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    Summary
    EudraCT Number:2009-016226-13
    Sponsor's Protocol Code Number:ANRS 151
    National Competent Authority:France - ANSM
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2009-10-06
    Trial results View 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 number2009-016226-13
    A.3Full title of the trial
    Etude de phase II randomisée évaluant l'immunogénicité et la tolérance du vaccin antigrippal A(H1N1)v adjuvanté comparativement au vaccin antigrippal A(H1N1)v non adjuvanté chez des patients infectés par le VIH (ANRS 151 HIFLUVAC)
    A.3.2Name or abbreviated title of the trial where available
    HIFLUVAC
    A.4.1Sponsor's protocol code numberANRS 151
    A.7Trial is part of a Paediatric Investigation Plan Information not present in EudraCT
    A.8EMA Decision number of Paediatric Investigation Plan
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorAgence nationale de recherches sur le sida et les hépatites virales
    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 support
    B.4.2Country
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisation
    B.5.2Functional name of contact point
    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 Pandemrix
    D.2.1.1.2Name of the Marketing Authorisation holderGlaxo SmithKline Biologicals
    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.3.1Product nameFLU D-PAN H1N1 (A/California/7/2009 (H1N1)v) (3.8µg) adjuvanté (AS03A)
    D.3.4Pharmaceutical form Emulsion for injection
    D.3.4.1Specific paediatric formulation Information not present in EudraCT
    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 INNSplit, inactivated A/California/7/2009 (H1N1)v-like
    D.3.10 Strength
    D.3.10.1Concentration unit µg/ml microgram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number7.5
    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) Information not present in EudraCT
    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 Information not present in EudraCT
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) Information not present in EudraCT
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product Information not present in EudraCT
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy Information not present in EudraCT
    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 Information not present in EudraCT
    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 No
    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 nameFLU D-PAN H1N1 (A/California/7/2009 (H1N1)v) (15µg)
    D.3.4Pharmaceutical form Suspension for injection
    D.3.4.1Specific paediatric formulation Information not present in EudraCT
    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 INNSplit, inactivated A/California/7/2009 (H1N1)v-like
    D.3.10 Strength
    D.3.10.1Concentration unit µg/ml microgram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number30
    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) Information not present in EudraCT
    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 Information not present in EudraCT
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) Information not present in EudraCT
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product Information not present in EudraCT
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy Information not present in EudraCT
    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 Information not present in EudraCT
    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
    infection VIH et vaccination anti-grippe A (H1N1)
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 12.0
    E.1.2Level LLT
    E.1.2Classification code 10016794
    E.1.2Term Flu vaccination
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 12.0
    E.1.2Level LLT
    E.1.2Classification code 10020161
    E.1.2Term HIV infection
    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 de comparer l’immunogénicité d’un vaccin antigrippal A (H1N1)v administré avec et sans adjuvant chez des patients infectés par le VIH après 1 et 2 injections
    E.2.2Secondary objectives of the trial
    Comparer la tolérance locale et générale d’un vaccin antigrippal A/H1N1v administré avec et sans adjuvant chez des patients VIH+
    Comparer l’immunogénicité d’un vaccin antigrippal A/H1N1v administré avec et sans adjuvant chez des patients VIH+ traités ou non par ARV
    Décrire les autres déterminants de la réponse vaccinale contre la grippe A/H1N1v chez des patients VIH+
    Comparer la durabilité de l’immunogénicité induite par 2 injections d’un vaccin antigrippal A/H1N1v administré avec et sans adjuvant chez des patients VIH+
    Explorer les réponses immunitaires cellulaires antigrippales induites par un vaccin antigrippal A/H1N1v administré avec et sans adjuvant chez des patients VIH+
    Comparer l’effet d’un vaccin antigrippal A/H1N1v administré avec et sans adjuvant sur l’infection par le VIH
    Evaluer les échecs de vaccination et décrire la présentation clinique de la grippe A dans cette population le cas échéant
    E.2.3Trial contains a sub-study Yes
    E.2.3.1Full title, date and version of each sub-study and their related objectives
    Etudier la réponse des lymphocytes à la vaccination.
    Cette sous étude portera sur 60 patients, 30 patients par bras.
    E.3Principal inclusion criteria
    - Agés de 18 ans et plus
    - Ayant signé leur consentement
    - Bénéficiant d’une couverture sociale
    - Présentant une infection par le VIH-1 documentée (sérologie VIH-1 positive ou charge virale VIH-1 positive)
    - Patients traités par HAART depuis au moins 6 mois et charge virale <50 copies/ml lors des 2 prélèvements précédents
    - Patients non traités depuis au moins 6 mois et sans indication prévisible de traitement antirétroviral dans les 3 mois à venir
    - Pris en charge pour une infection par le VIH dans un centre ANRS et dont le domicile est proche de ce centre permettant en cas de syndrome grippal, la consultation et l’hospitalisation le cas échéant dans l’hôpital où il est suivi
    - Pour les femmes en âge d’avoir des enfants, contraception jugée efficace par l’investigateur et test de grossesse négatif avant chaque vaccination
    E.4Principal exclusion criteria
    - Grossesse
    - Chimiothérapie, immunothérapie (Il2, Il7, IgIV), corticothérapie en cours ou reçu dans les 3 mois précédant l’inclusion
    - Thrombopénie < 20 000 /mm3
    - Episode fébrile (au moins 38°C mesurée par voie rectale ou à défaut au moins 37,5°C mesurée par voie orale) dans la semaine précédant la vaccination
    - Infection opportuniste évolutive (traitée depuis moins d’un mois)
    - Co-infection par le virus de l’hépatite C et traitement par l’IFNalpha
    - Grippe (documentée cliniquement ou virologiquement) dans les 6 derniers mois
    - Antécédent de maladie auto-immune documentée (lupus, maladie inflammatoire chronique…)
    - Cirrhose Child C
    - Transplantation d’organe
    - Intolérance à l’un des composants du vaccin
    - Autre vaccination reçue dans les 3 semaines précédant l’inclusion ou prévue jusqu’au mois suivant la dernière injection vaccinale.
    E.5 End points
    E.5.1Primary end point(s)
    Taux de séroprotection (défini par le pourcentage de patients ayant un titre sérique d’anticorps anti-hémagglutinine ≥ 1/40e), taux de séroconversion (défini par le pourcentage de patients ayant un titre d’anticorps <1/10e avant vaccination et ≥ 1/40e après vaccination ou ayant un titre ≥ 1/10e avant vaccination et au moins 4 fois supérieur après vaccination) et facteur de séroconversion (défini par le rapport post/pré vaccination des moyennes géométriques des titres) mesurés 3 semaines après chaque vaccination anti-grippale dans chacun des bras.
    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 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) 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 Yes
    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
    vaccin non-adjuvanté
    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 concerned20
    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 Information not present in EudraCT
    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
    la dernière visite du dernier patient à M12.
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years1
    E.8.9.1In the Member State concerned months2
    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 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.1.3Elderly (>=65 years) Yes
    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 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 No
    F.3.3.7Others Yes
    F.3.3.7.1Details of other specific vulnerable populations
    VIH+
    F.4 Planned number of subjects to be included
    F.4.1In the member state300
    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)
    Pas de traitement prévu à l'issue de l'essai puisqu'il s'agit d'un essai de vaccination en dehors du traitement antirétroviral pour les patients sous traitement à l'inclusion.
    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 Decision2009-10-09
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2009-10-15
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2010-12-16
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    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.

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