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    Summary
    EudraCT Number:2010-021034-63
    Sponsor's Protocol Code Number:114269
    National Competent Authority:Spain - AEMPS
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2010-07-16
    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 ConcernedSpain - AEMPS
    A.2EudraCT number2010-021034-63
    A.3Full title of the trial
    Estudio fase III multicéntrico, multinacional, aleatorizado, parcialmente ciego, controlado para evaluar la inmunogenicidad, reactogenicidad y seguridad de la vacuna antigripal tetravalente de GSK Biologicals (GSK2321138A) y para evaluar la consistencia clínica de tres lotes de producción de FLU D-QIV en términos de inmunogenicidad, administrada por vía intramuscular en adultos de 18 años de edad y mayores.
    A.3.2Name or abbreviated title of the trial where available
    FLUDQIV008
    A.4.1Sponsor's protocol code number114269
    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 SponsorGlaxoSmithKline S.A.
    B.1.3.4CountrySpain
    B.3.1 and B.3.2Status of the sponsorCommercial
    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 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 nameVacuna de la Gripe estacional cuadrivalente D-QIV de GlaxoSmithKline
    D.3.2Product code GSK2321138A
    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.3.9.3Other descriptive nameVirus fraccionado inactivado Tipo A/California/7/2009 (H1N1)-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.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.9.3Other descriptive nameVirus fraccionado inactivado Tipo A/Perth/16/2009 (H3N2)-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.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.9.3Other descriptive nameVirus fraccionado inactivado Tipo B/Brisbane/60/2008-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.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.9.3Other descriptive nameVirus fraccionado inactivado Tipo B/Florida/04/2006-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.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 FLUARIX suspensión inyectable en jeringa precargada
    D.2.1.1.2Name of the Marketing Authorisation holderGLAXOSMITHKLINE, S.A.
    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.3.4Pharmaceutical 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 INNVIRUS GRIPE A H1N1 INACTIVADO HEMAGLUTININA DE
    D.3.9.3Other descriptive nameVIRUS GRIPE A H1N1 INACTIVADO HEMAGLUTININA DE
    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.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNVIRUS GRIPE A H3N2 INACTIVADO HEMAGLUTININA DE
    D.3.9.3Other descriptive nameVIRUS GRIPE A H3N2 INACTIVADO HEMAGLUTININA DE
    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.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNVIRUS GRIPE B INACTIVADO HEMAGLUTININA DE
    D.3.9.3Other descriptive nameVIRUS GRIPE B INACTIVADO HEMAGLUTININA DE
    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.IMP: 3
    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 nameVacuna gripe estacional trivalente TIV-2 DE GlaxoSmithKline
    D.3.2Product code GSK2604409A
    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.3.9.3Other descriptive nameVirus fraccionado inactivado Tipo A/California/7/2009 (H1N1)-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.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.9.3Other descriptive nameVirus fraccionado inactivado Tipo A/Perth/16/2009 (H3N2)-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
    Inmunización de adultos de 18 años o más frente a la gripe
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 13
    E.1.2Level LLT
    E.1.2Classification code 10022000
    E.1.2Term Influenza
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    • Evaluar la consistencia entre tres lotes de la vacuna D-QIV, a partir de las medias geométricas de los títulos de anticuerpos (GMT) determinados mediante inhibición de la hemaglutinina (IH).
    • Evaluar la no inferioridad inmunitaria (de acuerdo con las GMT de los anticuerpos IH y las tasas de seroconversión (SCR)) de la vacuna D-QIV frente a las vacunas TIV-1 (Fluarix) y TIV-2 para las tres cepas incluidas en cada una de las vacunas TIV-1 (Fluarix) y TIV-2.
    • Evaluar la superioridad inmunitaria (en base a las GMT de los anticuerpos IH y las tasas de seroconversión (SCR)) de la vacuna D-QIV frente a las vacunas TIV-1 (Fluarix) y TIV-2 para la cepa B no incluida en cada vacuna TIV.
    E.2.2Secondary objectives of the trial
    • Describir la inmunogenicidad de la vacuna D-QIV, la vacuna TIV-1 (Fluarix) y la vacuna TIV-2 en base a las GMT y SPR en los días 0 y 21, y la SCR y el IMG en el día 21, en conjunto y en cada estrato etario.
    • Evaluar la reactogenicidad y la seguridad de las vacunas D-QIV, TIV-1 (Fluarix) y TIV-2, en conjunto y en cada estrato etario, a partir de:
    - Síntomas locales solicitados durante el periodo de seguimiento posvacunal de 7 días (día de la vacunación y 6 días posteriores).
    - Síntomas generales solicitados durante el periodo de seguimiento posvacunal de 7 días (día de la vacunación y 6 días posteriores).
    - Síntomas no solicitados durante el periodo de seguimiento posvacunal de 21 días (día de la vacunación y 20 días siguientes).
    - Acontecimientos adversos graves (AAG), AA con visita médica (MAV) y enfermedades de posible causa inmune (EpCI) durante todo el periodo de estudio
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    • Hombre o mujer de 18 años o más en el momento de la primera vacunación.
    • Sujetos que el investigador considere que pueden y desean cumplir los requisitos del protocolo (p. ej., cumplimentación de la tarjeta diario, retorno a las visitas de seguimiento).
    • Firma del consentimiento informado del sujeto antes de ningún procedimiento del estudio.
    • Sujetos sanos o aquellos con una enfermedad crónica bien controlada, de acuerdo con la exploración física realizada antes de la inclusión en el estudio.
    • En este estudio se podrá reclutar a mujeres con imposibilidad para procrear.
    - Se define como imposibilidad para procrear la ligadura tubárica actual, la histerectomía, la ovariectomía o el estado posmenopáusico.
    Consulte, por favor, la definición de menopausia en el [GLOSARIO DE TÉRMINOS].
    • Se podrá reclutar en este estudio a mujeres de edad fértil, si:
    - practican una anticoncepción adecuada durante 30 días antes de la vacunación, y
    - presentan una prueba negativa de embarazo en el día de la vacunación, y
    - dan su consentimiento para continuar con la anticoncepción adecuada durante todo el periodo de tratamiento y hasta 2 meses después de terminar la serie de vacunación.
    La definición de anticoncepción adecuada se ofrece en el [GLOSARIO DE TÉRMINOS].
    E.4Principal exclusion criteria
    • Uso de un producto (medicamento o vacuna) en investigación o no registrado, diferente de las vacunas del estudio, en los 30 días anteriores a la aplicación de la dosis de la vacuna del estudio o uso durante el periodo de estudio.
    • Administración crónica (definida por una duración mayor de 14 días en total) de inmunosupresores o de otros medicamentos inmunomoduladores durante los seis meses anteriores a la aplicación de la primera dosis de la vacuna. En el caso de los corticoides, esto significa 20 mg/día de prednisona o equivalente. Se permitirá el uso inhalado y tópico de esteroides.
    • Administración de una vacuna antigripal durante los 6 meses anteriores a la inclusión en el estudio.
    • Administración prevista/administración de una vacuna no incluida en el protocolo del estudio en los 30 días previos a la vacunación y hasta la visita 2.
    • Cualquier contraindicación para la administración intramuscular de las vacunas antigripales.
    • Antecedentes de hipersensibilidad/anafilaxia a una dosis previa de la vacuna antigripal, antecedentes de reacción e hipersensibilidad posiblemente exacerbadas por algún componente de las vacunas, incluido el látex.
    • Administración de un inmunomodulador de acción prolongada (p. ej., rituximab, infliximab) en los 3 meses anteriores al comienzo del estudio o administración prevista durante el periodo del estudio.
    • Cualquier estado de inmunosupresión o inmunodeficiencia confirmado o sospechoso, basado en la historia clínica y la exploración física (no se requerirá ninguna prueba de laboratorio).
    • Enfermedad aguda o fiebre o ambas en el momento del reclutamiento.
    - La fiebre se define como una temperatura mayor o igual a 37,5°C (99,5°F) con un ajuste oral o axilar. La vía preferida para el registro de la temperatura en este estudio será la axilar.
    - Los sujetos con enfermedades leves (del tipo de diarrea o infección respiratoria alta leve) sin fiebre podrán ser reclutados, si el investigador lo cree oportuno.
    • Anomalía de la función pulmonar, cardiovascular, hepática o renal de carácter agudo o crónico y con repercusión clínica, de acuerdo con la exploración física o las pruebas de laboratorio de cribado.
    • Antecedentes de síndrome de Guillain-Barre en las 6 semanas posteriores a la administración de una vacuna antigripal inactivada previa.
    • Administración de inmunoglobulinas y/o cualquier hemoderivado en los 3 meses previos a la aplicación de la primera dosis de la vacuna del estudio o administración prevista durante el periodo de estudio.
    • Mujeres embarazadas o lactantes.
    • Historia de consumo crónico de alcohol o de abuso de drogas o de ambos.
    • Cualquier estado que, en opinión del investigador, impida al sujeto participar en el estudio.
    La lista de los criterios que eliminan a los sujetos de los análisis ATP se encuentra en las secciones 6.7.1, 6.8 y 10.4
    E.5 End points
    E.5.1Primary end point(s)
    • Respuesta inmune humoral basada en los anticuerpos IH
    - Títulos de anticuerpos IH en suero frente a las cuatro cepas de la vacuna antigripal a fin de calcular:
    - GMT en el día 0 y en el día 21
    - SCR* en el día 21
    *La SCR se define como el porcentaje de vacunados con un título prevacunal < 1:10 y un título posvacunal mayor o igual 1:40 o bien con un título prevacunal mayor o igual 1:10 y, como mínimo, una cuadruplicación del título posvacunal.
    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 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 Yes
    E.6.13.1Other scope of the trial description
    Inmunogenicidad
    E.7Trial type and phase
    E.7.1Human pharmacology (Phase I) No
    E.7.1.1First administration to humans Information not present in EudraCT
    E.7.1.2Bioequivalence study Information not present in EudraCT
    E.7.1.3Other Information not present in EudraCT
    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) 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 Yes
    E.8.1.7.1Other trial design description
    Parcialmente ciego
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) Yes
    E.8.2.2Placebo No
    E.8.2.3Other Yes
    E.8.2.3.1Comparator description
    Vacuna gripe estacional trivalente TIV-2 GlaxoSmithKline
    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 concerned5
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA28
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA Yes
    E.8.6.2Trial being conducted completely outside of the EEA Information not present in EudraCT
    E.8.6.3If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned
    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
    Última Visita Último paciente
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years0
    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 years0
    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 Information not present in EudraCT
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) Information not present in EudraCT
    F.1.1.3Newborns (0-27 days) Information not present in EudraCT
    F.1.1.4Infants and toddlers (28 days-23 months) Information not present in EudraCT
    F.1.1.5Children (2-11years) Information not present in EudraCT
    F.1.1.6Adolescents (12-17 years) Information not present in EudraCT
    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 Yes
    F.3.2Patients No
    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 No
    F.4 Planned number of subjects to be included
    F.4.1In the member state650
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 1950
    F.4.2.2In the whole clinical trial 4600
    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)
    Como se trata de un ensayo profiláctico, no existe ningún plan de tratamiento o atención después de la finalización de la participación del sujeto en el estudio
    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 Decision2010-09-23
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2010-08-20
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2011-06-06
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