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    Summary
    EudraCT Number:2017-000849-50
    Sponsor's Protocol Code Number:MI-CP114
    Clinical Trial Type:Outside EU/EEA
    Date on which this record was first entered in the EudraCT database:2017-12-12
    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
    H.4 THIRD COUNTRY IN WHICH THE TRIAL WAS FIRST AUTHORISED
    Expand All   Collapse All
    A. Protocol Information
    A.2EudraCT number2017-000849-50
    A.3Full title of the trial
    A Phase I Randomized, Double-Blind Trial of the Safety and Immunogenicity of FluMist® A Live, Intranasal Influenza Virus Vaccine vs. Placebo in Immunocompromised Children Ages 5 Through 17 Years of Age
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Safety Study to Evaluate FluMist in Immunocompromised Children
    A.4.1Sponsor's protocol code numberMI-CP114
    A.5.2US NCT (ClinicalTrials.gov registry) numberNCT00112112
    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 SponsorMedImmune
    B.1.3.4CountryUnited States
    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 supportMedImmune
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationMedImmune
    B.5.2Functional name of contact pointInformation Center
    B.5.3 Address:
    B.5.3.1Street AddressOne MedImmune Way
    B.5.3.2Town/ cityGaithersburg
    B.5.3.3Post code20878
    B.5.3.4CountryUnited States
    B.5.6E-mailinformation.center@astrazeneca.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 FluMist
    D.2.1.2Country which granted the Marketing AuthorisationUnited States
    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 nameFluMist
    D.3.4Pharmaceutical form Nasal spray
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMP
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNINFLUENZA VACCINE (LIVE ATTENUATED
    D.3.9.2Current sponsor codeMEDI3250
    D.3.9.3Other descriptive nameINFLUENZA VACCINE (LIVE ATTENUATED, NASAL)
    D.3.9.4EV Substance CodeSUB129948
    D.3.10 Strength
    D.3.10.1Concentration unit log10 FAI50 log10 fluorescent assay infectious dose 50%
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number7
    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 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
    The prevention of Influenza Virus in Immunocompromised children ages 5 through 17 years of age.
    E.1.1.1Medical condition in easily understood language
    To prevent flu virus in children with cancer.
    E.1.1.2Therapeutic area Diseases [C] - Virus Diseases [C02]
    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
    The primary objective was to describe the safety of FluMist compared with placebo in mild to
    moderately immunocompromised children with cancer.
    E.2.2Secondary objectives of the trial
    The secondary objectives of this study were to describe the immune responses, and determine
    the incidence and duration of viral replication following vaccination with FluMist.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    - Age 5 through 17 years of age (not yet reached their 18th birthday) at the time of entry into the study;
    - Patient’s parent or legal guardian available by telephone during the course of the study;
    - Written informed consent (assent if applicable) and Health Insurance Portability and Accountability Act (HIPAA) authorization (if applicable) obtained from the patient’s parent or legal guardian;
    - Ability of the patient or patient’s parent/guardian to comply with the requirements of the protocol;
    - Currently receiving chemotherapy and/or radiation therapy for the treatment of cancer or have received chemotherapy in the past 12 weeks;
    - If the subject’s underlying cancer is a solid tumor, current status must be stable disease, partial response, or complete response to therapy; if the subject’s underlying disease is a hematologic malignancy, current status must be in remission;
    - Estimated life expectancy of >1 year; and
    - Currently has no worse than mild to moderate immunosuppression (meets none of the
    E.4Principal exclusion criteria
    Exclusion Criteria:
    - History of hypersensitivity to any component of FluMist, including egg or egg products, or monosodium glutamate;
    - History of hypersensitivity to gentamicin;
    - Close contact with a severely immunocompromised patient (e.g., a hematopoietic stem cell transplant patient, during those periods in which the immunocompromised patient requires care in a protective environment);
    - History of Guillain-Barré syndrome;
    - History of asthma;
    - Use of aspirin or salicylate-containing products in the 30 days prior to study vaccination or expected receipt within the study duration;
    - Use of anti-influenza medications (including amantadine, rimantadine, oseltamivir, and zanamivir) within 14 days prior to enrollment or expected receipt (unless medically indicated) during this study;
    - Currently receiving inhaled steroid therapy;
    - Receipt of immunoglobulin within the past 90 days;
    - Receipt of stem cell transplant;
    - Acute febrile [>100.0°F (37.8°C) oral] illness or acute respiratory illness, e.g., cough or sore throat, within three days prior to enrollment;
    - Administration of any live vaccine within 30 days prior to enrollment or if receipt of another live vaccine is expected within 30 days after the vaccination in this study;
    - Administration of any inactivated vaccine within two weeks prior to enrollment or if receipt of another inactivated vaccine is expected within two weeks after the vaccination in this study;
    - Receipt of an investigational product studied under an investigational new drug (IND) within 10 days prior to study entry or expected receipt of such an investigational product within 10 days after study vaccination (Note: an investigational product not studied under an IND is allowed at the investigator’s discretion);
    - Pregnancy or, in biologically capable females (e.g., menses within the last year), not willing to agree to acceptable birth control for three months after study vaccination (for those biologically capable, a urine pregnancy test must be performed on the day of vaccination with a negative result);
    - Female who is breastfeeding or lactating;
    - Any condition or receipt of other medication that, in the opinion of the investigator, might interfere with the evaluation of the vaccine or interpretation of study results;
    - At the study screening visit (within 16 days before study vaccination) a CD4+ T cell percentage of <15%;
    - At study entry, an absolute neutrophil count less than or equal to 500 cells/mm3;
    - Receipt of high-dose systemic corticosteroids (≥ 2 mg/kg total of prednisone or
    equivalent given daily or on alternating days) for ≥ 14 consecutive days within 30 days
    prior to or following study vaccination
    E.5 End points
    E.5.1Primary end point(s)
    Endpoints for the primary objective were:
    • The proportion of subjects experiencing each of the Reactogenicity events;
    • The proportion of subjects experiencing each reported AE; and
    • A list of SAEs.
    E.5.1.1Timepoint(s) of evaluation of this end point
    Through Day 180
    E.5.2Secondary end point(s)
    The secondary objectives of this study were to describe the immune responses, and determine
    the incidence and duration of viral replication following vaccination with FluMist.

    Endpoints in the evaluation of immune responses included:
    • Influenza-specific antibodies using the HAI assay
    • Influenza-specific serum antibodies using the microneutralization assay;
    • Influenza-specific serum antibody isotype levels (total IgG, IgG1, IgG2, and IgM)
    using ELISA;
    • Influenza-specific IgA from nasal swab specimens using ELISA;
    • T- and B-lymphocyte subsets by flow cytometry;
    • Antigen specific responses of the T-cell populations using HLA-matched tetramer
    assay; and
    • IFN-γ and IL-4 specific T-cell responses using ELISpot.

    Endpoints to evaluate viral replication included the titers of vaccine-type influenza virus isolated.
    E.5.2.1Timepoint(s) of evaluation of this end point
    Through Day 42
    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 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) Yes
    E.7.3Therapeutic confirmatory (Phase III) No
    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 Yes
    E.8.1.5Parallel group Yes
    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 Yes
    E.8.2.3Other No
    E.8.2.4Number of treatment arms in the trial2
    E.8.3 Will this trial be conducted at a single site globally? No
    E.8.4 Will this trial be conducted at multiple sites globally? Yes
    E.8.6 Trial involving sites outside the EEA
    E.8.6.2Trial being conducted completely outside of the EEA Yes
    E.8.6.3Specify the countries outside of the EEA in which trial sites are planned
    United States
    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
    Last subject last visit
    E.8.9 Initial estimate of the duration of the trial
    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 days0
    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: 20
    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: 8
    F.1.1.6Adolescents (12-17 years) No
    F.1.1.6.1Number of subjects for this age range: 12
    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 No
    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
    Children and adolescents
    F.3.3.7Others Yes
    F.3.3.7.1Details of other specific vulnerable populations
    Children with cancer
    F.4 Planned number of subjects to be included
    F.4.2 For a multinational trial
    F.4.2.2In the whole clinical trial 20
    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
    H.4 Third Country in which the Trial was first authorised
    H.4.1Third Country in which the trial was first authorised: United States
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