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    Summary
    EudraCT Number:2014-005106-38
    Sponsor's Protocol Code Number:V112_02
    Clinical Trial Type:Outside EU/EEA
    Date on which this record was first entered in the EudraCT database:2014-12-04
    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 number2014-005106-38
    A.3Full title of the trial
    A Pivotal Randomized, Single-Blind, Dose-Finding Study to Evaluate Immunogenicity, Safety and Tolerability of Different Formulations of an Adjuvanted and Non-Adjuvanted Egg-Derived, Inactivated Novel Swine Origin A/H1N1 Monovalent Subunit Influenza Virus Vaccine in Healthy Pediatric Subjects 3 to < 9 Years of Age
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Safety and Immunogenicity of A/H1N1-SOIV (Swine Flu) Vaccine With and Without Adjuvant in Children (3 to < 9 Years)
    A.4.1Sponsor's protocol code numberV112_02
    A.5.2US NCT (ClinicalTrials.gov registry) numberNCT00972816
    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.1.3.4CountryUnited 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 supportNovartis Vaccines and Diagnostics
    B.4.2CountryUnited States
    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, 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 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 nameMonovalent H1N1 influenza virus vaccine with or without MF59
    D.3.2Product code H1N1f
    D.3.4Pharmaceutical form Suspension for injection in pre-filled syringe
    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 Pandemic 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 see if one or more A/H1N1 S-OIV vaccine groups meet CBER criteria for immunogenicity in a population of children ages 3 to < 9 yrs (CBER 2007a)
    E.2.2Secondary objectives of the trial
    A. To perform pairwise comparisons in all vaccine groups according to 95% confidence intervals
    B. To evaluate each A/H1N1 S-OIV vaccine candidate hemagglutination inhibition (HI) assay results according to immunogenicity criteria defined by EMEA recommendations (CHMP 2007, CHMP 2008)
    C. To evaluate immunogenicity responses according to seasonal influenza vaccination status (2009/2010 Northern Hemisphere vaccine)
    D. To evaluate immunogenicity responses in subjects who are seropositive (A/H1N1 S-OIV HI titer ≥ 1:10) at Baseline (Day 1 (pre-vaccination)) as compared to those who are seronegative (HI titer < 1:10)
    E. To evaluate the immunogenicity of one versus two doses of A/H1N1 S-OIV vaccine
    F. To evaluate antibody persistence at Day 202 and Day 387

    Safety objective
    To evaluate safety and tolerability of the A/H1N1 S-OIV vaccine across all vaccine groups
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Males and females ages 3 to < 9 yrs

    2. Individuals in good health as determined by the outcome of medical history, physical assessment and clinical judgment of the investigator
    3. Documented consent provided by parents or legal guardians after the nature of the study has been explained to them according to local regulatory requirements
    4. Individuals and parents/guardians are able to comply with all study procedures and are available for all clinic visits scheduled in the study
    5. For individuals 7 yrs of age and older (in US; and according to local practice in ex-US locations), informed assent to participate in the study after the nature of the study has been explained to them in terms they can understand
    E.4Principal exclusion criteria
    1. Parents or legal guardians and individuals providing assent who are not able to comprehend and to follow all required study procedures for the whole period of the study
    2. Parents or legal guardians and individuals providing assent who do not consent to the retention of the subject’s serum samples after study completion
    3. 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
    4. Individuals with history or any illness that, in the opinion of the investigator, might interfere with the results of the study or pose additional risk to the subjects due to participation in the study
    5. History of any anaphylaxis, serious vaccine reactions, or hypersensitivity to influenza viral proteins, egg proteins (including ovalbumin), thimerosal (including mercury) or sodium ethylmercurothiosalicylate, polymyxin, neomycin, betapropiolactone and nonylphenol ethoxylate/nonoxynol-9 (spermacide).
    6. History of any serious disease
    E.5 End points
    E.5.1Primary end point(s)
    1. On Day 43, Day 22, and Day 29
    2. On Day 43, Day 22, and Day 29
    E.5.1.1Timepoint(s) of evaluation of this end point
    1. Day 1
    2. Day 22
    3. Day 29
    4. Day 43
    E.5.2Secondary end point(s)
    1. On Day 202 and Day 387
    2. On Day 43, Day 29 and Day 22
    3. On Day 202 and Day 387
    4. Day 43/Day 1, Day 22/Day1 and Day 29/Day 1
    E.5.2.1Timepoint(s) of evaluation of this end point
    1. Day 1
    2. Day 22
    3. Day 29
    4. Day 43
    5. Day 202
    6. Day 387
    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
    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 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 Yes
    E.8.2.3.1Comparator description
    dose finding
    E.8.2.4Number of treatment arms in the trial8
    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
    LSLV-03 NOV 2010
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.2In all countries concerned by the trial months13
    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: 1360
    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: 1360
    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 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 1360
    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)
    Novartis Vaccines or the investigator provided the ethics committee EC) with all appropriate material, including the Informed Consent form (ICF), according to local regulations. The EC should also was asked for a written statement regarding the composition of the ommittee and to comply with GCP (Good Clinical Practices) and with the applicable
    regulatory requirement(s). The trial was not initiated until appropriate EC approval of the protocol and the ICF was obtained.
    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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