida, Stany Zjednoczone, 33012
- Indago Research & Health Center Inc
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Homestead, Florida, Stany Zjednoczone, 33030
- Prestige Clinical Research
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Lake City, Florida, Stany Zjednoczone, 32055
- Multi Specialty Research Associates Inc
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Maitland, Florida, Stany Zjednoczone, 32751
- ClinCloud Clinical Research
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Miami, Florida, Stany Zjednoczone, 33126
- Finlay Medical Research
-
Miami, Florida, Stany Zjednoczone, 33135
- Suncoast Research Group
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Miami, Florida, Stany Zjednoczone, 33155
- Florida International Medical Research
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Miami, Florida, Stany Zjednoczone, 33144
- Dynamic Medical Research, LLC
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Miami, Florida, Stany Zjednoczone, 33185
- Felicidad Medical Research
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Miami, Florida, Stany Zjednoczone, 33124
- Nova Clinical Research Center
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Miami, Florida, Stany Zjednoczone, 33133
- Royal Care Medical Research Corporation
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Miami, Florida, Stany Zjednoczone, 33135
- Retreat Medical Research LLC
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Miami, Florida, Stany Zjednoczone, 33144-4273
- Continental Research
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Miami, Florida, Stany Zjednoczone, 33155
- Health- Life Research Inst
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Miami, Florida, Stany Zjednoczone, 33155
- Office of Dr. Marisela Gonzalez
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Miami, Florida, Stany Zjednoczone, 33186
- A and R Research Group
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Miami, Florida, Stany Zjednoczone, 33186
- Alpha Science Research
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Orlando, Florida, Stany Zjednoczone, 32808
- Omega Research Consultants
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Orlando, Florida, Stany Zjednoczone, 32801
- Clinical NeuroScience Solutions Inc
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Pembroke Pines, Florida, Stany Zjednoczone, 33024
- Pines Care Research Center Inc
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Plant City, Florida, Stany Zjednoczone, 33563
- Clinical Research of Central Florida
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Spring Hill, Florida, Stany Zjednoczone, 34609
- Care Access Research
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Tampa, Florida, Stany Zjednoczone, 33615
- Santos Research Center
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Tampa, Florida, Stany Zjednoczone, 33614
- St. Joseph's Comprehensive Research Institute
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Tampa, Florida, Stany Zjednoczone, 33603
- Tampa General Hospital
-
Tampa, Florida, Stany Zjednoczone, 33613
- Theia Clincial Research, LLC
-
Tampa, Florida, Stany Zjednoczone, 33614
- Precision Research Institute
-
Tampa, Florida, Stany Zjednoczone, 33625
- Care Access Research
-
-
Georgia
-
Atlanta, Georgia, Stany Zjednoczone, 30328
- Agile Clinical Research Trials, LLC
-
Columbus, Georgia, Stany Zjednoczone, 31904
- Columbus Regional Research Institute
-
Decatur, Georgia, Stany Zjednoczone, 30033
- Atlanta VA Medical Center
-
-
Idaho
-
Idaho Falls, Idaho, Stany Zjednoczone, 83404
- Clinical Research Prime
-
Idaho Falls, Idaho, Stany Zjednoczone, 83404
- Snake River Research, PLLC
-
-
Illinois
-
Chicago, Illinois, Stany Zjednoczone, 60612
- Jesse Brown VAMC Department of Surgery
-
Chicago, Illinois, Stany Zjednoczone, 60611
- Northwestern Medicine - Northwestern Memorial Hospital Galter Pavilion
-
Chicago, Illinois, Stany Zjednoczone, 60612
- University Of Illinois
-
-
Indiana
-
Evansville, Indiana, Stany Zjednoczone, 47714
- Medisphere Medical Research Center, Llc
-
Hammond, Indiana, Stany Zjednoczone, 46324
- Asha Clinical Research-Munster Llc
-
Mishawaka, Indiana, Stany Zjednoczone, 46544
- Mishawaka Osteopathic Clinic/MOC Research
-
-
Kansas
-
Wichita, Kansas, Stany Zjednoczone, 67226
- Cypress Medical Research Center
-
-
Louisiana
-
Marrero, Louisiana, Stany Zjednoczone, 70072
- Tandem Clinical Research
-
Natchitoches, Louisiana, Stany Zjednoczone, 71457
- KAMP Medical Research, Inc
-
New Orleans, Louisiana, Stany Zjednoczone, 70121
- Ochsner Medical Center
-
-
Maryland
-
Rockville, Maryland, Stany Zjednoczone, 20852
- Kaiser Permanente
-
-
Massachusetts
-
Boston, Massachusetts, Stany Zjednoczone, 02111
- Floating Hospital For Children at Tufts Medical Center
-
West Roxbury, Massachusetts, Stany Zjednoczone, 02132-4927
- West Roxbury Veterans Affairs Medical Center
-
-
Michigan
-
Detroit, Michigan, Stany Zjednoczone, 48202
- Henry Ford Hospital
-
Royal Oak, Michigan, Stany Zjednoczone, 48073
- William Beaumont Hospital
-
-
Mississippi
-
Petal, Mississippi, Stany Zjednoczone, 39465
- MediSync Clinical Research
-
-
Nebraska
-
Grand Island, Nebraska, Stany Zjednoczone, 68803
- Meridian Clinical Research, LLC
-
Lincoln, Nebraska, Stany Zjednoczone, 68516
- Be Well Clinical Studies
-
Norfolk, Nebraska, Stany Zjednoczone, 68701
- Meridian Clinical Research, LLC
-
-
Nevada
-
Las Vegas, Nevada, Stany Zjednoczone, 89106
- Sierra Clinical Research
-
Las Vegas, Nevada, Stany Zjednoczone, 89109
- Excel Clinical Research
-
Las Vegas, Nevada, Stany Zjednoczone, 89106
- Hope Research Institute
-
Reno, Nevada, Stany Zjednoczone, 89509
- VA Sierra Nevada Health Care System
-
-
New Jersey
-
Hillsborough, New Jersey, Stany Zjednoczone, 08844
- I.D. Care, Inc.
-
Teaneck, New Jersey, Stany Zjednoczone, 07666
- Holy Name Medical Center
-
-
New York
-
Binghamton, New York, Stany Zjednoczone, 13901
- Meridian Clinical Research, LLC
-
Endwell, New York, Stany Zjednoczone, 13760
- Meridian Clinical Research, LLC
-
New York, New York, Stany Zjednoczone, 10016
- Manhattan Medical Research
-
The Bronx, New York, Stany Zjednoczone, 10467
- Montefiore Medical Center
-
-
North Carolina
-
Durham, North Carolina, Stany Zjednoczone, 27705
- Durham VAMC
-
Fayetteville, North Carolina, Stany Zjednoczone, 28303
- Carolina Institute for Clinical Research
-
Greenville, North Carolina, Stany Zjednoczone, 27834
- ECU Health Vidant Medical Center
-
-
North Dakota
-
Fargo, North Dakota, Stany Zjednoczone, 58104
- Plains Clinical Research
-
-
Ohio
-
Centerville, Ohio, Stany Zjednoczone, 45458
- Kroger Health
-
Cleveland, Ohio, Stany Zjednoczone, 44106
- University Hospitals Cleveland Medical Center
-
Columbus, Ohio, Stany Zjednoczone, 43215
- Remington Davis Inc
-
Englewood, Ohio, Stany Zjednoczone, 45322
- Kroger Health
-
Englewood, Ohio, Stany Zjednoczone, 45322
- The Little Clinic
-
Wooster, Ohio, Stany Zjednoczone, 44691
- Comprehensive Internal Medicine
-
-
Oklahoma
-
Yukon, Oklahoma, Stany Zjednoczone, 73099
- Tekton Research Inc.
-
-
Oregon
-
Portland, Oregon, Stany Zjednoczone, 97227
- Kaiser Permanente
-
-
Pennsylvania
-
Camp Hill, Pennsylvania, Stany Zjednoczone, 17011
- Capital Area Research
-
West Reading, Pennsylvania, Stany Zjednoczone, 19611
- Reading Hospital
-
-
South Carolina
-
Charleston, South Carolina, Stany Zjednoczone, 29412
- Hugh D. Durrence, MD, PC
-
Little River, South Carolina, Stany Zjednoczone, 29566
- Waterway Familiy Medicine
-
-
Texas
-
Bellaire, Texas, Stany Zjednoczone, 77401
- Novel Research LLC
-
Dallas, Texas, Stany Zjednoczone, 75246
- North Texas Infectious Diseases Consultants
-
Dallas, Texas, Stany Zjednoczone, 75230
- Medical City Dallas
-
Dallas, Texas, Stany Zjednoczone, 75224
- Global Medical Research - Dallas
-
Houston, Texas, Stany Zjednoczone, 77024
- Digestive Health Associates
-
Lewisville, Texas, Stany Zjednoczone, 75057
- EPIC Clinical Research
-
Mesquite, Texas, Stany Zjednoczone, 75149
- SMS Clinical Research LLC
-
Round Rock, Texas, Stany Zjednoczone, 78681
- Be Well Clinical Studies
-
San Antonio, Texas, Stany Zjednoczone, 78229
- Audie L Murphy Memorial Va Ho
-
Sherman, Texas, Stany Zjednoczone, 75092
- Sherman Clinical Research
-
-
Utah
-
Draper, Utah, Stany Zjednoczone, 84020
- Lone Peak Family Medicine
-
-
Virginia
-
Annandale, Virginia, Stany Zjednoczone, 22003-7347
- Clinical Alliance for Research and Education
-
Charlottesville, Virginia, Stany Zjednoczone, 22911
- Charlottesville Medical Research Center, LLC
-
Lynchburg, Virginia, Stany Zjednoczone, 24501
- Infectious Disease Associates of Central Virginia
-
Suffolk, Virginia, Stany Zjednoczone, 23435
- IACT - Suffolk Multispecialty Research
-
Winchester, Virginia, Stany Zjednoczone, 22601
- Selma Medical Associates
-
-
Washington
-
Cheney, Washington, Stany Zjednoczone, 99004
- Multicare Institute For Research & Innovation - Rockwood Clinic - Cheney
-
-
West Virginia
-
Morgantown, West Virginia, Stany Zjednoczone, 26505
- Exemplar Research, Inc
-
-
Wisconsin
-
Marshfield, Wisconsin, Stany Zjednoczone, 54449
- Marshfield Clinic
-
-
-
-
-
Helsingborg, Szwecja, 25187
- Helsingborgs lasarett
-
Karlskrona, Szwecja, 37179
- BTH Research & Development Clinic
-
Linkoaping, Szwecja, 582 13
- CTC Ebbepark
-
Malmö, Szwecja, 21428
- Skanes universitetssjukhus
-
Mölndal, Szwecja, 43153
- CTC GoCo
-
Solna, Szwecja, 171 64
- ClinSmart Sweden AB
-
Uppsala, Szwecja, 752 37
- ClinSmart Sweden AB
-
Örebro, Szwecja, 70362
- Universitetssjukhuset Orebro
-
-
-
-
-
Bangkok, Tajlandia, 10330
- King Chulalongkorn Memorial Hospital
-
Bangkok, Tajlandia, 10700
- Siriraj Hospital
-
Bangkok, Tajlandia, 10400
- Ramathibodi Hospital
-
Bangkok, Tajlandia, 10400
- Tropical Medicine Hospital, Mahidol University
-
Bangkok, Tajlandia, 10330
- Thai Red Cross Aids Research Centre
-
-
-
-
-
Kaohsiung City, Tajwan, 813
- Kaohsiung Veterans General Hospital
-
Tainan, Tajwan, 704
- National Cheng Kung University Hospital
-
Taoyuan, Tajwan, 333
- Chang Gung Memorial Hospital Linkou Branch
-
-
-
-
-
Chieti, Włochy, 66100
- ASL2 Lanciano - Vasto - Chieti - Ospedale 'SS Annunziata' di Chieti
-
Roma, Włochy, 00144
- Istituto Nazionale Tumori Regina Elena
-
Rome, Włochy, 00189
- Azienda Ospedaliera Sant Andrea
-
-
-
-
-
Aberdeen, Zjednoczone Królestwo, AB25 2ZN
- Aberdeen Royal Infirmary
-
Atherstone, Zjednoczone Królestwo, CV9 1EU
- Atherstone Surgery
-
Banbury, Zjednoczone Królestwo, OX16 9AD
- Banbury Cross Health Center
-
Birkenhead, Zjednoczone Królestwo, CH62 6EE
- FutureMeds Bridle Clinic
-
Birmingham, Zjednoczone Królestwo, B21 0RY
- FutureMeds-Soho UK
-
Blackpool, Zjednoczone Królestwo, FY3 8NR
- Blackpool Teaching Hospitals NHS Foundation Trust
-
Bournemouth, Zjednoczone Królestwo, BH7 7DW
- Royal Bournemouth Hospital
-
Bristol, Zjednoczone Królestwo, BS10 5NB
- North Bristol NHS Trust
-
Bristol, Zjednoczone Królestwo, BS2 8BJ
- University Hospitals Bristol NHS Trust
-
Exeter, Zjednoczone Królestwo, EX2 5DW
- Royal Devon & Exeter NHS Foundation Trust
-
Eynsham, Zjednoczone Królestwo, OX29 4QB
- Eynsham Medical Centre
-
Guisborough, Zjednoczone Królestwo, TS14 7DJ
- The Garth Surgery
-
Leicester, Zjednoczone Królestwo, LE1 5WW
- University Hospitals Of Leicester Nhs Trust
-
London, Zjednoczone Królestwo, SE5 9RS
- King's College Hospital NHS Foundation Trust
-
Manchester, Zjednoczone Królestwo, M13 9WL
- Manchester Royal Infirmary
-
Manchester, Zjednoczone Królestwo, M23 9LT
- The NIHR Manchester Clinical Research Facility
-
Middlesbrough, Zjednoczone Królestwo, TS4 3BW
- South Tees Hospitals NHS Foundation Trust
-
Nottingham, Zjednoczone Królestwo, NG7 2UH
- Nottingham University Hospitals NHS Trust
-
Plymouth, Zjednoczone Królestwo, PL6 8DH
- Plymouth University Hospitals Trust
-
Pontypridd, Zjednoczone Królestwo, CF37 2DR
- Ashgrove Surgery
-
Poole, Zjednoczone Królestwo, BH15 4JQ
- The Adam Practice
-
Sheffield, Zjednoczone Królestwo, S10 2 JF
- Sheffield Teaching Hospitals NHS Foundation Trust
-
Stafford, Zjednoczone Królestwo, ST16 3SR
- Midlands Partnership NHS Foundation Trust
-
Stockton-on-Tees, Zjednoczone Królestwo, TS19 8PE
- North Tees Furturemeds
-
Wakefield, Zjednoczone Królestwo, WF1 4DG
- Mid Yorkshire Hospital NHS Trust- Pinderfields Hospital
-
Wantage, Zjednoczone Królestwo, OX12 9BN
- Church Street Practice
-
Witney, Zjednoczone Królestwo, OX28 6JS
- Windrush Medical Practice
-
-
Kryteria uczestnictwa
Kryteria kwalifikacji
Kryteria kwalifikacji
Wiek uprawniający do nauki
Akceptuje zdrowych ochotników
Płeć kwalifikująca się do nauki
Opis
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
Plan studiów
Jak projektuje się badanie?
Szczegóły projektu
- Główny cel: Zapobieganie
- Przydział: Randomizowane
- Model interwencyjny: Przydział równoległy
- Maskowanie: Podwójnie
Liczba ramion
Broń i interwencje
Grupa uczestników / ArmGrupa uczestników / Arm |
Interwencja / LeczenieInterwencja / Leczenie |
|---|---|
|
Eksperymentalny: 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.
Inne nazwy:
|
|
Komparator placebo: Placebo
Participants will receive a single IM injection of matching placebo on Day 1. |
Matching placebo will be administered as an IM injection. |
Co mierzy badanie?
Podstawowe miary wyniku
Podstawowe miary wyniku
Miara wyniku |
Opis środka |
Ramy czasowe |
|---|---|---|
|
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
Ramy czasowe: 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)
|
Miary wyników drugorzędnych
Miary wyników drugorzędnych
Miara wyniku |
Opis środka |
Ramy czasowe |
|---|---|---|
|
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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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)
Ramy czasowe: 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)
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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)
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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)
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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)
|
Współpracownicy i badacze
Sponsor
Sponsor
Śledczy
Śledczy
- Dyrektor Studium: Janssen Research & Development, LLC Clinical Trial, Janssen Research & Development, LLC
Publikacje i pomocne linki
Publikacje ogólne
- 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.
Daty zapisu na studia
Główne daty studiów
Rozpoczęcie studiów (Rzeczywisty)
Rozpoczęcie studiów
Zakończenie podstawowe (Rzeczywisty)
Zakończenie podstawowe
Ukończenie studiów (Rzeczywisty)
Ukończenie studiów
Daty rejestracji na studia
Pierwszy przesłany
Pierwszy przesłany
Pierwszy przesłany, który spełnia kryteria kontroli jakości
Pierwszy przesłany, który spełnia kryteria kontroli jakości
Pierwszy wysłany (Rzeczywisty)
Pierwszy wysłany
Aktualizacje rekordów badań
Ostatnia wysłana aktualizacja (Rzeczywisty)
Ostatnia wysłana aktualizacja
Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości
Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości
Ostatnia weryfikacja
Ostatnia weryfikacja
Więcej informacji
Terminy związane z tym badaniem
Inne numery identyfikacyjne badania
Inne numery identyfikacyjne badania
- CR109000
- 2020-005273-27 (Numer EudraCT)
- VAC52416BAC3001 (Inny identyfikator: Janssen Research & Development, LLC)
- 2023-506589-30-00 (Identyfikator rejestru: EUCT number)
- 2023 (Grant/umowa NIH USA)
Plan dla danych uczestnika indywidualnego (IPD)
Planujesz udostępniać dane poszczególnych uczestników (IPD)?
Opis planu 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
Informacje o lekach i urządzeniach, dokumenty badawcze
Bada produkt leczniczy regulowany przez amerykańską FDA
Bada produkt urządzenia regulowany przez amerykańską FDA
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