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    Summary
    EudraCT Number:2018-000468-27
    Sponsor's Protocol Code Number:BVX-010
    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:2018-04-04
    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 number2018-000468-27
    A.3Full title of the trial
    A pivotal, multicentre, randomized, modified double-blind, placebo-controlled phase 3 trial to assess the safety and clinical efficacy of M-001, an influenza vaccine administered intramuscularly twice in older adults and the elderly (≥50 years of age).
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A trial to assess the safety and efficacy of an influenza vaccine administered intramuscularly twice in older adults and the elderly (≥50 Years of age).
    A.4.1Sponsor's protocol code numberBVX-010
    A.5.2US NCT (ClinicalTrials.gov registry) numberNCT03450915
    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 SponsorBiondVax Pharmaceuticals Ltd.
    B.1.3.4CountryIsrael
    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 supportBiondVax Pharmaceuticals Ltd.
    B.4.2CountryIsrael
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationBiondVax Pharmaceuticals Ltd.
    B.5.2Functional name of contact pointTamar Ben-Yedidia
    B.5.3 Address:
    B.5.3.1Street AddressJerusalem BioPark, Hadassah Ein Kerem Campus
    B.5.3.2Town/ cityJerusalem
    B.5.3.4CountryIsrael
    B.5.6E-mailbenyedidia@BiondVax.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 nameMultimeric-001
    D.3.2Product code M-001
    D.3.4Pharmaceutical form 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 INNN/A
    D.3.9.2Current sponsor codeM-001
    D.3.9.3Other descriptive nameMULTIMERIC-001
    D.3.9.4EV Substance CodeSUB179565
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typerange
    D.3.10.3Concentration number2.0 to 3.0
    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 Yes
    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
    Flu vaccination
    E.1.1.1Medical condition in easily understood language
    Flu vaccination
    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 LLT
    E.1.2Classification code 10016794
    E.1.2Term Flu vaccination
    E.1.2System Organ Class 100000004865
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    Safety: To assess M-001 Safety by solicited local and systemic reactogenicity events occurring within 8 days (day of the vaccination inclusive) following receipt of each of the two doses of M-001 or placebo and to assess SAEs and new-onset of chronic medical illnesses (NOCIs) during period from Day 0 until end of first passive surveillance period in each group. To assess M-001 safety by occurrence of unsolicited AEs from the time of first study vaccination through 22 days after each M-001 vaccination (day of the vaccination inclusive).
    Clinical Efficacy: To assess efficacy of M-001 in the prevention of influenza disease by comparing the occurrence of either qRT-PCR or culture confirmed influenza in the M-001 experimental group vs. placebo caused by any influenza A or B virus in association with a protocol defined Influenza Like Illness (ILI)
    E.2.2Secondary objectives of the trial
    Clinical efficacy:
    1. Compare the occurrence of culture confirmed influenza in the M-001 experimental group vs. placebo caused by any influenza A or B virus in association with a protocol defined ILI.
    2. Reduced Severity of either qRT-PCR or culture -confirmed influenza illness by the time to all symptoms alleviation/fever resolution (“alleviation/resolution”).
    3. To assess the durability of vaccine efficacy over a second influenza season.
    4. To assess proportion of subjects having ILI symptoms in the experimental or control group.
    Immunogenicity and lots consistency:
    To assess in at least a subset of samples in season 2 the consistency of manufacturing between 3 batches of M-001 according to their T cell responses by IFN-g production in PBMCs.
    E.2.3Trial contains a sub-study Yes
    E.2.3.1Full title, date and version of each sub-study and their related objectives
    PBMC (CMI) substudy - To assess the immune response to the main trial vaccine, blood samples will be collected pre- and post-vaccination from a subset of 350 participants selected at random in pre-specified sites participating in Season 2. Approximately two hundred sixty two (263) will be selected from the M-001 group and 87 from the placebo group.
    E.3Principal inclusion criteria
    Subjects eligible to participate in this study must meet all of the following inclusion criteria:
    1. Male and female subjects 50 years of age (inclusive) or older, willing and able to give the written informed consent prior to study entry.
    2. Able to comply with the trial procedures and be available for all study visits including answering phone calls and coming to the site as defined by the Protocol.
    3. Medically stable (subjects may have underlying systemic chronic conditions such as hypertension, diabetes, ischemic heart disease, or hypothyroidism, as long as their symptoms/signs are controlled; if they are on systemic pharmacological treatment for such condition, the treatment must have been stable for at least 3 months preceding first vaccination).
    4. Women of childbearing potential (not surgically sterile or postmenopausal for greater than or equal to one year) and men must agree to practice adequate effective contraception - barrier or hormone-based methods or intra uterine device (IUD) for women and a condom for males -whose female partner has childbearing potential - throughout the study treatment and for at least up to day 81 (for females) and day 111 (for males) of the trial (i.e. 60 (for females) and 90 (for males) days after the last dose of the IMP). In addition, women of childbearing potential must have practiced the contraception for a minimum of 30 days prior to study product exposure.
    5. Female subjects of childbearing potential must have a negative urine or serum pregnancy test within 24 hours prior to both study vaccinations.
    E.4Principal exclusion criteria
    Subjects eligible to participate in this study must not meet any of the following exclusion criteria:
    1. History of neurological symptoms or signs, or anaphylactic shock following administration of any vaccine.
    2. Known or suspected (or have a high risk of developing) significant impairment/alteration of immune function (excluding that normally associated with advanced age - as judged by PI/SI
    3. Receipt of: a) Current (including within 60 days or planned during the study) daily use of immunosuppressive drugs: i) systemic glucocorticoids ≥ 10 mg prednisone per day ii) cytotoxic drugs b) Investigational drugs within 30 days before, or planned during, the study c) Blood products within 3 months before, or planned during, the study d) Influenza vaccine within 6 months before the study or planned during the study e) Other vaccines within 30 days before, or planned during, the study.
    4. Any serious disease such as: cancer, autoimmune disease, advanced arteriosclerotic disease or complicated diabetes mellitus, chronic obstructive pulmonary disease (COPD) that requires oxygen therapy, acute or progressive hepatic disease, acute or progressive renal disease, or congestive heart failure, as judged by the PI/SI.
    5. An acute illness, which occurred within 1 week before first vaccination, as judged by the PI/SI, or body temperature greater than: for participants age 50-59 37.9ºC (axillary or forehead) or 38.4 ºC (oral), or 38.9ºC (ear/tympanic or rectal); for participants of age 60 or more, greater than 37.2ºC (axillary or forehead) or 37.7 ºC (oral), or 38.2ºC (ear/tympanic or rectal), which occurred within 1 week before first vaccination.
    6. Anatomical deficiencies which exclude possibility of taking NP swab or throat and nasal swab.
    7. Women who are breastfeeding or planning pregnancy during the period of the study
    Institutionalized subjects or subjects unable to come to the study site as expected by the Protocol.
    E.5 End points
    E.5.1Primary end point(s)
    Safety:
    To assess M-001 Safety by solicited local and systemic reactogenicity events occurring within 8 days (day of the vaccination inclusive) following receipt of each of the two doses of M-001 or placebo and to assess SAEs, and new-onset of chronic medical illnesses (NOCIs) during period from Day 0 until end of first passive surveillance period in each group. To assess M-001 Safety by occurrence of unsolicited AEs from the time of first study vaccination through 22 days after each M-001 vaccination (day of the vaccination inclusive).

    Clinical Efficacy:
    Compare the occurrence of either qRT-PCR or culture confirmed influenza in the M-001 experimental group vs. placebo (≥ 15 days after the second vaccination until epidemiological levels of influenza are low as defined by the medical director) caused by any influenza A or B virus in association with a protocol defined Influenza Like Illness (ILI is defined as symptoms that include one of the following respiratory symptoms (sore throat, cough, sputum production, nasal discharge or congestion, wheezing or difficult breathing) and at least one additional systemic symptom [fever (oral temperature >37.2°C for age 50-59, or >36.7°C for age 60 or more, or increased ≥ 1.3°C from baseline), headache, myalgia and/or arthralgia, chills, and fatigue (tiredness for at least 12 hours)]. NP (Nasopharyngeal) or combined nasal and throat swab will be collected from participants who meet the ILI definition for qRT-PCR analysis of influenza A and/or B virus. Influenza positive samples by PCR will be further analysed for culture confirmation
    E.5.1.1Timepoint(s) of evaluation of this end point
    June 2019, 2020
    E.5.2Secondary end point(s)
    1. Compare the occurrence of culture confirmed influenza in the M-001 experimental group vs. placebo (≥ 15 days after the second vaccination until epidemiological levels of influenza are low as defined by the medical director) caused by any influenza A or B virus in association with a protocol defined ILI. Nasopharyngeal swab will be collected from participants who meet the ILI definition within 24 hours from ILI being reported to or identified by study personnel for qRT-PCR confirmation of influenza A and/or B virus (a nasal and throat sample can be collected as alternative method), and the samples identified with qRT-PCR as positive for influenza A or B virus will be verified with virus culture.
    2. Reduced Severity of influenza illness Reduction of either qRT-PCR or Culture-confirmed influenza illness severity;
    The timereduction due to lM-001 in the average number of days with respiratory or systemic symptoms during the first laboratory-confirmed influenza illness episode
    3. The percentage of subjects having ILI symptoms in the experimental and control group
    4. The change from baseline in the percentage of CD4+ lymphocytes producing Th1 cytokine (e.g. INF-γ) in response to any of the 9 peptides in M-001. This endpoint will be assessed within a randomly selected subset of participants from pre-selected sites participating to the substudy in Year 2.
    E.5.2.1Timepoint(s) of evaluation of this end point
    June 2020
    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 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 concerned32
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA85
    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
    Bulgaria
    Croatia
    Georgia
    Hungary
    Latvia
    Poland
    Ukraine
    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
    last subject last contact
    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 months6
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years3
    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: 6000
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 6000
    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 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 state6629
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 9600
    F.4.2.2In the whole clinical trial 12000
    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 Decision2018-06-27
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2018-03-26
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2020-07-02
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