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    Summary
    EudraCT Number:2014-005075-88
    Sponsor's Protocol Code Number:V110_08
    Clinical Trial Type:Outside EU/EEA
    Date on which this record was first entered in the EudraCT database:2014-12-15
    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 number2014-005075-88
    A.3Full title of the trial
    A Multi-center, Randomized, Single-blind, Dose-Ranging Study to Evaluate Immunogenicity, Safety and Tolerability of Different Doses of Adjuvanted Cell-Derived, Inactivated Novel Swine Origin A/H1N1Monovalent Subunit Influenza Virus Vaccine in Healthy Japanese Pediatric Subjects
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Single-blind, Dose-ranging Study of Novel Swine Influenza Virus Vaccine in Japanese Pediatric Subjects
    A.4.1Sponsor's protocol code numberV110_08
    A.5.2US NCT (ClinicalTrials.gov registry) numberNCT01000207
    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 K.K
    B.1.3.4CountryJapan
    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 K.K
    B.4.2CountryJapan
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationNovartis Vaccines and Diagnostics S.r.l
    B.5.2Functional name of contact pointposting director
    B.5.3 Address:
    B.5.3.1Street Addressvia Fiorentina 1
    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 Celtura
    D.2.1.1.2Name of the Marketing Authorisation holderNovartis Pharma K.K
    D.2.1.2Country which granted the Marketing AuthorisationJapan
    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 nameH1N1 Vaccine (FCC-H1N1sw) (3.75_halfMF59)
    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 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 Celtura
    D.2.1.1.2Name of the Marketing Authorisation holderNovartis Pharma K.K
    D.2.1.2Country which granted the Marketing AuthorisationJapan
    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 nameH1N1 Vaccine (FCC-H1N1sw) (7.5_fullMF59)
    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
    Prophylaxis of A (H1N1) 2009 Swine Origin Pandemic Influenza
    E.1.1.1Medical condition in easily understood language
    Prophylaxis of Pandemic Influenza
    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 identify the preferred vaccine dose (of antigen and adjuvant) and schedule (one or two administrations) of the cell-derived H1N1sw monovalent vaccine (FCC H1N1 101) in healthy children/adolescents based on EMEA/CHMP criteria, and safety & tolerability.
    E.2.2Secondary objectives of the trial
    Not Applicable
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Japanese males and females 6 months of age to 19 years of age on the day of informed consent;
    2. Individuals in good health as determined by the outcome of medical history; physical examination and clinical judgment of the investigator;
    3. Subjects, subject's parents or legal guardians that are able to comply with all study procedures and subjects are available for all clinic visits scheduled in the study;
    4. Subject's parents or legal guardians who have given written consent and the subjects has given assent consent, if applicable, after the nature of the study has been explained according to local regulatory requirements able to comply with all study procedures and requirements.
    E.4Principal exclusion criteria
    1. Individuals with history or any illness that, in the opinion of the investigator, pose additional risk to the subjects due to participation in the study;
    2. Individuals with any serious chronic or progressive disease according to judgment of the investigator (including, but not limited to neoplasm, insulin dependentdiabetes, cardiac, renal or hepatic disease);
    3. History of any anaphylaxis, serious vaccine reactions, or hypersensitivity to influenza viral proteins, to any excipients;
    4. Individuals who have had adjuvanted influenza vaccine or documented confirmed or suspected influenza disease* within 3 months prior to day 1.
    * “Laboratory-confirmed” includes:
    a. Positive serology result
    b. Positive viral culture
    c. Positive rapid antigen test
    “Suspected” influenza disease includes: subjects with influenza-like illness, such as systemic symptoms (high fever, headache, arthralgia, etc.) and/or respiratory symptoms (sore throat, nasal discharge, caugh, etc.) within the past 3 months with a household/intimate contact with “laboratory-confirmed” influenza disease.
    5. Receipt of another investigational agent within 4 weeks prior to enrollment or before completion of the safety follow-up period in this or in another study, unwilling to refuse a participation in another clinical study through the end of this study;
    6. Individuals who received any other vaccines within 4 weeks prior to enrolment in this study or who are planning to receive any vaccine within 4 weeks from the study vaccines; the only exception being plain seasonal influenza vaccines which are allowed until 1 week prior to and after 1 week study vaccinations
    7. Individuals with axillary temperature ≥ 37.5 degrees Celsius or oral/rectal temperature ≥ 38.0 degrees Celsius within 3 days of intended study vaccination;
    8. Known or suspected impairment/alteration of immune function, for example resulting from:
    a. receipt of immunosuppressive therapy such as systemic corticosteroids known to be associated with the suppression of hypothalamic-pituitaryadrenal (HPA) axis (15 mg/day of prednisone or its equivalent) or chronic use of inhaled high-potency corticosteroids (e.g. budesonide 800μg/day or fluticasone 750μg/day) within 60 days prior to Visit 1,
    b. cancer chemotherapy,
    c. receipt of immunostimulants within 60 days prior to Visit 1,
    d. receipt of parenteral immunoglobulin preparation, blood products, and/or plasma derivatives within 12 weeks prior to Visit 1 or planned during the full length of the study,
    e. known HIV infection or HIV-related disease;
    9. History of progressive or severe neurologic disorder (including Guillain-Barré syndrome and convulsions, but excluding febrile convulsions);
    10. Height or weight is above +2SD or below -2SD compared to standard curve (Report on development of infants in 2000, and Report on servey of school health in 2000)
    11. Bleeding diathesis;
    12. Surgery planned during the study period that in the Investigator’s opinion would interfere with the study visits schedule;
    13. If female, of childbearing potential, and has not used any of the “acceptable contraceptive methods” for at least 2 months prior to study entry:
    a. Female of childbearing potential is defined as a post onset of menarche capable of becoming pregnant and not surgically sterile
    b. Acceptable birth control methods are 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 must have been vasectomized for at least six months prior to the subject’s study entry;
    14. Females who are pregnant or nursing (breastfeeding) mothers, or females of childbearing potential who are sexually active and have not used or do not plan to use acceptable birth control measures during the first 3 weeks after vaccination;
    15. Relatives of members of research staff (research staff are individuals with direct contact with trial subjects, or study site personnel who have access to any study document containing subject information, including: e.g. receptionist, person scheduling appointments or making screening calls, regulatory specialists, laboratory technicians).
    E.5 End points
    E.5.1Primary end point(s)
    The measures for immunogenicity as determined by HI were as follows:
    1. HI Geometric mean titre (GMT) on day 1, day 22 and day 43;
    2. Day 22/day 1, day 43/day 1 and day 43/day 22 geometric mean ratio (GMR) of HI;
    3. Percentage of subjects achieving a seroconversion or a significant increase (defined as: HI ≥1:40 for subjects negative at baseline [<1:10]; a minimum 4-fold increase in HI titre for subjects positive at baseline [HI≥1:10]) on day 22 and day 43;
    4. Percentage of subjects with a HI titre ≥1:40 on day 1, day 22 and day 43.
    The measures of immunogenicity, as determined by MN, were as follows:
    1. MN GMT on day 1, day 22 and day 43;
    2. Day 22/day 1, and day 43/day 1 and day 43/day 22 geometric mean ratio (GMR) of MN;
    3. Percentage of subjects with a MN titre ≥1:40, 1:80, and 1:160 on day 1, day 22 and day 43;
    4. Percentage of subjects achieving at least a 4-fold increase in MN titre on day 22 and day 43
    Safety
    The safety measurements assessed up to day 43
    E.5.1.1Timepoint(s) of evaluation of this end point
    The measures for immunogenicity as determined by HI were as follows:
    1. day 1, day 22 and day 43;
    2. day 22/day 1, day 43/day 1 and day 43/day 22
    3. day 22 and day 43;
    4. day 1, day 22 and day 43.
    The measures of immunogenicity, as determined by MN, were as follows:
    1.day 1, day 22 and day 43;
    2. day 22/day 1, and day 43/day 1 and day 43/day 22
    3. day 1, day 22 and day 43;
    4. day 22 and day 43
    Safety:
    day 43
    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 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 No
    E.8.1.1Randomised Yes
    E.8.1.2Open No
    E.8.1.3Single blind Yes
    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.8.2.4Number 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
    Japan
    E.8.7Trial has a data monitoring committee Yes
    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: 10 DEC 09
    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 months3
    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: 120
    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) Yes
    F.1.1.4.1Number of subjects for this age range: 40
    F.1.1.5Children (2-11years) Yes
    F.1.1.5.1Number of subjects for this age range: 40
    F.1.1.6Adolescents (12-17 years) Yes
    F.1.1.6.1Number of subjects for this age range: 40
    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 120
    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: Japan
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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
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