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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT04899336




Registration number
NCT04899336
Ethics application status
Date submitted
21/05/2021
Date registered
24/05/2021

Titles & IDs
Public title
A Study of Vaccination With 9-valent Extraintestinal Pathogenic Escherichia Coli Vaccine (ExPEC9V) in the Prevention of Invasive Extraintestinal Pathogenic Escherichia Coli Disease in Adults Aged 60 Years And Older With a History of Urinary Tract Infection in the Past 2 Years
Scientific title
Randomized, Double-blind, Placebo-controlled, Multicenter Phase 3 Study to Assess the Efficacy, Safety And Immunogenicity of Vaccination With ExPEC9V in the Prevention of Invasive Extraintestinal Pathogenic Escherichia Coli Disease in Adults Aged 60 Years And Older With a History of Urinary Tract Infection in the Past 2 Years
Secondary ID [1] 0 0
2020-005273-27
Secondary ID [2] 0 0
CR109000
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Invasive Extraintestinal Pathogenic Escherichia Coli Disease (IED) Prevention 0 0
Condition category
Condition code
Infection 0 0 0 0
Other infectious diseases

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Other - ExPEC9V
Other interventions - Placebo

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

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


Treatment: Other: ExPEC9V
ExPEC9V will be administered as an IM injection.

Other interventions: Placebo
Matching placebo will be administered as an IM injection.
Intervention code [1] 0 0
Treatment: Other
Intervention code [2] 0 0
Other interventions
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Number of Participants with First Invasive Extraintestinal Pathogenic E.coli Disease (IED) Event with Microbiological Confirmation in Blood or Other Sterile Sites Caused by 9-valent Extraintestinal Pathogenic E. coli Vaccine (ExPEC9V) O-serotypes
Timepoint [1] 0 0
Up to 4 years
Secondary outcome [1] 0 0
Number of Participants with First IED Event with Microbiological Confirmation in Blood, Other Sterile Sites, or Urine, Caused by ExPEC9V O-serotypes
Timepoint [1] 0 0
Up to 4 years
Secondary outcome [2] 0 0
Number of All IEDs (Including Multiple IEDs per Participant) Caused by ExPEC9V O-serotypes
Timepoint [2] 0 0
Up to 4 years
Secondary outcome [3] 0 0
Number of Participants with First Hospitalized IED Event Caused by ExPEC9V O-serotypes
Timepoint [3] 0 0
Up to 4 years
Secondary outcome [4] 0 0
Number of Participants with First IED Event Meeting Criteria for Sepsis Caused by ExPEC9V O-serotypes
Timepoint [4] 0 0
Up to 4 years
Secondary outcome [5] 0 0
Number of Participants with First Bacteremic IED Event Caused by ExPEC9V O-serotypes
Timepoint [5] 0 0
Up to 4 years
Secondary outcome [6] 0 0
Number of Participants with First Pyelonephritis Event Caused by ExPEC9V O-serotypes
Timepoint [6] 0 0
Up to 4 years
Secondary outcome [7] 0 0
Number of Participants with First Urinary Tract Infection (UTI) Event Caused by ExPEC9V O-serotypes
Timepoint [7] 0 0
Up to 3 years
Secondary outcome [8] 0 0
Number of All UTIs (Including Multiple UTIs per Participant) Caused by ExPEC9V O-serotypes
Timepoint [8] 0 0
Up to 3 years
Secondary outcome [9] 0 0
Number of Participants with First IED Event Caused by Escherichia coli (E.coli)
Timepoint [9] 0 0
Up to 4 years
Secondary outcome [10] 0 0
Number of Participants with First Pyelonephritis Event caused By E.coli
Timepoint [10] 0 0
Up to 4 years
Secondary outcome [11] 0 0
Number of Participants with First UTI Event caused by E.coli
Timepoint [11] 0 0
Up to 3 years
Secondary outcome [12] 0 0
Antibody Titers to Vaccine O-serotype Antigens as Determined by Multiplex Electrochemiluminescent (ECL)-based Immunoassay
Timepoint [12] 0 0
Up to 4 years
Secondary outcome [13] 0 0
Antibody Titers to Genetically Detoxified Form of Exotoxin A Derived from Pseudomonas Aeruginosa (EPA) as Determined by Multiplex ECL-based Immunoassay
Timepoint [13] 0 0
Up to 4 years
Secondary outcome [14] 0 0
Antibody Titers to Vaccine O-serotype Antigens as Determined by Multiplex Opsonophagocytic Assay (MOPA)
Timepoint [14] 0 0
Up to 4 years
Secondary outcome [15] 0 0
Number of Participants with Solicited Local Adverse Events (AEs)
Timepoint [15] 0 0
Up to Day 15 (until 14 days post-vaccination)
Secondary outcome [16] 0 0
Number of Participants with Solicited Systemic AEs
Timepoint [16] 0 0
Up to Day 15 (until 14 days post-vaccination)
Secondary outcome [17] 0 0
Number of Participants with Unsolicited AEs
Timepoint [17] 0 0
Up to Day 30 (until 29 days post-vaccination)
Secondary outcome [18] 0 0
Number of Participants with Serious Adverse Events (SAEs)
Timepoint [18] 0 0
Up to 181 days
Secondary outcome [19] 0 0
Number of Participants with SAEs Related to Study Vaccine or Study Procedures
Timepoint [19] 0 0
Up to 4 years
Secondary outcome [20] 0 0
Short Form-36 (SF-36) Total Scores
Timepoint [20] 0 0
Up to 4 years
Secondary outcome [21] 0 0
European Quality of Life (EuroQol) 5-Dimension 5-Level Questionnaire (EQ-5D-5L) Scores
Timepoint [21] 0 0
Up to 4 years
Secondary outcome [22] 0 0
Change from Baseline in Frailty Index
Timepoint [22] 0 0
Baseline to 4 years
Secondary outcome [23] 0 0
Medical Resource Utilization (MRU) for IED Events Caused by ExPEC9V O-Serotype
Timepoint [23] 0 0
Up to Day 366 Post-IED
Secondary outcome [24] 0 0
MRU for UTI Events Caused by ExPEC9V O-Serotype
Timepoint [24] 0 0
Up to Day 29 Post-UTI
Secondary outcome [25] 0 0
MRU for Acute Bacterial Prostatitis (ABP) Events Caused by ExPEC9V O-Serotype
Timepoint [25] 0 0
Up to Day 29 Post-ABP
Secondary outcome [26] 0 0
Number of Participants with the Hospitalization for IED or, UTI, or ABP Events Caused by ExPEC9V O-Serotype
Timepoint [26] 0 0
Up to 4 years
Secondary outcome [27] 0 0
Length of Stay in Hospital for IED, UTI, or ABP Events Caused by ExPEC9V O-Serotype
Timepoint [27] 0 0
Up to 4 years
Secondary outcome [28] 0 0
Number of Participants with the Intensive Care Unit (ICU) Hospitalization for IED or UTI or ABP Events Caused by ExPEC9V O-Serotype
Timepoint [28] 0 0
Up to 3 months post clinical event
Secondary outcome [29] 0 0
Length of ICU Stay in Hospital for IED, UTI, or ABP Events Caused by ExPEC9V O-Serotype
Timepoint [29] 0 0
Up to 3 months post clinical event
Secondary outcome [30] 0 0
Number of Participants with IED-related and All-cause Mortality
Timepoint [30] 0 0
Up to 4 years

Eligibility
Key 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
Minimum age
60 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key 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

Study design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s


The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
30/06/2021
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
29/06/2029
Actual
Sample size
Target
19800
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
Saint Andrew's War Memorial Hospital - Brisbane
Recruitment hospital [2] 0 0
GP Surgery - Campbelltown - Campbelltown
Recruitment hospital [3] 0 0
Barwon Health - University Hospital Geelong - Geelong
Recruitment hospital [4] 0 0
CMAX Clinical Research - Melbourne
Recruitment hospital [5] 0 0
John Hunter Hospital - New Lambton
Recruitment hospital [6] 0 0
Fiona Stanley Hospital - Palmyra DC
Recruitment hospital [7] 0 0
McIntyre Medical Center - Para Hills West
Recruitment hospital [8] 0 0
North West Medical Center - Salisbury
Recruitment hospital [9] 0 0
Mater Medical Centre South Brisbane - South Brisbane
Recruitment hospital [10] 0 0
Bene Aged Care - Italian Village - St Agnes
Recruitment hospital [11] 0 0
Westmead Hospital - Sydney
Recruitment hospital [12] 0 0
AusTrials Pty Ltd - Taringa
Recruitment hospital [13] 0 0
AusTrials Pty Ltd - Tarragindi
Recruitment hospital [14] 0 0
Adelaide Medical Solutions - Woodville
Recruitment postcode(s) [1] 0 0
4001 - Brisbane
Recruitment postcode(s) [2] 0 0
5074 - Campbelltown
Recruitment postcode(s) [3] 0 0
3220 - Geelong
Recruitment postcode(s) [4] 0 0
5000 - Melbourne
Recruitment postcode(s) [5] 0 0
2305 - New Lambton
Recruitment postcode(s) [6] 0 0
6961 - Palmyra DC
Recruitment postcode(s) [7] 0 0
5096 - Para Hills West
Recruitment postcode(s) [8] 0 0
5108 - Salisbury
Recruitment postcode(s) [9] 0 0
4101 - South Brisbane
Recruitment postcode(s) [10] 0 0
5097 - St Agnes
Recruitment postcode(s) [11] 0 0
2145 - Sydney
Recruitment postcode(s) [12] 0 0
4068 - Taringa
Recruitment postcode(s) [13] 0 0
4121 - Tarragindi
Recruitment postcode(s) [14] 0 0
5011 - Woodville
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Alabama
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United States of America
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Arizona
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Connecticut
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Georgia
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Idaho
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Illinois
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Indiana
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Kansas
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Louisiana
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Maryland
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Massachusetts
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Michigan
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Mississippi
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Nebraska
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Nevada
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New Jersey
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New York
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North Carolina
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North Dakota
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Ohio
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Oklahoma
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Utah
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Virginia
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Washington
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West Virginia
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Wisconsin
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Alberta
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Hradec Kralove
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Olomouc
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Ostrava-Proskovice
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Czechia
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Plzen 1
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Czechia
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Plzen
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Czechia
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Praha 3
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Czechia
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Protivin
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Czechia
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Slany
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Czechia
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Vysoke Myto
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Hellerup
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Herlev
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Hilleroed
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Hvidovre
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Odense M
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Roskilde
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France
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Dijon
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Lyon
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Nîmes
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Saint-Priest en Jarez
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Germany
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Frankfurt
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Germany
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Jena
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Leipzig
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Germany
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Marburg
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Germany
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Oldenburg in Holstein
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Germany
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Reinfeld
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Germany
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Rostock
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India
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Belagavi
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India
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Jaipur
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India
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Kolkata
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Lucknow
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Mumbai
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India
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Mysuru
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New Delhi
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India
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Rajkot
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India
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Surat
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Israel
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Ashdod
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Israel
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Jerusalem
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Israel
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Kfar Saba
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Israel
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Ramat Gan
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Israel
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Tel Aviv Yafo
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Italy
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Chieti
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Italy
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Roma
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Italy
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Rome
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Akashi shi
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Fukuoka-Shi
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Fukuoka
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Hakodate
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Hashima-gun
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Hokkaido
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Iizuka
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Kasuya-gun
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Kawasaki
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Kitakyushu
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Kitakyusyu
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Nagasaki-Shi
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Japan
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Neyagawa
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Japan
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Oita
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Japan
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Omura
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Japan
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Omuta-Shi
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Japan
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Osaka City
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Japan
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Osaka-shi
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Japan
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Sanuki
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Japan
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Sapporo-Shi
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Japan
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Shimajiri-Gun
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Japan
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Shimonoseki-shi
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Japan
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Shinagawa City
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Japan
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Suita-Shi
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Japan
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Suwa-Shi
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Japan
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Yahatanishi-ku
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Japan
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Yamaguchi
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Japan
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Yokohama
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Korea, Republic of
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Busan
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Korea, Republic of
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ChunCheon
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Korea, Republic of
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Daejeon
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Korea, Republic of
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Gwangju
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Korea, Republic of
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Gyeonggi-do
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Korea, Republic of
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Incheon
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Korea, Republic of
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Seongnam-si
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Korea, Republic of
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Seoul Teugbyeolsi
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Korea, Republic of
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Seoul
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Suwon-si
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Korea, Republic of
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Wonju
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Netherlands
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Uden
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Utrecht
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Hamilton
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New Zealand
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Hastings
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New Zealand
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Lower Hutt
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New Zealand
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Nelson
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Palmerston North
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Papamoa
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Witney

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Janssen Research & Development, LLC
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Janssen Research & Development, LLC Clinical Trial
Address 0 0
Janssen Research & Development, LLC
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Study Contact
Address 0 0
Country 0 0
Phone 0 0
844-434-4210
Fax 0 0
Email 0 0
Participate-In-This-Study@its.jnj.com
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
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
When will data be available (start and end dates)?
Available to whom?
Available for what types of analyses?
How or where can data be obtained?
IPD available at link: https://www.janssen.com/clinical-trials/transparency


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results not provided in https://clinicaltrials.gov/study/NCT04899336