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    Summary
    EudraCT Number:2012-001223-13
    Sponsor's Protocol Code Number:V58_31
    Clinical Trial Type:Outside EU/EEA
    Date on which this record was first entered in the EudraCT database:2014-12-03
    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 number2012-001223-13
    A.3Full title of the trial
    A Phase III, Observer-blind, Randomized, Controlled, Multicenter Study to Evaluate the Safety of a Trivalent Subunit Influenza Vaccine Produced either in Mammalian Cell Culture or in Embryonated Chicken Eggs (Fluvirin®), in Healthy Children and Adolescents 4 to 17 Years of Age.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Safety of Two Trivalent Influenza Vaccines Evaluated in Children and Adolescents 4 to 17 Years of Age.
    A.3.2Name or abbreviated title of the trial where available
    Safety of Trivalent Subunit Influenza Vaccine administered to Healthy Children and adolescents.
    A.4.1Sponsor's protocol code numberV58_31
    A.5.2US NCT (ClinicalTrials.gov registry) numberNCT01857206
    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 pointPosting Director
    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 Yes
    D.2.1.1.1Trade name Flucelvax
    D.2.1.1.2Name of the Marketing Authorisation holderNovartis Vaccines and Diagnostics
    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 nameTrivalent influenza virus vaccine (surface antigen, inactivated, cell-based)
    D.3.4Pharmaceutical form Suspension for injection in pre-filled syringe
    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.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
    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 nameTrivalent influenza virus vaccine (surface antigen, inactivated, egg-derived, Fluvirin platform)
    D.3.4Pharmaceutical form Suspension for injection in pre-filled syringe
    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
    Prophylaxis: Influenza
    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 evaluate safety and tolerability of one or two doses (administered 4 weeks apart) of mammalian cell culture-derived influenza vaccine (TIVc) and Fluvirin (TIVf) in children and adolescents ≥4 to ≤17 years of age.
    E.2.2Secondary objectives of the trial
    Not applicable
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    In order to participate in this study, all subjects met all of the inclusion criteria described.
    1. Males and females ≥4 to ≤17 years of age at the time of enrollment.
    2. Individuals' parents or legal guardians who have given written consent after the nature of the study has been explained according to local regulatory requirements (and where applicable according to local regulations, informed assent for subjects above the
    specified age).
    3. Individuals in good health as determined by the outcome of medical history, physical examination and clinical judgment of the investigator.
    4. Individuals and individuals’ parents or legal guardians who can comply with study procedures and were available for follow-up.
    E.4Principal exclusion criteria
    In order to participate in this study, all subjects met none of the exclusion criteria described.
    1. Individuals with behavioral or cognitive impairment or psychiatric disease that, in the opinion of the investigator, may interfere with the subject's ability to participate in the study.
    2. Individuals who took any analgesic/antipyretic medication within 24 hours of study vaccination.
    3. Experienced a temperature ≥38.0°C or ≥100.4°F and/or any acute illness (defined as any moderate or severe symptom) within 3 days prior to day 1.
    4. Individuals with any progressive or severe neurologic disorder, seizure disorder or recent history of Guillian-Barré syndrome (history of febrile convulsions was allowed).
    5. Individuals/children's parents or legal guardians who were not able to comprehend and to follow all required study procedures for the whole period of the study.
    6. Individuals with a history of illness or with an ongoing illness that, in the opinion of the investigator, may pose additional risk to the subject if he/she participates in the study.
    7. Individuals with any serious chronic or progressive disease according to judgment of the investigator (including but not limited to insulin dependent diabetes, cardiac and renal or hepatic disease).
    8. Individuals with known or suspected impairment of the immune system (including but not limited to HIV, autoimmune disorders (excluding stable Eczema and Hashimoto disease), immunosuppressive therapy, chronic use of systemic corticosteroids etc).
    a. Stable eczema is defined as eczema involving less than 5% body surface, no significant morphological worsening and/or increase in medication in the previous 3 months.
    b. Hashimoto disease is defined as an autoimmune disease attacking the thyroid gland and often resulting in hypothyroidism.
    c. Chronic use of systemic corticosteroids is defined as use of systemic corticosteroids for more than 15 out of 30 days within the month prior to enrollment. The use of topic, inhaled and intranasal corticosteroids is not seen as systemic and therefore allowed.
    9. Individuals who were pregnant or breastfeeding.
    10. If ≥9 to ≤17 years female, “of childbearing potential”, sexually active, and has not used any of the “acceptable contraceptive methods” for at least 2 months prior to study entry:
    a. Of childbearing potential is defined as status post onset of menarche and not meeting any of the following conditions: status after bilateral tubal ligation for at least 1 year, status after bilateral oophorectomy, or status after hysterectomy.
    b. Acceptable birth control methods are defined as one or more of the following:
    - Sexual abstinence;
    - Hormonal contraceptive (such as oral, injection, transdermal patch, implant, cervical ring);
    - Barrier (condom with spermicide or diaphragm with spermicide) each and every time during intercourse;
    - Intrauterine device (IUD);
    - Monogamous relationship with vasectomized partner. Partner must have been vasectomized for at least six months prior to the Subject’s study entry.
    11. Female subjects of childbearing potential with a positive or indeterminate pregnancy test.
    12. Any ≥9 to ≤17 year female of childbearing potential who was sexually active and refused to use an “acceptable contraceptive method” through to the end of the study.
    13. Individuals who were allergic to any of the vaccine components.
    14. Individuals who have had ever a malignancy.
    15. Individuals who have been diagnosed in the past 2 years with any disorders in growth, such as failure to thrive or short stature.
    ▫ Failure to thrive and short stature diagnoses was based on published regional normative data.
    ▫ If no regional normative data were published, then children 2 standard deviations or more below World Health Organization normative data for height and weight were excluded from the study.
    16. Individuals participating in any clinical trial with another investigational product 30 days prior to first study visit or intent to participate in another clinical study at any time during the conduct of this study. Note: concomitant participation in an observational study (not involving drugs, vaccines or medical devices) was acceptable.
    17. Individuals who were acting as study personnel or immediate family members (brother, sister, child, parent) or the spouse of study personnel or individuals who were financially or emotionally dependent on study staff.
    18. Individuals with a history of drug or alcohol abuse within the past 2 years.
    E.5 End points
    E.5.1Primary end point(s)
    Number Of Subjects Reporting Solicited Local and Systemic Adverse Events and Other Indicators Of Reactogenicity After Any Vaccination.
    Number Of Subjects Reporting SAEs, NOCDs, AEs leading to withdrawal from study and medically attended AEs After Any Vaccination.
    E.5.1.1Timepoint(s) of evaluation of this end point
    Number of subjects reporting solicited AEs - Day 1 through Day7 and Day29 through Day35
    Number of subjects reporting unsolicited AEs - Day1 through Day28; and from Day29 through Day49
    Number of subjects reporting SAEs, NOCD, AEs leading to vaccine/study withdrawal and medically attended AEs - Day 213 for "not previously vaccinated” subjects ≥4 to ≤8 years of age or Day 183 for all other subjects
    E.5.2Secondary end point(s)
    Not Applicable
    E.5.2.1Timepoint(s) of evaluation of this end point
    Not Applicable
    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) 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
    Australia
    New Zealand
    Philippines
    Thailand
    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
    LVLS
    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: 2040
    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: 1020
    F.1.1.6Adolescents (12-17 years) Yes
    F.1.1.6.1Number of subjects for this age range: 1020
    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 Yes
    F.3.2Patients No
    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.4.2 For a multinational trial
    F.4.2.2In the whole clinical trial 2040
    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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    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
    As of 31 January 2023, all EU/EEA initial clinical trial applications must be submitted through CTIS . Updated EudraCT trials information and information on PIP/Art 46 trials conducted exclusively in third countries continues to be submitted through EudraCT and published on this website.

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