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    The EU Clinical Trials Register currently displays   43858   clinical trials with a EudraCT protocol, of which   7284   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:2004-001223-37
    Sponsor's Protocol Code Number:102038
    National Competent Authority:Spain - AEMPS
    Clinical Trial Type:EEA CTA
    Trial Status:
    Date on which this record was first entered in the EudraCT database:2004-09-16
    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 number2004-001223-37
    A.3Full title of the trial
    Ensayo clínico abierto en fase IV, para evaluar la inmunogenicidad y reactogenicidad de la vacuna combinada DTPa (Infanrix) de GlaxoSmithKline Biologicals administrada como dosis de recuerdo a los 4 años de edad en niños prematuros (<37 semanas) en comparación con niños nacidos a término, que previamente recibieron 4 dosis de la vacuna DTPa-HBV-IPV/Hib (Infanrix hexa) a los 2, 4, 6 y 18 meses de edad.
    A.3.2Name or abbreviated title of the trial where available
    DTPa-130
    A.4.1Sponsor's protocol code number102038
    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 Information not present in EudraCT
    D.2.1.1.1Trade name Infanrix
    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.3.1Product nameInfanrix
    D.3.2Product code No aplicable
    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 INNToxoide diftérico
    D.3.10 Strength
    D.3.10.1Concentration unit IU international unit(s)
    D.3.10.2Concentration typenot less then
    D.3.10.3Concentration number30
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNToxoide tetánico
    D.3.10 Strength
    D.3.10.1Concentration unit IU international unit(s)
    D.3.10.2Concentration typenot less then
    D.3.10.3Concentration number40
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNToxoide pertúsico
    D.3.10 Strength
    D.3.10.1Concentration unit µg microgram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number25
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNHemaglutinina filamentosa
    D.3.10 Strength
    D.3.10.1Concentration unit µg microgram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number25
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNPertactina
    D.3.10 Strength
    D.3.10.1Concentration unit µg microgram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number8
    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 Information not present in EudraCT
    D.3.11.8Extractive medicinal product Information not present in EudraCT
    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 primaria activa frente a la difteria, tétanos y tosferina en niños, a partir de los 2 meses de edad hasta los 7 años.
    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
    Demostrar que la inmunogenicidad inducida por la vacuna DTPa (Infanrix) un mes después de la dosis de recuerdo a los 4 años en el grupo de niños prematuros (< 37 semanas) no es inferior a la inducida en le grupo de niños nacidos a término ( 37 semanas).

    Quedará demostrada la no inferioridad si el límite superior del IC 95% de la diferencia en GMTs de los antígenos de Bordetella pertussis (PT, FHA y PRN) es menor a 1,5.

    Quedará demostrada la no inferioridad si el límite superior del IC 95% de la diferencia absoluta en las tasas de seroprotección para difteria y tétanos es menor del 10%.
    E.2.2Secondary objectives of the trial
     Evaluar la persistencia de anticuerpos anti-PRP, anti-HBV, anti-polio 1, anti-polio 2 y anti polio 3 inducidos por la vacuna hexavalente DTPa-HBV-IPV/Hib (Infanrix hexa) en el 4º año de vida.

     Evaluar la seguridad y la reactogenicidad de la vacuna DTPa (Infanrix) a partir del registro de síntomas solicitados, síntomas no solicitados y acontecimientos adversos graves.
    E.2.3Trial contains a sub-study Information not present in EudraCT
    E.3Principal inclusion criteria
     Niños/as de 4 años (y menores de 5 años) de edad en el momento de la administración de la vacuna de estudio.

     Sujetos sin patología evidente a juzgar por la historia clínica y la exploración física realizada antes de la inclusión del sujeto en el estudio.
     Sujetos participantes en el estudio SB217744/070 y posteriormente en el estudio SB217744/083 que hayan recibido 4 dosis de la vacuna hexavalente DTPa-HBV-IPV/Hib (Infanrix hexa) y hayan realizado todas las visitas de los estudios conforme a los correspodientes protocolos.
     Obtención del consentimiento informado por escrito del padre, madre o tutor legal del sujeto.
    E.4Principal exclusion criteria
     Administración programada o administración efectiva de una vacuna no prevista en el protocolo, durate el estudio o en los 30 días anteriores a la administración de la vacuna de estudio.

     Administración programada o efectiva de cualquier fármaco o vacuna en fase de investigación o registro, durante el estudio o en los 30 días anteriores a la administración de la vacuna de estudio.

     Administración previa de una quinta dosis de vacuna frente a difteria, tétanos, tos ferina, hepatitis B, polio y/o enfermedad por Haemophilus influenzae tipo b.

     Tratamiento inmunosupresor administrado de forma crónica (durante más de 14 días) o tratamiento inmunomodulador 30 días antes de la administración de la dosis de vacuna y durante todo el estudio. Para los esteroides, se considerarán inmunosupresoras, dosis de prednisona o equivalente  0.5 mg/kg/día. El tratamiento con esteroides por vía inhalatoria o tópica está permitido.

     Administración de inmunoglobulinas y/o hemoderivados, en los 3 meses previos a la inclusión del sujeto en el estudio o durante la duración del mismo.

     Antecedentes de difteria, tétanos, tos ferina, poliomielitis, hepatitis B y/o enfermedad invasiva por Haemophilus influenzae tipo b previos o intercurrentes.

     Antecedentes de daño neurológico severo o enfermedad neurológica progresiva.

     Inmunodeficiencia, sospechada o confirmada, incluida la infección por el virus de inmunodeficiencia humana (VIH).

     Malformaciones congénitas graves o enfermedades crónicas graves.

     Antecedentes de enfermedades o reacciones que pudieran exacerbarse por algún componente de la vacuna.

     Historia familiar de inmunodeficiencia congénita o hereditaria.

     Temperatura axilar/oral  37,5 ºC ó temperatura rectal  38ºC en el momento de la vacunación.

     Enfermedad aguda en el momento de la vacunación. (La enfermedad aguda se define como la presencia de una afección moderada o grave con o sin fiebre). Se podrá administrar la vacuna a los sujetos con enfermedades leves, tales como diarrea o infección leve de las vías respiratorias superiores, con o sin febrícula, es decir, temperatura oral/axilar < 37,5ºC o rectal < 38ºC.

     Cualquiera de los acontecimientos adversos siguientes que representan contraindicaciones o precauciones para la administración posterior de la vacuna DTP si ya se han observado tras la inyección previa de esta vacuna

     Reacción de hipersensibilidad a la vacuna.
     Encefalopatía definida como un trastorno agudo y grave del sistema nervioso central, sucedido durante los 7 días siguientes a la vacunación y caracterizado por alteraciones graves de conciencia, falta de respuesta a estímulos, crisis generalizadas o focales con persistencia durante varias horas, y ausencia de recuperación dentro de las primeras 24 horas.
     Fiebre = temperatura rectal  40,5°C (o axilar > 40°C) durante las 48 horas posteriores a la vacunación.
     Colapso o situación similar al shock (estado de hipotonía-hiporespuesta) dentro de las primeras 48 horas tras la vacunación.
     Llanto persistente e inconsolable de duración mayor a 3 horas, dentro de las primeras 48 horas tras la vacunación.
    E.5 End points
    E.5.1Primary end point(s)
    Concentración de anticuerpos (GMTs) frente a los antígenos de B. pertussis (PT, FHA y PRN) un mes después de la adminitración de la dosis de recuerdo en los dos grupos de 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 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 Information not present in EudraCT
    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) Information not present in EudraCT
    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) Information not present in EudraCT
    E.7.3Therapeutic confirmatory (Phase III) Information not present in EudraCT
    E.7.4Therapeutic use (Phase IV) Yes
    E.8 Design of the trial
    E.8.1Controlled Yes
    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 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
    niños nacidos a término
    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 Information not present in EudraCT
    E.8.7Trial has a data monitoring committee Information not present in EudraCT
    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
    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 months8
    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 Yes
    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) Yes
    F.1.1.6Adolescents (12-17 years) Information not present in EudraCT
    F.1.2Adults (18-64 years) Information not present in EudraCT
    F.1.3Elderly (>=65 years) Information not present in EudraCT
    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 Information not present in EudraCT
    F.3.3.1Women of childbearing potential not using contraception No
    F.3.3.2Women of child-bearing potential using contraception Information not present in EudraCT
    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
    Niños de cuatro años de edad
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state155
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 155
    F.4.2.2In the whole clinical trial 155
    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 Decision2004-07-12
    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
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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
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