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    Summary
    EudraCT Number:2018-001894-26
    Sponsor's Protocol Code Number:CP-PRO-QVLP-014
    National Competent Authority:Germany - PEI
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2018-07-23
    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 ConcernedGermany - PEI
    A.2EudraCT number2018-001894-26
    A.3Full title of the trial
    A Randomized, Observer-blind, Active Comparator-controlled, Multicenter, Phase 3 Study to Assess the Efficacy, Safety, and Immunogenicity of a Plant-derived Quadrivalent VLP Influenza Vaccine in Adults 65 Years of Age and Older
    Eine randomisierte, Beobachter-verblindete, mit aktivem Vergleichspräparat kontrollierte, multizentrische Phase-III-Studie zur Beurteilung der Wirksamkeit, Sicherheit und Immunogenität eines pflanzlichen quadrivalenten VLP-Grippeimpfstoffs bei Erwachsenen im Alter von 65 Jahren und älter
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A clinical trial to investigate a plant-derived flu vaccine in adults 65 years of age and older in order to assess efficacy, safety and to see how well it works at generating an immune response.
    A.4.1Sponsor's protocol code numberCP-PRO-QVLP-014
    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 SponsorMedicago R&D Inc.
    B.1.3.4CountryCanada
    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 supportMedicago R&D Inc
    B.4.2CountryCanada
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationMedicago R&D Inc
    B.5.2Functional name of contact pointDaniel Croteau
    B.5.3 Address:
    B.5.3.1Street Address1020 route de l'Église, bureau 600
    B.5.3.2Town/ cityQuébec
    B.5.3.3Post codeG1V 3V9
    B.5.3.4CountryCanada
    B.5.4Telephone number+1418658-9393378
    B.5.5Fax number+1418948-9208
    B.5.6E-mailcroteaud@medicago.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 nameQuadrivalent VLP Influenza Vaccine
    D.3.4Pharmaceutical form Suspension for injection in pre-filled syringe
    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 INNQuadrivalent VLP Influenza Vaccine
    D.3.9.3Other descriptive nameINFLUENZA VACCINE
    D.3.9.4EV Substance CodeSUB14211MIG
    D.3.10 Strength
    D.3.10.1Concentration unit µg/ml microgram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number60
    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.IMP: 2
    D.1.2 and D.1.3IMP RoleComparator
    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 Yes
    D.2.1.1.1Trade name Fluarix tetra / Influsplit - local source of comparator to be confirmed by Medicago.
    D.2.1.1.2Name of the Marketing Authorisation holderGlaxo Smithkline Biologicals
    D.2.1.2Country which granted the Marketing AuthorisationGermany
    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.3.4Pharmaceutical form Suspension for injection in pre-filled syringe
    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 INNQuadrivalent Influenza Vaccine
    D.3.9.3Other descriptive nameINFLUENZA VACCINE
    D.3.9.4EV Substance CodeSUB14211MIG
    D.3.10 Strength
    D.3.10.1Concentration unit µg/ml microgram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number30
    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
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Seasonal influenza
    E.1.1.1Medical condition in easily understood language
    Influenza (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 PT
    E.1.2Classification code 10022000
    E.1.2Term Influenza
    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 evaluate the efficacy, relative to an active comparator, of a single 30 µg/strain dose of the Quadrivalent VLP Influenza Vaccine, protocol-defined influenza-like illness (ILI) caused by any influenza viral types/subtypes (matched, mis-matched and un-typed).
    E.2.2Secondary objectives of the trial
    Efficacy
    To evaluate efficacy, relative to active comparator, of a single dose of test IMP (Quadrivalent VLP Influenza Vaccine), against laboratory-confirmed protocol-defined ILI caused by vaccine-matched strains;
    To evaluate efficacy, relative to active comparator, of a single dose of test IMP, against laboratory-confirmed protocol-defined respiratory illness caused by vaccine-matched strains or any influenza viral types/subtypes (matched, mismatched, and un-typed);
    To evaluate efficacy, relative to an active comparator, of a single dose of test IMP, as measured by the incidence of subjects presenting with symptoms of protocol-defined ILI, regardless of laboratory results.

    Safety
    To assess safety and tolerability, relative to an active comparator, of a single dose of test IMP.

    Immunogenicity (Subset of subjects)
    To assess immunogenicity of a single dose of test IMP as measured by HI assay, MN assay & SRH assay against homologous and heterologous (HI only) influenza strains
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Subjects must have read, understood, and signed the informed consent form (ICF);
    Subject must have a body mass index (BMI) ≤ 35 kg/m^2;
    Male and female subjects must be 65 years of age and older at the Screening/Vaccination visit (Visit 1);
    Subjects must be non-institutionalized (e.g. not living in rehabilitation centres or old-age homes; living in an elderly community is acceptable) and have no acute or evolving medical problems prior to study participation and no clinically relevant abnormalities that could jeopardize subject safety or interfere with study assessments
    E.4Principal exclusion criteria
    According to the Investigator’s opinion, history of an ongoing acute or evolving medical or neuropsychiatric illness (see protocol for definition of 'evolving');
    Any autoimmune disease other than hypothyroidism on stable replacement therapy or any confirmed or suspected immunosuppressive condition or immunodeficiency;
    Any history of status asthmaticus or ongoing serious problems with asthma, hospitalization for asthma control, or recurrent asthma episodes requiring medical attention in the last three years;
    Administration or planned administration of any non-influenza vaccine within 30 days prior to randomization up to blood sampling on Day 21;
    Administration of any adjuvanted or investigational influenza vaccine within one year prior to randomization or planned administration prior to the completion of the study;
    Administration of any ‘standard’, non-adjuvanted influenza vaccine within six months prior to randomization and up to completion of the study (see protocol for definition of 'standard');
    Treatment with systemic glucocorticoids at a dose exceeding 10 mg of prednisone (or equivalent) per day for more than seven consecutive days or for ten or more days in total, within one month of study vaccine administration; any other cytotoxic or immunosuppressant drug, or any immunoglobulin preparation within three months of vaccination and until the completion of the study;
    Any significant disorder of coagulation including, but not limited to, treatment with warfarin derivatives or heparin;
    History of allergy to any of the constituents of the Quadrivalent VLP Influenza Vaccine, any components of the active comparator quadrivalent vaccine, or tobacco;
    History of anaphylactic allergic reactions to plants or plants components;
    Use of antihistamines, prophylactic medications against influenza or antiviral treatment, or have a blood transfusion prior to study vaccination (see protocol for applicable time periods);
    Daily use of large doses of medication for pain control or inflammation;
    Have a rash, dermatological condition, tattoos, muscle mass at the injection site;
    Presence of any febrile illness within 24 hours prior to vaccination;
    Cancer or treatment for cancer within three years prior to study vaccine administration;
    Subjects with a history of Guillain-Barré Syndrome.
    E.5 End points
    E.5.1Primary end point(s)
    Vaccine efficacy will be defined as per by the applicable regulatory region-specific case definition as follows:
    Occurrences of protocol-defined ILI due to laboratory-confirmed influenza (≥ 14 days post-vaccination) caused by any influenza viral types/subtypes (matched, mismatched and un-typed).
    E.5.1.1Timepoint(s) of evaluation of this end point
    ≥ 14 days post-vaccination
    E.5.2Secondary end point(s)
    Efficacy
    Occurrences of laboratory-confirmed influenza illnesses (according to protocol defined ILI) caused by influenza viral types/subtypes that are matched (and/or antigenically similar) to the strains covered in the vaccine formulation;
    Occurrences of laboratory-confirmed influenza illnesses (according to protocol defined respiratory illness) caused by any influenza viral types/subtypes (matched, mismatched, and un-typed);
    Occurrences of laboratory-confirmed influenza illnesses (according to protocol defined respiratory illness) caused by any influenza viral types/subtypes that are matched (and/or antigenically similar) to the strains covered in the vaccine formulation;
    Occurrences of protocol-defined ILI (confirmed or not by laboratory testing).

    Safety
    Percentage, intensity, and relationship to vaccination of immediate complaints (15 minutes post-vaccination);
    Percentage, intensity, and relationship to vaccination of solicited local and systemic signs and symptoms (for seven days following study vaccine administration);
    Percentage, intensity, and relationship of TEAEs for 21 days following study vaccine administration;
    Occurrences of deaths, SAEs, AEs leading to withdrawal, and NOCDs up to the end of the surveillance period.

    Immunogenicity (subset of subjects):
    HI antibody response induced against the homologous and heterologous influenza strains on Days 0 and 21 will be assessed in a subset of 420 subjects (210 from each of the two treatment groups). HI antibody titers will be analyzed using the following parameters: geometric mean titer (GMT), seroconversion (SC) rate, seroprotection (SP) rate, and geometric mean fold rise (GMFR);
    MN antibody response induced by the Quadrivalent VLP Influenza Vaccine against the homologous influenza strains on Days 0 and 21, in a subset of subjects, will be analyzed using the following parameters: GMT, SC rate, and GMFR;
    SRH antibody response induced by the Quadrivalent VLP Influenza Vaccine against the homologous strains on Days 0 and 21, in a subset of subjects, will be analysed using the following parameters: geometric mean area (GMA), SC rate, SP rate, and GMFR.
    E.5.2.1Timepoint(s) of evaluation of this end point
    Efficacy endpoints - ≥ 14 days post-vaccination;
    Safety endpoints - Various, inc. 15 minutes post-vaccination, 7 & 21 days following study vaccine administration up to the end of surveillance period;
    Immunogenicity endpoints - Days 0 and 21.
    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 Yes
    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) Yes
    E.8.2.2Placebo No
    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 concerned24
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA35
    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
    Canada
    Finland
    Germany
    United States
    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 years0
    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 years0
    E.8.9.2In all countries concerned by the trial months8
    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) No
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 12000
    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 state2500
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 4000
    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)
    N/A
    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 Decision2018-09-06
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2018-10-18
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2019-06-25
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