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    The EU Clinical Trials Register currently displays   43865   clinical trials with a EudraCT protocol, of which   7286   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).

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    Summary
    EudraCT Number:2014-001924-31
    Sponsor's Protocol Code Number:STH18166
    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:2019-04-02
    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 number2014-001924-31
    A.3Full title of the trial
    Exploring novel mechanisms of vaccine failure and induction of pulmonary immunity following live attenuated influenza
    vaccination in HIV infected and uninfected individuals: a pilot study.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Exploring novel mechanisms of vaccine failure and induction of pulmonary immunity following live attenuated influenza
    vaccination in HIV infected and uninfected individuals: a pilot study.
    A.3.2Name or abbreviated title of the trial where available
    LAIV-HIV
    A.4.1Sponsor's protocol code numberSTH18166
    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 SponsorSheffield Teaching Hospitals NHS Foundation Trust
    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 supportUniversity of Sheffield
    B.4.2CountryUnited Kingdom
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationSheffield Teaching Hospitals NHS Foundation Trust
    B.5.2Functional name of contact pointLeesley
    B.5.3 Address:
    B.5.3.1Street AddressResearch Department
    B.5.3.2Town/ citySheffield
    B.5.3.3Post codeS10 2SE
    B.5.3.4CountryUnited Kingdom
    B.5.6E-mailanna.leesley@sth.nhs.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
    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 nasal spray suspension Influenza vaccine (live attenuated, nasal)
    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 INNReassortment influenza virus (live attenuated): Strain A/California/7/2009 (H1N1) pdm09like strain
    D.3.9.3Other descriptive nameINFLUENZA A VIRUS A/CALIFORNIA/7/2009 X-181 (H1N1) ANTIGEN (PROPIOLACTONE INACTIVATED)
    D.3.9.4EV Substance CodeSUB126491
    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 Yes
    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
    HIV (effect of HIV on the response to live attenuated intranasal influenza vaccine)
    E.1.1.1Medical condition in easily understood language
    HIV (effect of HIV on the response to live attenuated intranasal influenza vaccine)
    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 20.1
    E.1.2Level LLT
    E.1.2Classification code 10020160
    E.1.2Term HIV disease
    E.1.2System Organ Class 100000004862
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    Do HIVinfected individuals have distinct differential early gene expression profiles following intranasal live attenuated
    influenza vaccine, when compared to age and sexmatched HIVnegative subjects, thus providing insights into the aberrant immunological response to live vaccines modulated by HIV infection?
    E.2.2Secondary objectives of the trial
    Are blood and pulmonary influenza specific Tcells detectable in HIV infected and HIV negative subjects following administration of live attenuated influenza vaccine?
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Age
    18 – 49
    HIV1
    infected
    On
    antiretroviral therapy
    CD4
    count of >200/mm3 (for at least 6 months, last available measurement within 3 months)
    Viral
    load undetectable (for at least 6 months, last available measurement within 3 months)
    History
    of having received at least one dose of trivalent inactivated influenza vaccine in the past
    Nonsmoker
    E.4Principal exclusion criteria
    Severe
    egg allergy
    Hypersensitivity
    to gentamicin
    Pregnant
    or breastfeeding
    Chronic
    lung disease (e.g. bronchiectasis)
    A
    history of severe asthma or current active wheezing
    Other
    cause for immunosuppression (e.g. malignancy) or immunosuppressive
    medication
    Hepatitis
    B or C coinfection
    (as defined by a detectable HBSAg or HCV RNA)
    Planned
    close contact with severely immunocompromised individuals in 2 weeks
    following LAIV (e.g bone marrow transplant recipients)
    Recipient
    of any other vaccination within the last 4 weeks
    Individuals
    who have had a febrile illness or other symptoms of acute infectious
    illness (respiratory, enteric or soft tissue) within the last 2 weeks.
    Individuals
    with a known and current history of anaemia or any symptoms
    (shortness of breath, chronic fatigue, chest pain or pallor) suggestive of
    possible anaemia or haemoglobin below the lower limit of sex adjusted normal
    range on a full blood count taken within the last 3 months.
    Current
    (active) participation in any clinical trial
    Inability
    to communicate in English or convey willingness to participate
    E.5 End points
    E.5.1Primary end point(s)
    Differential gene expression profiles after LAIV in HIV infected and HIV uninfected
    individuals
    E.5.1.1Timepoint(s) of evaluation of this end point
    Day 3 following administration of the live attenuated influenza vaccination (LAIV).
    E.5.2Secondary end point(s)
    Influenza specific Tcell responses in blood (and in a subset of patients in lung).
    Antiinfluenza antibody titres in serum
    E.5.2.1Timepoint(s) of evaluation of this end point
    Day 7 - 28
    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 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 Yes
    E.6.13.1Other scope of the trial description
    Identify how HIV modulates innate and adaptive immunological responses to LAIV
    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) Yes
    E.7.3Therapeutic confirmatory (Phase III) No
    E.7.4Therapeutic use (Phase IV) No
    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 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 End of the Trial will be when all study specific laboratory procedures have been completed.
    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 months11
    E.8.9.1In the Member State concerned days30
    E.8.9.2In all countries concerned by the trial years1
    E.8.9.2In all countries concerned by the trial months11
    E.8.9.2In all countries concerned by the trial days30
    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: 30
    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 state30
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 30
    F.4.2.2In the whole clinical trial 30
    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. Subjects will continue to have annual inactivated influenza vaccine as per routine clinical care.
    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 Decision2014-08-26
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2014-07-15
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2015-06-15
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