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    Summary
    EudraCT Number:2020-005273-27
    Sponsor's Protocol Code Number:VAC52416BAC3001
    National Competent Authority:Netherlands - Competent Authority
    Clinical Trial Type:EEA CTA
    Trial Status:Trial now transitioned
    Date on which this record was first entered in the EudraCT database:2021-07-06
    Trial results
    Index
    A. PROTOCOL INFORMATION
    B. SPONSOR INFORMATION
    C. APPLICANT IDENTIFICATION
    D. IMP IDENTIFICATION
    D.8 INFORMATION ON PLACEBO
    E. GENERAL INFORMATION ON THE TRIAL
    F. POPULATION OF TRIAL SUBJECTS
    G. INVESTIGATOR NETWORKS TO BE INVOLVED IN THE TRIAL
    N. REVIEW BY THE COMPETENT AUTHORITY OR ETHICS COMMITTEE IN THE COUNTRY CONCERNED
    P. END OF TRIAL
    Expand All   Collapse All
    A. Protocol Information
    A.1Member State ConcernedNetherlands - Competent Authority
    A.2EudraCT number2020-005273-27
    A.3Full title of the trial
    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.
    Een gerandomiseerd, dubbelblind, placebogecontroleerd fase 3-onderzoek in meerdere centra ter beoordeling van de werkzaamheid, veiligheid en immunogeniciteit van vaccinatie met ExPEC9V bij de preventie van invasieve extra-intestinale pathogene Escherichia coli-ziekte bij volwassenen van 60 jaar en ouder met een voorgeschiedenis van urineweginfectie in de afgelopen 2 jaar
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A study to evaluate ExPEC9V vaccine for the prevention of Invasive E. coli Disease in adults aged 60 years and older with a history of urinary tract infection in the past two years.
    Een onderzoek ter beoordeling van het ExPEC9V-vaccin, voor de preventie van invasieve E. coli-ziekte bij volwassenen van 60 jaar en ouder met een voorgeschiedenis van urineweginfectie in de afgelopen twee jaar.
    A.3.2Name or abbreviated title of the trial where available
    E.mbrace
    E.mbrace
    A.4.1Sponsor's protocol code numberVAC52416BAC3001
    A.5.2US NCT (ClinicalTrials.gov registry) numberNCT04899336
    A.5.4Other Identifiers
    Name:INDNumber:18773
    A.7Trial is part of a Paediatric Investigation Plan No
    A.8EMA Decision number of Paediatric Investigation Plan
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorJanssen Vaccines & Prevention B.V
    B.1.3.4CountryNetherlands
    B.3.1 and B.3.2Status of the sponsorCommercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing supportJanssen Research and Development
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationJanssen Research & Development
    B.5.2Functional name of contact pointClinical Registry Group
    B.5.3 Address:
    B.5.3.1Street AddressArchimedesweg 20
    B.5.3.2Town/ cityLeiden
    B.5.3.3Post code2333 CN
    B.5.3.4CountryNetherlands
    B.5.6E-mailClinicalTrialsEU@its.jnj.com
    D. IMP Identification
    D.IMP: 1
    D.1.2 and D.1.3IMP RoleTest
    D.2 Status of the IMP to be used in the clinical trial
    D.2.1IMP to be used in the trial has a marketing authorisation No
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.1Product nameExPEC9V
    D.3.2Product code JNJ-78901563
    D.3.4Pharmaceutical form Solution for injection
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntramuscular use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNEcoO1A
    D.3.9.3Other descriptive nameEcoO1A
    D.3.9.4EV Substance CodeSUB221304
    D.3.10 Strength
    D.3.10.1Concentration unit µg/ml microgram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number16
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNEcoO2
    D.3.9.3Other descriptive nameEcoO2
    D.3.9.4EV Substance CodeSUB221305
    D.3.10 Strength
    D.3.10.1Concentration unit µg/ml microgram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number16
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNEcoO4
    D.3.9.3Other descriptive nameEcoO4
    D.3.9.4EV Substance CodeSUB221306
    D.3.10 Strength
    D.3.10.1Concentration unit µg/ml microgram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number16
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNEcoO6A
    D.3.9.3Other descriptive nameEcoO6A
    D.3.9.4EV Substance CodeSUB221307
    D.3.10 Strength
    D.3.10.1Concentration unit µg/ml microgram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number16
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNEcoO15
    D.3.9.3Other descriptive nameEcoO15
    D.3.9.4EV Substance CodeSUB221309
    D.3.10 Strength
    D.3.10.1Concentration unit µg/ml microgram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number16
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNEcoO16
    D.3.9.3Other descriptive nameEcoO16
    D.3.9.4EV Substance CodeSUB221310
    D.3.10 Strength
    D.3.10.1Concentration unit µg/ml microgram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number16
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNEcoO18A
    D.3.9.3Other descriptive nameEcoO18A
    D.3.9.4EV Substance CodeSUB221311
    D.3.10 Strength
    D.3.10.1Concentration unit µg/ml microgram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number16
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNEcoO25B
    D.3.9.3Other descriptive nameEcoO25B
    D.3.9.4EV Substance CodeSUB221312
    D.3.10 Strength
    D.3.10.1Concentration unit µg/ml microgram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number32
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNEcoO75
    D.3.9.3Other descriptive nameEcoO75
    D.3.9.4EV Substance CodeSUB221313
    D.3.10 Strength
    D.3.10.1Concentration unit µg/ml microgram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number32
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin No
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) Yes
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) No
    D.3.11.3.1Somatic cell therapy medicinal product No
    D.3.11.3.2Gene therapy medical product No
    D.3.11.3.3Tissue Engineered Product No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) Yes
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product No
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product No
    D.8 Information on Placebo
    D.8 Placebo: 1
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboSolution for injection
    D.8.4Route of administration of the placeboIntramuscular use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Invasive Extraintestinal Pathogenic Escherichia coli Disease
    E.1.1.1Medical condition in easily understood language
    Invasive E. coli disease
    E.1.1.2Therapeutic area Diseases [C] - Bacterial Infections and Mycoses [C01]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 21.1
    E.1.2Level PT
    E.1.2Classification code 10052238
    E.1.2Term Escherichia urinary tract infection
    E.1.2System Organ Class 10021881 - Infections and infestations
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level HLT
    E.1.2Classification code 10015295
    E.1.2Term Escherichia infections
    E.1.2System Organ Class 10021881 - Infections and infestations
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To demonstrate in a hierarchical manner:
    - the efficacy of ExPEC9V compared to placebo in the prevention of the first IED event with
    microbiological confirmation from blood, other sterile sites, or urine caused by ExPEC serotypes O1A, O2, O4, O6A, O15, O16, O18A, O25B, and O75 and
    - the efficacy of ExPEC9V compared to placebo in the prevention of the first IED event with microbiological confirmation from blood or other sterile sites caused by ExPEC serotypes O1A, O2, O4, O6A, O15, O16, O18A, O25B, and O75
    E.2.2Secondary objectives of the trial
    To demonstrate the efficacy of ExPEC9V compared to placebo in the prevention of
    •all IEDs caused by ExPEC9V O-serotypes
    •the first hospitalized IED event caused by ExPEC9V O-serotypes
    •the first IED event meeting criteria for sepsis caused by ExPEC9V O-serotypes
    •the first bacteremic IED event caused by ExPEC9V O-serotypes
    •the first pyelonephritis event caused by ExPEC9V O-serotypes
    •the first UTI event caused by ExPEC9V O-serotypes
    •all UTIs caused by ExPEC9V O-serotypes
    •the first IED event caused by any ExPEC O-serotype
    •the first pyelonephritis event caused by any ExPEC O-serotype
    •the first UTI event caused by any ExPEC O-serotype
    To evaluate:
    •the immunogenicity of ExPEC9V in the Immunogenicity Subset
    •the safety and reactogenicity of ExPEC9V
    •the preservation of health status and health-related quality of life (HRQoL) of ExPEC9V compared to placebo
    the impact of IED and UTI, caused by ExPEC9V O-serotypes, on physical and mental health, and overall HRQoL
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    -Participant must be ≥60 years of age on the day of signing the ICF and is expected to be available for the duration of the study, with no current intention of moving away from a study site area or travelling for periods longer than 30 consecutive days during the course of the study.
    -Participant must have a history of UTI in the past 2 years that is documented in the medical records. In case of a recent history of UTI, the condition must have resolved >14 days prior to randomization.
    -Participant must be medically stable at the time of vaccination such that, according to the judgment of the investigator, hospitalization within the study period is not anticipated and the participant appears likely to be able to remain on study through the end of protocol-specified follow-up. A stable medical condition is defined as disease not requiring significant change in therapy during the 6 weeks before enrollment and when hospitalization for worsening of the disease is not anticipated. Participants will be included on the basis of physical examination, medical history, and vital signs performed between ICF signature and vaccination.

    -Before randomization, participants who were born female must be either (as defined in Section 10.4, Appendix 4, Contraceptive Guidance and Collection of Pregnancy Information):
    a. postmenopausal or permanently sterile, and
    b. 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.
    -Participant or his/her designated caregiver must be able to work with smartphones/tablets/computers.
    -Participant and his/her designated caregiver (if applicable) must be able to read, understand, and complete questionnaires in the eCOA (ie, the electronic patient-reported outcomes [ePROs] and the eDiary).
    E.4Principal exclusion criteria
    -Participant has a serious chronic disorder or significant cognitive impairment for which, in the opinion of the investigator, participation would not be in the best interest of the participant (eg, compromise well-being) or that could prevent, limit, or confound the protocol-specified assessments.
    - Participant has end-stage renal disease for which dialysis is required.
    - Chronic use of antimicrobials. In case of prolonged antimicrobial treatment (>3 weeks) or chronic use of antimicrobials, the last dose must have been administered >60 days prior to randomization.
    - Participant has a history of malignancy within 5 years before screening not in the following categories:(a) Participants with squamous and basal cell carcinomas of the skin and carcinoma in situ of the cervix may be enrolled at the discretion of the investigator; (b) Participants with diagnosis of localized prostate cancer may be enrolled at the discretion of the investigator if they completed treatment, or, if they remain under observation or active surveillance; (c) Participants with a history of other malignancy within 5 years, which is considered adequately treated with minimal risk of recurrence per the investigator’s judgment, may be enrolled.
    - Participant has a known allergy or history of anaphylaxis or other serious adverse reactions to vaccines or their excipients (including specifically the excipients of the study vaccine; refer to IB).

    - Abnormal function of the immune system resulting from:
    a. Clinical conditions (eg, autoimmune disease or immunodeficiency).
    b. Chronic or recurrent use of systemic corticosteroids
    c. Administration of antineoplastic and immunomodulating agents or radiotherapy.

    - Participant has a history of acute polyneuropathy (eg, Guillain-Barré syndrome) or chronic inflammatory demyelinating polyneuropathy
    - Participant has received any E. coli or ExPEC vaccine.
    - Participant has received a hematopoietic stem cell transplant based on medical history, treatment with immunoglobulins within 2 months, apheresis therapies within 4 months, or blood products within 4 months prior to the planned administration of the study vaccine or has any plans to receive such treatment during the study.
    - Participant has received or plans to receive: (a)licensed live attenuated vaccines - within 28 days before or after planned administration of the study vaccination; (b)other licensed (not live) vaccines - within 14 days before or after planned administration of the study vaccination; (c)vaccination with a licensed or authorized for Emergency Use Authorization, conditional Marketing Authorisation or a similar program) COVID-19 vaccine is permitted when given at least 28 days before or after planned administration of the study vaccination.
    - Participant has had major surgery (per the investigator’s judgment) within 4 weeks before dosing or will not have recovered from surgery per the investigator’s judgment at time of vaccination.
    - Participant has chronic active hepatitis B or hepatitis C infection based on medical history. Note: participant may have stable HBV or HCV infection.
    - Participant has evidence of HIV type 1 or type 2 infection by medical history. Note: participant may have stable/well-controlled HIV.
    E.5 End points
    E.5.1Primary end point(s)
    The primary analysis of the primary endpoints will evaluate:
    • the number of participants with at least 1 IED event, with microbiological confirmation in blood, other sterile sites, or urine, caused by ExPEC serotypes O1A, O2, O4, O6A, O15, O16, O18A, O25B, and O75 with onset at least 29 days after vaccination (from Day 30) in the active vaccine (ExPEC9V) group compared to the placebo group in the PPE population and
    • the number of participants with at least 1 IED event with microbiological confirmation in blood or other sterile sites caused by ExPEC serotypes O1A, O2, O4, O6A, O15, O16, O18A, O25B, and O75 with onset at least 29 days after vaccination (from Day 30) in the active vaccine (ExPEC9V) group compared to the placebo group in the PPE population.
    E.5.1.1Timepoint(s) of evaluation of this end point
    • First IED event , with microbiological confirmation from blood, other sterile sites, or urine, caused by ExPEC9V O serotypes O1A, O2, O4, O6A, O15, O16, O18A, O25B, and O75
    •First IED event, with microbiological confirmation from blood or other sterile sites, caused by ExPEC9V O serotypes
    E.5.2Secondary end point(s)
    •All IEDs (including multiple IEDs per participant) caused by ExPEC9V O serotypes
    • First hospitalized IED event caused by ExPEC9V O serotypes
    • First IED event meeting criteria for sepsis caused by ExPEC9V O serotypes
    • First bacteremic IED event caused by ExPEC9V O serotypes
    • First pyelonephritis event caused by ExPEC9V O serotypes
    • First UTI event caused by ExPEC9V O serotypes
    • All UTIs (including multiple UTIs per participant) caused by ExPEC9V O serotypes
    • First IED event caused by any ExPEC O serotype
    • First pyelonephritis event caused by any ExPEC O-serotype
    • First UTI event caused by any ExPEC O serotype
    • Antibody titers to vaccine O-serotype antigens in the Immunogenicity Subset, as determined by multiplex ECL-based immunoassay and multiplex opsonophagocytic killing assay (MOPA) on Day 30, Day 181, Year 1, Year 2, and Year 3
    • Solicited local and systemic AEs (collected until 14 days post-vaccination [from Day 1 to Day 15] in the Safety Subset)
    • Unsolicited AEs (collected until 29 days post-vaccination [from Day 1 to Day 30] in all participants)
    • Serious adverse events (SAEs) in all participants
    • SF-36 and EQ-5D-5L responses at scheduled timepoints
    • Frailty index as a measure of frailty at baseline, Year 1, Year 2, Year 3, and at the time of an IED
    • Medical resource utilization for IED events
    • Medical resource utilization for UTI events (Immunogenicity Subset only)
    • Hospitalization and length of stay in hospital for IED or UTI events
    • IED-related and all-cause mortality
    E.5.2.1Timepoint(s) of evaluation of this end point
    As described in section E.5.2
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis No
    E.6.2Prophylaxis Yes
    E.6.3Therapy No
    E.6.4Safety Yes
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic No
    E.6.7Pharmacodynamic No
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic No
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic No
    E.6.13Others No
    E.7Trial type and phase
    E.7.1Human pharmacology (Phase I) No
    E.7.1.1First administration to humans No
    E.7.1.2Bioequivalence study No
    E.7.1.3Other No
    E.7.1.3.1Other trial type description
    E.7.2Therapeutic exploratory (Phase II) No
    E.7.3Therapeutic confirmatory (Phase III) Yes
    E.7.4Therapeutic use (Phase IV) No
    E.8 Design of the trial
    E.8.1Controlled Yes
    E.8.1.1Randomised Yes
    E.8.1.2Open No
    E.8.1.3Single blind No
    E.8.1.4Double blind Yes
    E.8.1.5Parallel group No
    E.8.1.6Cross over No
    E.8.1.7Other No
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) No
    E.8.2.2Placebo Yes
    E.8.2.3Other No
    E.8.2.4Number of treatment arms in the trial2
    E.8.3 The trial involves single site in the Member State concerned No
    E.8.4 The trial involves multiple sites in the Member State concerned Yes
    E.8.4.1Number of sites anticipated in Member State concerned2
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA32
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA Yes
    E.8.6.2Trial being conducted completely outside of the EEA No
    E.8.6.3If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned
    Australia
    Canada
    Japan
    Korea, Republic of
    New Zealand
    United States
    Denmark
    Netherlands
    Spain
    United Kingdom
    E.8.7Trial has a data monitoring committee Yes
    E.8.8 Definition of the end of the trial and justification where it is not the last visit of the last subject undergoing the trial
    If Part 2 of the study is not conducted, the end of study is considered as the last Year 3 assessment (Day 1096) for the last participant in Part 1. If Part 2 of the study is conducted, the end of study is considered as the last Year 3 assessment (Day 1096) for the last participant in Part 2.
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years7
    E.8.9.1In the Member State concerned months0
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years7
    E.8.9.2In all countries concerned by the trial months0
    E.8.9.2In all countries concerned by the trial days0
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 No
    F.1.1.1In Utero No
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) No
    F.1.1.3Newborns (0-27 days) No
    F.1.1.4Infants and toddlers (28 days-23 months) No
    F.1.1.5Children (2-11years) No
    F.1.1.6Adolescents (12-17 years) No
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 3712
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 14844
    F.2 Gender
    F.2.1Female Yes
    F.2.2Male Yes
    F.3 Group of trial subjects
    F.3.1Healthy volunteers Yes
    F.3.2Patients No
    F.3.3Specific vulnerable populations No
    F.3.3.1Women of childbearing potential not using contraception No
    F.3.3.2Women of child-bearing potential using contraception No
    F.3.3.3Pregnant women No
    F.3.3.4Nursing women No
    F.3.3.5Emergency situation No
    F.3.3.6Subjects incapable of giving consent personally No
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state1600
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 3700
    F.4.2.2In the whole clinical trial 18556
    F.5 Plans for treatment or care after the subject has ended the participation in the trial (if it is different from the expected normal treatment of that condition)
    None
    G. Investigator Networks to be involved in the Trial
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2021-07-05
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2021-11-23
    P. End of Trial
    P.End of Trial StatusTrial now transitioned
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