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The European Union Clinical Trials Register allows you to search for protocol and results information on:
  • interventional clinical trials that are conducted in the European Union (EU) and the European Economic Area (EEA);
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    The EU Clinical Trials Register currently displays   42336   clinical trials with a EudraCT protocol, of which   6971   are clinical trials conducted with subjects less than 18 years old.
    The register also displays information on   18700   older paediatric trials (in scope of Article 45 of the Paediatric Regulation (EC) No 1901/2006).


    Phase 1 trials conducted solely in adults and that are not part of an agreed PIP are not public in the EU CTR (refer to European Guidance 2008/C 168/02   Art. 3 par. 2 and   Commission Guideline 2012/C 302/03,   Art. 5) .

    Clinical Trials marked as "Trial now transitioned" were transitioned to the Clinical Trial Regulation 536/2014 and can be further followed in the Clinical Trial Information System  
     
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    Summary
    EudraCT Number:2015-003019-39
    Sponsor's Protocol Code Number:
    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:2015-07-15
    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 number2015-003019-39
    A.3Full title of the trial
    Efficacy & Safety of Nasal Influenza Immunisation in Children - The SNIFFLE-3 study
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Is a nasal spray 'flu vaccine effective and safe for use in children, including those with asthma/wheezing?
    A.3.2Name or abbreviated title of the trial where available
    SNIFFLE-3 Study
    A.4.1Sponsor's protocol code number
    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 Sponsor
    B.1.3.4CountryUnited Kingdom
    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 supportPublic Health England (Department of Health Research and Development Directorate)
    B.4.2CountryUnited Kingdom
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationImperial College London
    B.5.2Functional name of contact pointDr Paul Turner
    B.5.3 Address:
    B.5.3.1Street AddressPaediatric Research Unit, 7th Floor QEQM Building, St Mary’s Hospital, Praed Street
    B.5.3.2Town/ cityLondon
    B.5.3.3Post codeW2 1NY
    B.5.3.4CountryUnited Kingdom
    B.5.4Telephone number02033127754
    B.5.5Fax number02033127571
    B.5.6E-mailp.turner@imperial.ac.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 nasal spray suspension Influenza vaccine
    D.2.1.1.2Name of the Marketing Authorisation holderMedImmune, LLC
    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.3.1Product nameFluenz Tetra
    D.3.4Pharmaceutical form Nasal spray, suspension
    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 INNReassortant influenza virus (live attenuated)
    D.3.9.4EV Substance CodeAS2
    D.3.10 Strength
    D.3.10.1Concentration unit Other
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration numberas above
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin Information not present in EudraCT
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) Information not present in EudraCT
    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
    Children aged 2-18 years (inclusive), some of whom will have asthma and/or food allergies.
    E.1.1.1Medical condition in easily understood language
    Children aged 2-18 years (inclusive), some of whom will have asthma and/or food allergies.
    E.1.1.2Therapeutic area Diseases [C] - Immune System Diseases [C20]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 18.0
    E.1.2Level LLT
    E.1.2Classification code 10001738
    E.1.2Term Allergy
    E.1.2System Organ Class 100000004870
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    Is the intranasal LAIV influenza ('flu) vaccine effective in children?
    E.2.2Secondary objectives of the trial
    1) Do laboratory tests (both blood test and a nasal swab) correlate with vaccine effectiveness?
    2) Is the intranasal LAIV influenza ('flu) vaccine effective and safe in children, including those with asthma / a history of recurrent wheezing?
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Aged 2 – 18 years.

    2. Written informed consent from parent/guardian (or the patient themselves from age 16 years), with assent from children aged 8 years and above wherever possible.
    E.4Principal exclusion criteria
    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 site PI 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 of prednisolone at 20mg or more per day (any age); or for children under 20kg, a dose of 1mg/kg/day or more.

    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 and 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. Contraindication to vaccination on that occasion, e.g. due to child being acutely unwell:

    a. Febrile ≥38.0oC in last 72 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. Received any blood or blood products within the past 12 weeks
    f. 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.

    Recent antihistamine use is not a contra-indication to LAIV administration, but use of any antihistamine in the 96 hours prior to LAIV will be logged on the CRF.
    E.5 End points
    E.5.1Primary end point(s)
    Incidence of laboratory confirmed influenza and other respiratory viruses in participants receiving LAIV, compared to their unvaccinated sibling controls.
    E.5.1.1Timepoint(s) of evaluation of this end point
    Up to the end of the influenza season (end March 2016)
    E.5.2Secondary end point(s)
    1. Immune response to vaccine and non-vaccine influenza strains before and after a single dose of LAIV administration, with respect to
    i. serological measures, including:
    • Geometric mean titre. GMTs (with 95% confidence intervals) for HI (H3N2, H1N1, H7N9, B) and MN (H1N1 and H7N9) prior to and 3-6 weeks post LAIV (pre and post bleed);
    • Geometric Mean Ratio. GMRs (95% CI) will be calculated for the HI, MN results (for all viruses) for post bleed / pre bleed (day 0) sample;
    • Percentages of subjects with Seroconversion or Significant Increase in HI and MN Titre. Seroconversions or significant increase (negative titres at D0; <10 and ≥ 40 at D21 or at least 4-fold increase in titre) in HI titres or MN (for all viruses) from pre-immunization to 3-6 weeks post LAIV (pre and post bleed);
    • Percentages of subjects achieving each of the following thresholds: HI ≥ 40, MN ≥ 40; MN ≥ 80, four-fold rise in MN titres: The number and proportion of subjects achieving each threshold prior to and 3-6 weeks post LAIV (pre and post bleed) will be tabulated for all viruses.
    ii. Change in specific nasal IgA responses prior to and 3-6 weeks post LAIV (and how these correlate to the above serological measures)

    with sub-analyses according to whether participants have received prior vaccination with pandemic influenza vaccine / LAIV / both.

    2. To monitor for incidence of adverse events (AE) and serious adverse events (SAEs) in children receiving LAIV, with the following sub-analyses:
    • AEs occurring up to 72 hours after LAIV in participants with a history of atopy / asthma / recurrent wheezing, compared to non-atopic participants.
    • Wheezing / asthma symptoms in subjects given LAIV who have a past medical history of asthma or recurrent wheeze in the 4 weeks prior to vaccine administration vs the four weeks after LAIV.
    E.5.2.1Timepoint(s) of evaluation of this end point
    Delayed events will be assessed by telephone follow-up within 4-7 days of vaccination.
    Asthma control will be assessed by validated questionnaire pre and 3-4 weeks post LAIV.
    Immune responses to vaccine will be assessed pre and 3-6 weeks post LAIV.
    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 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 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 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 intervention phase: LVLS
    For overall trial: end of surveillance period (end of March 2016)
    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 days18
    E.8.9.2In all countries concerned by the trial years0
    E.8.9.2In all countries concerned by the trial months6
    E.8.9.2In all countries concerned by the trial days18
    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: 200
    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) Yes
    F.1.1.5.1Number of subjects for this age range: 150
    F.1.1.6Adolescents (12-17 years) Yes
    F.1.1.6.1Number of subjects for this age range: 50
    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 No
    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 state200
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 200
    F.4.2.2In the whole clinical trial 200
    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)
    As per expected normal treatment
    G. Investigator Networks to be involved in the Trial
    G.4 Investigator Network to be involved in the Trial: 1
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2015-07-13
    N.Ethics Committee Opinion of the trial application
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2016-05-27
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