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    Summary
    EudraCT Number:2018-003377-97
    Sponsor's Protocol Code Number:KLLVACC-2018
    National Competent Authority:Sweden - MPA
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2018-11-05
    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 ConcernedSweden - MPA
    A.2EudraCT number2018-003377-97
    A.3Full title of the trial
    Long term effect on immune response after pneumococcal vaccination in patients with chronic lymphocytic leukemia and evaluation of the effect of revaccination.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Long term effect on immune response after pneumococcal vaccination in patients with chronic lymphocytic leukemia and evaluation of the effect of revaccination.
    A.4.1Sponsor's protocol code numberKLLVACC-2018
    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 SponsorSwedish CLL-group
    B.1.3.4CountrySweden
    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 supportSwedish CLL group
    B.4.2CountrySweden
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationRegion Örebro län
    B.5.2Functional name of contact pointDept of Medicine, Hematology
    B.5.3 Address:
    B.5.3.1Street AddressÖrebro University Hospital
    B.5.3.2Town/ cityÖrebro
    B.5.3.3Post code70185
    B.5.3.4CountrySweden
    B.5.4Telephone number+46196027665
    B.5.6E-mailbertil.uggla@regionorebrolan.se
    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 Pneumovax
    D.2.1.1.2Name of the Marketing Authorisation holderMSD BV
    D.2.1.2Country which granted the Marketing AuthorisationSweden
    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
    D.3.4Pharmaceutical form Solution 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 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 Prevenar
    D.2.1.1.2Name of the Marketing Authorisation holderPfizer Ltd
    D.2.1.2Country which granted the Marketing AuthorisationSweden
    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 namePrevenar
    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.2.1.1.1Trade name Covid-19 vaccine, all vaccines with marketing authorisation in Sweden are allowed.
    D.2.1.1.2Name of the Marketing Authorisation holderN/A
    D.2.1.2Country which granted the Marketing AuthorisationSweden
    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 nameCovid-19 vaccine
    D.3.2Product code N/A
    D.3.4Pharmaceutical form Concentrate 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) No
    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 aim of the study is to evaluate pneumococcal vaccination strategy with PPSV23 and PCV13 in patients with chronic lymphocytic leukemia (CLL) initially randomized in a clinical study.
    E.1.1.1Medical condition in easily understood language
    Chronich Lymphocytic Leukemia
    E.1.1.2Therapeutic area Diseases [C] - Blood and lymphatic diseases [C15]
    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
    1) To determine and compare the sustained immune response 3-5 years after vaccination with a single dose of 13-valent pneumococcal conjugated vaccine (PCV13, Prevenar13®) or conventional 23-valent capsular polysaccharide vaccine (PPSV23, Pneumovax®) in the cohort from our previous randomized phase III trial.

    2) To study the effect of revaccination with PCV13 in both vaccination groups and to investigate if there is an additive effect of another dose of PCV13 in patients with CLL. For the group that did not receive PPSV23 in the randomized trial, this vaccine will be given to broaden the serotype response and determine the additive effect after PCV13 vaccination.
    E.2.2Secondary objectives of the trial
    1) To determine the prevalence of pneumococcal colonization in nasopharynx.
    2) To determine the incidence of invasive pneumococcal disease in the study cohort.
    3) To study the effect of pneumococcal revaccination on immune cells and cytokine levels.
    4) To compare the sustained immune response between CLL patients and immunocompetent controls, 3-5 years after vaccination with PCV13 and PPSV23.
    5) To compare the immune response between CLL patients and immunocompetent controls, after revaccination with one dose of PCV13.
    6) To compare the prevalence of pneumococcal colonization and incidence of invasive pneumococcal disease between CLL patients and immunocompetent controls after vaccination and revaccination.
    7) To compare the effect of pneumococcal revaccination on immune cells and cytokine levels between CLL patients and immunocompetent controls.
    8) To compare the immune response after SARS-CoV-2 vaccination to the immune response after pneumococcal revaccination.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    CLL patients
    CLL patients earlier included in the Pneumococcal vaccination study 0887x1-20003 (EudraCT No: 2009-012642-22), who have received either PCV13 or PPSV23 are eligible for evaluation of the long-term immune response. The median age of the patient group was at inclusion 70 years (range 46-87) with an equal number men and women (65/63). The same patients are eligible for revaccination if they do not meet any exclusion criteria. Ongoing or recent CLL specific treatment is not an exclusion criteria.

    Controls
    A control group (n=40) of immunocompetent subjects will be recruited in Region Örebro County. The control group will be matched to the CLL group by age and gender. For inclusion they should have been vaccinated with either PCV13 (n=20) or PPSV23 (n=20) approximately 3-5 years ago and not meet any exclusion criteria. They will subsequently be eligible for long-term immune response and revaccination according to the study protocol.
    E.4Principal exclusion criteria
    CLL patients
    1. Patients receiving high dose corticosteroids ( ≥20 mg Prednisolone) or other immunosuppressive drugs that is not part of active CLL treatment
    2. Patients who have had an allergic reaction to any vaccination in the past
    3. Patients with a positive DAT (Direct Antiglobulin Test) or known present or previous hemolysis, ITP and Guillain-Barre
    4. Patients failing to give informed consent
    5. Patients with ongoing immunoglobulin therapy
    6. Patients with known HIV infection
    7. Patients who have received a pneumococcal vaccine outside the study protocol within the last 12 months
    8. Active febrile infection
    9. Increased bleeding risk due to severe thrombocytopenia or other coagulopathies that would, in the opinion of the investigator, contraindicate intramuscular injection

    Controls
    1. Serious chronic disorder including chronic obstructive pulmonary disease (COPD) requiring supplemental oxygen treatment, end-stage renal disease, clinically unstable cardiac disease or any other disorder that, in the investigator’s opinion, excludes the subject from participating in the study;
    2. Known or suspected immunodeficiency or other conditions associated with immunosuppression including immunoglobulin class/subclass deficiencies with or without substitution treatment, splenectomy in the medical history, generalized malignancy, human immunodeficiency virus (HIV) infection, haematological malignancies, bone marrow or organ transplant in the medical history;
    3. Subjects receiving treatment with high dose corticosteroids (≥20 mg Prednisolone) or other immunosuppressive drugs, or planned to receive through study participation;
    4. Subjects who have had an allergic reaction to any component of PCV13 in the past;
    5. Subjects with known present or previous hemolysis, ITP and Guillain-Barre;
    6. Subjects failing to give informed consent;
    7. Subjects who have received a pneumococcal vaccine after the primary vaccination aproximately 3-5 years ago;
    8. Active febrile infection;
    1.9. Increased bleeding risk due to severe thrombocytopenia or other coagulopathies that would, in the opinion of the investigator, contraindicate intramuscular injection (for treatment with oral anticoagulation therapy, see section 7.3).

    E.5 End points
    E.5.1Primary end point(s)
    1) To study the long-term immune response between the two groups 3-5 years after vaccination with PCV13 or PPSV23, measured as the proportion of subjects with a positive vaccination response in each of the two groups.

    2) To study the short-term immune response 8 weeks and 16 weeks after revaccination of the initial PCV 13 Group A with PCV13/PPSV23 and of the initial PPSV23 Group B with PCV13/PCV13, measured as the proportion of subjects with a positive vaccination response pre- and post- revaccination.





    E.5.1.1Timepoint(s) of evaluation of this end point
    8 and 16 weeks after revaccination.
    E.5.2Secondary end point(s)
    1) To study the persistent immune response after revaccination in terms of OPA
    titers 12 months after first dose of revaccination compared to the short-term pre- and post-revaccination sera.
    2) To compare ELISA GMCs for each serotype measured 3-5 years after initial
    vaccination.
    3) To compare ELISA GMCs for each serotype measured 8 weeks, 16 weeks and 12
    months after revaccination.
    4) To study the incidence of IPD during the period from the initial vaccination to
    maximum five years after the first dose of revaccination.
    5) To study the incidence of pneumococcal colonization by culturing of
    nasopharyngeal swabs at inclusion after 8 weeks, 16 weeks and 12 months.
    6) To study the long-term immune response (ELISA and OPA) 3-5 years after vaccination with PCV13 or PPSV23, by comparing CLL patients and controls.
    7) To study the short-term immune response (ELISA and OPA) 8 weeks after revaccination with one dose of PCV13, by comparing CLL patients and controls.
    8) To study the additive immune response (ELISA and OPA) after a second revaccination dose (PCV13 or PPSV23) of CLL patients in comparison with controls with no second revaccination dose, 16 weeks and 12 months after revaccination.
    9) To study the immune response 3-4 weeks, 6-8 weeks, 6 months and 12 months after initial SARS-CoV-2 vaccination in terms of antibody titers/function induced by the vaccine and compare to the immune response after pneumococcal revaccination.
    E.5.2.1Timepoint(s) of evaluation of this end point
    PCV13 or PPSV23 vaccination: 8 weeks, 16 weeks and 12 months after revaccination.

    Covid-19 vaccination: 3-4 weeks after each dose and 6 and 12 months after the first Covid-19 vaccination.
    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 Yes
    E.6.4Safety Yes
    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 No
    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) Yes
    E.7.4Therapeutic use (Phase IV) Yes
    E.8 Design of the trial
    E.8.1Controlled Yes
    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 Yes
    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 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 concerned8
    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 years3
    E.8.9.1In the Member State concerned months6
    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 months6
    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 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: 41
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 105
    F.2 Gender
    F.2.1Female Yes
    F.2.2Male Yes
    F.3 Group of trial subjects
    F.3.1Healthy volunteers No
    F.3.2Patients Yes
    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
    CLL-patients
    F.4 Planned number of subjects to be included
    F.4.1In the member state126
    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)
    Standard of care for this patient group.
    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 Decision2018-12-18
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2018-11-28
    P. End of Trial
    P.End of Trial StatusOngoing
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