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    Summary
    EudraCT Number:2012-005367-27
    Sponsor's Protocol Code Number:10-PN-PD-DIT-087
    National Competent Authority:Slovakia - SIDC (Slovak)
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2013-02-05
    Trial 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
    N. REVIEW BY THE COMPETENT AUTHORITY OR ETHICS COMMITTEE IN THE COUNTRY CONCERNED
    P. END OF TRIAL
    Expand All   Collapse All
    A. Protocol Information
    A.1Member State ConcernedSlovakia - SIDC (Slovak)
    A.2EudraCT number2012-005367-27
    A.3Full title of the trial
    Evaluation of the immunogenicity and safety of a booster dose of Pfizer’s 13-valent pneumococcal conjugate vaccine (PCV) in children primed with 2 doses of either GSK’s 10-valent PCV or Pfizer’s 13-valent PCV in the Slovak Republic.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Evaluation of the immune response and safety of a booster dose of Pfizer's
    13-valent pneumococcal conjugate vaccine in children primed with 2 doses
    of either GSK's 10-valent pneumococcal conjugate vaccine or Pfizer's 13-
    valent pneumococcal conjugate vaccine in the Slovak Republic
    A.3.2Name or abbreviated title of the trial where available
    PCV-MIXED-SCHEDULE
    A.4.1Sponsor's protocol code number10-PN-PD-DIT-087
    A.5.4Other Identifiers
    Name:eTrack study NumberNumber:117293
    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 SponsorBIOVOMED
    B.1.3.4CountryCzech Republic
    B.3.1 and B.3.2Status of the sponsorNon-Commercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing supportGSK
    B.4.2CountryBelgium
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationChildren Faculty Hospital Košice
    B.5.2Functional name of contact pointIngrid Urbancikova
    B.5.3 Address:
    B.5.3.1Street AddressTrieda SNP 1
    B.5.3.2Town/ cityKošice
    B.5.3.3Post code04011
    B.5.3.4CountrySlovakia
    B.5.4Telephone number0421911700240
    B.5.6E-mailurbancikova@dfnkosice.sk
    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 Prevenar 13
    D.2.1.1.2Name of the Marketing Authorisation holderWyeth Lederle Vaccines S.A.
    D.2.1.2Country which granted the Marketing AuthorisationSlovakia
    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 namePrevenar 13
    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 Yes
    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
    To induce appropriate protection against pneumococcal disease. To
    assess non-inferiority of OPA response for serotype 19A after booster
    dose of PCV13 administered between 11-12 months of age in subjects
    primed with 10Pn-PD-DiT vs those primed with PCV13.
    E.1.1.1Medical condition in easily understood language
    To induce comparable protection against pneumococcal disease in
    combination schedule with 2 different pneumococcal conjugate vaccines
    or in schedule with one vaccine.
    E.1.1.2Therapeutic area Diseases [C] - Bacterial Infections and Mycoses [C01]
    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 assess non-inferiority of OPA response for serotype 19A after booster
    dose of PCV13 administered between 11-12 months of age in subjects
    primed with 10Pn-PD-DiT vs those primed with PCV13.
    E.2.2Secondary objectives of the trial
    To assess non-inferiority of antibody response for serotype 19A after
    booster dose of PCV13 administered between 11-12 months of age in
    subjects primed with 10Pn-PD-DiT vs those primed with PCV13.
    To assess antibody and OPA responses one month after booster dose of
    PCV13 administered between 11-12 months of age for serotypes in 1, 3,
    4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, 23F.
    To assess the antibody persistence and OPA 12 months following the
    PCV booster dose for serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A,
    19F, 23F.
    To evaluate safety and reactogenicity of the booster dose of PCV13 given
    at 11-12 months
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    All subjects must satisfy ALL the following criteria at study entry:
    • Subjects who the investigator believes that their parent(s)/Legally
    Acceptable Representative(s) (LARs) can and will comply with the
    requirements of the protocol (e.g. completion of the diary cards, return
    for follow-up visits).
    • Written informed consent obtained from the parents/LAR(s) of the
    subject.
    • Healthy subjects as established by medical history and clinical
    examination before entering into the study.
    • Subjects between and including 11 to 12 months of age at the time of
    vaccination for booster dose with PCV13.
    • Previously completed two-dose vaccination course till month 6 with
    either 10Pn-PD-DiT for Group 10Pn-PD-DiT or PCV13 for Group PCV13.
    E.4Principal exclusion criteria
    The following criteria should be checked at the time of study entry for all subjects. If ANY exclusion criterion applies, the subject must not be
    included in the study:
    • Child in care (A child who has been placed under the control or
    protection of an agency, organisation, institution or entity by the courts,
    the government or a government body, acting in accordance with powers
    conferred on them by law or regulation.)
    • Use of any investigational or non-registered product (drug or vaccine)
    other than the study vaccine within 30 days preceding the dose of study
    vaccine, or planned use during the study period.
    • Chronic administration (defined as more than 14 days in total) of
    immunosuppressants or other immune-modifying drugs since birth. For
    corticosteroids, this will mean prednisone ≥ 0.5 mg/kg/day, or
    equivalent. Inhaled and topical steroids are allowed.
    • Planned administration/administration of a vaccine not foreseen by
    the study protocol during the study period starting from 30 days before
    the dose and ending 30 days after the dose of vaccine(s), with the
    exception of licensed influenza vaccines and licensed DTP vaccines.
    The licensed influenza vaccines are always allowed, even if
    concomitantly administered with the study vaccines.
    Administration of any of the vaccines mentioned above has to be
    documented in the "Concomitant vaccination" of the CRF (Case Record
    Form).
    • Concurrently participating in another clinical study, at any time
    during the study period, in which the subject has been or will be exposed
    to an investigational or a non-investigational product (pharmaceutical
    product or device).
    • Previous booster vaccination against S. pneumoniae.
    • Any confirmed or suspected immunosuppressive or immunodeficient
    condition, based on medical history and physical examination (no
    laboratory testing required).
    • Family history of congenital or hereditary immunodeficiency.
    • History of any reaction or hypersensitivity likely to be exacerbated by
    any component of the vaccine(s).
    • Major congenital defects or serious chronic illness.
    • History of any neurological disorders or seizures.
    • Acute disease and/or fever at the time of enrolment. Subjects with
    temperature bellow 37.5°C on oral, axillary or tympanic setting, or
    bellow 38.0°C on rectal setting and subjects with mild disease without
    fever e.g mild diarrhea or mild URTI may be enrolled at the discreation
    of the investigator.
    • Administration of immunoglobulins and/or any blood products within
    the 3 months preceding vaccination or planned administration during
    study period.
    • Any medical condition which might interfere with the assessment of
    the study objectives in the opinion of the investigator.
    • Anaphylaxis following previous administration of a pneumococcal
    conjugate vaccine.
    E.5 End points
    E.5.1Primary end point(s)
    To assess non-inferiority of OPA response for serotype 19A after booster
    dose of PCV13 administered between 11-12 months of age in subjects
    primed with 10Pn-PD-DiT vs those primed with PCV13.
    • Opsonophagocytic activity (titres) against vaccine pneumococcal
    serotype 19A one month after booster dose.
    E.5.1.1Timepoint(s) of evaluation of this end point
    Month 1 ± 14 days (Age 12-13 months)
    Months 12 ± 14 days (Age 23-24 months)
    E.5.2Secondary end point(s)
    To assess non-inferiority of antibody response for serotype 19A after
    booster dose of PCV13 administered between 11-12 months of age in
    subjects primed with 10Pn-PD-DiT vs those primed with PCV13.
    • Concentrations of antibodies against vaccine pneumococcal serotype
    19A one month after booster dose.
    • Concentrations of antibodies against vaccine pneumococcal serotypes
    1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, 23F one month after booster
    dose.
    • Opsonophagocytic activity (titres) against vaccine pneumococcal
    serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, 23F one month
    after booster dose.
    • Concentrations of antibodies against vaccine pneumococcal serotypes
    1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, 23F 12 months after booster
    dose.
    • Opsonophagocytic activity against vaccine pneumococcal serotypes 1,
    3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, 23F, 12 months after booster
    dose.
    Safety and reactogenicity:
    • Occurrence of each solicited adverse event within 4 days after
    booster vaccination with PCV13.
    - Local (any, grade 3) adverse events (Day 0-3)
    - General (any, grade 3, related) adverse events (Day 0-3)
    • Occurrence of unsolicited adverse events within 31 days (Day 0-30)
    after booster vaccination with PCV13.
    • Occurrence of serious adverse events during the entire study period.
    E.5.2.1Timepoint(s) of evaluation of this end point
    Immunogenicity
    Month 1 ± 14 days (Age 12-13 months)
    Months 12 ± 14 days (Age 23-24 months)
    Safety
    30 minutes, 4 days, 30 days, follow-up
    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 No
    E.8.1.2Open Yes
    E.8.1.3Single blind No
    E.8.1.4Double blind No
    E.8.1.5Parallel group Yes
    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 The trial involves single site in the Member State concerned No
    E.8.4 The trial involves multiple sites in the Member State concerned Yes
    E.8.4.1Number of sites anticipated in Member State concerned4
    E.8.5The trial involves multiple Member States No
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA No
    E.8.6.2Trial being conducted completely outside of the EEA No
    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.8.9.1In the Member State concerned years1
    E.8.9.1In the Member State concerned months3
    E.8.9.1In the Member State concerned days
    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: 92
    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: 92
    F.1.1.5Children (2-11years) No
    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 Yes
    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 Yes
    F.3.3.6.1Details of subjects incapable of giving consent
    Small children 11-12 months of age at enrollment
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state92
    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)
    No special treatment or procedures. Immunization schedule will be
    considered as completed.
    G. Investigator Networks to be involved in the Trial
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2013-02-12
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2012-11-20
    P. End of Trial
    P.End of Trial StatusOngoing
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