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   43872   clinical trials with a EudraCT protocol, of which   7291   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:2019-004541-33
    Sponsor's Protocol Code Number:immvzmpr1
    National Competent Authority:Sweden - MPA
    Clinical Trial Type:EEA CTA
    Trial Status:
    Date on which this record was first entered in the EudraCT database:2021-07-27
    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 ConcernedSweden - MPA
    A.2EudraCT number2019-004541-33
    A.3Full title of the trial

    A clinical study to examine cellular and humoral immunity against measles and chickenpox in children and adolescents 0-18 years in childhood cancer.
    Klinisk studie för undersökning av cellulär och humoral immunitet mot mässling och vattkoppor för barn och ungdomar 0-18 år vid cancerbehandling.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A study of immunity for chickenpox and measles in childhood cancer patients.
    En undersökning av immunitet mot vattenkoppor och mässling hos barn och ungdomar med cancerbehandling.
    A.3.2Name or abbreviated title of the trial where available
    immvzmpr1
    immvzmpr1
    A.4.1Sponsor's protocol code numberimmvzmpr1
    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 SponsorVästra Götalandsregionen
    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 supportVästra Götalandsregionen
    B.4.2CountrySweden
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationBarncancercentum i Västra Sverige
    B.5.2Functional name of contact pointDrottning Silvias barnsjukhus
    B.5.3 Address:
    B.5.3.1Street AddressBehandlingsvägen 7
    B.5.3.2Town/ cityGothenburg
    B.5.3.3Post code41650
    B.5.3.4CountrySweden
    B.5.5Fax number+4631 215486
    B.5.6E-mailtorben.ek@vgregion.se
    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.2.5The 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 Lyophilisate and solvent for solution for injection
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntramuscular use
    Subcutaneous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNJ05BD52
    D.3.9.3Other descriptive nameMEASLES, MUMPS AND RUBELLA VACCINE (LIVE)
    D.3.9.4EV Substance CodeSUB14489MIG
    D.3.10 Strength
    D.3.10.1Concentration unit ml millilitre(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number0.5
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNJ07BK01
    D.3.9.3Other descriptive nameVARICELLA VIRUS OKA/MERCK STRAIN (LIVE, ATTENUATED)
    D.3.9.4EV Substance CodeSUB21611
    D.3.10 Strength
    D.3.10.1Concentration unit ml millilitre(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number0.5
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin Yes
    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 Lyophilisate and solvent for suspension for injection
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntramuscular use
    Subcutaneous use
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin Yes
    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
    This study will be conducted as a longitudinal study. Former studies have shown that immunity is affected after treatment against childhood cancer. We want to investigate humoral and cell-mediated immunity specifically targeted for varicella and measles, during and after treatment for childhood cancer. We also want to investigate vaccin response for varicella and measles.
    Denna studien är utformad som en longitudinell studie. Tidigare studier har visat att immunitet påverkas vid behandling mot barncancer Vi vill undersöka humoral och cellmedierad immunitet specifikt riktad mot varicella och mässling, under och efter behandling för barncancer. Vi vill även undersöka vaccinrespons för varicella och mässlingen.
    E.1.1.1Medical condition in easily understood language
    We specifically want to find out how immunity is affected for chickenpox and measles when treated with chemotherapy at childhood cancer and vaccin response for chickenpox and measles.
    Vi vill specifikt ta reda på hur immunförsvaret påverkas mot vattkoppor och mässling efter cytostatikabehandling samt svar på vaccination mot vattkoppor och mässlingen.
    E.1.1.2Therapeutic area Diseases [C] - Cancer [C04]
    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
    After cancer treatment, it is known that the level of antibodies formed after previous vaccination decreases. There is a difference in the residual concentration of antibodies between groups that have received low and high intensive chemotherapy treatment, respectively. Studies and experience also show that vaccinations after completing cancer treatment do not give high enough titers for protection against, for example, measles.
    Vaccine response will be investigated, thereby looking for immunological variables that may be able to predict a good immune response. The results may form a better scientific basis for recommendations on prophylaxis and vaccinations against chickenpox and measles for childhood cancer patients.
    Efter en cancerbehandling är det känt att nivå av antikroppar som bildats efter tidigare vaccination minskar. Det finns en skillnad i kvarvarande koncentration av antikroppar mellan grupper som fått låg respektive hög intensiv cytostatikabehandling. Studier och erfarenhet visar även att vaccinationer efter avslutad cancerbehandling inte ger tillräckligt höga titrar för skydd mot exempelvis mässlingen.
    Respons på vaccinationer kommer att undersökas och härigenom leta efter immunologiska variabler som eventuellt kan förutsäga ett bra immunsvar. Resultaten kan ligga till grund för bättre vetenskapligt underlag för rekommendationer kring profylax och vaccinationer mot vattkoppor och mässling för barncancerpatienter.
    E.2.2Secondary objectives of the trial
    Measles and chickenpox are two of our most contagious infectious diseases. For cancer patients, it is of most importance to find out immunity to these two diseases in order to be able to treat the patient properly during ongoing treatment and after treatment has ended. In the event of an outbreak of measles or chickenpox, it can have life-threatening consequences in patients with impaired immunity, such as disseminated cutaneous infection, pneumonia and meningitis. Cell-mediated immunity (CMI) includes cell types such as macrophages, natural killer (NK) cells, B lymphocytes and T lymphocytes. When the cells are activated via antigen (foreign body substance from the outside, e.g. virus), a reaction with cytokine activation follows. Cell-mediated immunity (CMI) is profiled to take care of intracellular microorganisms such as viruses and bacteria. Studies on cell-mediated immunity to varicella and measles are scarce and need further evaluation.
    Mässling och vattkoppor är två av våra mest smittsamma infektiösa sjukdomar. För cancerpatienter är det av yttersta vikt att ta reda på immunitet mot dessa två sjukdomar för att kunna handlägga patienten på rätt sätt under pågående behandling samt efter avslutad behandling. Vid utbrott av mässling eller vattkoppor kan det hos en patient med nedsatt immunitet ge livshotande konsekvenser som disseminerad kutan infektion, pneumoni och meningit. I cellmedierad immunitet (CMI) ingår celltyper som makrofager, natural killer (NK) celler, B lymfocyter och T lymfocyter. När cellerna aktiveras via antigen (kroppsfrämmande ämne utifrån, t.e.x. virus), följer en reaktion med cytokinpåslag. CMI är profilerad att ta hand om intracellulära mikroorganismer som virus och bakterier. Studier om cellmedierad immunitet mot varicella och mässlingen är sparsam och behöver utvärderas vidare.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    • Children and young people (0-18.0 years) who start cancer treatment at the childhood cancer center in Gothenburg.
    • Known vaccination status for measles and chickenpox before start of cancer treatment.
    • Oral and written information for the study and signed consent form.
    • Barn och ungdomar (0-18.0 år) som startar cancerbehandling via Barncancercentrum i Göteborg.
    • Vaccinationsstatus för mässling och vattkoppor före cancerbehandling är känt.
    • Muntlig och skriftlig information om studien samt påskrivet samtycke.
    E.4Principal exclusion criteria
    • Known pre-existing primary immunodeficiency.
    • Patients planned for relapse therapy or will undergo allogeneic stem cell transplantation (SCT).
    • Known contraindication to any of the suggested vaccines.
    • Known primary immunodeficiency.
    • Ongoing treatment with immunomodulatory, immunosuppressive therapy.
    • Patients who are scheduled to undergo relapse therapy or stem cell transplantation (SCT).
    • Known contraindication to any of the proposed vaccines.
    • Female participants with pregnancy at diagnosis or during the study.
    • Female participants with suspected or ongoing pregnancy where contraindication for pregnancy is present prior to vaccination against chickenpox and measles.
    • Ongoing breastfeeding.
    E.5 End points
    E.5.1Primary end point(s)
    Primära frågeställningar
    Primary endpoints
    1) Immunity after revaccination with varicella vaccine after treatment for childhood cancer, measured as IgG antibodies to VZV before and after vaccination. (Proportion (%) of patients with protective level of VZ-IgG after vaccination - proportion (%) of patients with protective level of VZ-IgG before vaccination).

    2) Immunity after revaccination with measles vaccine, measured as IgG antibodies to morbilli before and after vaccination. (Proportion (%) of patients with protective level of morbilli IgG after vaccination - proportion (%) patients with protective level of morbilli IgG before vaccination). 1)
    Primära frågeställningar
    1) Immunitet efter revaccination med varicella vaccin efter behandling mot barncancer, mätt som IgG antikroppar mot VZV före och efter vaccination. (Andel (%) patienter med skyddande nivå av VZ-IgG efter vaccination – andel (%) patienter med skyddande nivå av VZ-IgG före vaccination).

    2) Immunitet efter revaccination med mässlingsvaccin, mätt som IgG antikroppar mot morbilli före och efter vaccination. (Andel (%) patienter med skyddande nivå av morbilli-IgG efter vaccination – andel (%) patienter med skyddande nivå av morbilli-IgG före vaccination).

    E.5.1.1Timepoint(s) of evaluation of this end point
    Two timepoints will be used as evaluation for primary endpoints: Timepoint before the start of treatment and timepoint a few weeks after end of treatment. Proportion of patients with protective immunity against varicella and measles before start of treatment compared with proportion of patients with protective immunity against varicella and measles after start of treatment measured in IgG.
    Två tidpunkter kommer användas vid utvärdering av endpoint: Tidpunkt före start av behandling samt tidpunkt som är några veckor efter avslutad behandling. Andel patienter med skyddande immunitet mot varicella samt mässling före start av behandling jämfört med andel patienter med skyddande immunitet mot varicella samt mässling efter start av behandling mätt i IgG.
    E.5.2Secondary end point(s)
    Secondary endpoints
    1) Proportion of patients who lose immunity to varicella and morbidity after cancer treatment (Proportion (%) immune patients before treatment - proportion (%) immune patients after treatment).

    2) Change in CMI against varicella and measles during treatment and after revaccination. Comparisons will be made with a healthy control group.

    3) Subgroup analyzes: Differences in antibody levels and CMI between different diagnostic groups (leukemia / solid tumor), different age groups, low- and high-intensity treatment and preimmune versus non-immune groups at specific times.
    Sekundära frågeställningar
    1) Andel patienter som förlorar immuniteten mot varicella och mässling efter cancerbehandling (Andel (%) immuna patienter före behandling – andel (%) immuna patienter efter behandling).

    2) Förändring av CMI mot varicella och mässling under behandling och efter revaccination. Jämförelser kommer att göras med en frisk kontrollgrupp.

    3) Subgruppsanalyser: Skillnader i antikroppsnivåer och CMI mellan olika diagnosgrupper (leukemi/solid tumör), olika åldersgrupper, låg- resp högintensiv behandling och preimmuna versus icke-immuna grupper vid specifika tidpunkter.
    E.5.2.1Timepoint(s) of evaluation of this end point
    Blood samples are taken at 8 specific timepoints:
    -Before start of cancer treatment.
    -An occasion during treatment.
    -A few weeks after the end of treatment.
    -Before vaccination against varicella.
    -2-3 months after vaccination against varicella.
    -Before vaccination against measles.
    -2-3 months after vaccination against measles.
    -1 year after the last vaccination.
    Blodprover tas på 8 specifika tidpunkter:
    -Innan start med cancerbehandling.
    -Ett tillfälle under behandling.
    -Några veckor efter avslutad behandling.
    -Inför vaccination mot varicella.
    -2-3 månader efter vaccination mot varicella.
    -Inför vaccination mot mässling.
    -2-3 månader efter vaccination mot mässling.
    -1 år efter sista vaccinationen.


    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 Yes
    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 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) 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 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 No
    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 Yes
    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 definition of the study time is from sampling at the start of cancer treatment to sampling 1 year after the last vaccination in the study. Patient inclusion ends after 4 full years.
    Definition av studietid är från provtagning vid start av cancerbehandling till provtagning 1 år efter sista vaccinationen i studien. Patientinklusion avslutas efter 4 fulla år.
    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 months0
    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 Yes
    F.1.1Number of subjects for this age range: 160
    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) Information not present in EudraCT
    F.1.1.4.1Number of subjects for this age range: 15
    F.1.1.5Children (2-11years) Information not present in EudraCT
    F.1.1.5.1Number of subjects for this age range: 85
    F.1.1.6Adolescents (12-17 years) Yes
    F.1.1.6.1Number of subjects for this age range: 60
    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 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 Yes
    F.3.3.6.1Details of subjects incapable of giving consent
    Gurdian or guardians give consent for patients under the age of 18.
    Vårdnadshavare ger samtycke för patienter som är under 18 år.
    F.3.3.7Others Yes
    F.3.3.7.1Details of other specific vulnerable populations
    Pediatric population age between 0-18 years, consent from guradian is needed.
    Pediatrisk population med ålder mellan 0-18 år, samtycke behövs från vårdnadshavare.
    F.4 Planned number of subjects to be included
    F.4.1In the member state160
    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
    Inga
    G. Investigator Networks to be involved in the Trial
    G.4 Investigator Network to be involved in the Trial: 1
    G.4.1Name of Organisation Hallands sjukhus, Halmstad
    G.4.3.4Network Country Sweden
    G.4 Investigator Network to be involved in the Trial: 2
    G.4.1Name of Organisation Norra älvsborgs sjukhus (NÄL)
    G.4.3.4Network Country Sweden
    G.4 Investigator Network to be involved in the Trial: 3
    G.4.1Name of Organisation Centralsjukhuset Karlstad
    G.4.3.4Network Country Sweden
    G.4 Investigator Network to be involved in the Trial: 4
    G.4.1Name of Organisation Södra älvsborgs sjukhus
    G.4.3.4Network Country Sweden
    G.4 Investigator Network to be involved in the Trial: 5
    G.4.1Name of Organisation Länssjukhuset Ryhov
    G.4.3.4Network Country Sweden
    G.4 Investigator Network to be involved in the Trial: 6
    G.4.1Name of Organisation Skaraborgs sjukhus
    G.4.3.4Network Country Sweden
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2021-09-14
    N.Ethics Committee Opinion of the trial application
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion
    P. End of Trial
    P.End of Trial Status
    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-Mon May 06 13:50:55 CEST 2024 | Domenico Scarlattilaan 6, 1083 HS Amsterdam, The Netherlands
    EMA HMA