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    Summary
    EudraCT Number:2020-003620-16
    Sponsor's Protocol Code Number:IIV-465
    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:2021-05-27
    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 number2020-003620-16
    A.3Full title of the trial
    Vaccine immunogenicity in Dutch frail versus non-frail older individuals (participating in the Doetinchem Cohort study)
    Vaccin immuniteit in Dutch kwetsbare versus niet-kwetsbare ouderen (deelnemend aan de Doetinchem Cohort study)
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Vaccines, Immunity and Aging study
    Vaccinaties, Immuniteit en VerouderingsOnderzoek
    A.3.2Name or abbreviated title of the trial where available
    VIVO
    VIVO
    A.4.1Sponsor's protocol code numberIIV-465
    A.5.4Other Identifiers
    Name:ABR number Number:74843.041.20
    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 Health and the Environment
    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 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 of Health and the Environment (RIVM)
    B.5.2Functional name of contact pointVIVO studieteam
    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-mailVIVO@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 Pneumovax 23
    D.2.1.1.2Name of the Marketing Authorisation holderMerck Sharp & Dohme B.V.
    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 namePneumovax 23
    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.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.2.1.2Country 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.3.4Pharmaceutical form Suspension for injection in pre-filled injector
    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: 3
    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.2.1.2Country 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 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 Yes
    D.3.11.10Medicinal product containing genetically modified organisms Yes
    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
    Older adults 73-79 years of age, birth cohorts year 1941-1947, still participating in round 6 of the Doetinchem Cohort Study.
    Oudere volwassenen 73-79 jaar oud, geboortecohort 1941-1947, die meedoen aan ronde 6 van de Doetinchem Cohort Studie.
    E.1.1.1Medical condition in easily understood language
    Older adults 73-79 years of age, birth cohorts year 1941-1947, still participating in round 6 of the Doetinchem Cohort Study.
    Oudere volwassenen 73-79 jaar oud, geboortecohort 1941-1947, die meedoen aan ronde 6 van de Doetinchem Cohort Studie.
    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
    Assess the relation of frailty in 73-79 years old male and female persons with antibody responses to both vaccine pneumococcal polysaccharide serotypes and the Influenza virus vaccine strains by measuring HI titers pre and 4-6 weeks post vaccination.
    Bekijken van de relatie tussen kwetsbaarheid, in 73-79 jarigen mannen en vrouwen, en antistof response tegen vaccine pneumokokken serotypen en influenza virus stammen, door het meten van antistoftiters voor en 4-6 weken na vaccinatie.
    E.2.2Secondary objectives of the trial
    Antibody responses to pneumococci, Influenza and SARS-CoV-2 till 1 year post vaccination in the relation to frailty in 73-79 years old male and female persons.
    Baseline numbers of immune cell subsets as well as the inflammatory status at baseline and integration of these data for their association with frailty and vaccine responsiveness.
    Inter-individual differences in biological ageing of the immune system with specific frailty characteristics or morbidities that are related to low vaccine responses.
    Mucosal salivary pneumococcal, Influenza and SARS-CoV-2-specific antibody titers related to frailty.
    Monocyte and lymphocyte function in subgroups of frail versus non-frail participants at baseline and compared to vaccine responsiveness.
    Possible interference of infection with SARS-CoV-2 on vaccine responsiveness by measuring virus-specific serum IgG antibodies to SARS-CoV-2 core protein.
    Antistof reactie tegen pneumokokken, Influenza en SARS-CoV-2 tot 1 jaar na (booster) vaccinatie in vergelijking tot kwetsbaarheid van 73-79 jaar oude mannen en vrouwen.
    Basiswaarden van aantal soorten immuun cellen en de ontstekingswaarden en integreren van deze data met hun associatie met kwetsbaarheid en vaccin reactie.
    Inter-individuele verschillen in biologische leeftijd van het immuun systeem met specifieke kwetsbaarheid karakteristieken of morbiditeit, die gerelateerd zijn aan lage vaccinatie response.
    Mucosale speeksel pneumokokken, influenza en SARS-CoV-2 specifieke antistof titers en het relateren hiervan aan kwetsbaarheid.
    Monocyten en lymphocyten functies in subgroepen van kwetsbaar ten opzichte van niet kwetsbare deelnemers (bij aanvang studie) en vergelijken met vaccin reactie.
    Mogelijke interferentie van infectie met SARS-CoV-2 op vaccin reactie door het meten van virus-specifieke serum IgG antistoffen tegen SARS-CoV-2 kern eiwit.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Participant in round 6 of the Doetinhem Cohort study and born between 1941-1947
    Willing to receive the PPV23 vaccine in 2020
    Have signed Informed Consent

    SARS-CoV-2 part (optional)
    Signed an additional informed consent for blood sampling after SARS-CoV2 vaccination (optional).

    SARS-CoV-2 booster (optional, in case of booster vaccination)
    Signed an additional informed consent for blood sampling after SARS-CoV-2 booster
    vaccination
    Deelnemer aan de Doetinchem studie in ronde 6 en geboren tussen 1941-1947
    Bereid om gevaccineerd te worden met het PPV23 vaccine in 2020
    Een getekend Informed Consent.

    SARS-CoV-2 onderdeel (optioneel)
    Een getekend Informed Consent voor bloedafname na coronavaccinatie. (optioneel)

    SARS-CoV-2 booster onderdeel (optioneel)
    Een getekend Informed Consent voor bloedafname na corona booster vaccinatie.
    E.4Principal exclusion criteria
    Having had a previous pneumococcal vaccination
    Known or suspected allergy to any of the vaccine components or having experienced a previous severe adverse reaction to any vaccine.
    Receipt of any high-dose (≥ 20 mg of prednisone daily or equivalent) daily corticosteroids (locally applied including inhaled steroids are acceptable) within 2 weeks of study entry.
    Repeated use of any high dose of corticosteroids (a dose of > 30 mg of prednisone or equivalent per day for multiple days) in the last month, or, as medically prescribed, within two weeks after the vaccination.
    Receipt of a recent organ- or bone marrow transplant during the last 5 years .
    Have an anatomical or functional asplenia.
    Receipt of blood products or immunoglobulin, within one month of the study entry.
    Known or suspected coagulation disorder that in the opinion of the investigator would contraindicate against receiving an intramuscular injection or undergo frequent blood sampling.
    Known to be positive for human immunodeficiency virus (HIV), and/or hepatitis C virus (HCV) and/or hepatitis B virus (HBV).
    Al eerder een Pneumokokken vaccinatie gehad
    Een bekende allergie of allergische reacties tegen een vaccin.
    Ontvangen van hoge dosis (≥ 20 mg prednison per dag of equivalent) dagelijkse corticosteroïden (lokaal aangebracht inclusief inhalatie steroïden zijn aanvaardbaar) binnen 2 weken voor de studie start.
    Herhaald gebruik van een hoge dosis corticosteroïden (een dosis> 30 mg prednison of equivalent per dag gedurende meerdere dagen) in de afgelopen maand, of zoals medisch voorgeschreven, binnen twee weken na de vaccinatie.
    Een recente beenmerg of orgaan transplantatie is ontvangen gedurende de laatste 5 jaar.
    Een anatomische of functionele asplenectomie.
    Ontvangst van bloed producten of immunoglobuline binnen een maand voor de start van de studie.
    Bekende of vermoede stollingsstoornis die naar het oordeel van de onderzoeker een contra-indicatie zou zijn voor het krijgen van een intramusculaire injectie of voor een frequente bloedafname.
    Positief zijn getest voor AIDS of Hepatitis B of C.
    E.5 End points
    E.5.1Primary end point(s)
    Antibody levels for all PPV23 vaccine serotypes and for the 4 Influenza virus vaccine types at 4 to 6 weeks post vaccination. IgG antibody levels will be considered as the quantity that expresses the strength of the of response.
    Antilichaam responsen tegen 23-vaccin type Pneumokokken en tegen 4 vaccin typen Influenza virussen, beide rond week 4-6 na vaccinatie. IgG-antilichaamniveaus worden beschouwd als weergave die de sterkte van de respons uitdrukt.
    E.5.1.1Timepoint(s) of evaluation of this end point
    4 to 6 weeks post vaccination
    4-6 na vaccinatie
    E.5.2Secondary end point(s)
    Persistence of Pneumococcal antibodies will be assessed till 2 years post-vaccination and that of SARS-CoV-2 till about 18 months post vaccination. Potential cellular and serological biomarkers before vaccination will be identified for their association with immune response to vaccination.
    In addition, the possible interference of infection with SARS-CoV-2 in vaccine responsiveness will be determined by measuring serum antibodies to SARS-CoV-2 virus core protein.
    Aanwezigheid van pneumokokkenantilichamen tot aan 2 jaar na vaccinatie en SARS-CoV-2 antilichamen tot 18 maanden na vaccinatie;
    Potentiele cellulaire en serologische biomarkers voorafgaand aan de vaccinatie wordt geïdentificeerd vanwege hun associatie met de immuunreacties op vaccinatie.
    Ook zal de eventuele invloed van een mogelijke infectie met SARS-CoV-2 op de vaccinrespons worden bepaald door het meten van antilichamen tegen SARS-CoV-2 kern eiwitten in het bloed.
    E.5.2.1Timepoint(s) of evaluation of this end point
    Persistence of Pneumococcal antibodies will be assessed till 2 years post-vaccination and that of SARS-CoV-2 till about 18 months post vaccination.
    Aanwezigheid van pneumokokkenantilichamen tot aan 2 jaar na vaccinatie en SARS-CoV-2 antilichamen tot 18 maanden na vaccinatie
    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 response to pneumococcal, flu and optionally SARS-CoV-2 vaccines.
    Immuunreactie tegen pneumokokken, griep en optioneel SARS-CoV-2 vaccins.
    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 Information not present in EudraCT
    E.8.1.3Single blind Information not present in EudraCT
    E.8.1.4Double blind Information not present in EudraCT
    E.8.1.5Parallel group Information not present in EudraCT
    E.8.1.6Cross over Information not present in EudraCT
    E.8.1.7Other Information not present in EudraCT
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) Information not present in EudraCT
    E.8.2.2Placebo Information not present in EudraCT
    E.8.2.3Other Information not present in EudraCT
    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
    LVLD
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years3
    E.8.9.1In the Member State concerned months6
    E.8.9.1In the Member State concerned days0
    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: 400
    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 No
    F.3.3.7Others Yes
    F.3.3.7.1Details of other specific vulnerable populations
    Elderly born between 1941-1947
    Ouderen geboren tussen 1941-1947
    F.4 Planned number of subjects to be included
    F.4.1In the member state400
    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 Decision2021-05-27
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2020-09-04
    P. End of Trial
    P.End of Trial StatusOngoing
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