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    Summary
    EudraCT Number:2017-001239-38
    Sponsor's Protocol Code Number:CP-PRO-QVLP-012
    National Competent Authority:UK - MHRA
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2017-06-21
    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 ConcernedUK - MHRA
    A.2EudraCT number2017-001239-38
    A.3Full title of the trial
    A Randomized, Observer-blind, Placebo-controlled, Multicenter, Phase 3 Study to Assess the Efficacy, Safety, and Immunogenicity of a Plant-Derived Quadrivalent VLP Influenza Vaccine in Adults 18-64 Years of Age
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A Phase 3 Study to Assess the Efficacy, Safety, and Immunogenicity of a Plant-Derived Quadrivalent VLP Influenza Vaccine in Adults 18-64 Years of Age
    A.4.1Sponsor's protocol code numberCP-PRO-QVLP-012
    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+1418658-9393 x378
    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.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 in pre-filled syringe
    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
    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 placebo, of a single dose of the Quadrivalent VLP Influenza Vaccine given at a dose of 30 μg/strain, against laboratory-confirmed influenza caused by vaccine-matched strains.
    E.2.2Secondary objectives of the trial
    Efficacy:
    To evaluate the efficacy, relative to placebo, of a single dose of the Quadrivalent VLP Influenza Vaccine given at a dose of 30 μg/strain;
    - Against any laboratory-confirmed influenza strain;
    - Against laboratory-confirmed protocol-defined influenza-like illness (ILI) caused by vaccine-matched strains.
    - As measured by the incidence of subjects presenting with symptoms of protocol-defined ILI, regardless of laboratory results.
    Safety:
    - To assess the safety and tolerability, relative to placebo, of a single dose of the Quadrivalent VLP Influenza Vaccine given at a dose of 30 μg/strain.
    Immunogenicity:
    - To assess, in a subset of 400 subjects, the immunogenicity of a single dose of Quadrivalent VLP Influenza Vaccine given at a dose of 30 μg/strain, as measured by haemagglutination inhibition (HI) assay, microneutralisation (MN) assay, and single radial haemolysis (SRH) assay against homologous and heterologous (HI only) influenza strains.
    E.2.3Trial contains a sub-study Yes
    E.2.3.1Full title, date and version of each sub-study and their related objectives
    A subset of subjects from selected sites in US and Canada will have an additional blood sample collected at D0 and D21 for immunogenicity and T cell response assessments.
    E.3Principal inclusion criteria
    Subjects must meet all of the following inclusion criteria to be eligible for participation in this
    study:
    1. Subjects must be able to read, understand, and sign the informed consent form (ICF); complete study-related procedures; and communicate with the study staff at visits and by phone;
    2. Subject must have a body mass index (BMI) below 40 kg/m2;
    3. Subjects are considered by the Investigator to be reliable and likely to cooperate with the assessment procedures and be available for the duration of the study;
    4. Male and female subjects must be 18 to 64 (has not yet had his/her 65th birthday) years of age, inclusive, at the Screening/Vaccination visit (Visit 1);
    5. Subjects must be in good general health prior to study participation, with no clinically relevant abnormalities that could jeopardise subject safety or interfere with study assessments, as assessed by the Principal Investigator or sub-Investigator (there after referred as Investigator) and determined by medical history, physical examination, and vital signs;
    Note: Subjects with a pre-existing chronic disease will be allowed to participate if the disease is stable and, according to the Investigator’s judgment, the condition is unlikely to confound the results of the study or pose additional risk to the subject by participating in the study. Stable disease is generally defined as no new onset or exacerbation of pre-existing chronic disease three months prior to vaccination. Based on the Investigator’s judgment, a subject with more recent stabilisation of a disease could also be eligible.
    6. Female subjects must have a negative urine pregnancy test result at the Screening/Vaccination visit (Visit 1);
    7. Female subjects of childbearing potential must use an effective method of contraception for one month prior to vaccination and agree to continue employing adequate birth control measures for at least 60 days post-vaccination. Moreover, female subjects must have no plan to become pregnant for at least two months post-vaccination. Abstinent subjects should be asked what method(s) they would use should their circumstances change, and subjects without a well-defined plan should be excluded. The following relationship or methods of contraception are considered to be effective:
    - Hormonal contraceptives (e.g. injectable, topical [patch], or oestrogenic vaginal ring);
    - Intra-uterine device with or without hormonal release;
    - Male partner using a condom plus spermicide or sterilised partner (at least one year prior to vaccination);
    - Credible self-reported history of heterosexual abstinence until at least 60 days postvaccination;
    - Female partner;
    8. Non-childbearing females are defined as:
    - Surgically-sterile (defined as bilateral tubal ligation, hysterectomy or bilateral oophorectomy performed more than one month prior to vaccination); or
    - Post-menopausal (absence of menses for 24 consecutive months and age consistent with natural cessation of ovulation).
    E.4Principal exclusion criteria
    Subjects who meet any of the following criteria will be excluded from participating in this study:
    1. Any subject whose medical condition(s) is sufficiently severe that annual influenza vaccination would be routinely recommended in the jurisdiction of recruitment;
    2. According to the Investigator’s opinion, history of significant acute or chronic, uncontrolled medical or neuropsychiatric illness. ‘Uncontrolled’ is defined as:
    - Requiring a new medical or surgical treatment during the three months prior to study vaccine administration unless the criteria outlined in inclusion criterion no. 5 can be met (i.e. the Investigator can justify inclusion based upon the innocuous nature of medical/surgical events and/or treatments);
    - Requiring any significant change in a chronic medication (i.e. drug, dose, frequency) during the three months prior to study vaccine administration due to uncontrolled symptoms or drug toxicity unless the innocuous nature of the medication change meets the criteria outlined in inclusion criterion no. 5 and is appropriately justified by the Investigator.
    3. Any medical or neuropsychiatric condition or any history of excessive alcohol use or drug abuse which, in the Investigator’s opinion, would render the subject unable to provide informed consent or unable to provide valid safety observations and reporting;
    4. Any autoimmune disease other than hypothyroidism on stable replacement therapy (including, but not limited to rheumatoid arthritis, systemic lupus erythematosus, Crohn’s disease, and inflammatory bowel disease) or any confirmed or suspected immunosuppressive condition or immunodeficiency including known or suspected human immunodeficiency virus (HIV), Hepatitis B or C infection, the presence of lymphoproliferative disease;
    5. History of chronic pulmonary (including asthma, bronchopulmonary dysplasia, and cystic fibrosis) or cardiovascular (except isolated hypertension), renal, hepatic, neurologic, haematologic (including anaemia and haemoglobinopathy), or metabolic disorders (including diabetes mellitus);
    6. Because this is a placebo-controlled study, any subjects in close contact with individuals considered to be at high risk for developing influenza-related complications (individuals considered at high risk for complications include adults and children who have chronic pulmonary or cardiovascular [except isolated hypertension], renal, hepatic, neurologic, haematologic, or metabolic disorders [including diabetes mellitus]);
    7. Administration or planned administration of any non-influenza vaccine within 30 days prior to randomisation up to blood sampling on Day 21. Immunisation on an emergency basis will be evaluated case-by-case by the Investigator;
    8. Administration of any adjuvanted or investigational influenza vaccine within one year prior to randomisation or planned administration prior to the completion of the study;
    9. Administration of any ‘standard’, non-adjuvanted influenza vaccine (e.g. live attenuated trivalent/quadrivalent inactivated influenza vaccine or split trivalent/quadrivalent inactivated influenza vaccine administered by intranasal, intradermal, or IM route) within six months prior to randomisation and up to completion of the study;
    10. Use of any investigational or non-registered product within 30 days or five half-lives, whichever is longer, prior to randomisation or planned use during the study period. Subjects may not participate in any other investigational or marketed drug study while participating in this study until after the study;
    11. Treatment with systemic glucocorticoids at a dose exceeding 10 mg of prednisone (or equivalent) per day for more than seven consecutive days or for 10 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. Low doses of nasal or inhaled glucocorticoids are allowed. Topical steroids are permitted;
    12. Any significant disorder of coagulation including, but not limited to, treatment with warfarin derivatives or heparin. Persons receiving prophylactic anti-platelet medications (e.g. low-dose aspirin [no more than 325 mg/day]), and without a clinically apparent bleeding tendency are eligible. Subjects treated with new generation drugs that do not increase the risk of Intra Muscular (IM) bleeding (e.g. clopidogrel) are also eligible;
    13. History of allergy to any of the constituents of the Quadrivalent VLP Influenza Vaccine or tobacco;
    14. History of anaphylactic allergic reactions to plants or plants components;
    Please refer to protocol for further exclusion criteria.
    E.5 End points
    E.5.1Primary end point(s)
    Efficacy:
    - Occurrences of laboratory-confirmed influenza illnesses (≥ 14 days post-vaccination) caused by influenza viral types/subtypes that are matched (and/or antigenically similar) to the strains covered in the vaccine formulation.
    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 (≥ 14 days post-vaccination) caused by any influenza viral types/subtypes (matched, mismatched, and un-typed);
    - Occurrences of laboratory-confirmed influenza (according to protocol defined ILI) illnesses (≥ 14 days post-vaccination) caused by influenza viral types/subtypes that are matched (and/or antigenically similar) to the strains covered in the vaccine formulation;
    - Occurrences of protocol-defined ILI ≥ 14 days postvaccination (confirmed or not).
    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 treatment emergent adverse events (TEAEs) for 21 days following study vaccine administration;
    - Occurrences of deaths, SAEs, AEs leading to withdrawal, and new onset of chronic disease's (NOCDs) up to the end of the surveillance period.
    Immunogenicity (subset of subjects):
    - Haemagglutination inhibition (HI) antibody response induced by the Quadrivalent VLP Influenza Vaccine against the homologous and heterologous influenza strains on Days 0 and 21 will be assessed in a subset of 400 subjects (300 who received the VLP vaccine and 100 who received the placebo). HI antibody titers will be analysed using the following parameters: geometric mean titers (GMT), seroconversion (SC) rate, seroprotection (SP) rate, and geometric mean fold rise (GMFR);
    - Microneutralisation (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 analysed using the following parameters: GMT, SC rate, and GMFR;
    - Single radial haemolysis (SRH) antibody response induced by the Quadrivalent VLP Influenza Vaccine against the homologous strains on Days 0 and 21, 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
    Various times as detailed in the protocol
    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) 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) 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 EEA21
    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
    Philippines
    Thailand
    United Kingdom
    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
    The study will be considered to be completed with the last contact with the last subject participating in the study.
    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 months11
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial months11
    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: 10000
    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 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 state590
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 2000
    F.4.2.2In the whole clinical trial 10000
    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 Decision2017-08-14
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2017-10-03
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2018-06-12
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