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    The EU Clinical Trials Register currently displays   35504   clinical trials with a EudraCT protocol, of which   5838   are clinical trials conducted with subjects less than 18 years old.
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    Summary
    EudraCT Number:2016-003678-42
    Sponsor's Protocol Code Number:IIV-316
    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:2017-06-07
    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 number2016-003678-42
    A.3Full title of the trial
    Immunological effects of an acellular pertussis booster vaccination in children, young adults and elderly with different immunisation background.
    An international study in Finland, the Netherlands and the United Kingdom
    Immunologische effecten van een boostervaccinatie met acellulaire kinkhoest vaccin bij kinderen, jonge volwassenen en ouderen met een verschillende immunisatie achtergrond. Een internationaal onderzoek in Finland, Nederland en het Verenigd Koninkrijk
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Immunological effects of an acellular pertussis booster vaccination in children, young adults and the elderly with different immunisation background.
    An international study in Finland, the Netherlands and the United Kingdom
    Immunologische effecten van een boostervaccinatie met acellulaire kinkhoest vaccin bij kinderen, jonge volwassenen en ouderen met een verschillende immunisatie achtergrond. Een internationaal onderzoek in Finland, Nederland en het Verenigd Koninkrijk
    A.3.2Name or abbreviated title of the trial where available
    Booster against pertussis (Bert)
    Booster against pertussis (Bert)
    A.4.1Sponsor's protocol code numberIIV-316
    A.5.4Other Identifiers
    Name:ABRNumber: NL60807.100.17
    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 supportHorizon 2020/IMI
    B.4.2CountryEuropean Union
    B.4.1Name of organisation providing supportGSK Vaccines
    B.4.2CountryBelgium
    B.4.1Name of organisation providing supportSanofi Pasteur SA
    B.4.2CountryFrance
    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 pointPeriscope-Booster Information
    B.5.3 Address:
    B.5.3.1Street AddressAntonie van Leeuwenhoeklaan 9
    B.5.3.2Town/ cityBilthoven
    B.5.3.3Post code3720 MA
    B.5.3.4CountryNetherlands
    B.5.6E-mailPeriscope@rivm.nl
    B.Sponsor: 2
    B.1.1Name of SponsorClinical Trials and Research Governance
    B.1.3.4CountryUnited Kingdom
    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 supportHorizon 2020/IMI
    B.4.2CountryEuropean Union
    B.4.1Name of organisation providing supportGSK Vaccines
    B.4.2CountryBelgium
    B.4.1Name of organisation providing supportSanofi Pasteur SA
    B.4.2CountryFrance
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationClinical Trials and Research Governance
    B.5.2Functional name of contact pointChurchill Hospital
    B.5.3 Address:
    B.5.3.1Street AddressOld Road
    B.5.3.2Town/ cityOxford
    B.5.3.4CountryUnited Kingdom
    B.5.6E-mailDominic.kelly@paediatrics.ox.ac.uk
    B.Sponsor: 3
    B.1.1Name of SponsorTurun Yliopisto
    B.1.3.4CountryFinland
    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 supportHorizon 2020/IMI
    B.4.2CountryEuropean Union
    B.4.1Name of organisation providing supportGSK Vaccines
    B.4.2CountryBelgium
    B.4.1Name of organisation providing supportSanofi Pasteur SA
    B.4.2CountryFrance
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationTurun Yliopisto
    B.5.2Functional name of contact pointTurku University
    B.5.3 Address:
    B.5.3.1Street AddressKiinamyllynkatu 13
    B.5.3.2Town/ city20520 Turku
    B.5.3.4CountryFinland
    B.5.6E-mailJussi.mertsola@tyks.fi
    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-Polio or Boostrix-IPV
    D.2.1.1.2Name of the Marketing Authorisation holderGlaxoSmithKline
    D.2.1.2Country which granted the Marketing AuthorisationUnited Kingdom
    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.3.4Pharmaceutical 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
    Pertussis infection
    Kinkhoest infectie
    E.1.1.1Medical condition in easily understood language
    Whooping Cough
    Kinkhoest
    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 assess magnitude and changes in pertussis toxin (PT) specific IgG antibody levels just before (T0) and 28 days (T4) after the booster vaccination in 2 cohorts of children (7-10 and 11-15 years of age), 1 cohort of young adults (20-34 years of age) and 1 cohort of elderly (60-70 years of age) in three different countries.
    E.2.2Secondary objectives of the trial
    • Assess the PT specific IgG antibody levels 1 year (T5) after vaccination.
    • Assess the specific IgG antibody levels against other pertussis vaccine antigens (e.g. FHA, Prn and Fim2,3), as well as non-pertussis vaccine antigens (e.g. diphtheria toxoid, tetanus toxoid) at T0, T4 and T5.
    • Determine pertussis-specific IgG-subclasses and -avidity at T0, T4 and T5.
    • Determine functional pertussis-specific antibody levels at T0, T4 and T5.
    • Assess magnitude and longevity of memory B cell responses against the various B. pertussis vaccine proteins at T0, 7 days post vaccination (T2), T4 and T5, to determine the effects of an aP booster vaccination in children, young adults and elderly on memory and effector cell populations.
    • Compare pertussis antigen-specific T helper responses and their ratio’s at T0, 14 days post vaccination (T3), T4 and T5.
    • Collection and biobanking of biological samples for identifying biomarkers of lasting memory or waning of immunity to Pertussis.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    • normal general health;
    • within the right age group for the cohort;
    • received all regular vaccines for their age group according to the Dutch NIP, UK NIP or Finnish NIP; a copy of the vaccination booklet will be included in the participant’s documents. If booklet is not available for cohorts A, B and C, vaccination status will be checked with regulatory agencies / GP. For cohort D this booklet might not be available due to their age;
    • provision of written informed consent (see section 11.2 for details);
    • willing to adhere to the protocol and be available during the study period.
    E.4Principal exclusion criteria
    • present evidence of serious disease(s) within the last 3 months before inclusion requiring immunosuppressive or immune modulating medical treatment, such as systemic corticosteroids, that might interfere with the results of the study ;
    • chronic infection
    • known or suspected immune deficiency;
    • history of any neurologic disorder, including epilepsy;
    • previous administration of serum products (including immunoglobulins) within 6 months before vaccination and blood sampling;
    • known or suspected allergy to any of the vaccine components (by medical history);
    • occurrence of serious adverse events (SAEs) after primary DTwP-IPV vaccination, DTaP-IPV vaccination or any other vaccination (by medical history);
    • vaccination with any other pertussis vaccine than those described in the inclusion criteria (i.e. only according to NIP);
    • vaccination with any other DT-IPV vaccine in the last 5 years, DT-IPV vaccination according to NIP in cohort B is no exclusion;
    • children between 8 and 10 years of age eligible for cohort A in the Netherlands who have already received the diphtheria and tetanus toxoid vaccine (DT)-IPV booster vaccination according to the Dutch NIP around 9 years of age;
    • mixed wP and aP priming within a participant, cohort B;
    E.5 End points
    E.5.1Primary end point(s)
    Anti-PT specific IgG-antibodies in serum and their avidity will be determined for all samples in a PERISCOPE serological core assay, comparing T0, T4 and T5.
    E.5.1.1Timepoint(s) of evaluation of this end point
    before vaccination (T0)
    1 month after vaccination (T4)
    1 year after vaccination (T5)
    E.5.2Secondary end point(s)
    -Specific IgG-levels to other pertussis vaccine antigens (FHA; Prn and Fim2,3), as well as to non-pertussis antigens (diphtheria toxoid and tetanus toxoid) will be determined at T0, T4 and T5, using a PERISCOPE serological multiplex immunoassay.
    -Functional pertussis-specific antibody levels will be determined in serum samples at T0, T4 and T5, using PERISCOPE core assays as described in section 8.3.4. Differences in levels of functional antibodies will be measured before and after vaccination. Functional antibody assays include bacterial adherence inhibition (BAI), PT neutralisation (PTNA), serum bactericidal activity (SBA), and bacterial opsonophagocytosis assay (OPA). Other serological parameters such as avidity, subclass distribution (IgA, IgM) are optional in serum samples .
    -Antigen-specific memory B cell responses at time points T0, T2, T4 and T5 will be measured to determine the effects of aP booster vaccination in children, young adults and elderly, using PERISCOPE B cell core assay.
    -Characterisation of the effect of an aP booster on the specific T cell immune response, both early after the boost and later on, in different age groups, vaccinated initially either with a whole cell or an acellular vaccine.
    -Collection and biobanking of biological samples to be used for testing in novel exploratory immunoassays and for possible bridging to other pertussis vaccine studies.
    E.5.2.1Timepoint(s) of evaluation of this end point
    before vaccination (T0)
    1 day after vaccination (T1)
    7 days after vaccination (T2)
    14 days after vaccination (T3)
    1 month after vaccination (T4)
    1 year after vaccination (T5)
    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
    immune responses
    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 Yes
    E.8.1.7.1Other trial design description
    longitudinal intervention study
    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 Yes
    E.8.5.1Number of sites anticipated in the EEA3
    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 years2
    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 years3
    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: 216
    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: 108
    F.1.1.6Adolescents (12-17 years) Yes
    F.1.1.6.1Number of subjects for this age range: 108
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 75
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 75
    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 For clinical trials recorded in the database before the 10th March 2011 this question read: "Women of childbearing potential" and did not include the words "not using contraception". An answer of yes could have included women of child bearing potential whether or not they would be using contraception. The answer should therefore be understood in that context. This trial was recorded in the database on 2017-06-07. Yes
    F.3.3.2Women of child-bearing potential using contraception Yes
    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 state122
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 366
    F.4.2.2In the whole clinical trial 366
    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 Decision2017-06-07
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2017-09-01
    P. End of Trial
    P.End of Trial StatusOngoing
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