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    Summary
    EudraCT Number:2017-000952-24
    Sponsor's Protocol Code Number:Flu-shed
    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:2018-05-03
    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 number2017-000952-24
    A.3Full title of the trial
    Assessment of viral shedding in children previously in receipt of multiple doses of live attenuated influenza vaccine (LAIV) compared to influenza vaccine-naïve controls
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Assessment of viral shedding in children previously in receipt of multiple doses of live attenuated influenza vaccine (LAIV) compared to influenza vaccine-naïve controls
    A.3.2Name or abbreviated title of the trial where available
    Flu-shed
    A.4.1Sponsor's protocol code numberFlu-shed
    A.7Trial is part of a Paediatric Investigation Plan Information not present in EudraCT
    A.8EMA Decision number of Paediatric Investigation Plan
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorPublic Health England
    B.1.3.4Country
    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 supportDepartment of Health
    B.4.2CountryUnited Kingdom
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationPublic Health England
    B.5.2Functional name of contact pointJo Southern
    B.5.3 Address:
    B.5.3.1Street Address61 Colindale Ave
    B.5.3.2Town/ cityLondon
    B.5.3.3Post codeNW9 5EQ
    B.5.3.4CountryUnited Kingdom
    B.5.4Telephone number0208 327 6021
    B.5.5Fax number0208 200 7868
    B.5.6E-mailjo.southern@phe.gov.uk
    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 Fluenz Tetra
    D.2.1.1.2Name of the Marketing Authorisation holderMedImmune, LLC Lagelandseweg 78 6545 CG Nijmegen Netherlands
    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 nameFluenz Tetra
    D.3.4Pharmaceutical form Nasal spray
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntranasal use (Noncurrent)
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNA/California/7/2009 (H1N1)pdm09 - like strain (A/Bolivia/559/2013, MEDI 255962)
    D.3.9.4EV Substance CodeAS1
    D.3.10 Strength
    D.3.10.3Concentration number107.0±0.5 to FFU per dose
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNA/Hong Kong/4801/2014 (H3N2) - like strain (A/New Caledonia/71/2014, MEDI 263122)
    D.3.9.4EV Substance CodeAS2
    D.3.10 Strength
    D.3.10.3Concentration number107.0±0.5 to FFU per dose
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNB/Brisbane/60/2008 - like strain (B/Brisbane/60/2008, MEDI 228030)
    D.3.9.4EV Substance CodeAS3
    D.3.10 Strength
    D.3.10.3Concentration number107.0±0.5 to FFU per dose
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNB/Phuket/3073/2013 - like strain (B/Phuket/3073/2013, MEDI 254977)
    D.3.9.4EV Substance CodeAS4
    D.3.10 Strength
    D.3.10.3Concentration number107.0±0.5 to FFU per dose
    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) No
    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
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    N/A - the vaccine will be administered to children according to current DH Immunisation schedule for England.
    E.1.1.1Medical condition in easily understood language
    N/A
    E.1.1.2Therapeutic area Body processes [G] - Immune system processes [G12]
    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
    To measure type-specific vaccine virus shedding and immunogenicity in 2017/18 and determine if there has been any change compared to previous studies in 2016/17 (conducted by this group, Eudract 2013-003592-35 and 2016-002352‐24) following change in the A/H1N1pdm09 vaccine virus strain amongst children with the same prior vaccine history
    E.2.2Secondary objectives of the trial
    • To determine if there is any association between type-specific vaccine virus shedding and prior vaccine status in 2017/18
    • To determine if there is any association between type-specific vaccine virus shedding and baseline HAI immunity in 2017/18 / nasal influenza-specific IgA in 2017/18
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Children may only be included in the study if all the inclusion criteria are met:
    • Children age 6 to 13 years of age on enrolment and with either:
    o Prior LAIV vaccination (at least 2 doses) over the previous 3 years
    o Never received LAIV or IIV in previous years
    • Children eligible to receive LAIV in accordance with Green Book advice [https://www.gov.uk/government/organisations/public-health-england/series/immunisation-against-infectious-disease-the-green-book]
    • Written informed consent given by parent/ guardian and assent from child (both must be in place to proceed)
    E.4Principal exclusion criteria
    Children may not be included in the study if any of the following apply:
    1. Contraindications to LAIV (notwithstanding allergy to egg protein), which include:
    a. Hypersensitivity to the active ingredients, gelatin or gentamicin (a possible trace residue)
    b. Previous systemic allergic reaction to LAIV
    c. Previous allergic reaction to an influenza vaccine (not LAIV) is a relative contra-indication, which must be discussed with the CI to confirm patient suitability
    d. Children/adolescents who are clinically immunodeficient due to conditions or immunosuppressive therapy such as: acute and chronic leukaemias; lymphoma; symptomatic HIV infection; cellular immune deficiencies; and high-dose corticosteroids*.

    *High-dose steroids is defined as a treatment course for at least one month, equivalent to a dose greater than 20mg prednisolone per day (any age), or for children under 20kg, a dose greater than 1mg/kg/day.

    NB: LAIV is not contraindicated for use in individuals with asymptomatic HIV infection; or individuals who are receiving topical/inhaled/low-dose oral systemic corticosteroids or those receiving corticosteroids as replacement therapy, e.g. for adrenal insufficiency.

    e. Children / adolescents younger than 18 years of age receiving salicylate therapy because of the association of Reye's syndrome with salicylates and wild-type influenza infection.
    f. Pregnancy

    2. Contraindications to vaccination on that occasion, e.g. due to child being acutely unwell:
    a. Febrile ≥38.0oC in last 48 hours
    b. **Acute wheeze in last 72 hours requiring treatment beyond that normally prescribed for regular use by the child’s treating healthcare professional
    c. **Recent admission to hospital in last 2 weeks for acute asthma
    d. **Current oral steroid for asthma exacerbation or course completed within last 2 weeks
    e. Any other significant condition or circumstance which, in the opinion of the investigator, may either put the participant at risk because of participation in the study, or may influence the result of the study, or the participant’s ability to participate in the study.

    **Items 3b-3d are relative contra-indications: Many children with “difficult-to-control” symptoms fail to meet these criteria on a routine basis. Where these are present, the CI is able to authorise participation on a case-by-case basis, after assessing the child at the time of enrolment.

    Administration of another live vaccine (e.g. MMR) within the previous 4 weeks is no longer a contra-indication to LAIV administration, according to updated DoH guidelines.

    NB: See Summary of Product Characteristics for full details of contra-indications to LAIV
    E.5 End points
    E.5.1Primary end point(s)
    LAIV vaccine virus shedding for the 4 viral strains present in the LAIV vaccines used; A/H1N1pdm09 virus (yes/no), A/H3N2 and B at at least one time point (days 1,3,6).
    E.5.1.1Timepoint(s) of evaluation of this end point
    Days 1,3 and 6 after LAIV administration (on Day 0)
    E.5.2Secondary end point(s)
    Area under the curve between days 1 and 6 for the quantitative shedding based on viral load and straight lines between levels of virus shed on days for subjects with all 3 swabs.
    HAI and MN titres to A/H1N1pdm09, A/H3N2 and B at days 0 and 21 as well as whether they show 4 fold changes
    E.5.2.1Timepoint(s) of evaluation of this end point
    Day 0 and 21 after LAIV administration.
    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 Yes
    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 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 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 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 concerned3
    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
    Date of reporting of the final laboratory test result for incorporation to the database, completing the study dataset.
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years1
    E.8.9.1In the Member State concerned months0
    E.8.9.1In the Member State concerned days31
    E.8.9.2In all countries concerned by the trial years1
    E.8.9.2In all countries concerned by the trial months0
    E.8.9.2In all countries concerned by the trial days31
    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: 400
    F.1.1.1In Utero No
    F.1.1.1.1Number of subjects for this age range: 0
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) No
    F.1.1.2.1Number of subjects for this age range: 0
    F.1.1.3Newborns (0-27 days) No
    F.1.1.3.1Number of subjects for this age range: 0
    F.1.1.4Infants and toddlers (28 days-23 months) No
    F.1.1.4.1Number of subjects for this age range: 0
    F.1.1.5Children (2-11years) No
    F.1.1.5.1Number of subjects for this age range: 320
    F.1.1.6Adolescents (12-17 years) No
    F.1.1.6.1Number of subjects for this age range: 80
    F.1.2Adults (18-64 years) No
    F.1.2.1Number of subjects for this age range: 0
    F.1.3Elderly (>=65 years) No
    F.1.3.1Number of subjects for this age range: 0
    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 state400
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 400
    F.4.2.2In the whole clinical trial 400
    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 - influenza vaccine is given once per year, after this year the child's care would revert to the routine schedule for forthcoming years
    G. Investigator Networks to be involved in the Trial
    G.4 Investigator Network to be involved in the Trial: 1
    G.4.1Name of Organisation none
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2017-04-20
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2017-05-17
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2018-02-28
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