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    The EU Clinical Trials Register currently displays   43871   clinical trials with a EudraCT protocol, of which   7290   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).

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    Summary
    EudraCT Number:2014-004799-50
    Sponsor's Protocol Code Number:PNEUMOREG
    National Competent Authority:Spain - AEMPS
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2014-12-22
    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 ConcernedSpain - AEMPS
    A.2EudraCT number2014-004799-50
    A.3Full title of the trial
    Evaluation of the immunoregulatory role of pneumococcal conjugate vaccination in pediatric patients with allergic asthma or type 1 diabetes mellitus versus pediatric population control.
    Evaluación del papel inmunoregulador de la vacunación conjugada antineumocócica en pacientes pediátricos con asma alérgica o diabetes mellitus tipo 1 versus población pediátrica control.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Regulatory role of the immune system of Prevenar 13 vaccine in children with asthma and diabetes.
    Papel regulador del sistema inmune de la vacuna Prevenar 13 en niños con asma y diabetes .
    A.4.1Sponsor's protocol code numberPNEUMOREG
    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 SponsorFederico Martinon Torres
    B.1.3.4CountrySpain
    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 supportGenetic, Vaccines, Infectious Disease and Pediatrics Research Group
    B.4.2CountrySpain
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationLucia Vilanova Trillo
    B.5.2Functional name of contact pointLucia Vilanova Trillo
    B.5.3 Address:
    B.5.3.1Street AddressTravesia da Choupana s/n
    B.5.3.2Town/ citySantiago de Compostela
    B.5.3.3Post code15706
    B.5.3.4CountrySpain
    B.5.4Telephone number0034981955093
    B.5.5Fax number0034981950596
    B.5.6E-maillucia.vilanova.trillo@sergas.es
    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
    D.2.1.2Country which granted the Marketing AuthorisationSpain
    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 13
    D.3.4Pharmaceutical form Suspension for injection
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntramuscular use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNPneumococcal polysaccharide serotype 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F,23F
    D.3.9.3Other descriptive namePNEUMOCOCCAL POLYSACCHARIDE CONJUGATE VACCINE (13-VALENT, ADSORBED) CONJUGATED TO CRM197 CARRIER PROTEIN AND ADSORBED ON ALUMINIUM PHOSPHATE
    D.3.9.4EV Substance CodeSUB129658
    D.3.10 Strength
    D.3.10.1Concentration unit µg microgram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number2.2
    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
    Allergic asthma and type 1 diabetes mellitus in pediatric subjects.
    Asma alérgica y diabetes mellitus tipo 1 en sujetos pediátricos.
    E.1.1.1Medical condition in easily understood language
    Asthma and diabetes in children
    Asma y diabetes en niños
    E.1.1.2Therapeutic area Diseases [C] - Immune System Diseases [C20]
    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
    The main purpose of this clinical trial is to evaluate the possible inmunoregulatory capacity of vaccination with Prevenar 13 in a pediatric population with two pathologies with a well-defined inmunological basis: type 1 diabetes mellitus and allergic asthma.
    El objetivo principal del ensayo clinico es evaluar la eventual capacidad inmunoreguladora de la vacunacón con Prevenar 13 en población infantil con dos patologías de base inmunológica bien definida: la diabetes mellitus tipo 1 y el asma alérgica.
    E.2.2Secondary objectives of the trial
    ? In vivo and in vitro study of the effect of vaccination on the number and function of T cell populations (Th1, Th2, Treg and Th17) and B cell populations (B10 regulatory cells).
    ? In vivo and in vitro study of the altered response of chemokines / cytokines induced by vaccination and its interaction with T cells and B.
    ? Analysis of dose effect on changes in cell subpopulation under study.
    ? Comparison of the immunomodulatory response to vaccination among individuals with underlying disease and immune healthy control individuals.
    ? Evaluation of anti-inflammatory therapeutic claims made by vaccination.
    ? Analysis of differential transcriptomic response induced by vaccination in all three groups.
    ? Estudio in vivo e in vitro del efecto de la vacunación en el número y funcionalidad de poblaciones celulares T (Th1, Th2, Th17 y Treg) y en las poblaciones celulares B (células B10 reguladoras).
    ? Estudio in vivo e in vitro de la alteración en la respuesta de quimiocinas/citocinas provocado por la vacunación y su interacción con las células T y B.
    ? Análisis del efecto de la dosis en los cambios en las subpoblaciones celulares sometidas a estudio.
    ? Comparación de la respuesta inmunomoduladora de la vacunación entre individuos con patología inmunológica de base e individuos control sanos.
    ? Evaluación de las propiedades terapéuticas anti-inflamatorias efectuadas por la vacunación.
    ? Análisis de la respuesta transcriptómica diferencial inducida por la vacunación en los tres grupos.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Inclusion criteria applicable to all groups (1, 2, 3):
    1. Subjects 5-14 years of age (inclusive) at inclusion.
    2. Subjects who have given written informed assent (if applicable) and whose parents / guardians have given written informed after they have explained the nature of the study consent.
    3. Subjects who are available for all scheduled study visits.
    Inclusion criteria applicable to group 1:
    4. Subjects diagnosed with respiratory allergic asthma according to criteria of the Global Initiative for Asthma (GINA 2014 review [41]). Allergic sensitization demonstrated by specific cutaneous blood test (Skin Prick Test (SPT)) and / or immunoglobulin E.

    Inclusion criteria applicable to group 2:
    4. Subjects diagnosed with type 1 diabetes mellitus insulin-dependent.

    Inclusion criteria applicable to Group 3:
    4. Healthy immunocompetent subjects with good health determined by medical history, physical examination and clinical judgment of the investigator. Healthy subject is defined as that which has no known immune-based disease.
    Criterios de inclusión aplicables a todos los grupos (1, 2, 3):
    1. Sujetos de 5 a 14 años de edad (ambos inclusive) en la inclusión.
    2. Sujetos que hayan otorgado el asentimiento informado por escrito (si procede) y cuyos padres/tutor legal hayan otorgado el consentimiento informado por escrito después de que se les haya explicado la naturaleza del estudio.
    3. Sujetos que estén disponibles para todas las visitas programadas del estudio.

    Criterio de inclusión aplicable al grupo 1:
    4. Sujetos diagnosticados de asma alérgica respiratoria según criterios de la Global Initiative for Asthma (GINA, revisión 2014 [41]). Sensibilización alérgica demostrada por prueba cutánea (Skin Prick Test (SPT)) y/ o Inmunoglobulina E específica en sangre.

    Criterio de inclusión aplicable al grupo 2:
    4. Sujetos diagnosticados de diabetes mellitus tipo 1 insulin-dependiente.

    Criterio de inclusión aplicable al grupo 3:
    4. Sujetos immunocompetentes sanos, con buena salud determinada mediante la historia clínica, la exploración física y el criterio clínico del investigador. Se define como sujeto sano aquel que no presente ninguna enfermedad de base inmunológica conocida.
    E.4Principal exclusion criteria
    1. Prior vaccination with Prevenar 13®
    2. Previous anaphylactic reaction or allergy to any vaccine or vaccine component.
    3. Contraindications to vaccination with any standard pediatric vaccine.
    4. Subjects with thrombocytopenia or any coagulation disorder that would contraindicate intramuscular injection
    5. History of invasive S. pneumoniae demonstrated by culture.
    6. Known or suspected immune deficiency or suppression.
    7. Congenital malformation most known character or serious chronic illness.
    8. Neurological disease or major process (history of seizures will be assessed at the discretion of the investigator), either stable or evolving, such as cerebral palsy, encephalopathy, hydrocephalus or other relevant disease from a clinical point of view.
    9. Pregnant women who may become pregnant or are breastfeeding.
    10. Women of childbearing age who have not used or plan to use acceptable contraceptive measures during the 4-month study. Are acceptable contraceptive oral hormonal contraceptives, injected or implanted, barrier methods (diaphragm or condom with spermicide), intrauterine device, or abstinence. If subjects are sexually active, they should have used one of the accepted methods of birth control for at least 60 days before inclusion in the study.
    11. Patients receiving treatment with oral corticosteroids continuously or received oral corticosteroids within 30 days prior to inclusion.
    12. Patients who are under treatment: specific desensitizing therapy allergens or anti-IgE monoclonal antibody.
    13. Patients who have received any vaccinations in the 30 days prior to inclusion in the study or intend to receive in the clinical trial (except the flu vaccine).
    14. Illness or process more character in the investigator's opinion, could substantially increase the risk associated with the subject's participation in the study and its completeness or prevent the evaluation of the subject's response.
    15. Use of an investigational product (drug or vaccine) in research or not registered within 30 days prior to the first dose of study vaccine or plan to receive during the course of this study.
    16. Subject who is a direct descendant of study personnel.
    1. Vacunación previa con Prevenar 13®
    2. Reacción anafiláctica previa o alergia a cualquier vacuna o componente de una vacuna.
    3. Contraindicación a la vacunación con cualquier vacuna pediátrica habitual.
    4. Sujetos con trombocitopenia o cualquier trastorno de la coagulación que pudiera contraindicar la inyección intramuscular
    5. Antecedentes de enfermedad invasiva por S. pneumoniae, demostrado por cultivo.
    6. Conocimiento o sospecha de deficiencia o supresión inmunitaria.
    7. Malformación congénita de carácter mayor o enfermedad crónica grave conocidas.
    8. Enfermedad neurológica o proceso importante (los antecedentes de convulsiones serán valorados a criterio del investigador), ya sea estable o en evolución, como parálisis cerebral, encefalopatía, hidrocefalia u otra enfermedad relevante desde un punto de vista clínico.
    9. Mujeres embarazadas, que deseen quedarse embarazadas o que estén en periodo de lactancia.
    10. Mujeres en edad fértil que no hayan utilizado ni tengan previsto utilizar medidas anticonceptivas aceptables durante los 4 meses del estudio. Se consideran métodos anticonceptivos aceptables los anticonceptivos hormonales orales, inyectados o implantados, los métodos de barrera (diafragma o preservativo con espermicida), el dispositivo intrauterino o la abstinencia sexual. Si los sujetos son sexualmente activos, deberán haber utilizado uno de los métodos anticonceptivos aceptados durante al menos 60 días antes de la inclusión en el estudio.
    11. Pacientes que reciben tratamiento con corticoides orales de modo continuo o han recibido corticoides orales en los 30 días previos a la inclusión.
    12. Pacientes que se encuentren bajo tratamiento con: terapia desensibilizante específica con alérgenos o con anticuerpo monoclonal anti IgE.
    13. Pacientes que hayan recibido cualquier vacunación en los 30 días previos a la inclusión en el estudio o que tengan previsto recibirla durante el ensayo clínico (a excepción de la vacuna frente a la gripe).
    14. Enfermedad o proceso de carácter mayor que, en opinión del investigador, pudiera aumentar sustancialmente el riesgo derivado de la participación del sujeto en el estudio y de su compleción o que impidiera la evaluación de la respuesta del sujeto.
    15. Uso de un producto en investigación (vacuna o medicamento) en investigación o no registrado en los 30 días anteriores a la primera dosis de la vacuna del estudio o que tenga previsto recibirlo durante el transcurso del presente estudio.
    16. Sujeto que es descendiente directo de personal del estudio.
    E.5 End points
    E.5.1Primary end point(s)
    ? Number and function of regulatory T cell population (CD4 + CD25 + Foxp3 +)
    ? Number and function of regulatory B cell population (cell B10)
    ? Number and function of Th1 cell population
    ? Number and function of Th2 cell population
    ? Number and function of Th17 cell population
    ? Transcriptomic markers
    ? Número y funcionalidad de población célula T reguladora (CD4+ CD25+ Foxp3+)
    ? Número y funcionalidad de población célula B reguladora (célula B10)
    ? Número y funcionalidad de población células Th1
    ? Número y funcionalidad de población células Th2
    ? Número y funcionalidad de población células Th17
    ? Marcadores Transcriptómicos
    E.5.1.1Timepoint(s) of evaluation of this end point
    After obtaining the samples, which will be held on day 1, day 56 and day 112 of the study.
    Tras la obtención de las muestras, las cuales se realizarán el 1, día 56 y día 112 del estudio.
    E.5.2Secondary end point(s)
    ? Levels of cytokines / chemokines secreted: IL2, IL4, IL5, IL6, IL10, IFN-gamma, TNF-alpha and IL17.
    ? Density of the pathogen in the nasopharynx.
    ? Levels of specific immunoglobulins.
    ? Marker of inflammation (ultra sensitive PCR).
    ? Niveles de citocinas/quimiocinas secretadas: IL2, IL4, IL5, IL6, IL10, IFN-gamma, TNF-alpha e IL17.
    ? Densidad del patógeno en nasofaringe.
    ? Niveles de Inmunoglobulinas especificas.
    ? Marcador de inflamación (PCR-Ultrasensible).
    E.5.2.1Timepoint(s) of evaluation of this end point
    After obtaining the samples, which will be held on day 1, day 56 and day 112 of the study.
    Tras la obtención de las muestras, las cuales se realizarán el 1, día 56 y día 112 del estudio.
    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 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 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 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) No
    E.8.2.2Placebo No
    E.8.2.3Other Yes
    E.8.2.3.1Comparator description
    No se administrará dosis booster
    No booster dose administered
    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
    Ultima visita del último sujeto reclutado
    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 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: 150
    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) Yes
    F.1.1.5.1Number of subjects for this age range: 75
    F.1.1.6Adolescents (12-17 years) Yes
    F.1.1.6.1Number of subjects for this age range: 75
    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 Yes
    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
    Subjects aged between 5 and 12 years old, or mature minors who are unable to give consent from the medical point of view.
    Sujetos con edad comprendida entre los 5 y los 12 años, o menores maduros que, desde el punto de vista médico, son incapaces de dar su consentimiento.
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state150
    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
    N/A
    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 Decision2015-02-13
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2015-01-30
    P. End of Trial
    P.End of Trial StatusOngoing
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