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    The EU Clinical Trials Register currently displays   43874   clinical trials with a EudraCT protocol, of which   7294   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:2012-005658-52
    Sponsor's Protocol Code Number:AOI2012LAURICHESSE
    National Competent Authority:France - ANSM
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2015-09-25
    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 ConcernedFrance - ANSM
    A.2EudraCT number2012-005658-52
    A.3Full title of the trial
    /
    Impact d’une supplémentation en vitamine D sur les fonctions immunitaires : Etude chez des sujets âgés de plus de 65 ans vaccinés contre la grippe.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    /
    Impact d’une supplémentation en vitamine D sur les fonctions immunitaires : Etude chez des sujets âgés de plus de 65 ans vaccinés contre la grippe.
    A.3.2Name or abbreviated title of the trial where available
    Supplémentation en vitamine D et réponse immunitaire
    A.4.1Sponsor's protocol code numberAOI2012LAURICHESSE
    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 SponsorCHU de Clermont-Ferrand
    B.1.3.4CountryFrance
    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 supportCHU de Clermont-Ferrand
    B.4.2CountryFrance
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationCHU de Clermont-ferrand
    B.5.2Functional name of contact pointPatrick LACARIN
    B.5.3 Address:
    B.5.3.1Street Address58, rue Montalembert
    B.5.3.2Town/ cityClermont-Ferrand
    B.5.3.3Post code63000
    B.5.3.4CountryFrance
    B.5.4Telephone number0033473751195
    B.5.5Fax number003347375754730
    B.5.6E-mailplacarin@chu-clermontferrand.fr
    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 UVEDOSE
    D.2.1.1.2Name of the Marketing Authorisation holderLaboratoires CRINEX
    D.2.1.2Country which granted the Marketing AuthorisationFrance
    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 Oral solution
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOral use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.9.3Other descriptive nameCHOLECALCIFEROL
    D.3.9.4EV Substance CodeSUB34314
    D.3.10 Strength
    D.3.10.1Concentration unit IU international unit(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number100000
    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) No
    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.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.2.1.1.1Trade name INTANZA 15
    D.2.1.1.2Name of the Marketing Authorisation holderSanofi
    D.2.1.2Country which granted the Marketing AuthorisationFrance
    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 Solution for injection in pre-filled syringe
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntradermal use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.9.1CAS number 8500000-45-5
    D.3.9.3Other descriptive nameINFLUENZA VIRUS VACCINE POLYVALENT
    D.3.9.4EV Substance CodeSUB14213MIG
    D.3.10 Strength
    D.3.10.1Concentration unit µg microgram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number15
    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
    D.8 Placebo: 1
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboOral liquid
    D.8.4Route of administration of the placeboOral use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    /
    Carence en vitamine D
    E.1.1.1Medical condition in easily understood language
    /
    Carence en vitamine D
    E.1.1.2Therapeutic area Body processes [G] - Immune system processes [G12]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 18.0
    E.1.2Level LLT
    E.1.2Classification code 10046242
    E.1.2Term Unspecified vitamin D deficiency
    E.1.2System Organ Class 100000004861
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    /
    L’objectif principal est d’évaluer la variation du taux plasmatique de cathélicidine avant et après vaccination antigrippale.
    E.2.2Secondary objectives of the trial
    /
    Les objectifs secondaires sont :
    - Evaluer les variations des profils cytokiniques pro-inflammatoires et anti-inflammatoires (IL4, IL-5, IL-10, IL-13, IL-17, IL23, TFN a, IFNg, TGFb).
    - Evaluer l’expression génique leucocytaire : analyse transcriptomique globale dont marqueurs du métabolisme de la vitamine D (VDR, CYP27B1, CYP24A1), du stress oxydant (NOX, SOD, GPX), de l’inflammation (PTGS2), du transport membranaire et du métabolisme glucidique (GLUT, récepteur à l’insuline), de la synthèse protéique (eIF2a, eIF4E, 4EPB1).
    - Quantifier l’expression protéique de marqueurs identifiés par l’analyse transcriptomique.
    - Evaluer des activités enzymatiques et des métabolistes au niveau plasmatique et leucocytaire : indoleamine 2,3-dioxygénase (IDO) et ses substrats (tryptophane) et métabolites (kynurénines) ; NOX, CAT, GPX, glutathion.
    - Efficacité vaccinale antigrippale par l’évaluation du taux de séroconversion, de séroprotection, de la MGT des anticorps.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    /
    - Sujet âgé de 65 ans ou plus,
    - Sujets ayant un taux de vitamine D inférieur à 30 ng/ml,
    - Acceptation d’une supplémentation en vitamine D (UVEDOSE® 100 000 UI)
    - Acceptation de la vaccination antigrippale avec INTANZA15®
    - Affiliation à un régime de Sécurité Sociale
    - Le sujet s’engage à ne pas modifier ses habitudes alimentaires
    E.4Principal exclusion criteria
    /
    - Maladies hépatiques : cirrhose, hépatite chronique.
    - Insuffisance rénale quel que soit le degré
    - Hypercalcémie (calcémie > 2,6 mol/l)
    - Antécédents d’hypo ou hyperparathyroïdie, antécédents de colique néphrétique.
    - Maladie/infection aigüe, modérée ou grave (à l’appréciation de l’investigateur) le jour de la vaccination ou maladie fébrile (température ≥38°C). Le sujet ne doit pas être inclus dans l’étude tant que sa pathologie n’est pas guérie ou que sa fièvre n’a pas baissé).
    - Traitement au long cours par biphosphonates, corticoïdes, anti-inflammatoires, anticonvulsivants, antiépileptiques, fibrates.
    - Hypersensibilité connue à la vitamine D
    - Supplémentation préalable (au cours de l’année précédente) ou supplémentation en cours de vitamine D
    - Participation au moment de l’inclusion dans l’essai, ou participation prévue, au cours de la même période que le présent essai, à un autre essai clinique portant sur un vaccin, un médicament, un dispositif médical.
    - Vaccination au cours des 4 semaines précédant la vaccination de l’essai ou vaccination prévue dans les trois semaines suivant la vaccination de l’essai.
    - Précédente vaccination contre la grippe avec le vaccin hémisphère Nord 2012-2013, que ce soit avec le vaccin à l’essai ou avec un autre vaccin.
    - Transfusion d’immunoglobulines, de sang ou de dérivés sanguins au cours des 3 derniers mois
    - Immunodéficience congénitale ou acquise, connue ou suspectée ; traitements immunosuppresseurs au cours des 6 derniers mois, tels qu’une chimiothérapie anticancéreuse ou une radiothérapie ; corticothérapie systémique à long-terme (prednisone ou équivalent pendant plus de deux semaines consécutives au cours des 3 mois précédents).
    - Hypersensibilité systémique connue à l’un des composants du vaccin ; ou antécédent de réaction au vaccin grippal ou à un vaccin contenant l’une des substances du vaccin à l’essai, ayant engagé le pronostic vital.
    - Privation de liberté par injonction administrative ou émanant d’un tribunal, sujet en situation d’urgence médicale ou hospitalisation non volontaire
    E.5 End points
    E.5.1Primary end point(s)
    /
    L’évolution du taux plasmatique de cathélicidine le jour de la randomisation (visite 2) avant (visite 3) et après vaccination (visite 4) chez les sujets supplémentés (BS) et non supplémentés (BC).
    E.5.1.1Timepoint(s) of evaluation of this end point
    /
    Taux plasmatique de cathélicidine : visite 2, visite 3, visite 4
    E.5.2Secondary end point(s)
    /
    L’évaluation des critères secondaires sera effectuée le jour de la randomisation (visite 2) avant (visite 3) et après vaccination (visite 4)
    Les critères secondaires étudiés sont les suivants :
    - L’évolution du taux plasmatique de 25(OH)D.
    - Le statut immunitaire évalué sur la production de cytokines pro-inflammatoires et anti-inflammatoires (IL4, IL-5, IL-10, IL-13, IL-17, IL23, TFN a, IFNg, TGFb).
    - Evaluation de l’expression génique leucocytaire : analyse transcriptomique globale dont marqueurs du métabolisme de la vitamine D (VDR, CYP27B1, CYP24A1), du stress oxydant (NOX, SOD, GPX), de l’inflammation (PTGS2), du transport membranaire et du métabolisme glucidique (GLUT, récepteur à l’insuline), de la synthèse protéique (eIF2a, eIF4E, 4EPB1).
    - Quantification de l’expression protéique de marqueurs identifiés par l’analyse transcriptomique.
    - Evaluation d’activités enzymatiques et de métabolites au niveau plasmatique et leucocytaire : indoleamine 2,3-dioxygénase (IDO) et ses substrats (tryptophane) et métabolites (kynurénines) ; NOX, CAT, GPX, gluthation.
    - Efficacité vaccinale antigrippale par l’évaluation du taux de séroconversion, de séroprotection, de la MGT des anticorps.
    E.5.2.1Timepoint(s) of evaluation of this end point
    /
    Visite 2, visite 3, visite 4 :
    Taux plasmatique de 25(OH)D
    Production de cytokines
    Expression génique leucocytaire
    Expression protéique de marqueurs leucocytaires
    Activités enzymatiques et de métabolites
    Taux de séroconversion, de séroprotection
    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 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 Yes
    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) Yes
    E.7.3Therapeutic confirmatory (Phase III) No
    E.7.4Therapeutic use (Phase IV) No
    E.8 Design of the trial
    E.8.1Controlled Yes
    E.8.1.1Randomised Yes
    E.8.1.2Open No
    E.8.1.3Single blind No
    E.8.1.4Double blind Yes
    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 Yes
    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 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
    /
    Fin de l'essai : dernière visite du dernier sujet
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years
    E.8.9.1In the Member State concerned months12
    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) No
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 100
    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 No
    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 No
    F.4 Planned number of subjects to be included
    F.4.1In the member state100
    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)
    /
    Suivi des sujet après l'essai identique à la prise en charge usuelle de la condition médicale étudiée.
    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 Decision2013-03-22
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2013-05-15
    P. End of Trial
    P.End of Trial StatusOngoing
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