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    Summary
    EudraCT Number:2014-004498-17
    Sponsor's Protocol Code Number:V71_18
    Clinical Trial Type:Outside EU/EEA
    Date on which this record was first entered in the EudraCT database:2014-11-13
    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 number2014-004498-17
    A.3Full title of the trial
    A Multi-center, Phase III, Randomized, Observer Blind Study to Evaluate the Safety, Tolerability, and Immunogenicity of a Trivalent Subunit Inactivated Influenza Vaccine (Agriflu™) in Healthy Children and Adolescents 3 to 17 Years of Age.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Safety and Immunogenicity of Trivalent Subunit Inactivated Flu Vaccine Administered to Healthy Children and Adolescents 3 to 17 Years of Age.
    A.3.2Name or abbreviated title of the trial where available
    Safety and Immunogenicity of Trivalent Subunit Inactivated Vaccine Administered to Healthy Children
    A.4.1Sponsor's protocol code numberV71_18
    A.5.2US NCT (ClinicalTrials.gov registry) numberNCT01209780
    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 Vaccines and Diagnostics
    B.1.3.4CountryItaly
    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 Vaccines and Diagnostics
    B.4.2CountryItaly
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationNovartis Vaccines and Diagnostics
    B.5.2Functional name of contact pointNovartis Vaccines and Diagnostics
    B.5.3 Address:
    B.5.3.1Street AddressVia Fiorentina
    B.5.3.2Town/ citySiena
    B.5.3.3Post code53100
    B.5.3.4CountryItaly
    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 No
    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 nameAgriflu™ (Trivalent Subunit Inactivated Influenza Vaccine)
    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 Fluvirin
    D.2.1.1.2Name of the Marketing Authorisation holderNovartis Vaccines and Diagnostics Ltd. , United Kingdom
    D.2.1.2Country which granted the Marketing AuthorisationColombia
    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 nameFluvirin (NVD trivalent inactivated subunit influenza vaccine)
    D.3.4Pharmaceutical form Solution 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: 3
    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 No
    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 nameFluzone
    D.3.4Pharmaceutical form Solution for injection
    D.3.4.1Specific paediatric formulation Information not present in EudraCT
    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
    Safety and Immunogenicity of Trivalent Subunit Inactivated Flu Vaccine Administered to Healthy Children and Adolescents 3 to 17 Years of Age
    E.1.1.1Medical condition in easily understood language
    Influenza Disease
    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
    To demonstrate the non-inferiority of the HI antibody responses of Agriflu for the three influenza strains when compared to US licensed trivalent inactivated influenza vaccines (controls) 21 days after last vaccination1 in children ages 3 to 8 years as measured by:
    ▫differences in percentage of subjects achieving seroconversion
    ▫ vaccines ratio of post-vaccination geometric mean titers (GMT)
    E.2.2Secondary objectives of the trial
    To evaluate the immunogenicity of Agriflu and comparators for the three influenza strains 21 days after last vaccination in children ages 3 to 8 years as measured by:
    ▫ Percentage of subjects achieving an HI titer ≥1:40
    ▫ Percentage of subjects achieving a seroconversion.
    Safety Objective
    To evaluate the safety and tolerability of Agriflu and comparator in children and adolescents 3 to 17 years of age.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Males and females aged 3 to 17 years (inclusive) on the day of enrollment.
    2. Individuals in good health as determined by medical history, physical examination and clinical judgment of the investigator.
    3. Documented consent provided by parents or legal guardians after the nature of the study was explained to them according to local regulatory requirements.
    4. For individuals 8 years of age and older, informed assent to participate in the study after the nature of the study was explained to them in terms they could understand better.
    5. Individuals and parents/guardians who were able to comply with all study procedures and were available for all clinic visits scheduled in the study.
    E.4Principal exclusion criteria
    1. Parents/legal guardians and individuals who had to provide assent, who were not able to comprehend and follow all required study procedures for the whole period of the study.
    2. Parents/legal guardians and individuals who had to provide assent, who could not consent to the retention of the subject’s serum samples after study completion.
    3. Individuals with behavioral/cognitive impairment/psychiatric disease that, in the opinion of the investigator, interfered with the subject's ability to participate in the study.
    4. Individuals with history/any illness that, in the opinion of investigator, interfered with the results of the study or posed additional risk to the subjects due to study participation
    5. History of any anaphylaxis, serious vaccine reactions, or hypersensitivity to influenza viral proteins, latex, any excipients, and eggs (including ovalbumin), chicken protein, influenza viral protein, kanamycin, neomycin sulphate, cetyltrimethylammonium bromide (CTAB), polysorbate 80, neomycin, polymixin, formaldehyde, thimerosal, beta propriolactone, or nonoxynol-9
    6. History of any serious disease, such as:
    a. cancer
    b. history of serious chronic diseases (cardiac, renal, hepatic, metabolic (including diabetes mellitus), rheumatologic (including autoimmune disease such as rheumatoid arthritis), neurologic (including history of atypical febrile seizure or history of Guillain-Barré disease), and hematologic (including bleeding diathesis).
    c. history of underlying medical condition such as inborn errors of metabolism, failure to thrive, broncho-pulmonary dysplasia, or any major congenital abnormalities requiring surgery, chronic treatment, or associated with developmental delay (e.g., Down’s syndrome).
    7. Known/suspected impairment/alteration of immune function, included:
    a. chronic use of oral steroids within 60 days prior to Visit 1 (use of inhaled, intranasal, or topical corticosteroids is allowed)
    b. received immuno-stimulants within 60 days prior to Visit 1
    c. received parenteral immunoglobulin preparation, blood products, and/or plasma derivates within 3 months prior to Visit 1 or planned during the full length of the study
    d. HIV infection or HIV-related disease
    e. Heritable immunodeficiency
    f. Abnormalities of splenic or thymic function
    8. Pregnant or breast-feeding female
    9. Any positive or indetermined pregnancy test
    10. If female, ―of childbearing potential‖, sexually active, and did not use any of the
    ―acceptable contraceptive methods for at least 2 months prior to study entry
    a. Of childbearing potential was defined as status post onset of menarche and not surgically sterile
    b. Acceptable birth control methods were defined as one or more of the following:
    i. Hormonal contraceptive (such as oral, injection, transdermal patch, implant, cervical ring)
    ii. Barrier (condom with spermicide or diaphragm with spermicide) each and every time during intercourse
    iii. Intrauterine device (IUD)
    iv. Monogamous relationship with vasectomized partner. Partner had
    to be vasectomized for at least six months prior to the subject’s
    study entry
    11. If female of childbearing potential and sexually active, refused to use an
    ―acceptable contraceptive method‖ during the first 3 weeks after vaccination
    12. If female of childbearing potential, refused to submit for pregnancy testing prior to study vaccination
    13. Received influenza vaccine within 6 months prior to Visit 1
    14. Laboratory-confirmed or suspected influenza disease within 6 months prior to
    Visit 1. ―Laboratory-confirmed:
    a. Positive serology result
    b. Positive viral culture
    c. Positive rapid antigen test
    ―Suspected‖ influenza disease: subjects with influenza-like illness within the past 6 months with a household/intimate contact with ―laboratory-confirmed influenza disease
    15. Received another vaccine within 2 weeks (for inactivated vaccines) or 4 weeks (for live vaccines) prior to enrollment in this study
    16. Experienced fever and/or any acute illness within 3 days prior
    to each study vaccination
    17. Used antipyretic/analgesic medication within 24 hours of each study vaccination
    18. Received another investigational agent within 30 days prior to enrollment in the study or before completion of the safety follow-up period in another study, whichever was longer, prior to enrollment and unwilling to refuse participation in another clinical study through the end of the study
    19. Research staff or research staff children directly involved with the clinical study or family members or household members of research staff. Research staff were individuals with direct or indirect contact with study subjects, or study site personnel who had access to any study documents containing subject information.
    This included receptionists, persons scheduling appointments or making screening calls, regulatory specialists, laboratory technicians, etc
    20. Elective surgery or hospitalization planned during the period of study participation
    E.5 End points
    E.5.1Primary end point(s)
    Primary
    Non-inferiority was to be demonstrated if:
    ▫ The upper bound of the two-sided 95% confidence interval (CI) on the ratio of the
    GMTs (GMTcontrol/GMTAgriflu) at 21 days after last vaccination does not exceed 1.5.
    ▫ The upper bound of the two-sided 95% CI on the difference between the seroconversion rates (Seroconversioncontrol – SeroconversionAgriflu) at 21 days after last vaccination does not exceed 10 percentage points.
    E.5.1.1Timepoint(s) of evaluation of this end point
    Day 21
    E.5.2Secondary end point(s)
    Secondary
    ▫ the lower bound of the two-sided 95% CI for the percentage of subjects achieving an heamagglutination (HI) HI antibody titer ≥1:40 (seroprotection).
    ▫ the lower bound of the two-sided 95% CI for the percentage of subjects achieving seroconversion in HI antibody titer.
    For the subset of subjects who received two vaccine doses, the same immunogenicity endpoints were evaluated at Day 29 (i.e. 4 weeks after the first injection).

    Safety Endpoints
    The measures of safety included solicited reactions, unsolicited adverse events (AEs) and concomitant medications in all subjects exposed to study vaccines.
    E.5.2.1Timepoint(s) of evaluation of this end point
    Immunogenicity endpoints
    Day 29

    Safety endpoint
    6months and 7months for subjects receiving one dose and two doses after initial study vaccination respectively
    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 Yes
    E.6.13.1Other scope of the trial description
    Immunogenecity
    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 trial4
    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
    Colombia
    Mexico
    Panama
    Philippines
    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 Trial corresponds to the last visit of the last subject undergoing the trial (LSLV, 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 months7
    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: 1386
    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: 1386
    F.1.1.6Adolescents (12-17 years) No
    F.1.1.6.1Number of subjects for this age range: 0
    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 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
    Subject and/or legal guardian and/or witness (if subject/legal guardian were unable to read and write) signed the consent form indicating their agreement to participate in the study before conducting study-related procedures.
    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 1764
    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 Novartis Vaccines and Diagnostics
    G.4.3.4Network Country Italy
    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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