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    Summary
    EudraCT Number:2011-002103-15
    Sponsor's Protocol Code Number:VAC-259
    National Competent Authority:Netherlands - Competent Authority
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2013-08-13
    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
    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 ConcernedNetherlands - Competent Authority
    A.2EudraCT number2011-002103-15
    A.3Full title of the trial
    Development of humoral and cellular immune response in infants after pneumococcal conjugate vaccinations with
    Synflorix® or Prevenar-13®
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Immunity and immunological memory after pneumococcal vaccination in children
    Immuniteit en immunologisch geheugen na pneumokokkenvaccinatie in kinderen
    A.3.2Name or abbreviated title of the trial where available
    Pneumococcal immune response to PCV10 and PCV13 in infants
    A.4.1Sponsor's protocol code numberVAC-259
    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 SponsorRIVM
    B.1.3.4CountryNetherlands
    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 supportRIVM
    B.4.2CountryNetherlands
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationRIVM
    B.5.2Functional name of contact pointClinical and Regulatory Research
    B.5.3 Address:
    B.5.3.1Street AddressPO Box 1
    B.5.3.2Town/ cityBilthoven
    B.5.3.3Post code3720 BA
    B.5.3.4CountryNetherlands
    B.5.4Telephone number0031302743299
    B.5.5Fax number0031302744415
    B.5.6E-mailVAC-259@rivm.nl
    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 Synflorix
    D.2.1.1.2Name of the Marketing Authorisation holderGlaxoSmithKline Biologicals S.A.
    D.2.1.2Country which granted the Marketing AuthorisationEuropean Union
    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.3.4Pharmaceutical form Suspension for injection
    D.3.4.1Specific paediatric formulation Yes
    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 Prevenar-13
    D.2.1.1.2Name of the Marketing Authorisation holderWyeth Lederle Vaccines S.A.
    D.2.1.2Country which granted the Marketing AuthorisationEuropean Union
    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.3.4Pharmaceutical form Suspension for injection
    D.3.4.1Specific paediatric formulation Yes
    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
    Immunity and immune memory after pneumococcal vaccination against S. pneumoniae serotypes present in either Synflorix or Prevenar-13
    E.1.1.1Medical condition in easily understood language
    Immunity and immunological memory after pneumococcal vaccination
    E.1.1.2Therapeutic area Body processes [G] - Immune system processes [G12]
    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 compare immunogenicity (humoral and cellular) induced by PCV10 and PCV13 after the booster dose of a complete vaccination series (3+1, the current NIP schedule)
    E.2.2Secondary objectives of the trial
    To compare immunogenicity (humoral) induced by PCV10 and PCV13 at 5, 8, 11 and 12 months of a complete vaccination series (3+1, the current NIP schedule)

    To investigate the possible influence of the pneumococcal vaccination on the serological responses of other vaccine components of the NIP which are administered simultaneously in the other limb (DTaP-Hib)
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    • The children have to be of normal health (same health criteria apply as used in well-baby clinics when a child receives a vaccination, e.g. also children with small increases in temperature (≤38.5 °C) or cold are seen as children with normal health)
    • The parents/legally representatives have to be willing and able to allow their child to participate in the trial according to the described procedures
    • Presence of a signed informed consent (the parents/legally representatives have given written informed consent after receiving oral and written information)
    • Group 1: The children are 2 months old (± 2 weeks), have not received any vaccinations and will receive all vaccinations (DTaP-IPV-Hib-HepB and PCV13) by the study team
    • Group 2: The children are 4-6 months old and have received three DTaP-IPV-Hib-HepB and PCV10 vaccinations according to the 3+1 schedule of the Dutch NIP*.

    *The Dutch NIP 3+1 schedule: All children born as of August 1st 2011 will receive Synflorix (PCV10) and DTaP-IPV-Hib-HepB vaccinations, at the age of 2, 3 4 and 11 months of age.
    E.4Principal exclusion criteria
    Exclusion criteria
    • Group 1: Previous vaccinations with PCV7 or PCV10
    • Group 2: Previous vaccinations with PCV7 of PCV13
    • Vaccinations using a schedule that differs from the Dutch 3+1 schedule
    • Presence of a serious disease that requires medical care that can interfere with the results of the study
    • Known or expected allergy/hypersensitivity against one of the vaccine ingredients
    (anamnestic, be alert if the child has had medical complaints after previous pneumococcal vaccinations)
    • Known or suspected immunological disorder
    • Previously administration of plasma products (including immunoglobulin), within three months of study enrolment
    • Presence of bleeding disorders
    • Communication problems that interfere with the trial
    • Prematurity (<37 weeks after gestation)
    E.5 End points
    E.5.1Primary end point(s)
    Pneumococcal serotypes
    • Cellular immune response (Plasma B cells and memory B cells) immediately before and 7-9 days after the booster at 11-months of age
    • Humoral immune response (antibody concentrations and geometric mean concentrations (GMT)) at 12 months of age
    E.5.1.1Timepoint(s) of evaluation of this end point
    Cellular: at 11 months and 7-9 days after 11 months vaccination
    Humoral: at 12 months
    E.5.2Secondary end point(s)
    Pneumococcal serotypes
    • Opsonophagocytoses immediately before and 7-9 days after the booster at 11-months of age
    • Avidity at 5, 8, immediately before and 7-9 days after the booster at 11-months and at 12 months of age
    • Antibody concentrations and geometric mean concentrations (GMT) at 5, 8, immediately before and 7-9 days after the booster at 11-months and at 12 months of age
    • Kinetics of antibody concentrations and geometric mean concentrations (GMT) over time (at 5, 8, 11 and 12 months of age)

    DTaP-HIb
    • Antibody concentrations and geometric mean concentrations (GMT) at 5, 8, 11 and 12 months of age
    E.5.2.1Timepoint(s) of evaluation of this end point
    Humoral: at 5, 8, 11, 7-9 days after 11 months vaccination and 12 months

    Opsonophagocytoses: immediately before and 7-9 days after the booster at 11-months of age

    Avidity: at 5, 8, immediately before and 7-9 days after the booster at 11-months and at 12 months of age

    DTaP-Hib, humoral: at 5, 8, 11 and 12 months of age
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis No
    E.6.2Prophylaxis No
    E.6.3Therapy No
    E.6.4Safety No
    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
    immunity and immune memory after pneumococcal vaccination
    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 Yes
    E.8.1.1Randomised Yes
    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 Yes
    E.8.1.7.1Other trial design description
    exploratory
    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 Yes
    E.8.4 The trial involves multiple sites in the Member State concerned No
    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
    last subjects last visit
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years0
    E.8.9.1In the Member State concerned months0
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years0
    E.8.9.2In all countries concerned by the trial months0
    E.8.9.2In all countries concerned by the trial days0
    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: 132
    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: 132
    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
    infants
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state132
    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)
    Group 1. Options in case of premature termination are needed to make sure that the child receives the necessary vaccinations. A schedule started with PCV13 should be finished with either PCV13 or PCV7 (not by PCV10). Completion of the schedule can be done by the study team, who can give PCV13. If parents refuse home visits from the study team the well-baby clinic can complete the schedule, with PCV7 (since PCV13 is not part of the RVP and the well-baby clinic can therefore not provide PCV13).
    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 Decision2011-08-01
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2011-09-07
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2012-12-13
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