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    Summary
    EudraCT Number:2014-005107-24
    Sponsor's Protocol Code Number:V112_06
    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 number2014-005107-24
    A.3Full title of the trial
    Pivotal, Multicenter, Observer-Blind, Randomized Study of Influenza A (H1N1) 2009 Monovalent Subunit Vaccine With and Without Adjuvant in Children Ages 6 to <36 Months
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Pivotal, Multicenter, Observer-Blind, Randomized Study of Influenza A (H1N1)2009 Monovalent Subunit Vaccine With and Without Adjuvant in Children Ages 6 to <36 Months.
    A.4.1Sponsor's protocol code numberV112_06
    A.5.2US NCT (ClinicalTrials.gov registry) numberNCT00996307
    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 Srl
    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 adjuvant
    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 evaluate hemagglutination inhibition (HI) assay results for each vaccine group after 1 and 2 doses and according to immunogenicity criteria defined by CBER recommendations
    Safety:
    • To evaluate the safety and tolerability of each A/H1N1 2009 vaccine group in this
    young pediatric population.
    E.2.2Secondary objectives of the trial
    To evaluate for superiority in GMT HI titer first after one dose and second after two doses of the 3.75 μg and 7.5 μg A/H1N1 2009 groups adjuvanted with MF59 as compared to the unadjuvanted 7.5 μg and 15 μg A/H1N1 2009 groups
    • To evaluate whether the 3.75 μg, and 7.5 μg A/H1N1 2009 groups with MF59 adjuvant are non-inferior in GMT as compared to the unadjuvanted 7.5 μg and 15 μg A/H1N1 2009 groups first after one dose and second after two doses. To evaluate each A/H1N1 2009 vaccine candidate HI assay results first after one dose and second after two doses according to immunogenicity criteria defined by CHMP recommendations. To evaluate immunogenicity responses according to seasonal influenza vaccination status within the past 12 months.• To evaluate immunogenicity responses in subjects who are seropositive (A/H1N1 2009 HI titer ≥ 1:10) at Baseline (Day 1) as compared to those who are seronegative (HI titer < 1:10)
    • To evaluate antibody persistence at Day 202 and Day 387.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1.Males and females of 6 to < 36 months age.
    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 were able to comply with all study procedures and are available for all clinic visits scheduled in the study
    E.4Principal exclusion criteria
    1.Parents or legal guardians who were not able to comprehend and follow all requiredstudy procedures for the whole period of the study.
    2. Parents or legal guardians who did not consent to the retention of the subject’s serum samples after study completion.
    3. Subjects whose parents or legal guardians had behavioral or cognitive impairment or psychiatric disease that, in the opinion of the investigator, could interfere with the subject's ability to participate in the study.
    4. Individuals with history of 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, such as:
    a. cancer
    b. history of serious chronic diseases (cardiac, renal, hepatic, metabolic (including diabetes mellitus), rheumatologic (including autoimmunedisease such as rheumatoid arthritis), neurologic (including history of
    atypical febrile seizure, afebrile seizures 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, bronchopulmonary dysplasia, or any major
    congenital abnormalities requiring surgery, chronic treatment, or
    associated with developmental delay (e.g., Down’s syndrome)
    7. Known or suspected impairment/alteration of immune function, including:
    a. chronic use of oral steroids (≥15 days of use) within 60 days prior to Visit
    1 (use of inhaled, intranasal, or topical corticosteroids was allowed).
    b. Receipt of parenteral steroids within 60 days prior to Visit 1
    c. receipt of immunostimulants within 60 days prior to Visit 1
    d. receipt of 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
    e. HIV infection or HIV-related disease
    f. Heritable immunodeficiency
    g. Abnormalities of splenic or thymic function
    8. Laboratory-confirmed or suspected influenza disease within 6 months prior to Visit 1.
    “Laboratory-confirmed” includes:
    a. Positive serology result
    b. Positive viral culture
    c. Positive rapid antigen test
    d. “Suspected” influenza disease includes: subjects with influenza-like illness
    within the past 6 months with a household/intimate contact with
    “laboratory-confirmed” influenza disease
    9. Subjects who have received influenza or routine childhood vaccines within 7 days prior to first study vaccination or who had planned to receive influenza or routine childhood vaccine within -7 or +7 days of either study vaccination.
    10. In addition to the vaccines described above, receipt of another vaccine (e.g., travel vaccines) within 2 weeks (for inactivated vaccines) or 4 weeks (for live vaccines) prior to enrollment in this study.
    11. Experienced a fever (axillary: ≥37.5°C/ oral: ≥38.0°C/ rectal: ≥38.5°C/ tympanic membrane: ≥37.7°C) and/or any acute illness within 3 days prior to each study vaccination.
    12. Use of antipyretic/analgesic medication within 24 hours of each study vaccination
    13. Receipt of 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 is longer, prior to enrollment and unwilling to refuse participation in another clinical study through the end of the study.
    14. Children of research staff directly involved with the clinical study or family members or household members of research staff. Research staff are individuals with direct or indirect contact with study subjects, or study site personnel who have access to any study documents containing subject information. This would include receptionists, persons scheduling appointments or making screening calls, regulatory specialists,
    laboratory technicians, etc.
    15. Elective surgery or hospitalization planned during the period of study participation
    16. Informed consent had to be obtained for all the subjects before enrolment into the study after the nature of the study had been explained.
    E.5 End points
    E.5.1Primary end point(s)
    1.Antibody Responses After the First and Second Vaccinations.
    2. Number of Participants Reporting Solicited Local and Systemic Reactions After First Vaccination
    3. Number of Participants Reporting Solicited Local and Systemic Reactions After Second Vaccination
    E.5.1.1Timepoint(s) of evaluation of this end point
    1. 21 days after each vaccination
    2. Day 1 to 7
    3. Day 22 to 28
    E.5.2Secondary end point(s)
    1.Immunogenicity Measurement by Geometric Mean Titers (GMT)
    2.Antibody Responses With and Without Seasonal Influenza Vaccination for Year 2009 to 2010
    3. Geometric Mean Titers (GMTs) With and Without Seasonal Influenza Vaccination for Year 2009 to 2010
    4. Antibody Response Based on Baseline Seropositivity
    5. Geometric Mean Titers (GMTs) Based on Baseline Seropositivity
    6. Antibody Persistence 6 Months and 12 Months After the Second Vaccination
    7. Antibody Persistence by Geometric Mean Titers (GMT) vaccination
    E.5.2.1Timepoint(s) of evaluation of this end point
    1. 21 days after each vaccination
    2. Past 12 months
    3. Up to Day 43
    4. 6 months and 12 months after second vaccination
    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 No
    E.8.1.1Randomised Yes
    E.8.1.2Open No
    E.8.1.3Single blind No
    E.8.1.4Double blind No
    E.8.1.5Parallel group No
    E.8.1.6Cross over No
    E.8.1.7Other Yes
    E.8.1.7.1Other trial design description
    Observer-blind
    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 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
    Mexico
    United States
    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
    LSLV- 06 DEC 10
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.2In all countries concerned by the trial years1
    E.8.9.2In all countries concerned by the trial months1
    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: 668
    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: 334
    F.1.1.5Children (2-11years) Yes
    F.1.1.5.1Number of subjects for this age range: 334
    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 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 654
    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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