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    Summary
    EudraCT Number:2015-003279-31
    Sponsor's Protocol Code Number:IPV46/EFC13614
    Clinical Trial Type:Outside EU/EEA
    Date on which this record was first entered in the EudraCT database:2016-04-19
    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 number2015-003279-31
    A.3Full title of the trial
    Immunogenicity and Safety of IMOVAX POLIO® Subcutaneous as a Booster Given in Pre-school Age Children in Japan (IPV46)
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Study of IMOVAX POLIO® Subcutaneous as a Booster Vaccine in Pre-school Age Children in Japan
    A.4.1Sponsor's protocol code numberIPV46/EFC13614
    A.5.2US NCT (ClinicalTrials.gov registry) numberNCT02005536
    A.5.3WHO Universal Trial Reference Number (UTRN)U1111-1143-8561
    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 SponsorSanofi 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 supportSanofi K.K.
    B.4.2CountryJapan
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationSanofi K.K.
    B.5.2Functional name of contact pointPMS Management Supervisor
    B.5.3 Address:
    B.5.3.1Street Address3-20-2, Nishi Shinjuku, Shinjuku-ku
    B.5.3.2Town/ cityTokyo
    B.5.3.3Post code163-1448
    B.5.3.4CountryJapan
    B.5.4Telephone number334376 56799
    B.5.6E-mailEmmanuel.vidor@sanofipasteur.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 SP059, IMOVAX POLIO® (Inactivated Poliovirus Vaccine: IPV)
    D.2.1.1.2Name of the Marketing Authorisation holderSanofi Pasteur SA
    D.2.1.2Country which granted the Marketing AuthorisationFrance
    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 nameSP059, IMOVAX POLIO® (Inactivated Poliovirus Vaccine: IPV)
    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 IMPSubcutaneous 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
    Poliovirus types 1, 2, and 3
    E.1.1.1Medical condition in easily understood language
    Polio
    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 investigate the booster vaccine response rate against poliovirus types 1, 2 and 3 one month following the vaccination dose with SP059 as a second booster.
    E.2.2Secondary objectives of the trial
    Immunogenicity
    To investigate seroprotection rates (percentage of subjects presenting poliovirus neutralizing antibody titers above 1:8 (1/dil.) at pre- and post-booster time points, geometric mean of titers (GMT) at pre- and post-booster time points and geometric mean
    of individual titer ratio (GMTR)

    Safety
    To describe the safety after dosing of SP059 as a second booster.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    - Aged 4 to 6 years inclusive on the day of inclusion
    - Subjects who received 4 times an IPV-containing vaccine (DTaP-IPV or IPV) during first (3 doses) and second year of life (one dose)
    - Informed consent form signed by the parent(s) or other legal representative
    - Able to attend all scheduled visits and to comply with all trial procedures
    E.4Principal exclusion criteria
    - Fever ≥ 37.5°C (axillary temperature) on the day of inclusion
    - Any serious disease whether acute or chronic
    - Past or current medical history of Guillain-Barre syndrome, acute thrombocytopenic purpura or encephalopathy
    - History of poliomyelitis infection
    - History of a life threatening reaction to a vaccine containing the same substances of the study vaccine (Inactivated poliovirus types 1, 2, and 3, 2-Phenoxyethanol, Formaldehyde, M199 Hanks medium)
    - History of anaphylaxis or allergy to any of the study vaccine components ((Inactivated poliovirus types 1, 2, and 3, 2-Phenoxyethanol, Formaldehyde, M199 Hanks medium)
    - Congenital or current/ previous acquired immunodeficiency, immunosuppressive therapy such as long-term systemic corticosteroids therapy*
    - Participation in another clinical trial within 6 months before the trial inclusion**
    - Planned participation in another clinical trial during the present trial period
    - Received oral or injected antibiotic therapy within the 72 hours prior to any blood draw
    - Received antipyretics/analgesics/NSAIDs (considered as category 1) within 4 hours prior to vaccination
    - Blood or blood–derived products received in the past or current or planned administration during the trial (including immunoglobulins).
    - Any vaccination with live vaccines within the past 27 days preceding the first trial vaccination.
    - Any vaccination with inactivated vaccines within the past 6 days preceding the first trial vaccination.
    - Clinical or known serological evidence of systemic illness including Hepatitis B, Hepatitis C and/or HIV infection
    - Subject ineligible according to the Investigator’s clinical judgment

    * Systemic corticosteroids therapy (prednisone or equivalent at ≥ 0.5 mg/kg/day) for more than 2 consecutive weeks within the past 2 months.
    ** Participation in another clinical trial investigating a vaccine, a drug, a medical device or a medical procedure.
    E.5 End points
    E.5.1Primary end point(s)
    Percentage of subjects developing at least a four-fold rise in their antibody titers between the pre-booster (Visit 1) and one month (4-6 weeks [28-42 days]) after the dose of IPV (Visit 2).
    E.5.1.1Timepoint(s) of evaluation of this end point
    Pre-booster (Visit 1) and 1 post-IPV dose (Visit 2)
    E.5.2Secondary end point(s)
    Immunogenicity
    1) Before (Visit 1) and one month (4-6 weeks [28-42 days]) after the dose of IPV (at Visit 2):
    - % of subjects with anti-polio 1, 2 and 3 antibody titers ≥8 (1/dil)
    - Geometric Mean of Titers (GMT) against polio 1, 2 and 3
    - Geometric Mean of individual Titer Ratio (GMTR) against polio 1, 2 and 3 between pre- and post-booster time points

    Safety
    The secondary endpoints for the safety evaluation were:
    1) Occurrence, intensity, and relationship to vaccination of any unsolicited systemic AEs reported within 30 minutes after vaccination.
    2) Occurrence, time to onset, number of days of occurrence, and intensity of solicited injection-site and systemic reactions (terms prelisted in the subject’s diary card and eCRF) occurring from Day 0 to Day 7 after vaccination.
    3) Occurrence, nature (MedDRA preferred term), maximum intensity (for non-serious AEs only), and relationship to vaccination (for systemic AEs only) of unsolicited AEs up to 28 days after vaccination.
    4) Occurrence of any SAE regardless of the relationship to the vaccination(s) throughout the trial from Visit 1 to Visit 2.
    E.5.2.1Timepoint(s) of evaluation of this end point
    Immunogenicity
    1) Pre-dose (Visit 1) and 1 month post-IPV dose (Visit 2)

    Safety
    1) Within 30 minutes of vaccination
    2) Day 0 up to Day 7 post-vaccination
    3) Day 0 up to Day 28 post-vaccination
    4) Day 0 up to Day 28 post-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 Yes
    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) No
    E.7.4Therapeutic use (Phase IV) Yes
    E.8 Design of the trial
    E.8.1Controlled No
    E.8.1.1Randomised No
    E.8.1.2Open Yes
    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 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 trial1
    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 No
    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 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 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: 60
    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) No
    F.1.1.5Children (2-11years) Yes
    F.1.1.5.1Number of subjects for this age range: 60
    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 60
    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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