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    Summary
    EudraCT Number:2014-004248-36
    Sponsor's Protocol Code Number:V70_50
    Clinical Trial Type:Outside EU/EEA
    Date on which this record was first entered in the EudraCT database:2014-10-14
    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 number2014-004248-36
    A.3Full title of the trial
    A phase 3, Observed-Blind, Randomized, Multi-center Study to Evaluate Safety and Immunogenicity of an Adjuvanted Trivalent Influenza Vaccine in Children 6 to <72 Months of Age in Mexico.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    The administration of adjuvanted Trivalent Influenza Vaccine (aTIV) has come to result in a more immunogenic and effective response compared with conventional influenza vaccines in elderly and adults.
    The aim of this study is to evaluate safety and immunogenicity of Novartis aTIV in Children 6 to <72 months of age, Mexican population, in comparison to Fluzone, a non adjuvanted Trivalent Influenza Vaccine (TIV).
    A.3.2Name or abbreviated title of the trial where available
    V70_50
    A.4.1Sponsor's protocol code numberV70_50
    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 SponsorNovartis Pharma Services AG
    B.1.3.4CountrySwitzerland
    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 supportNovartis Pharma Services AG
    B.4.2CountrySwitzerland
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationNovartis Pharma Services AG
    B.5.2Functional name of contact pointClinical Trial Information Desk
    B.5.3 Address:
    B.5.3.1Street AddressLichtstrasse 35
    B.5.3.2Town/ cityBasel
    B.5.3.3Post code4056
    B.5.3.4CountrySwitzerland
    B.5.6E-mailRegistryContactVaccinesUS@novartis.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 Fluad
    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.3.4Pharmaceutical form Suspension for injection
    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.IMP: 2
    D.1.2 and D.1.3IMP RoleComparator
    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 Fluzone
    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.3.4Pharmaceutical form Suspension for injection
    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
    Influenza
    E.1.1.1Medical condition in easily understood language
    Influenza is an acute respiratory disease at high impact on public health worldwide. It has high morbidity rates for people of all ages including children.
    E.1.1.2Therapeutic area Diseases [C] - Respiratory Tract Diseases [C08]
    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
    1. To assess the safety of aTIV and TIV vaccines administered to healthy subjects 6 to <72 months of age, from day 1 to day 50 (naïve subjects) and from day 1 to day 22 (non-naïve subjects).
    2. To demonstrate non-inferiority of aTIV to TIV as measured by geometric mean titers (GMTs) in all three homologous virus strains, 21 days after last immunization, in subjects 6 to <72 months of age.
    E.2.2Secondary objectives of the trial
    1. To evaluate non-inferiority of aTIV to TIV as measured by % of subjects with
    seroconversion in all three homologous virus strains, 21 days after last
    immunization, in subjects 6 to <72 months of age.
    2. To evaluate the immunogenicity of aTIV and TIV as measured by GM ratios
    (GMRs), % of subjects with HI titers ≥ 40, ≥110 and > 330 in all three homologous
    virus strains, 21 days after last immunization, in subjects 6 to <72 months of age.
    3. If non-inferiority will be established, to evaluate the GMT ratio of aTIV relative to TIV in all three homologous virus strains, 21 days after last immunization, in
    subjects 6 to <72 months of age, using margins greater than the non-inferiority cutoff of 0.67.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    In order to participate in this study, all subjects must meet ALL of the inclusion criteria described.
    1. Individuals of >6 months through <72 months of age on the day of informed consent.
    2. Individuals whose parent(s)/legal guardian(s) have voluntarily given written informed consent after the nature of the study has been explained according to local regulatory requirements, prior to study entry.
    3. Individuals who can comply with study procedures.
    4. Willingness to allow for serum samples to be stored beyond the study period, for potential additional future testing to better characterize immune response.
    E.4Principal exclusion criteria
    Each subject must not have:
    1. Progressive, unstable or uncontrolled clinical conditions.
    2. Hypersensitivity, including allergy, to any component of vaccines, medicinal products or medical equipment whose use is foreseen in this study.
    3. History of progressive or severe neurologic disorder, seizure disorder or Guillian-Barré syndrome.
    4. Surgery planned during the study period that in the Investigator’s opinion would interfere with the study visits schedule.
    5. Known bleeding diathesis, or any condition that may be associated with a prolonged bleeding time.
    6. Any fatal prognosis of an underlying medical condition (<12 month life expectancy).
    7. Clinical conditions representing a contraindication to intramuscular vaccination and blood draws.
    8. Abnormal function of the immune system resulting from:
    a. Clinical conditions.
    b. Systemic administration of corticosteroids (PO/IV/IM) for more than 14 consecutive days within 90 days prior to informed consent.
    c. Administration of antineoplastic and immunomodulating agents or radiotherapy within 90 days prior to informed consent.
    9. Received immunoglobulins or any blood products within 180 days prior to informed consent.
    10. Received an investigational or non-registered medicinal product within 30 days prior to informed consent.
    11. Study personnel as an immediate family or household member.
    12. Any other clinical condition that, in the opinion of the investigator, might interfere with the results of the study or pose additional risk to the subject due to participation in the study.
    13. Received any influenza vaccine (licensed or investigational) or with laboratory
    confirmed influenza within 6 months prior enrollment.
    14. Received any other vaccines within 14 days (for inactivated vaccines) or 28 days (for live vaccines) prior to enrolment in this study or who are planning to receive any vaccine within 28 days from the study vaccines.
    E.5 End points
    E.5.1Primary end point(s)
    1. Percentage of subjects reporting solicited local and systemic AEs from day 1 to
    day 7 following each vaccination;
    2. Percentage of subjects reporting all unsolicited AEs from day 1 to day 50
    (vaccine naïve subjects), from day 1 to day 22 (non-naïve subjects);
    3. Percentage of subjects reporting medically attended AEs (MAAEs), AEs leading
    to study withdrawal and SAEs from day 1 to day 50 (naïve subjects), from day 1
    to day 22 (non-naïve subjects).
    4. GMTs on day 1, day 22 (non-naïve subjects) or day 50 (naïve subjects), as
    applicable.
    E.5.1.1Timepoint(s) of evaluation of this end point
    1. from day 1 to day 7 following each vaccination;
    2. from day 1 to day 50 (vaccine naïve subjects), from day 1 to day 22 (non-naïve subjects);
    3. from day 1 to day 50 (naïve subjects), from day 1 to day 22 (non-naïve subjects).
    4. day 1, day 22 (non-naïve subjects) or day 50 (naïve subjects),
    E.5.2Secondary end point(s)
    1. Percentage of subjects achieving seroconversion defined as: HI ≥ 40 subject with a pre-vaccination HI titer <10; a minimum 4-fold increase HI titer for subjects with a prevaccination HI titer ≥10, on day 22 (non-naïve subjects) or day 50 (naïve subjects), as applicable;
    2. Day 22/day 1 (non-naïve subjects) or day 50/day 1 (naïve subjects) GMRs of HI, as applicable;
    3. Percentage of subjects with a HI titer ≥ 40, ≥110 and ≥330 on day 1, day 22
    (non-naïve subjects) or day 50 (naïve subjects), as applicable.
    E.5.2.1Timepoint(s) of evaluation of this end point
    1. day 22 (non-naïve subjects) or day 50 (naïve subjects);
    2. day 1 and day 22 (non-naïve subjects) or day 50 (naïve subjects);
    3. day 1, day 22 (non-naïve subjects) or day 50 (naïve subjects).
    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 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
    Immunogenicity
    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) Yes
    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 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) Yes
    E.8.2.2Placebo No
    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
    Mexico
    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
    For the purpose of this study, as defined in the protocol, end of study is defined as the completion of the testing of all biological samples needed for the evaluation of the primary and secondary immunogenicity objectives, i.e. last serology results available = 23-Jun-15.
    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 months4
    E.8.9.2In all countries concerned by the trial days21
    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: 282
    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.1.1.3.1Number of subjects for this age range: 0
    F.1.1.4Infants and toddlers (28 days-23 months) Yes
    F.1.1.4.1Number of subjects for this age range: 120
    F.1.1.5Children (2-11years) Yes
    F.1.1.5.1Number of subjects for this age range: 162
    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 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
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.2 For a multinational trial
    F.4.2.2In the whole clinical trial 282
    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
    G.4 Investigator Network to be involved in the Trial: 1
    G.4.1Name of Organisation CENTRO MEDICO UNIVERSITARIO
    G.4.3.4Network Country Mexico
    G.4 Investigator Network to be involved in the Trial: 2
    G.4.1Name of Organisation UNIDAD DE ATENCION MEDICA E INVESTIGACION EN SALUD S.C. (UNAMIS)
    G.4.3.4Network Country Mexico
    G.4 Investigator Network to be involved in the Trial: 3
    G.4.1Name of Organisation MEDICAL CARE AND RESEARCH S.A. DE C.V.
    G.4.3.4Network Country Mexico
    H.4 Third Country in which the Trial was first authorised
    H.4.1Third Country in which the trial was first authorised: Mexico
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