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   43845   clinical trials with a EudraCT protocol, of which   7282   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:2019-001301-24
    Sponsor's Protocol Code Number:IIV-407
    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:2020-02-24
    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 number2019-001301-24
    A.3Full title of the trial
    ‘Primary and booster meningococcal vaccination in Dutch elderly: study to investigate the immune response and determine functional antibodies after the tetravalent MenACWY-TT conjugate vaccine in the elderly population’
    Primaire en booster meningokokkenvaccinatie in Nederlandse ouderen: een studie om de immuunrespons te onderzoeken en functionele antistoffen te bepalen na een meningokokken ACWY-vaccinatie in de oudere populatie
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Study to investigate the immune response and determine functional antibodies after a MenACWY-vaccination
    Studie naar de werkzaamheid van een MenACWY-vaccinatie bij volwassenen van 65 jaar en ouder
    A.3.2Name or abbreviated title of the trial where available
    Men4age study
    Men4age studie
    A.4.1Sponsor's protocol code numberIIV-407
    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)
    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 for Public Health and the Environment (RIVM)
    B.4.2CountryNetherlands
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationNational Institute for Public Health and the Environment (RIVM)
    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 number+31-3-2743496
    B.5.6E-mailguy.berbers@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 Nimenrix
    D.2.1.1.2Name of the Marketing Authorisation holderPfizer Europe MA EEIG
    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.3.4Pharmaceutical form Powder and solution for solution 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 tetravelent MenACWY-TT vaccin administered in this study is used to prevent invasive disease caused by Meningococcal serogroup A, C, W and Y.
    Het tetravalente MenACWY-TT vaccin 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 aim of this study is to investigate the immune response to a primary and a booster immunization with a tetravalent MenACWY-TT conjugate vaccine in elderly aged 65-85 years of age. Functional antibody levels against MenA, MenC, MenW and MenY are measured using the serum bactericidal antibody (SBA) assay. In addition, serum MenA-PS, MenC-PS, MenW-PS and MenY-PS specific IgG and IgA and IgM levels, subclasses and avidity are measured using fluorescent-bead-based multiplex immunoassay (MIA).
    E.2.2Secondary objectives of the trial
    ▪ To compare SBA levels of ≥8 (persistence of vaccine induced protective antibody levels) at 1 month and 1 year after the booster vaccination between the single vaccination cohort and the booster vaccination cohort
    ▪ To determine serum MenA-PS, MenC-PS, MenW-PS and MenY-PS specific IgG levels at 1 month and 1 year and compare between the single vaccination cohort and booster cohort
    ▪ To determine serum IgG antibody levels against tetanus, the carrier protein for both vaccines, at 1 month and 1 year and compare between the single vaccination cohort and booster cohort at and 1 month and 1 year after the booster
    ▪ To determine serum IgA and IgM levels against MenA, MenC, MenW and MenY at 1 month and 1 year and compare between the single vaccination cohort and booster cohort
    ▪ To determine MenC-PS specific IgG subclasses (IgG1/IgG2 ratio) and avidity and compare the single vaccination cohort and booster cohort
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Participants eligible for this study are healthy Dutch elderly 65-85 years of age, who did not receive a MenACWY-TT vaccine before.
    E.4Principal exclusion criteria
    A potential subject who meets any of the following criteria will be excluded from participation in this study:
     Antibiotic use within 14 days of enrolment
     Severe acute infectious illness or fever above 38.0 °C within 14 days before vaccination;
     Present evidence of serious diseases either demanding regular use of oral immunosuppressive medical treatment, like corticosteroids, that might interfere with the results of the study within the last 3 months or demanding acute use of high dose oral immunosuppressive that might interfere with the results of the study within the last 2 weeks;
     Known or suspected allergy to any of the vaccine components (by medical history);
     Occurrence of a serious adverse event after other vaccination by medical history;
     Known or suspected immune deficiency;
     Known or suspected coagulation disorder;
     Oral hormone use, such as postmenopausal hormones, within the last 3 months;
     History of one of the following neurological disorders: multiple sclerosis, Parkinson’s disease, or epilepsy;
     Previous administration of plasma-serum products including immunoglobulins within 6 months before vaccination and blood sampling;
     Serious surgery within the last 3 months;
     Previous vaccination with the MenC, MenC-TT or MenACWY-TT vaccine;
     Previous confirmed or suspected meningococcal disease;
     Any vaccination within a month before enrolment.
    Presence of in-and exclusion criteria will be checked by interviewing the participant during the first phone call. In addition, presence of in-and exclusion criteria will be checked at the first study visit again, prior to signing the informed consent.
    E.5 End points
    E.5.1Primary end point(s)
    The primary objective is to determine the level of protection in the elderly (divided into two groups: single vaccination cohort and booster vaccination cohort) to the MenACWY-TT conjugate vaccine. The primary parameter to determine the level of protection will be by measuring meningococcal specific serum bactericidal antibody (SBA) levels pre-vaccination (T0) and 1 month (T1) and 1 year (T2) after vaccination. Also, in the booster-subcohort SBA levels will be determined 1 month (T3) and 1 year (T4) after the booster vaccination. At T4, blood samples will also be drawn from the participants who only received a single vaccination.
    E.5.1.1Timepoint(s) of evaluation of this end point
    The total duration of the study is two years and comprises three visits for the participants that receive only the primary vaccination, and five visits for the participants that receive the booster vaccination, to a study site. All participants (n=140) will receive the tetravalent MenACWY-TT conjugate vaccination. Blood samples will be drawn prior to this vaccination (T0) and 1 month (T1) and 1 year (T2) after vaccination. In the booster subcohort (n=70), after the venipuncture at T2, the participants will receive a booster vaccination. Blood samples will be drawn 1 month (T3) and 1 year (T4) after booster vaccination. At T4, blood samples will also be drawn from the participants who only received a single vaccination.
    E.5.2Secondary end point(s)
    ▪ To compare SBA levels of ≥8 (persistence of vaccine induced protective antibody levels) at 1 month and 1 year after the booster vaccination between the single vaccination cohort and the booster vaccination cohort
    ▪ To determine serum MenA-PS, MenC-PS, MenW-PS and MenY-PS specific IgG levels at 1 month and 1 year and compare between the single vaccination cohort and booster cohort at 1 month and 1 year after the booster vaccination
    ▪ To determine serum IgG antibody levels against tetanus, the carrier protein for both vaccines, at 1 month and 1 year and compare between the single vaccination cohort and booster cohort at and 1 month and 1 year after the booster
    ▪ To determine serum IgA and IgM levels against MenA, MenC, MenW and MenY at 1 month and 1 year and compare between the single vaccination cohort and booster cohort at 1 month and 1 year after the booster vaccination
    ▪ To determine MenC-PS specific IgG subclasses (IgG1/IgG2 ratio) and avidity at 1 month and 1 year and compare the single vaccination cohort and booster cohort at 1 month and 1 year after the booster vaccination
    ▪ Explorative: to explore possible differences in protective levels against at all timepoints between sub age groups (65-75 years and 75-85 years of age)
    E.5.2.1Timepoint(s) of evaluation of this end point
    The total duration of the study is two years and comprises three visits for the participants that receive only the primary vaccination, and five visits for the participants that receive the booster vaccination, to a study site. All participants will receive the tetravalent MenACWY-TT conjugate vaccination. Blood samples will be drawn prior to this vaccination (T0) and 1 month (T1) and 1 year (T2) after vaccination. In the booster subcohort (n=70 for each age group, total subcohort n=140), after the venipuncture at T2, the participants will receive a booster vaccination. Blood samples will be drawn 1 month (T3) and 1 year (T4) after booster vaccination. At T4, blood samples will also be drawn from the participants who only received a single vaccination.
    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 Yes
    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
    Immunological 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 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) No
    E.8.2.2Placebo No
    E.8.2.3Other Yes
    E.8.2.3.1Comparator description
    treatment arms
    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
    LVLS
    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 No
    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) No
    F.1.1.6Adolescents (12-17 years) No
    F.1.2Adults (18-64 years) No
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 140
    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 state140
    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 Decision2020-02-24
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2020-03-20
    P. End of Trial
    P.End of Trial StatusOngoing
    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-Thu Apr 18 13:01:19 CEST 2024 | Domenico Scarlattilaan 6, 1083 HS Amsterdam, The Netherlands
    EMA HMA