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    Summary
    EudraCT Number:2018-001857-29
    Sponsor's Protocol Code Number:V130_14
    National Competent Authority:Bulgarian Drug Agency
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2018-12-11
    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 ConcernedBulgarian Drug Agency
    A.2EudraCT number2018-001857-29
    A.3Full title of the trial
    A Phase III, Randomized, Observer-blind, Multicenter Study to Evaluate the Efficacy, Immunogenicity and Safety of Seqirus' Cell-Based Quadrivalent Subunit Influenza Virus Vaccine (QIVc) Compared to a Non-Influenza Vaccine when Administrated in Healthy Subjects aged 6 Months through 47 Months
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A Phase III Efficacy Study with QIVc in Pediatric Subjects
    A.4.1Sponsor's protocol code numberV130_14
    A.7Trial is part of a Paediatric Investigation Plan Yes
    A.8EMA Decision number of Paediatric Investigation PlanP/341/2017
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorSeqirus UK Limited
    B.1.3.4CountryUnited Kingdom
    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 supportSeqirus UK Limited
    B.4.2CountryUnited Kingdom
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationSeqirus UK Limited
    B.5.2Functional name of contact pointClinical Trial Disclosures
    B.5.3 Address:
    B.5.3.1Street AddressPoint, 29 Market Street
    B.5.3.2Town/ cityMaidenhead
    B.5.3.3Post codeSL6 8AA
    B.5.3.4CountryUnited Kingdom
    B.5.6E-mailSeqirus.ClinicalTrials@seqirus.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 Yes
    D.2.1.1.1Trade name Flucelvax Tetra
    D.2.1.1.2Name of the Marketing Authorisation holderSeqirus Netherlands B.V.
    D.2.1.2Country which granted the Marketing AuthorisationEuropean Union
    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 INNA/(H1N1)-LIKE VIRUS ANTIGEN
    D.3.9.3Other descriptive nameA/(H1N1)-LIKE VIRUS ANTIGEN
    D.3.9.4EV Substance CodeSUB117552
    D.3.10 Strength
    D.3.10.1Concentration unit µg microgram(s)
    D.3.10.2Concentration typenot less then
    D.3.10.3Concentration number15
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNA/(H3N2)-LIKE VIRUS ANTIGEN
    D.3.9.3Other descriptive nameA/(H3N2)-LIKE VIRUS ANTIGEN
    D.3.9.4EV Substance CodeSUB117553
    D.3.10 Strength
    D.3.10.1Concentration unit µg microgram(s)
    D.3.10.2Concentration typenot less then
    D.3.10.3Concentration number15
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNB/ -LIKE VIRUS ANTIGEN
    D.3.9.3Other descriptive nameB/ -LIKE VIRUS ANTIGEN
    D.3.9.4EV Substance CodeSUB117554
    D.3.10 Strength
    D.3.10.1Concentration unit µg microgram(s)
    D.3.10.2Concentration typenot less then
    D.3.10.3Concentration number15
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNB/ -LIKE VIRUS ANTIGEN
    D.3.9.3Other descriptive nameB/ -LIKE VIRUS ANTIGEN
    D.3.9.4EV Substance CodeSUB117554
    D.3.10 Strength
    D.3.10.1Concentration unit µg microgram(s)
    D.3.10.2Concentration typenot less then
    D.3.10.3Concentration number15
    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.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 NeisVac-C
    D.2.1.1.2Name of the Marketing Authorisation holderPfizer Pharma GmbH
    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 INNNeisseria meningitidis group C (strain 11) polysaccharide (de-O-acetylated)
    D.3.9.3Other descriptive nameN. MENINGITIDIS GROUP C POLYSACCHARIDE
    D.3.9.4EV Substance CodeSUB26071
    D.3.10 Strength
    D.3.10.1Concentration unit µg microgram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number10
    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
    Prophylaxis of influenza virus infection
    E.1.1.1Medical condition in easily understood language
    Seasonal Influenza
    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
    EFFICACY: To demonstrate the absolute vaccine efficacy of QIVc versus a non-influenza vaccine to prevent at least one of the following:
    - RT-PCR confirmed illness caused by any influenza Type A and/or Type B virus, regardless of antigenic match.
    - Culture confirmed illness caused by influenza virus strains antigenically matched to the influenza strains selected for the seasonal influenza vaccine.
    E.2.2Secondary objectives of the trial
    EFFICACY: Efficacy objectives evaluating QIVc compared to a non-influenza vaccine or placebo:
    - Prevention of culture confirmed illness caused by influenza virus strains antigenically dissimilar to the influenza strains selected for the seasonal vaccine.
    - Prevention of culture confirmed illness caused by any Type A and/or Type B virus.
    - Prevention of RT-PCR confirmed moderate-to-severe influenza caused by any influenza Type A and/or Type B virus.

    IMMUNOGENICITY: To evaluate the immune response after vaccination with QIVc, 4 weeks after last vaccination in a sub-set of subjects 6 months
    through 47 months of age in each study vaccine group.

    SAFETY: To evaluate the safety and tolerability of QIVc among subjects 6 months through 47 months of age in the QIVc group and comparator group.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Individuals of 6 through 47 months of age on the day of informed consent.
    Individuals whose parent(s)/LAR have voluntarily given written informed consent after the nature of the study has been explained according to local regulatory requirements, prior to study entry.
    Individuals who can comply with study procedures including follow-up.
    Individuals in generally good health as per the Investigator’s medical judgement.
    E.4Principal exclusion criteria
    1. Acute (severe) febrile illness (see Section 4.3 Criteria for Delay of
    Vaccination). Enrollment could be considered if the fever is absent for 72
    hours.
    2. History of any anaphylaxis, serious vaccine reactions or
    hypersensitivity, including allergic reactions, to any component of
    vaccine or medical equipment whose use is foreseen in this study.
    3. Clinical conditions representing a contraindication to intramuscular
    vaccination and blood draws. These may include known bleeding
    disorders, or treatment with anticoagulants in the 3 weeks preceding
    vaccination.
    4. A known history of Guillain-Barré Syndrome or other demyelinating
    diseases such as encephalomyelitis and transverse myelitis.
    5. Abnormal function of the immune system resulting from clinical
    conditions, which include:
    a. Known or suspected congenital or acquired immunodeficiency.
    b. Systemic administration of corticosteroids (PO/IV/IM) at any dose for
    more than 14 days, within 90 days prior to informed consent. Topical,
    inhaled and intranasal corticosteroids are permitted. Intermittent use
    (one dose in 30 days) of intra-articular corticosteroids is also permitted.
    c. Administration of antineoplastic and immunomodulating agents or
    radiotherapy within 90 days prior to informed consent.
    6. Received immunoglobulins or any blood products within 180 days
    prior to informed consent.
    7. Received an investigational or non-registered medicinal product
    within 30 days prior to informed consent, or intend to participate in
    another clinical trial during the study.
    8. Participated in this trial in a prior season or is discontinued after
    randomization in the current season.
    9. Study personnel, family and household members of study personnel
    should not participate.
    10. Any other clinical condition that, in the opinion of the investigator,
    might interfere with the results of the study or pose additional risk to
    the subject due to participation in the study.
    11. Received influenza vaccination or has had documented influenza
    disease in the last 6 months prior to informed consent.
    12. Prior vaccination to prevent Neisseria meningitides serogroup C
    disease or prior infection caused by this organism.
    13. Received any other vaccines than influenza vaccine within 14 days
    (for inactivated vaccines) or 28 days (for live vaccines) prior to study
    vaccination or who are planning to receive any vaccine within 28 days
    after study vaccination.
    E.5 End points
    E.5.1Primary end point(s)
    1. Efficacy Endpoint: First occurrence of RT-PCR confirmed influenza, due to any influenza Type A and/or B virus regardless of antigenic match to the influenza strains selected for the seasonal influenza vaccine in association with protocol-defined ILI symptoms
    2.Efficacy Endpoint: First occurrence of culture confirmed influenza, due to influenza Type A and/or B virus antigenically matched by ferret antigenicity testing to the influenza strains selected for the seasonal influenza vaccine in association with protocol-defined ILI symptoms
    E.5.1.1Timepoint(s) of evaluation of this end point
    > 14 days after the last vaccination and until the end of the influenza season
    E.5.2Secondary end point(s)
    1. Efficacy Endpoint: first occurrence of culture confirmed influenza caused by influenza virus strains antigenically dissimilar to the influenza strains selected for the seasonal vaccine
    2. Efficacy Endpoint: first occurrence of culture confirmed influenza due to any influenza Type A and/or Type B virus regardless of antigenic match to the influenza strains selected for the seasonal influenza vaccine in association with protocol-defined ILI symptoms.
    3.Efficacy Endpoint: first occurrence of RT-PCR confirmed moderate-to-severe influenza due to any influenza Type A and/or Type B virus regardless of antigenic match to the influenza strains selected for the seasonal influenza vaccine
    4. Immunogenicity Endpoint: Pre and post-vaccination geometric mean titers (GMTs)
    5.Immunogenicity Endpoint: 2. Seroconversion rates (SCR)
    6. Immunogenicity Endpoint: Geometric mean ratio (GMR)
    7. Safety Endpoint: Percentage of subjects with solicited local and systemic adverse events
    8. Safety Endpoint: Percentage of subjects with unsolicited adverse events
    9. Safety Endpoint: Percentage of subjects with SAEs, NOCDs, AE leading to withdrawal from the study or vaccination
    10. Safety Endpoint: Percentage of subjects with medically attended adverse events after ILI onset
    E.5.2.1Timepoint(s) of evaluation of this end point
    Efficacy endpoints 1, 2 and 3: > 14 days after the last vaccination and until the end of the influenza season
    Immunogenicity endpoint 4, 5 and 6: Day 1 and 28 days after last vaccination
    Safety endpoint 7: 1 to 7 days after each vaccination
    Safety endpoint 8: Day 1 to 28 days after last vaccination
    Safety endpoint 9: Day 1 to LSLV
    Safety endpoint 10: day of ILI onset to 30 days after ILI onset
    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 No
    E.8.2.3Other Yes
    E.8.2.3.1Comparator description
    Non-flu vaccine comparator and saline
    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 concerned6
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA41
    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
    Bangladesh
    Dominican Republic
    Honduras
    Malaysia
    New Zealand
    Pakistan
    Philippines
    South Africa
    Thailand
    Ukraine
    Bulgaria
    Czechia
    Estonia
    Latvia
    Poland
    Romania
    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
    For the purpose of this protocol, end of study is defined as the completion of the testing of such biological samples, to be achieved no later than 8 months after the date of last unscheduled visit by a subject who manifested signs of influenza-like-illness (ILI) during the protocol defined influenza season and from whom a NP sample was taken.
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years5
    E.8.9.1In the Member State concerned months0
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial years5
    E.8.9.2In all countries concerned by the trial months6
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 Yes
    F.1.1Number of subjects for this age range: 3830
    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) Yes
    F.1.1.4.1Number of subjects for this age range: 1150
    F.1.1.5Children (2-11years) Yes
    F.1.1.5.1Number of subjects for this age range: 2680
    F.1.1.6Adolescents (12-17 years) No
    F.1.2Adults (18-64 years) No
    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 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 Yes
    F.3.3.6.1Details of subjects incapable of giving consent
    Subjects are children aged 6 through 47 months . Written informed consent will be obtained from parent(s) or legally acceptable representative(s) of the subjects
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state363
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 1000
    F.4.2.2In the whole clinical trial 6227
    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)
    Subjects age 6 through 11 months, who received a study vaccination will be vaccinated with a dose of Neisvac-C at study completion, according to the schedule in the prescribing information.
    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 Decision2019-01-31
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2019-03-13
    P. End of Trial
    P.End of Trial StatusCompleted
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