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    Summary
    EudraCT Number:2021-003804-42
    Sponsor's Protocol Code Number:INCENTIVE-QIV2-EU
    National Competent Authority:Norway - NOMA
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2021-08-05
    Trial 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 ConcernedNorway - NOMA
    A.2EudraCT number2021-003804-42
    A.3Full title of the trial
    Immunogenicity, molecular profiling and safety of a marketed quadrivalent influenza vaccine (Vaxigrip Tetra) administered by the intramuscular route in children 3-11 years old
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Immunogenicity, molecular profiling and safety of a marketed quadrivalent influenza vaccine (Vaxigrip Tetra) administered by the intramuscular route in children 3-11 years old
    A.4.1Sponsor's protocol code numberINCENTIVE-QIV2-EU
    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 SponsorHelse Bergen HF
    B.1.3.4CountryNorway
    B.3.1 and B.3.2Status of the sponsorNon-Commercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing supportEU (H2020)
    B.4.2CountryNorway
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationHelse Bergen HF
    B.5.2Functional name of contact pointRebecca Jane Cox
    B.5.3 Address:
    B.5.3.1Street AddressJonas Lies vei 65
    B.5.3.2Town/ cityBergen
    B.5.3.4CountryNorway
    B.5.6E-mailrebecca.cox@uib.no
    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 Vaxigriptetra
    D.2.1.1.2Name of the Marketing Authorisation holderSanofi Pasteur Europe
    D.2.1.2Country which granted the Marketing AuthorisationNorway
    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 nameVaxigriptetra
    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.3.11 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
    Immune response to infuenza vaccine in young children
    E.1.1.1Medical condition in easily understood language
    Immune response to infuenza vaccine in young children
    E.1.1.2Therapeutic area Body processes [G] - Immune system processes [G12]
    MedDRA Classification
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    • To measure the level of the immune response (HAI titres) after two intramuscular doses of the quadrivalent inactivated influenza vaccine (Vaxigrip Tetra) in mainly healthy children aged 3-11 years old.
    E.2.2Secondary objectives of the trial
    Secondary Objectives
    • To measure the levels, avidity, biophysical characteristics and functionality of influenza-specific antibodies induced by the vaccine
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1) Healthy children or children with well-controlled pre-existing medical conditions (as concluded from the medical history with a stable regimen for at least 2 weeks prior to study entry , physical examination, and clinical judgment) age range ≥ 3 and ≤ 11 years old.
    2) Signed informed consent from parents/guardians.
    3) Parents/guardians able to understand and comply with the study protocol requirements, including availability for all scheduled visits of the study.
    E.4Principal exclusion criteria
    1) Acute illness, at the time of study vaccine administration (once acute illness is resolved, participants will be re-revaluated for eligibility).
    2) Recorded fever (for eligibility purpose defined as a body temperature greater than 37.5°C) within 3 days prior to study vaccine administration (once fever/acute illness is resolved, participants will be re-evaluated for eligibility by the investigator).
    3) Current or previous, laboratory confirmed case of influenza during the past 6 months, based on anamnesis or medical record (if available) at screening visit.
    4) Household contact with and/or intimate exposure to an individual with any laboratory confirmed influenza infection during the past 6 months prior to vaccination.
    5) History of severe allergic reactions after previous vaccinations or hypersensitivity to any study vaccine components (ovalbumin, egg proteins), neomycin, formaldehyde or octoxynol-9.
    6) Previous history of Guillain Barré Syndrome.
    7) Any confirmed or suspected condition with impaired/altered function of immune system (e.g. immunodeficient or autoimmune conditions).
    8) Having any bleeding disorder which is considered as a contraindication to intramuscular injection or blood draw according to the opinion of the investigator
    9) Chronic administration (defined as more than 14 days) of immunosuppressant or other immune-modifying drugs within three months prior to the study vaccination or planned use throughout the study period. (For corticosteroids, this means prednisone, or equivalent, ≥ 0.5 mg/kg per day. Inhaled, intranasal and topical steroids are allowed.
    10) Neoplastic disease or any hematologic malignancy (except localized skin or prostate cancer that is stable at the time of vaccination in the absence of therapy and subjects who have a history of neoplastic disease and have been disease-free for ≥5 years).
    11) Administration of blood, blood products and/or plasma derivatives or any parenteral immunoglobulin preparation in the past 3 months or planned use throughout the study period.
    12) Administration of any vaccine within 28 days prior to enrolment in the study or planned administration of any vaccine during study participation.
    13) Use of any investigational or non-registered drug or vaccine within 30 days prior to the administration of study vaccines or planned during the study.
    14) Having received systemic antibiotic treatment within 3 days prior to enrolment.
    15) Acute or chronic, clinically significant pulmonary, cardiovascular, metabolic, neurological, hepatic, or renal functional abnormality, as determined by medical history or physical examination if uncontrolled or without appropriate treatment
    16) Any other condition that in the opinion of the investigator would jeopardize the safety or rights of the volunteer participating in the study or make it unlikely that the participant could complete the protocol.

    For the second vaccine dose the exclusion criteria are:
    1) Previous influenza vaccination before study start, as these children only require one vaccination.
    2) Acute illness, at the time of study vaccine administration (once acute illness is resolved, participants will be re-revaluated for eligibility).
    3) Recorded fever (for eligibility purpose defined as a body temperature greater than 37.5°C) within 3 days prior to study vaccine administration (once fever/acute illness is resolved, participants will be re-evaluated for eligibility by the investigator).
    4) History of severe allergic reactions after previous vaccinations or hypersensitivity to any study vaccine components (ovalbumin, egg proteins), neomycin, formaldehyde or octoxynol-9.
    E.5 End points
    E.5.1Primary end point(s)
    • HAI antibody titres on D0 and D58
    • Proportion of participants with HAI titres ≥ 40 at D58
    • HAI antibody titres fold increase between D0 and D58
    Proportion of participants with Seroconversion (titre < 10 at D0 and post-vaccination titre ≥ 40 at D30 (one dose) or D58 (two dose), or titre ≥ 10 at D0 and a ≥ 4-fold increase in titre
    E.5.1.1Timepoint(s) of evaluation of this end point
    day 58 after first vaccination dose (for two doses) / day 30 (for one dose)
    E.5.2Secondary end point(s)
    secondary endpoints
    a) Neutralizing antibody titres will be measured for each vaccine strain with the microneutralization (MN) assay. The analyses will be performed on blood samples obtained on D0, D30 and D58.
    • Individual MN antibody titre on D0, D30 and D58
    • Detectable MN (MN antibody titre ≥ 10 at D0, D30, D58
    • Proportion of participants with MN antibody titres ≥ 20, ≥ 40, ≥ 80) at D30, D58
    • Individual MN antibody titre fold-increase D30 and D58 post-vaccination relative to D0
    • Fold-increase in MN antibody titre [D58/D0] or [D30/D0] ≥ 2 and ≥ 4

    b) Anti-Haemagglutinin (HA) and Neuraminidase (NA) antibody titres to vaccine strain and antibody avidity.
    • Individual HA and NA antibody titres on D0, D30 and D58
    • Detectable HA and NA antibody titre ≥ 10 at D0, D30 and D58
    • Proportion of participants with HA and NA antibody titres ≥ 20, ≥ 40, ≥ 80 at D30 and D58
    • Individual HA and NA antibody titre ratio (D58/ D0) (D30/ D0)
    • Fold-increase in HA and NA antibody titre [post/pre] ≥ 2 and ≥ 4 at D30 and D58
    • Avidity index of HA and NA antibody at D0, D30 and D58

    c) Level (mean fluorescence intensity) and avidity (avidity index) of influenza-specific antibody isotypes at D0, D30 and D58
    d) Level of influenza-specific antibody isotypes triggering Fc-dependent effector functions (proportion of activated cells, phagocytic score or mean fluorescence intensity) at D0, D30 and D58
    E.5.2.1Timepoint(s) of evaluation of this end point
    Day 30, Day 58 post vaccination
    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 No
    E.6.5Efficacy No
    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) No
    E.7.4Therapeutic use (Phase IV) Yes
    E.8 Design of the trial
    E.8.1Controlled No
    E.8.1.1Randomised No
    E.8.1.2Open Yes
    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 No
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) No
    E.8.2.2Placebo No
    E.8.2.3Other No
    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 months
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial years2
    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: 50
    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) Yes
    F.1.1.5.1Number of subjects for this age range: 50
    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 Yes
    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 state50
    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 Decision2021-10-01
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2021-10-04
    P. End of Trial
    P.End of Trial StatusOngoing
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