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    Summary
    EudraCT Number:2019-000836-24
    Sponsor's Protocol Code Number:IIV-406
    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:2019-04-30
    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 number2019-000836-24
    A.3Full title of the trial
    Immune responses to influenza and pneumococcal conjugate vaccines in older adults compared to middle-aged adults and adults.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Immune responses to influenza and pneumococcal conjugate vaccines in older adults compared to middle-aged adults and adults.
    Afweerreacties tegen influenza en pneumokokken vaccin vergeleken tussen 3 leeftijdsgroepen
    A.3.2Name or abbreviated title of the trial where available
    VITAL
    A.4.1Sponsor's protocol code numberIIV-406
    A.5.4Other Identifiers
    Name:ABR numberNumber:NL69701.041.19
    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 supportInnovative Medicines Initiative
    B.4.2CountryEuropean Union
    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 pointVITAL studyteam
    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-mailVITAL-studie@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 Prevenar-13
    D.2.1.1.2Name of the Marketing Authorisation holderPfizer Europe MA EEIG
    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.3.2Product code EU/1/09/590
    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.2.5The 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 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: 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 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 Dispersion 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 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
    Healthy volunteers above 25 years of age
    E.1.1.1Medical condition in easily understood language
    Healthy volunteers above 25 years of age
    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
    •Compare serotype-specific IgG antibody response to pneumococcal PCV13 vaccination in older adults with the response in middle-aged adults and adults one month after vaccination.
    •Compare influenza vaccine strain-specific serum antibody titers in older adults with the response in middle-aged adults and adults one month after influenza vaccination.
    E.2.2Secondary objectives of the trial
    Comparison of age groups:
    QIV, PCV13 (total and protein-specific) and SARS-CoV-2 vaccine induced Ab responses protein-specific T-cell responses pre- and post-vaccination.
    Determine the impact of clinical baseline status and changes in baseline status, as a predictive marker for vaccine response.
    Determine the impact of (immunological) biomarkers status at baseline as a predictive marker for vaccine response for each subject.
    Kinetics and longevity of SARS-CoV-2 specific Ab subclasses and functionality induced by COVID-19 (booster) vaccination.
    Assessment of the magnitude, characteristics and longevity of the adaptive cellular response induced by the SARS-CoV-2 vaccine: activation, phenotype and function of vaccine-specific (effector, memory, regulatory) T-cells and B-cells.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    •Be 25 years or older at the time of inclusion.
    •Have received a seasonal influenza vaccination in previous season (2018-2019).
    •Be capacitated.
    •Have signed Informed Consent
    E.4Principal exclusion criteria
    •Having had a previous pneumococcal vaccination (PCV or the 23-valent pneumococcal polysaccharide vaccine (PPV23)).
    •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 (local incl. 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 recent past.
    •Receipt of an organ- or bone marrow transplant
    •Have a (functional) asplenie.
    •Receipt of chemotherapy in the last 3 years.
    •Receipt of blood products or immunoglobulin, within three months of 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 anemia, measured as Hb < ( 8,5 mmol/l for men and 7,5 mmol/l for woman; NHG standard Anemia)
    •Known to be positive for human immunodeficiency virus (HIV), and/or hepatitis C virus (HCV) and/or hepatitis B virus (HBV).

    Exclusion criteria COVID-19 vaccination study

    • Treatment with COVID-19 monoclonal antibodies less that 3 months before COVID-19 vaccination.
    • Known pregnancy at the moment of COVID-19 vaccination.
    E.5 End points
    E.5.1Primary end point(s)
    1.Pneumococcal serotype- specific serum IgG antibody concentrations (GMCs) pre-vaccination (T5) and one-month post (T8) PCV13 vaccination measured by bead-based multiplex immune assay.
    2.Influenza vaccine strain-specific serum antibody titers (GMTs) will be measured pre- vaccination (T0) and one-month post-influenza vaccination (T4) by Hemagglutinin Inhibition (HI) assay.
    E.5.1.1Timepoint(s) of evaluation of this end point
    1. 6 months and 7 months after start study
    2. 1 month and 2 months after start of the study
    E.5.2Secondary end point(s)
    1.Influenza strain-specific and pneumococcal serotype-specific antibody titers in serum pre- and post-vaccination: ((T1, T5, T3, T7, T4, T8, T5, T9, T10).
    2.CRM197-specific serum antibody titers before (T5) and at 7 days (T7), 1 (T8) and 6 (T9) months post pneumococcal vaccination
    3. Influenza-specific and CRM197-specific T-cells measured by Enzyme-Linked Immunosorbent Spot (ELISPOT) in peripheral blood mononuclear cells (PBMCs) of pre- (T0; T5) and post-vaccination samples (T3, T4, T7, T8).
    4. A- health status assessment will be done by questionnaires, which include demographics, the short-form (SF) 36 health assessment of quality of life that covers 8 different sections (vitality, physical functioning, pain, general health perception, physical role functioning, emotional role functioning, social role functioning and mental health), a EQ-5D QoL-assessment, socio-economic status (SES), chronic diseases and medication use (including other vaccines), level of exercise, body mass index (BMI) and life style characteristics. In addition, grip strength and blood pressure will be measured by standardized protocols.
    Questionnaires and measurements will be done at 3 time points during the study at T0, T5 and T9.
    A deficit accumulation index will be calculated for each subject and the subjects will be ranked based on this index.
    5. Measure absolute numbers of immune cell types, a.o. lymphocytes, granulocytes and monocytes, in whole blood by Trucount (T0, T5).
    Measure cell frequency, phenotype and functional capacity of immune cells by Fluorescence-Activated Cell Sorting (FACS).
    Measure priming efficacy of T-cells specific for influenza or model antigens.
    Measure systemic and local immune and inflammatory profiles by systems immunology, serology and molecular methods in serum, saliva and swabs. (T0, T5, T9).
    Determine biomarkers, such as creatinine and cystatin C in plasma.
    Determine both broad and targeted transcriptome profile at baseline (T0, T5).
    6. Measure cell frequency, phenotype and functional capacity of SARS-CoV-2 specific immune cells by Fluorescence-Activated Cell Sorting (FACS).
    7. SARS-CoV-2 specific IgG/IgA/IgM GMC in serum at baseline (T0), at day 28 following 1st dose, and at day 28, at 6 months and at 12 months after second vaccination and 28 days, 3, 6 and 12 months after booster COVID-19 vaccination, assessed by MIA.
    8. SARS-CoV-2 specific vaccine-induced antibody neutralizing capacity, assessed by MIA as pseudoneutralization potential in all participants and assessed and validated in golden standard neutralization assay against various circulating SARS-CoV-2 genotypes in the subset of participants; at 28 days following completion of vaccination.
    9. Phenotype and function (such as memory, follicular and regulatory) of SARS-CoV-2 specific T-cells by in vitro stimulation of PBMC with viral antigen followed by ELISpot, supernatant analysis for cytokines and Fluorescence-Activated Cell Sorting (FACS).
    10. Phenotype and functional capacity of SARS-CoV-2 vaccine-specific memory B-cells, by in vitro stimulation of PBMC with viral antigen followed by ELISpot, supernatant analysis for secreted antibodies and FACS.
    11. Ig (A1/A2/G) GMC in saliva and/or nasal lining fluid measured at 28 days following completion of vaccination, compared to baseline (Ta or if no Ta available T9).
    E.5.2.1Timepoint(s) of evaluation of this end point
    1. month 1, 2, 6, 7, 12 and 18 after start study
    2. month 6, 7, 12 after start study
    3. month 0, 2, 6, 7 after start study
    4. month 0, 6 and 12 after start study
    5. month 0, 6 and 12 after start study
    7. before and 28 days after 1st dose, 28 days, 6 and 12 month after 2nd dose and 28 days,3, 6 and 12 months after booster dose
    8. 28 days after second dose; 28 days after booster dose
    11. before 1st dose and 28 days after 2nd dose; 28 days after booster dose
    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 after influenza and pneumococcal vaccination
    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
    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 No
    E.8.4 The trial involves multiple sites in the Member State concerned Yes
    E.8.4.1Number of sites anticipated in Member State concerned2
    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
    LSLV
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years4
    E.8.9.1In the Member State concerned months6
    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) Yes
    F.1.2.1Number of subjects for this age range: 220
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 165
    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 2019-04-30. Yes
    F.3.3.2Women of child-bearing potential using contraception Yes
    F.3.3.3Pregnant women No
    F.3.3.4Nursing women Yes
    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 state385
    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 Decision2019-04-30
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2019-06-19
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2024-10-07
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