Flag of the European Union EU Clinical Trials Register Help

Clinical trials

The European Union Clinical Trials Register   allows you to search for protocol and results information on:
  • interventional clinical trials that were approved in the European Union (EU)/European Economic Area (EEA) under the Clinical Trials Directive 2001/20/EC
  • clinical trials conducted outside the EU/EEA that are linked to European paediatric-medicine development

    • EU/EEA interventional clinical trials approved under or transitioned to the Clinical Trial Regulation 536/2014 are publicly accessible through the
    Clinical Trials Information System (CTIS).

    The EU Clinical Trials Register currently displays   44335   clinical trials with a EudraCT protocol, of which   7366   are clinical trials conducted with subjects less than 18 years old.   The register also displays information on   18700   older paediatric trials (in scope of Article 45 of the Paediatric Regulation (EC) No 1901/2006).

    Phase 1 trials conducted solely on adults and that are not part of an agreed paediatric investigation plan (PIP) are not publicly available (see Frequently Asked Questions ).  
     
    Examples: Cancer AND drug name. Pneumonia AND sponsor name.
    How to search [pdf]
    Search Tips: Under advanced search you can use filters for Country, Age Group, Gender, Trial Phase, Trial Status, Date Range, Rare Diseases and Orphan Designation. For these items you should use the filters and not add them to your search terms in the text field.
    Advanced Search: Search tools
     

    < Back to search results

    Print Download

    Summary
    EudraCT Number:2013-001823-38
    Sponsor's Protocol Code Number:IMS-267
    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:2013-08-05
    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 ConcernedNetherlands - Competent Authority
    A.2EudraCT number2013-001823-38
    A.3Full title of the trial
    Second meningococcal vaccination in Dutch children: Study to compare the tetravalent MenACWY-TT conjugate vaccine with the monovalent MenC-TT conjugate vaccine.
    Tweede meningokokken vaccinatie bij nederlandse kinderen: Een onderzoek waarbij het tetravelente MenACWY-TT vaccin vergeleken zal worden met het monovalente MenC-TT vaccin.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Second meningococcal vaccination in Dutch children: Study to compare the tetravalent MenACWY-TT conjugate vaccine with the monovalent MenC-TT conjugate vaccine.
    Tweede meningokokken vaccinatie bij nederlandse kinderen: Een onderzoek waarbij het tetravelente MenACWY-TT vaccin vergeleken zal worden met het monovalente MenC-TT vaccin.
    A.3.2Name or abbreviated title of the trial where available
    JIM study
    JIM studie
    A.4.1Sponsor's protocol code numberIMS-267
    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 of Public Health and 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 supportNational Institute of Public Health and Environment (RIVM, the Netherlands)
    B.4.2CountryNetherlands
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationNational Institute of Public Health and Environment (RIVM, the Netherlands)
    B.5.2Functional name of contact pointGuy Berbers
    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 number0031302742496
    B.5.6E-mailguy.berbers@rivm.nl
    D. IMP Identification
    D.IMP: 1
    D.1.2 and D.1.3IMP RoleComparator
    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 NeisVac-C
    D.2.1.1.2Name of the Marketing Authorisation holderBaxter Healthcare Limited
    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 nameNeisVac-C
    D.3.2Product code NeisVac-C
    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.IMP: 2
    D.1.2 and D.1.3IMP RoleComparator
    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 Nimenrix
    D.2.1.1.2Name of the Marketing Authorisation holderGSK
    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 nameNimenrix
    D.3.2Product code Nimenrix
    D.3.4Pharmaceutical form Suspension for injection
    D.3.4.1Specific paediatric formulation Information not present in EudraCT
    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 monovalent MenC-TT vaccin administered in this study is used to prevent invasive disease caused by Meningococcal group C. The tetravelent MenACWY-TT vaccin administered in this study is used to prevent invasive disease caused by Meningococcal serogroup A, C, W and Y.
    Het monovalente MenC-TT vaccine beschermt tegen invasieve meningokokkenziekte van type C. Het tetravalente MenACWY-TT vaccine beschermt tegen invasieve meningokokkenziekte van type A, C, W en Y.
    E.1.1.1Medical condition in easily understood language
    Invasive meningococcal disease - meningitis - sepsis
    Invasieve meningokokkenziekte - hersenvliesontsteking - bloedvergiftiging
    E.1.1.2Therapeutic area Diseases [C] - Bacterial Infections and Mycoses [C01]
    MedDRA Classification
    E.1.3Condition being studied is a rare disease Yes
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    The primary objective is to demonstrate non-inferiority of SBA levels against MenC at 1 year (T2) after vaccination in the group vaccinated with tetravalent MenACWY-TT vaccine as compared with the group vaccinated with monovalent MenC-TT conjugate vaccine in 10-, 12-, and 15-years old children.
    If non-inferiority is demonstrated, the objective is to compare SBA levels against MenA, MenW and MenY at 1 year (T2) after vaccination between the three age groups that are vaccinated with tetravalent MenACWY-TT vaccine.
    E.2.2Secondary objectives of the trial
    See E.5.2 Secondary end points
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Participants are 10-, 12, and 15-year old children who have received a primary vaccination with a single dose of MenC-TT vaccine (NeisVac-C™) either during the mass catch-up campaign in 2002 (group 4 and 5) or at the age of 14 months (regular vaccination time point since 2002 according to the Dutch NIP; group 1,2 and 3).
    Furthermore, participants have to fulfil all of the following criteria:
    - Provision of written informed consent by both parents and (if child is 12 or 15 years old; see Annex 3) child;
    - Good general health;
    - Received all regular vaccines according to Dutch NIP;
    - Adherent to protocol, and available during the study period.
    E.4Principal exclusion criteria
    Any of the following criteria at the start of the study will exclude a volunteering child from participation:
    - Severe acute (infectious) illness or fever (>38.5°C) within 14 days before vaccination;
    - Antibiotic use within 14 days of enrollment;
    - Present evidence of serious disease(s) demanding (immunosuppressive) medical treatment that might interfere the results of the study within the last 3 months (like, corticosteroids, chronic infection, bleeding disorder, immune dysfunction, genetic anomaly);
    - Known or suspected allergy to any of the vaccine components (by medical history);
    - Occurrence of serious adverse event after primary MenC-TT vaccination or other vaccination (by medical history)
    - Known or suspected immune deficiency;
    - History of any neurologic disorder, including epilepsy;
    - Previous administration of plasma products (including immunoglobulins) within the last 6 months;
    - Pregnancy;
    - Previous confirmed or suspected meningococcal disease;
    - Former received doses of MenC vaccines in addition to the primary vaccination;
    - Former received any tetravalent MenACWY vaccination;
    - Received any vaccination in the past month.
    E.5 End points
    E.5.1Primary end point(s)
    The primary objective is to demonstrate non-inferiority of SBA levels against MenC at 1 year (T2) after vaccination in the group vaccinated with tetravalent MenACWY-TT vaccine as compared with the group vaccinated with monovalent MenC-TT conjugate vaccine in 10-, 12-, and 15-years old children.
    If non-inferiority is demonstrated, the objective is to compare SBA levels against MenA, MenW and MenY at 1 year (T2) after vaccination between the three age groups that are vaccinated with tetravalent MenACWY-TT vaccine.
    E.5.1.1Timepoint(s) of evaluation of this end point
    T0: First visit (Informed consent, blood sample, saliva sample and vaccination)
    T1: Second visit 1 month after T0 (blood sample, saliva sample)
    T2: Final visit 1 year after T0 (blood sample, saliva sample)
    E.5.2Secondary end point(s)
    - To compare SBA levels against MenC at 1 month (T1) between the vaccine groups within the
    three age groups.
    - To compare SBA levels against MenC of ≥8 (persistence of vaccine induced protective antibody levels) at 1 month (T1) and 1 year (T2) between the vaccine groups within the three age groups.
    - To compare serum MenC-PS specific IgG levels at 1 month (T1) and 1 year (T2) between the vaccine groups within the three age groups.
    - To compare the decay rate of SBA levels and MenC-PS specific IgG levels after secondary vaccination (i.e. the difference between T2 and T1) between the vaccine groups within the three age groups.
    - To compare SBA levels against MenA, MenW and MenY at 1 month (T1) between the three age groups within the MenACWY-TT vaccine group.
    - To compare SBA levels against MenA, MenW and MenY of ≥8 at 1 month (T1) and 1 year (T2) between the three age groups within the MenACWY-TT vaccine group.
    - To compare serum MenA-PS, MenY-PS and MenW-PS specific IgG levels at 1 month (T1) and 1 year (T2) between the three age groups within the MenACWY-TT vaccine group.
    - To compare serum IgG antibody levels against tetanus, the carrier protein for both vaccines, at 1 month (T1) and 1 year (T2)? between the vaccine groups within the three age groups.
    - To compare serum IgA levels against MenA, MenC, MenW and MenY at 1 month (T1) and at 1 year (T2) between the vaccine groups within the three age groups.
    - To compare MenC-PS specific IgG subclasses (IgG1/IgG2 ratio) and avidity at 1 month (T1) and 1 year (T2)? between the vaccine groups within the three age groups.
    - To compare SBA and IgG levels against MenC at 1 month and 1 year between the MenC-TT group of the current study and the TIM-study for the the 12- and 15- year olds, to establish the effect of the age at priming on antibody responses to a second MenC-TT vaccination during adolescence.
    - Explorative: To measure saliva IgG and IgA levels at T0 1 month (T1) and 1 year (T2) in all groups.
    - Explorative: To measure B- and T-cell memory immune responses at T0, 1 month (T1) and 1 year (T2) in all groups.
    E.5.2.1Timepoint(s) of evaluation of this end point
    T0: First visit (Informed consent, blood sample, saliva sample and vaccination)
    T1: Second visit 1 month after T0 (blood sample, saliva sample)
    T2: Final visit 1 year after T0 (blood sample, saliva sample)
    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 Yes
    E.6.7Pharmacodynamic Yes
    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 respons
    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 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) 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
    The end of the trial is defined as the last visit of the last subject.
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years
    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: 410
    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: 82
    F.1.1.6Adolescents (12-17 years) Yes
    F.1.1.6.1Number of subjects for this age range: 328
    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
    Subjects under age incapable of giving consent personally. The participant and his/her parents are asked to sign the informed consent form in advance to ensure that both parents signed the form. Afterwards, the study will start.
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state410
    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 Decision2013-08-05
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2013-08-01
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2015-05-12
    For support, Contact us.
    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
    As of 31 January 2023, all EU/EEA initial clinical trial applications must be submitted through CTIS . Updated EudraCT trials information and information on PIP/Art 46 trials conducted exclusively in third countries continues to be submitted through EudraCT and published on this website.

    European Medicines Agency © 1995-Sat May 10 11:00:51 CEST 2025 | Domenico Scarlattilaan 6, 1083 HS Amsterdam, The Netherlands
    EMA HMA