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    Summary
    EudraCT Number:2017-004971-30
    Sponsor's Protocol Code Number:FLUGEN-H3N2-V002
    National Competent Authority:Belgium - FPS Health-DGM
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2018-02-28
    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 ConcernedBelgium - FPS Health-DGM
    A.2EudraCT number2017-004971-30
    A.3Full title of the trial
    A Phase 2a Randomized, Double-blind, Placebo-controlled Trial to Evaluate the Safety, Immunogenicity, and Efficacy of Bris10 M2SR (H3N2 A/Brisbane/10/2007) Vaccine Administered as a Single Intranasal Dose (Versus Placebo) in Healthy Adult Volunteers who are Subsequently Challenged with a Live, Antigenically Different Wild-type Influenza Type A Virus (A/Belgium/4217/2015 H3N2)
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    na
    A.4.1Sponsor's protocol code numberFLUGEN-H3N2-V002
    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 SponsorFluGen, 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 supportFluGen, Inc
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationFluGen, Inc
    B.5.2Functional name of contact pointPamuk Bilsel
    B.5.3 Address:
    B.5.3.1Street Address597 Science Drive
    B.5.3.2Town/ cityMadison
    B.5.3.3Post codeWI USA 53711
    B.5.3.4CountryUnited States
    B.5.4Telephone number +1 608-442-6562
    B.5.5Fax number+1 608-260-7704
    B.5.6E-mailpbilsel@flugen.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 nameBris10 M2SR Vaccine
    D.3.4Pharmaceutical form Nasal spray, solution
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntranasal use (Noncurrent)
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNna
    D.3.9.1CAS number na
    D.3.9.2Current sponsor codeBris10 M2SR Vaccine
    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 Yes
    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 placeboIntranasal use (Noncurrent)
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Prophylactic H3N2(A/Brisbane/10/2007) monovalent influenza vaccine, Bris10 M2SR, for protection against influenza disease caused by seasonal influenza A viruses.
    E.1.1.1Medical condition in easily understood language
    flu
    E.1.1.2Therapeutic area Diseases [C] - Virus Diseases [C02]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level HLT
    E.1.2Classification code 10022005
    E.1.2Term Influenza viral infections
    E.1.2System Organ Class 100000004862
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    1. To assess the effect of vaccination with Bris10/2007 M2SR (H3N2) vaccine on influenza viral shedding after intranasal challenge with a drifted H3N2 virus, A/Belgium/4217/2015.
    2. To assess the safety of the Bris10 M2SR (H3N2) vaccine during the period from study vaccine administration until influenza virus challenge.
    E.2.2Secondary objectives of the trial
    see protocol
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Give written informed consent to participate.
    2. Age 18 – 55 years old, inclusive.
    3. Judged suitable by the Principal Investigator, as determined by medical history, physical examination, vital signs, and clinical safety laboratory examinations.
    4. Negative test for pregnancy at screening visit, on Day-28 and at Day -2.
    5. Negative test for alcohol (breath) and drugs of abuse (urine).
    6. Negative test for influenza prior to vaccination.
    7. Female subjects should fulfill one of the following criteria:
    a. Post-menopausal status defined as no menses for 12 months without an alternative medical cause and/or high follicle-stimulating hormone (FSH) level (>30 mIU/mL) prior to screening.
    b. Surgically sterile.
    c. Willing to use oral, implantable, transdermal or injectable contraceptives, as outlined in inclusion criteria 8, from screening and until 28 days after challenge infection.
    8. Female subjects of childbearing potential must agree to use a reliable form of contraception approved by the Investigator (e.g., oral, implantable, transdermal, or injectable contraception, combined oral, intrauterine device [IUD], or a sterile sexual partner) from screening and until 28 days after challenge infection. Non-surgically sterile male subjects who are sexually active with a female partner(s) of childbearing potential (i.e. males who have not been sterilized by vasectomy for at least 6 months prior to screening) must be willing to use condoms from screening and until 28 days after challenge infection.
    9. Willing to adhere to the requirements of the study and willing and able to communicate with the Investigator and understand the requirements of the study.
    10. Willing to be confined during the challenge portion of the study.
    11. Non-smoker (including prior smokers having stopped smoking for more than 1 year at time of screening) or non-habitual smoker (non-habitual smokers are persons who smoke fewer than 4 cigarettes or other tobacco products on a weekly basis) who agrees to not use tobacco products during the challenge phase of the study.
    12. Absent or low levels of detectable pre-existing antibodies to influenza virus H3N2 subtype, strain A/Belgium/4217/2015, as determined by a MN titer of ≤20 at screening.
    E.4Principal exclusion criteria
    1.Any subject who is a family member of a) study site personnel, b) personnel involved in conduct or monitoring of study, or c) Sponsor.
    2.Has a BMI at screening of less than or equal to 19.0 kg/m2 or greater than or equal to 32.0 kg/m2.
    3.Any condition that would limit the subject’s ability to complete the study based on the opinion of the Investigator
    4.Abnormal screening hematology or chemistry value per the FDA
    5.Pulse rate, blood pressure, or ECG outside the reference range for this study population and considered as clinically significant by the Investigator.
    6.Has an acute or chronic medical condition or history of a medical condition
    7. Has been vaccinated against influenza within the last 6 months or plans to be inoculated with an influenza vaccine (other than study vaccine) until one month after completion of in-person follow up.
    8.Had a flu-like illness, influenza treatment, or prophylactic influenza viral drug administered in the previous 6 months before screening.
    9Positive screening test or known infection with HIV, HBV and HCV.
    10.History of cancer within 5 years prior to screening
    11.Presence or history of lung disease, asthma, chronic obstructive pulmonary disease, or otherwise poor lung function. Childhood asthma that resolved by age 12 years is not criteria for exclusion.
    12.Having a forced expiratory volume in 1 second (FEV1)/forced vital capacity (FVC) ratio <0.70 and FEV1 <80 % at screening. The interpretation of the spirometry result is at the investigator’s discretion. At the discretion of the investigator or designee, subjects with up to 10% deviation from these values may be included.
    13.Any significant abnormality altering the anatomy of the nose or nasopharynx. A test swabbing by mock swab may be performed at screening at the Investigator’s discretion.
    14.Any confirmed or suspected immunosuppressive or immunodeficient state including: asplenia, recurrent severe infections and chronic immunosuppressant medication within the last 6 months.
    15.Use of immunosuppressive medications, such as allergy shots, immune globulin, interferon, immunomodulators, in the past 6 months or planned to be used during the course of the trial.
    16.Use of intranasal corticosteroids within the last 7 days before screening.
    17.Significant adulthood history of seasonal hay fever, a seasonal allergic rhinitis, perennial allergic rhinitis, chronic nasal or sinus condition such as sinusitis, at the discretion of the investigator.
    18.Received any licensed vaccine within 1 month before screening or planned receipt during the 30 days post challenge.
    19. Received or planned administration of another investigational vaccine or drug during the period from 90 days prior to Day 1 to 1 month after completion of in-person follow up.
    20.History of allergy/hypersensitivity to any vaccine or virus challenge component challenge agent component or material in nasal delivery device
    21.Experienced a life-threatening reaction(s) after a previous administration of any vaccine, or experienced an allergic reaction after a previous administration of any influenza vaccine or component.
    22.A history or prior diagnosis of Guillain-Barré Syndrome.
    23.Presence of household member or close personal or professional contact for 14 days post-inoculation who:
    a.is a child under one year of age;
    b.is pregnant;
    c.has known immunodeficiency or is receiving immunosuppressant medication;
    d.is undergoing or soon to undergo cancer chemotherapy;
    e.has been diagnosed with emphysema, COPD, or other severe lung disease and resides in a nursing home;
    f.has received a bone marrow or solid organ transplant.
    24.History of drug or alcohol abuse in the 6 months before the study.
    25.Concomitant use of any prescription, OTC medications, herbal medications, or supplement starting 7 days prior to vaccination. Note, please see list of permitted medications that can be administered post-vaccination to treat vaccination related signs and symptoms. Permitted medications include contraceptive pills, implants, transdermal or injections in female subjects.
    26.Receipt of blood products or immunoglobulin within 6 months before study entry or planned for within 180 days after the vaccination.
    27.Donation of blood or blood products within 30 days before study entry or at any time during the 30 days post vaccination.
    28.Females who are pregnant or lactating
    29.Acute febrile illness within 72 hours prior to vaccination, defined as the presence of a moderate or severe illness with or without fever, or presence of a fever >38ºC orally. Vaccination should be delayed until the subject has recovered. Persons with a minor illness, such as diarrhea, or mild upper respiratory tract infection with or without low-grade fever may be considered for enrollment after resolution of the illness.
    30.Any condition that, in the opinion of the Investigator, might interfere with the primary study objectives for safety of the study subject.
    E.5 End points
    E.5.1Primary end point(s)
    1. Area under the curve (AUC) of the influenza RNA log10 viral load by real-time quantitative reverse transcription polymerase chain reaction (qRT-PCR) from nasopharyngeal swabs of study subjects from the time of challenge inoculation with A/Belgium/4217/2015 until discharge (10 days after inoculation) in the vaccine and placebo groups.
    2. Number and proportions of study subjects reporting solicited and unsolicited adverse events (AEs) and serious adverse events (SAEs) from the time of administration of the vaccine or placebo until administration of challenge virus.
    E.5.1.1Timepoint(s) of evaluation of this end point
    during the trial
    E.5.2Secondary end point(s)
    1. Proportion of study subjects in vaccine and placebo groups with infection following challenge with A/Belgium/4217/2015 as determined by qRT-PCR. Infection is defined as at least two consecutive qRT-PCR positive swabs starting on the second day after challenge (Day 3).
    2. Proportion of study subjects in vaccine and placebo groups with infection AND influenza illness following intranasal challenge with A/Belgium/4217/2015. Influenza illness is defined as either at least one respiratory symptom on two consecutive days OR at least one respiratory and at least one systemic symptom on two consecutive days.
    3. Number (%) of vaccine and placebo study subjects reporting occurrence of solicited local reactions and systemic events during the 8-day period that includes the day of vaccination and the following 7 days. The intensity and duration of these reactions and events will be described.
    4. Nasal vaccine virus shedding at 72 hours post-vaccination and every 24 hours thereafter until PCR negative.
    5. Number (%) of study subjects reporting treatment-emergent solicited and unsolicited AEs and SAEs.
    6. Number (%) of study subjects reporting challenge-emergent solicited and unsolicited AEs and SAEs.
    7. Viral load (qRT-PCR) and viral titer (TCID50), in samples of upper respiratory tract secretions collected following influenza virus challenge with A/Belgium/4217/2015 (time to start, time to peak, and time to cessation of viral shedding) in the vaccine and placebo groups.
    8. Following administration of investigational product (IP, vaccine or placebo):
    a. Influenza-specific serum antibody responses measured at immunogenicity serum sampling time points;
    b. Influenza-specific mucosal IgA antibody responses measured at immunogenicity nasal swab sampling time points;
    c. Influenza-specific cellular immune responses measured by cytokine enzyme-linked immunospot (ELISPOT) at immunogenicity peripheral blood mononuclear cell (PBMC) sampling time points.
    9. Following challenge with A/Belgium/4217/2015:
    a. Influenza-specific serum antibody responses measured at immunogenicity serum sampling time points;
    b. Influenza-specific mucosal IgA antibody responses measured at immunogenicity nasal swab sampling time points;
    c. Influenza-specific cellular immune responses measured by cytokine ELISPOT at immunogenicity PBMC sampling time points.
    E.5.2.1Timepoint(s) of evaluation of this end point
    during the trial
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis No
    E.6.2Prophylaxis No
    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) Yes
    E.7.3Therapeutic confirmatory (Phase III) No
    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 Yes
    E.8.4 The trial involves multiple sites in the Member State concerned No
    E.8.5The trial involves multiple Member States No
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA No
    E.8.6.2Trial being conducted completely outside of the EEA No
    E.8.7Trial has a data monitoring committee No
    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
    LVLS
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years
    E.8.9.1In the Member State concerned months9
    E.8.9.1In the Member State concerned days
    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: 120
    F.1.3Elderly (>=65 years) No
    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 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 state120
    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)
    see protocol
    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 Decision2018-04-27
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2018-02-27
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2019-03-06
    The status of studies in GB is no longer updated from 1.1.2021
    For the UK, as from 1.1.2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI
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