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    Summary
    EudraCT Number:2013-001864-50
    Sponsor's Protocol Code Number:IIV-268
    National Competent Authority:Netherlands - Competent Authority
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2013-05-31
    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 ConcernedNetherlands - Competent Authority
    A.2EudraCT number2013-001864-50
    A.3Full title of the trial
    Long-term memory immunity against Bordetella pertussis in children 9 years of age who have been vaccinated with acellular pertussis vaccines: effect of an extra preadolescent acellular booster vaccination
    Lange termijn geheugen immuniteit tegen Bordetella pertussis in kinderen 9 jaar oud die zijn gevaccineerd met een acelullair pertussis vaccin: effect van een extra preadolescente acellulaire booster vaccinatie
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Pertussis immunization study
    Kinkhoest immunisatie studie
    A.3.2Name or abbreviated title of the trial where available
    KIM-study
    KIM-studie
    A.4.1Sponsor's protocol code numberIIV-268
    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 SponsorNational Institute for Public Health and the Environment (RIVM, the Netherlands)
    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 pointAnnemarie Buisman
    B.5.3 Address:
    B.5.3.1Street AddressPostbus 1
    B.5.3.2Town/ cityBilthoven
    B.5.3.3Post code3720 BA
    B.5.3.4CountryNetherlands
    B.5.4Telephone number+31302743944
    B.5.6E-mailannemarie.buisman@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 Boostrix IPV
    D.2.1.1.2Name of the Marketing Authorisation holderGlaxoSmithKline
    D.2.1.2Country which granted the Marketing AuthorisationNetherlands
    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 nameBoostrix Polio
    D.3.2Product code Boostrix Polio
    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 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
    The vaccine administered in this study is used to prevent pertussis caused by the bacterium Bordetella pertussis
    E.1.1.1Medical condition in easily understood language
    The vaccine used to vaccinate the participants in this study is used to prevent pertussis caused by the bacterium Bordetella pertussis
    E.1.1.2Therapeutic area Health Care [N] - Environment and Public Health [N06]
    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 pertussis specific IgG antibody levels in serum to determine the effects of a second aP booster vaccination and determine whether there is a difference in IgG levels between wP and aP primed children at 8-9 years of age;
    • To assess memory B- and T-cell responses against the various B. pertussis proteins and determine whether there is a difference between wP and aP primed children at 9 years of age.
    E.2.2Secondary objectives of the trial
    • To assess pertussis specific IgG-subclasses and -avidity;
    • To measure serum specific IgG-antibodies, -subclasses and -avidity and memory B- and T-cell responses against the other vaccine components (Diphtheria, Tetanus, Polio, Mumps, Measles and Rubella);
    • To measure serum specific IgG-antibodies, -subclasses and -avidity against other vaccine components from the NIP;
    • To measure IgA- and IgE- antibodies in serum against the proteins of B. pertussis and other vaccine components from the NIP.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    • Good general health;
    • 8-9 years of age;
    • Vaccinated with Infanrix-IPV + Hib (GSK) at 2, 3, 4, and 11 months of age and with Infanrix-IPV (GSK) at 4 years of age;
    • Received all other regular vaccines according to the Dutch NIP;
    • Provision of written informed consent by both parents or legal representatives;
    • Adherent to protocol and available during the study period
    E.4Principal exclusion criteria
    • Present evidence of serious disease(s) demanding immunosuppressive medical treatment, like corticosteroids, that might interfere with the results of the study within the last 3 months;
    • Antibiotic use within 14 days of enrollment;
    • Any known primary or secondary immunodeficiency;
    • Previous administration of plasma products (including immunoglobulins) within the last 6 months;
    • Vaccination with any other pertussis vaccine than those described in the inclusion criteria (i.e. vaccinated with Pediacel or Triaxis (both from Sanofi Pasteur MSD));
    • Vaccination other than those used in the NIP within a month before vaccination/ blood sampling;
    • Boostrix Polio® must not be given to people with a known hypersensitivity after a previous injection of diphtheria-, tetanus-, pertussis- or poliomyelitis-vaccines or one of the substances of the vaccines;
    • Boostrix Polio® is contraindicated to people who suffered from an encephalopathy without a known cause within 7 days after a former pertussis vaccination;
    • Boostrix Polio® must not be administered to people who suffered from a temporary trombocytopathia or people who had neurologic complications (convulsions or hypotonehyporesponsive episodes) after a former administration with a diphtheria or tetanus vaccine.
    E.5 End points
    E.5.1Primary end point(s)
    Overview of current pertussis specific IgG -levels and -avidity and numbers of B- and T-cells before and after vaccination to determine vaccine responses
    E.5.1.1Timepoint(s) of evaluation of this end point
    After second blood sample and after third and optional fourth blood sample
    E.5.2Secondary end point(s)
    Overview of current IgG -levels and -avidity and numbers of B- and T-cells before and after vaccination to determine vaccine responses of the other vaccine components
    E.5.2.1Timepoint(s) of evaluation of this end point
    After second blood sample and after third and optional fourth blood sample
    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
    Immunologic response
    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.8.3 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
    LVLS
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years7
    E.8.9.1In the Member State concerned months
    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: 80
    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: 80
    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.4.1In the member state80
    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
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2013-05-31
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2013-07-22
    P. End of Trial
    P.End of Trial StatusOngoing
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