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    Summary
    EudraCT Number:2013-000775-32
    Sponsor's Protocol Code Number:H-030-014
    National Competent Authority:Poland - Office for Medicinal Products
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2015-10-06
    Trial results View 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 ConcernedPoland - Office for Medicinal Products
    A.2EudraCT number2013-000775-32
    A.3Full title of the trial
    Efficacy, Immunogenicity, and Safety Study of Clostridium difficile Toxoid Vaccine in Subjects at Risk for C. difficile Infection
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Protection, Immune Response, and Safety Study of Clostridium difficile Toxoid Vaccine in Subjects at Risk for C. difficile Infection
    A.3.2Name or abbreviated title of the trial where available
    C diffense
    A.4.1Sponsor's protocol code numberH-030-014
    A.5.2US NCT (ClinicalTrials.gov registry) numberNCT01887912
    A.5.3WHO Universal Trial Reference Number (UTRN)U1111-1127-7162
    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 SponsorSanofi Pasteur Inc
    B.1.3.4CountryUnited States
    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 supportSanofi Pasteur Inc.
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationSanofi Pasteur France
    B.5.2Functional name of contact pointRegulatory Affairs Greater Europe
    B.5.3 Address:
    B.5.3.1Street Address1541, avenue Marcel Mérieux
    B.5.3.2Town/ cityMarcy l'Etoile
    B.5.3.3Post code69280
    B.5.3.4CountryFrance
    B.5.4Telephone number33437 66 8033
    B.5.5Fax number33437 37 9511
    B.5.6E-mailstephane.liceras@sanofipasteur.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 nameClostridium difficile Toxoid Vaccine
    D.3.2Product code 453
    D.3.4Pharmaceutical form Powder and solvent for suspension 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 INNCLOSTRIDIUM DIFFICILE TOXOID (A AND B)
    D.3.9.2Current sponsor code453
    D.3.9.3Other descriptive nameCLOSTRIDIUM DIFFICILE TOXOID (A AND B)
    D.3.9.4EV Substance CodeSUB121156
    D.3.10 Strength
    D.3.10.1Concentration unit µg/ml microgram(s)/millilitre
    D.3.10.2Concentration typenot less then
    D.3.10.3Concentration number200
    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
    Prevention of primary Clostridium difficile infection
    E.1.1.1Medical condition in easily understood language
    Prevention of bacterial infection caused by the organism Clostridium difficile
    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 20.0
    E.1.2Level LLT
    E.1.2Classification code 10036897
    E.1.2Term Prophylactic vaccination
    E.1.2System Organ Class 10042613 - Surgical and medical procedures
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level SOC
    E.1.2Classification code 10042613
    E.1.2Term Surgical and medical procedures
    E.1.2System Organ Class 10042613 - Surgical and medical procedures
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level HLGT
    E.1.2Classification code 10043413
    E.1.2Term Therapeutic procedures and supportive care NEC
    E.1.2System Organ Class 10042613 - Surgical and medical procedures
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level PT
    E.1.2Classification code 10021430
    E.1.2Term Immunisation
    E.1.2System Organ Class 10042613 - Surgical and medical procedures
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level HLT
    E.1.2Classification code 10021431
    E.1.2Term Immunisations
    E.1.2System Organ Class 10042613 - Surgical and medical procedures
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To assess the efficacy of the C. difficile vaccine in preventing the onset of symptomatic primary C. difficile infection (CDI) confirmed by polymerase chain reaction (PCR) in adult subjects aged ≥50 years who are at risk for CDI and have received at least 1 injection
    E.2.2Secondary objectives of the trial
    Efficacy: To assess
    - prevention of symptomatic PCR-confirmed primary CDI cases (SPCR-CPCDIC) after 3 injections (inj) administered at 0, 7, and 30 days (D)
    - prevention of (SPCR-CPCDIC) after completion of at least 2 inj
    - durability of prevention (SPCR-CPCDIC) up to 3.0 years after the third inj
    - prevention of severe primary CDI cases in subjects withPCR-confirmed primary CDI
    - effect of the vaccine on reduction of loose stool frequency in subjects who are (SPCR-CPCDIC)
    - effect of the vaccine on reduction of CDI episode/illness duration in subjects who are (SPCR-CPCDIC)
    Immunogenicity: To describe the immunogenicity to toxin A and toxin B in the subset (1650 out of 16500) of subjects and in subjects with CDI (250) at Day 0 and Day 60 and in the subset (1650 out of 16500) of subjects at Day 14, Day 30 and every 6 months up to 3.0 years after the third injection
    Safety: To describe the safety profile of all subjects who receive at least 1 inj
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    An individual must fulfill all of the following criteria in order to be eligible for trial enrollment:
    1) Aged ≥ 50 years on the day of inclusion
    2) Informed consent form has been signed and dated
    3) Able to attend all scheduled visits and to comply with all trial procedures
    4) Covered by health insurance (only valid for specific countries)
    5) Must fulfill at least 1 of the following criteria*
    Risk Stratum 1:
    - Has had at least 2 hospital stays, each lasting at least ≥ 24 hours, in the 12 months before enrollment
    and
    - Has received systemic (not topical) antibiotics in the 12 months before enrollment
    or
    Risk Stratum 2:
    Is anticipated to have an in-patient hospitalization for a planned surgical procedure within 60 days of enrollment. The impending hospital stay is planned to be ≥ 72 hours for a surgery involving 1 of the following:
    Kidney/bladder/urinary system, Musculoskeletal system, Respiratory system, Circulatory system, Central nervous system
    * If an individual is either an in-patient in the hospital or had a previous hospitalization, the enrollment date must be at least 30 days from hospital discharge.
    E.4Principal exclusion criteria
    An individual fulfilling any of the following criteria is to be excluded from trial enrollment:
    1) Subject is pregnant, or lactating, or of childbearing potential (to be considered of nonchildbearing potential, a female must be post-menopausal for at least 1 year, surgically sterile, or using an effective method of contraception or abstinence from at least 4 weeks prior to the first vaccination and until at least 4 weeks after the last vaccination)
    2) Participation in the 4 weeks preceding the first trial vaccination or participation during the present trial period in another clinical trial investigating a vaccine, drug, medical device, or medical procedure
    3) Receipt of any vaccine in the 4 weeks preceding the first trial vaccination except for influenza (seasonal or pandemic) and pneumococcal vaccines. This exception includes monovalent pandemic influenza vaccines and multivalent influenza vaccines
    4) Previous vaccination against C. difficile with either the trial vaccine, another vaccine, or monoclonal antibodies
    5) Diarrhea on day of enrollment
    6) Self-reported current or prior CDI episode
    7) Anticipated or current receipt of kidney dialysis treatment
    8) History of gastrointestinal surgery for gastrointestinal malignancy (Note: Colonoscopy, polypectomy, and appendectomy are not exclusion criteria.)
    9) History of inflammatory bowel disease, irritable bowel syndrome (must include diarrhea as a symptom), colostomy, or small or large intestine bowel surgery where resection was performed
    10) Receiving enteral feeding (e.g., nasogastric, gastrostomy, and jejunostomy tube feeding)
    11) Known or suspected congenital or acquired immunodeficiency; or receipt of immunosuppressive therapy, such as anti-cancer chemotherapy or radiation therapy, within the preceding 6 months; or long-term systemic corticosteroid therapy (prednisone or equivalent for more than 2 consecutive weeks within the past 3 months)
    12) Known systemic hypersensitivity to any of the vaccine components, or history of a lifethreatening reaction to the vaccine used in the trial or to a vaccine containing any of the same substances
    13) Self-reported thrombocytopenia, contraindicating IM vaccination
    14) Deprived of freedom by an administrative or court order, or in an emergency setting, or hospitalized involuntarily
    15) Current alcohol abuse or drug addiction that might interfere with the ability to comply with trial procedures in the opinion of the Investigator
    16) Chronic illness that, in the opinion of the investigator, is at a stage where it might interfere with trial conduct or completion
    17) Moderate or severe acute illness/infection (according to investigator judgment) on the day of vaccination or febrile illness (temperature ≥ 38.0°C [≥ 100.4°F]). A prospective subject should not be included in the study until the condition has resolved or the febrile event has subsided
    18) Identified as an Investigator or employee of the Investigator or study center with direct involvement in the proposed study, or identified as an immediate family member (i.e., parent, spouse, natural or adopted child) of the Investigator or employee with direct involvement in the proposed study
    E.5 End points
    E.5.1Primary end point(s)
    Symptomatic PCR-confirmed primary CDI cases, defined as:
    -Presence of both of the following clinical symptoms:
    ≥ 3 loose stools in ≤ 24-hours
    loose stools lasting ≥ 24 hours
    and
    Stool sample positive for C. difficile by PCR
    or
    Confirmatory test of pseudomembranous colitis diagnosed through colonoscopy, and, if available, provision of a stool sample for PCRtesting
    E.5.1.1Timepoint(s) of evaluation of this end point
    All subjects will be followed actively for efficacy (the primary occurrence or recurrence of a CDI) from Day 0 through the follow-up period for occurrence of repeated episodes of loose stools and provision of a stool sample. Some subjects may be followed for a shorter period of time if the trial is completed and the subject has not reached their maximum follow-up period.
    E.5.2Secondary end point(s)
    Efficacy:
    The number of symptomatic PCR-confirmed primary CDI cases after 3 injections (the per-protocol population)
    The number of symptomatic PCR-confirmed primary CDI cases after at least 2 injections
    The number of symptomatic PCR-confirmed primary CDI cases after 3 injections as a function of time since enrollment and within 3.0 years after the third injection
    The number of severe PCR-confirmed primary CDI cases. A severe CDI case is defined when a subject has 1 or more of the following: fever ≥ 38.5°C, white blood cell count ≥ 15,000 cells/mm3 (ifavailable), ileus, pseudomembranous colitis, serum albumin <3 g/dl, abdominal distension, abdominal tenderness, or admission to the intensive care unit within 7 days of CDI diagnosis.
    The maximum number of loose stools per day associated with a symptomatic PCR-confirmed primary CDI case
    The CDI episode/illness duration associated with a symptomatic PCRconfirmed primary CDI case. Duration is calculated as (clinical cure date – clinical case date + 1)
    Immunogenicity:
    Serum antibody concentrations against toxins A and B, measured by enzyme-linked immunosorbent assays (ELISA)
    Serum antibody titers against toxins A and B, measured by toxin neutralization assay (TNA)
    Exploratory assays may be performed
    Safety:
    1) Occurrence, nature (MedDRA preferred term), duration, intensity, and relationship to vaccination of any unsolicited systemic adverse events (AEs) reported in the 30 minutes after vaccination
    2) Occurrence, time to onset, number of days of occurrence, intensity, action taken, and whether the reaction led to early termination from the study, of solicited (prelisted in the subject diary card and eCRF) injection site reactions occurring up to 6 days after vaccination in subjects in the reactogenicity subset
    3) Occurrence, time to onset, number of days of occurrence, intensity, action taken, and whether the reaction led to early termination from the study, of solicited (prelisted in the subject diary card and eCRF) systemic reactions occurring up to 6 days after vaccination in subjects in the reactogenicity subset
    4) Occurrence, nature (MedDRA preferred term), time to onset, duration, intensity, action taken, relationship to vaccination (for systemic AEs only), and whether the event led to early termination from the study, of unsolicited AEs up to 30 days after vaccination
    5) Occurrence, nature (MedDRA preferred term), time to onset, duration, seriousness criteria, relationship to vaccination, outcome, and whether the SAE led to early termination from the study, of SAEs through 6 months after the last injection
    6) Occurrence, nature (MedDRA preferred term), time to onset, duration, seriousness criteria, outcome, and whether the SAE led to early termination from the study, of SAEs considered related to vaccination and/or study procedures 6 months after the last injection through the end of the follow-up period
    E.5.2.1Timepoint(s) of evaluation of this end point
    Blood sampling:
    All subjects will provide a pre-vaccination blood sample at Day (D)0 and at D60. An immunogenicity subset (1650 / 16500 subjects enrolled) will provide additional blood samples at D14, pre-vaccination on D30, and every 6 months during the follow-up period.

    Safety:
    For subjects in the reactogenicity subset (3,300 / 16,500 subjects enrolled), solicited reactions will be recorded for 6 D after each injection. All subjects will record information about unsolicited AEs through 30 D after the last injection. All SAEs (related and unrelated) will be collected in all subjects from D0 through the end of the follow-up period.
    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 Yes
    E.6.13.1Other scope of the trial description
    Immunogenicity
    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 No
    E.8.1.5Parallel group No
    E.8.1.6Cross over No
    E.8.1.7Other Yes
    E.8.1.7.1Other trial design description
    observer-blind
    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 concerned5
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA80
    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
    Brazil
    Canada
    Chile
    Colombia
    Czech Republic
    Denmark
    Finland
    France
    Germany
    Korea, Republic of
    Mexico
    Peru
    Poland
    Romania
    Singapore
    Spain
    Sweden
    Taiwan
    United Kingdom
    United States
    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
    Last Contact Last Subject.
    Main population: 4 visits (D0, D7, D30 and D60), contact at D210 then contact every 2 weeks.
    Immunogenicity subset: 5 visits (D0, D7, D14, D30 and D60), then every 6 months for a maximum of 3 years (visits 6, 7, 8, 9, 10).
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years2
    E.8.9.1In the Member State concerned months10
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial years4
    E.8.9.2In all countries concerned by the trial months1
    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: 8250
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 8250
    F.2 Gender
    F.2.1Female Yes
    F.2.2Male Yes
    F.3 Group of trial subjects
    F.3.1Healthy volunteers No
    F.3.2Patients Yes
    F.3.3Specific vulnerable populations Yes
    F.3.3.1Women of childbearing potential not using contraception No
    F.3.3.2Women of child-bearing potential using contraception Yes
    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 state450
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 3000
    F.4.2.2In the whole clinical trial 16500
    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 Decision2015-10-30
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2015-09-01
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2018-06-12
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