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    The EU Clinical Trials Register currently displays   44334   clinical trials with a EudraCT protocol, of which   7366   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:2014-001120-30
    Sponsor's Protocol Code Number:201334
    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:2016-05-17
    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 number2014-001120-30
    A.3Full title of the trial
    A phase IV, open-label, non-randomised, multi-centre study to assess the immunogenicity and safety of a booster dose of Infanrix hexa? in healthy infants born to mothers vaccinated with Boostrix? during pregnancy or immediately post-delivery.
    Estudio multicéntrico de fase IV, abierto, no aleatorizado para evaluar la inmunogenicidad y seguridad de una dosis de recuerdo de Infanrix hexa® en niños sanos, nacidos de madres vacunadas con Boostrix® durante el embarazo o en el postparto inmediato.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Evaluation of immunogenicity and safety of a booster dose of Infanrix hexa? in healthy infants born to mothers vaccinated with Boostrix? during pregnancy or immediately post-delivery.
    Evaluación de la inmunogenicidad y seguridad de una dosis de recuerdo de Infanrix hexa® en niños sanos nacidos de madres vacunadas con Boostrix® en el embarazo o en el posparto inmediato
    A.3.2Name or abbreviated title of the trial where available
    DTPA (BOOSTRIX)-049 BST: 048
    A.4.1Sponsor's protocol code number201334
    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 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 supportGlaxoSmithKline Biologicals
    B.4.2CountryBelgium
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationGlaxoSmithKline S.A.
    B.5.2Functional name of contact pointCentro de Información
    B.5.3 Address:
    B.5.3.1Street AddressC/Severo Ochoa, 2 (P.T.M.)
    B.5.3.2Town/ cityTres Cantos (Madrid)
    B.5.3.3Post code28760
    B.5.3.4CountrySpain
    B.5.4Telephone number34902202700
    B.5.5Fax number34918070479
    B.5.6E-mailes-ci@gsk.com
    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 Limited
    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.3.4Pharmaceutical 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 INNPolisacárido pneumocócico serotipo 1 conjugado con CRM197
    D.3.9.3Other descriptive namePolisacárido pneumocócico serotipo 1 conjugado con CRM197
    D.3.9.4EV Substance CodeSUB30925
    D.3.10 Strength
    D.3.10.1Concentration unit µg microgram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number2.2
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNPolisacárido pneumocócico serotipo 3 conjugado con CRM197
    D.3.9.3Other descriptive namePolisacárido pneumocócico serotipo 3 conjugado con CRM197
    D.3.9.4EV Substance CodeSUB30926
    D.3.10 Strength
    D.3.10.1Concentration unit µg microgram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number2.2
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNPolisacárido pneumocócico serotipo 4 conjugado con CRM197
    D.3.9.3Other descriptive namePolisacárido pneumocócico serotipo 4 conjugado con CRM197
    D.3.9.4EV Substance CodeSUB25336
    D.3.10 Strength
    D.3.10.1Concentration unit µg microgram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number2.2
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNPolisacárido pneumocócico serotipo 5 conjugado con CRM197
    D.3.9.3Other descriptive namePolisacárido pneumocócico serotipo 5 conjugado con CRM197
    D.3.9.4EV Substance CodeSUB30927
    D.3.10 Strength
    D.3.10.1Concentration unit µg microgram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number2.2
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNPolisacárido pneumocócico serotipo 6A conjugado con CRM197
    D.3.9.3Other descriptive namePolisacárido pneumocócico serotipo 6A conjugado con CRM197
    D.3.9.4EV Substance CodeSUB30928
    D.3.10 Strength
    D.3.10.1Concentration unit µg microgram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number2.2
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNPolisacárido pneumocócico serotipo 6B conjugado con CRM197
    D.3.9.3Other descriptive namePolisacárido pneumocócico serotipo 6B conjugado con CRM197
    D.3.9.4EV Substance CodeSUB25356
    D.3.10 Strength
    D.3.10.1Concentration unit µg microgram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number4.4
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNPolisacárido pneumocócico serotipo 7F conjugado con CRM197
    D.3.9.3Other descriptive namePolisacárido pneumocócico serotipo 7F conjugado con CRM197
    D.3.9.4EV Substance CodeSUB30929
    D.3.10 Strength
    D.3.10.1Concentration unit µg microgram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number2.2
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNPolisacárido pneumocócico serotipo 9V conjugado con CRM197
    D.3.9.3Other descriptive namePolisacárido pneumocócico serotipo 9V conjugado con CRM197
    D.3.9.4EV Substance CodeSUB25343
    D.3.10 Strength
    D.3.10.1Concentration unit µg microgram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number2.2
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNPolisacárido pneumocócico serotipo 14 conjugado con CRM197
    D.3.9.3Other descriptive namePolisacárido pneumocócico serotipo 14 conjugado con CRM197
    D.3.9.4EV Substance CodeSUB25341
    D.3.10 Strength
    D.3.10.1Concentration unit µg microgram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number2.2
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNPolisacárido pneumocócico serotipo 18C conjugado con CRM197
    D.3.9.3Other descriptive namePolisacárido pneumocócico serotipo 18C conjugado con CRM197
    D.3.9.4EV Substance CodeSUB25338
    D.3.10 Strength
    D.3.10.1Concentration unit µg microgram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number2.2
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNPolisacárido pneumocócico serotipo 19A conjugado con CRM197
    D.3.9.3Other descriptive namePolisacárido pneumocócico serotipo 19A conjugado con CRM197
    D.3.9.4EV Substance CodeSUB30930
    D.3.10 Strength
    D.3.10.1Concentration unit µg microgram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number2.2
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNPolisacárido pneumocócico serotipo 19F conjugado con CRM197
    D.3.9.3Other descriptive namePolisacárido pneumocócico serotipo 19F conjugado con CRM197
    D.3.9.4EV Substance CodeSUB25337
    D.3.10 Strength
    D.3.10.1Concentration unit µg microgram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number2.2
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNPolisacárido pneumocócico serotipo 23F conjugado con CRM197
    D.3.9.3Other descriptive namePolisacárido pneumocócico serotipo 23F conjugado con CRM197
    D.3.9.4EV Substance CodeSUB25368
    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.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 INFANRIX HEXA
    D.2.1.1.2Name of the Marketing Authorisation holderGlaxoSmithKline 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.3.4Pharmaceutical form Powder and suspension for 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 INNTOXOIDE DIFTERICO
    D.3.9.2Current sponsor codeD
    D.3.9.3Other descriptive nameTOXOIDE DIFTERICO
    D.3.9.4EV Substance CodeSUB12489MIG
    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.3.9.2Current sponsor codeT
    D.3.9.3Other descriptive nameTOXOIDE TETÁNICO
    D.3.9.4EV Substance CodeSUB12608MIG
    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 PERTUSICO
    D.3.9.2Current sponsor codePT
    D.3.9.3Other descriptive nameTOXOIDE PERTUSICO
    D.3.9.4EV Substance CodeSUB14817MIG
    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.3.9.2Current sponsor codeFHA
    D.3.9.3Other descriptive nameHEMAGLUTININA FILAMENTOSA
    D.3.9.4EV Substance CodeSUB38509
    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 PERTUSICA
    D.3.9.2Current sponsor codePRN
    D.3.9.3Other descriptive namePERTACTINA PERTUSICA
    D.3.9.4EV Substance CodeSUB20527
    D.3.10 Strength
    D.3.10.1Concentration unit µg microgram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number8
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNANTIGENO SUPERFICIE HEPATITIS B
    D.3.9.2Current sponsor codeHBsAg
    D.3.9.3Other descriptive nameANTIGENO SUPERFICIE HEPATITIS B
    D.3.9.4EV Substance CodeSUB14083MIG
    D.3.10 Strength
    D.3.10.1Concentration unit µg microgram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number10
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNPOLIOVIRUS (INACTIVADO) TIPO 1 (CEPA MAHONEY)
    D.3.9.2Current sponsor codeIPV type 1
    D.3.9.3Other descriptive namePOLIOVIRUS (INACTIVADO) TIPO 1 (CEPA MAHONEY)
    D.3.9.4EV Substance CodeSUB25292
    D.3.10 Strength
    D.3.10.1Concentration unit DAgU D antigen unit(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number40
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNPOLIOVIRUS (INACTIVADO) TIPO 2 (CEPA MEF-1)
    D.3.9.2Current sponsor codeIPV type 2
    D.3.9.3Other descriptive namePOLIOVIRUS (INACTIVADO) TIPO 2 (CEPA MEF-1)
    D.3.9.4EV Substance CodeSUB25266
    D.3.10 Strength
    D.3.10.1Concentration unit DAgU D antigen unit(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number8
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNPOLIOVIRUS (INACTIVADO) TIPO 3 (CEPA SAUKETT)
    D.3.9.2Current sponsor codeIPV type 3
    D.3.9.3Other descriptive namePOLIOVIRUS (INACTIVADO) TIPO 3 (CEPA SAUKETT)
    D.3.9.4EV Substance CodeSUB25264
    D.3.10 Strength
    D.3.10.1Concentration unit DAgU D antigen unit(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number32
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNVacuna conjugada frente Haemophilus tipo B (conjugada con toxoide tetánico)
    D.3.9.2Current sponsor codeHib
    D.3.9.3Other descriptive nameVacuna conjugada frente Haemophilus tipo B (conjugada con toxoide tetánico)
    D.3.9.4EV Substance CodeSUB14050MIG
    D.3.10 Strength
    D.3.10.1Concentration unit µg microgram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number10
    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 Yes
    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
    Infanrix Hexa is indicated for the prevention of diphtheria, tetanus, pertussis, hepatitis B, poliomyelitis and disease caused by Haemophilus influenzae type b (Hib).
    Infanrix Hexa está indicada para la prevención frente a difteria, tétanos, tos ferina, hepatitis B, poliomielitis y enfermedad causada por Haemophilus influenzae de tipo b (Hib).
    E.1.1.1Medical condition in easily understood language
    Infanrix hexa is a vaccine that protects people against infections like diphtheria, lock jaw, whopping cough, hepatitis B, polio and meningitis.
    Infanrix hexa es una vacuna que protege de infecciones como la difteria, tétanos, tos ferina, hepatitis B, polio y meningitis
    E.1.1.2Therapeutic area Diseases [C] - Bacterial Infections and Mycoses [C01]
    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
    To assess the immunological response to Infanrix hexa in terms of seroprotection status for diphtheria, tetanus, hepatitis B, poliovirus and Hib antigens, and in terms of booster response for the pertussis antigens, one month after the booster dose in infants born to mothers vaccinated with Boostrix during pregnancy or immediately post-delivery.
    Evaluar la respuesta inmunológica a Infanrix hexa a juzgar por las tasas de seroprotección frente a los antígenos de difteria, tétanos, hepatitis B, poliovirus y Hib, y por la respuesta frente a los antígenos pertussis a la dosis de recuerdo, un mes después de su administración a los lactantes nacidos de madres vacunadas con Boostrix durante el embarazo o inmediatamente después del parto.
    E.2.2Secondary objectives of the trial
    1. To assess persistence of antibodies to all vaccine antigens before the booster dose in infants born to mothers vaccinated with Boostrix during pregnancy or immediately post-delivery.
    2. To assess immunological response to Infanrix hexa and Prevenar 13 in terms of antibody concentrations against all antigens, one month after the booster dose in infants born to mothers vaccinated with Boostrix during pregnancy or immediately post-delivery.
    3. To assess immunological response to Infanrix hexa in terms of seropositivity rates against pertussis antigens, one month after the booster dose in infants born to mothers vaccinated with Boostrix during pregnancy or immediately post-delivery.
    4. To assess safety and reactogenicity of Infanrix hexa and Prevenar 13 in terms of solicited/unsolicited symptoms and SAEs.
    5. To assess neurodevelopmental status of infants born to mothers vaccinated with Boostrix during pregnancy or immediately post-delivery, at 9 and 18 months of age.
    Evaluar:
    1. Persistencia de anticuerpos frente a todos los antígenos vacunales, antes de administrar la dosis de recuerdo a los niños de madres vacunadas con Boostrix durante el embarazo o posparto inmediato.
    2.Respuesta inmunitaria a Infanrix hexa y Prevenar 13 en base a las concentraciones o títulos de anticuerpos frente a todos los antígenos, 1m tras la dosis de recuerdo de los niños de madres vacunadas con Boostrix durante el embarazo o posparto inmediato.
    3.Respuesta inmunitaria a Infanrix hexa en base a las tasas de seropositividad frente a los antígenos pertussis, 1m tras la dosis de recuerdo a los niños de madres vacunadas con Boostrix durante el embarazo o posparto inmediato.
    4.Seguridad y reactogenicidad de Infanrix hexa y Prevenar 13 en base a los síntomas solicitados y no solicitados y los acontecimientos adversos graves (AAG).
    5.Desarrollo neurológico a los 9 y 18 meses de edad de los niños de madres vacunadas con Boostrix durante el embarazo o posparto inmediato.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    ? Subjects? parent(s)/LAR(s) who, in the opinion of the investigator, can and will comply, with the requirements of the protocol (e.g. completion of the diary cards, return for follow-up visits).
    ? Written informed consent obtained from the parent(s)/LAR(s) of the subject prior to performing any study specific procedure.
    ? A male or female child 9 months of age at the time of enrolment.
    ? Healthy subjects as established by medical history and clinical examination before entering into the study.
    ? Subjects born to mothers who were vaccinated in 116945 [DTPA (BOOSTRIX)-047] study.
    ?Padres/RLA de los sujetos que, en opinión del investigador puedan y vayan a cumplir los requisitos del protocolo (p. ej., cumplimentación de las tarjetas diario, retorno a las visitas de seguimiento).
    ?Consentimiento informado y firmado por los padres/RLA del sujeto antes de realizar ningún procedimiento específico.
    ?En niños o niñas con una edad de 9 meses en el momento del reclutamiento.
    ?Sujetos sanos, según lo establecido en la historia clínica y exploración física previas a la entrada en el estudio.
    ?Sujetos nacidos de madres vacunadas en el estudio 116945 [DTPA (BOOSTRIX)-047].
    E.4Principal exclusion criteria
    ? Child in care
    ? Concurrently participating in another clinical study, within three months prior to the booster vaccine dose and at any time during the present booster study, in which the subject has been or will be exposed to an investigational or a non-investigational vaccine/product (pharmaceutical product or device).
    ? Chronic administration (defined as more than 14 days in total) of immunosuppressants or other immune-modifying drugs during the period within six months prior to the booster vaccine dose. For corticosteroids, this will mean prednisone ? 0.5mg/kg/day, or equivalent. Inhaled and topical steroids are allowed.
    ? Administration of long-acting immune-modifying drugs at any time during the study period (e.g. infliximab).
    ? A vaccine not foreseen by the study protocol administered during the period starting from 30 days before the booster dose of study vaccine and ending 30 days after*, with the exception of inactivated influenza vaccine and other vaccines given as a part of the national/regional immunisation schedule, that are allowed at any time during the study period.
    *In case an emergency mass vaccination for an unforeseen public health threat (e.g.: a pandemic) is organised by the public health authorities, outside the routine immunisation program, the time period described above can be reduced if necessary for that vaccine provided it is licensed and used according to its SPC or Product Information (PI) and according to the local governmental recommendations and provided a written approval of the Sponsor is obtained.
    ? Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination (no laboratory testing required).
    ? Major congenital defects.
    ? Serious chronic illness.
    ? Administration of immunoglobulins and/or any blood products during the period within three months before the booster dose of study vaccines or planned administration during the study period.
    ? Encephalopathy defined as an acute, severe central nervous system disorder occurring within 7 days following vaccination with Infanrix hexa and generally consisting of major alterations in consciousness, unresponsiveness, generalised or focal seizures that persist more than a few hours, with failure to recover within 24 hours.
    ? History of Hib, diphtheria, tetanus, pertussis, pneumococcal, poliovirus and hepatitis B diseases since the conclusion visit of study 201330 [DTPA (BOOSTRIX)-048 PRI]
    ? Previous booster vaccination against Hib, diphtheria, tetanus, pertussis, pneumococcus, hepatitis B and/or poliovirus since the conclusion visit of study 201330 [DTPA (BOOSTRIX)-048 PRI].
    ? History of any reaction or hypersensitivity likely to be exacerbated by any component of the vaccines (e.g: antigen, excipients).
    ? Hypersensitivity to latex.
    ? History of any neurological disorders or seizures.
    ? Any condition that in the judgment of the investigator would make intramuscular injection unsafe.
    ? Acute disease and/or fever at the time of vaccination.
    - Fever is defined as temperature ? 37.5°C /99.5°F for oral, axillary or tympanic route, or ? 38.0°C /100.4°F on rectal route.
    - Subjects with a minor illness (such as mild diarrhoea, mild upper respiratory infection) without fever may be enrolled at the discretion of the investigator.
    ?Niño en acogida.
    ?Participación simultánea en otro ensayo clínico, durante los tres meses anteriores a la administración de la dosis de recuerdo de la vacuna y en cualquier momento del estudio de recuerdo actual, en el que el sujeto ha sido o será expuesto a una vacuna/producto en investigación o de naturaleza no experimental (producto farmacéutico o sanitario), en cualquier momento del estudio.
    ?Administración crónica (definida por una duración mayor de 14 días en total) de inmunosupresores o de otros medicamentos inmunomoduladores durante el período de seis meses anteriores a la administración de la dosis de recuerdo de la vacuna. En el caso de los corticoides, esto significa una dosis de prednisona ? 0,5 mg/kg/día o equivalente. Se permitirá el uso inhalado y tópico de esteroides.
    ?Administración de inmunomoduladores de acción prolongada en cualquier momento durante el período de estudio (p. ej., infliximab).
    ?Vacuna no prevista en el protocolo del estudio que se administre desde 30 días antes de la dosis de recuerdo de la vacuna del estudio hasta 30 días después*, con excepción de la vacuna de la gripe inactivada y de otras vacunas que se administren como parte del calendario de vacunación nacional/regional, que están permitidas en cualquier momento del período de estudio.
    *Si las autoridades de salud pública organizan, fuera del calendario de vacunación habitual, una vacunación masiva de emergencia por una amenaza imprevista para la salud pública (p. ej., una pandemia), se podrá reducir, si fuera necesario, el período descrito para la vacuna, siempre que esté autorizada y se utilice de acuerdo con la ficha técnica o el prospecto (P) y según las recomendaciones del gobierno local y siempre que el promotor obtenga la aprobación por escrito.
    ?Cualquier estado de inmunosupresión o inmunodeficiencia confirmado o sospechado en base a la historia clínica y la exploración física (no se exigirá ninguna prueba de laboratorio).
    ?Defectos congénitos mayores.
    ?Enfermedad crónica grave.
    ?Administración de inmunoglobulinas y/o hemoderivados desde tres meses antes hasta la administración de la dosis de recuerdo de las vacunas del estudio o bien, administración programada durante el período de estudio.
    ?Encefalopatía, definida como un trastorno agudo y grave del sistema nervioso central que ocurre en los siete días siguientes a la vacunación con Infanrix hexa y que consiste, por lo general, en alteraciones importantes de la conciencia, falta de respuesta, convulsiones generalizadas o focales que persisten durante más de unas horas y falta de recuperación en un plazo de 24 horas.
    ?Antecedentes de Hib, difteria, tétanos, tos ferina, enfermedad por neumococo, virus de la polio o hepatitis B desde la visita de conclusión del estudio 201330 [DTPA (BOOSTRIX)-048 PRI]..
    ?Vacunación de recuerdo previa frente a Hib, difteria, tétanos, tos ferina, neumococo, hepatitis B y/o polio desde la visita de conclusión del estudio 201330 [DTPA (BOOSTRIX)-048 PRI].
    ?Antecedentes de reacción o de hipersensibilidad que se pueda exacerbar por algún componente de las vacunas (p. ej., antígeno, excipientes).
    ?Hipersensibilidad al látex.
    ?Antecedentes de enfermedades neurológicas o de crisis convulsivas.
    ?Cualquier afección que, a criterio del investigador, haga insegura la inyección intramuscular.
    ?Enfermedad aguda y/o fiebre en el momento de la vacunación.
    - La fiebre se define como una temperatura ? 37,5°C /99,5°F por vía oral, axilar o timpánica, o ? 38,0°C /100,4°F por vía rectal.
    - Los sujetos con enfermedades leves (por ejemplo, diarrea leve, infección respiratoria alta leve) y sin fiebre podrán ser reclutados, a criterio del investigador.
    E.5 End points
    E.5.1Primary end point(s)
    1. Number of seroprotected subjects for anti-diphtheria, anti-tetanus, anti-HBs, anti poliovirus type 1, anti-poliovirus type 2, anti-poliovirus type 3 and anti-polyribosylribitol phosphate.
    2. Number of subjects with a booster response to PT, FHA and PRN antigens.
    1.Estado de seroprotección (anticuerpos antidiftéricos, antitetánicos, anti-HBs, anti-poliovirus tipo I, anti-poliovirus tipo 2, anti-poliovirus tipo 3 y anti-polirribosil-ribitol fosfato (anti-PRP)) un mes después de la dosis de recuerdo
    2.Respuesta a los antígenos TP, FHA y PRN
    E.5.1.1Timepoint(s) of evaluation of this end point
    1. One month after the booster dose
    2. One month after the booster dose
    1. Un mes tras la dosis de recuerdo.

    2. Un mes tras la dosis de recuerdo.
    E.5.2Secondary end point(s)
    1. Number of seroprotected subjects against anti-diphtheria, anti-tetanus, anti-poliovirus type 1, anti-poliovirus type 2, anti-poliovirus type 3, anti-HBs and anti-PRP.
    2. Number of seropositive subjects Anti-PT, anti-FHA and anti-PRN and anti-pneumococcal serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, 23F).
    3. Anti-diphtheria, anti-tetanus, anti-PT, anti-FHA, anti-PRN, anti-poliovirus type 1, anti-poliovirus type 2, anti-poliovirus type 3, anti-HBs and anti-pneumococcal serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, 23F) and anti-PRP antibody con-centrations or titres.
    4. Number of seropositive subjects for anti-PT, anti-FHA and anti-PRN.
    5. Number of subjects with solicited local and general symptoms .
    6. Number of subjects with unsolicited adverse events (AEs).
    7. Number of subjects with serious adverse events (SAEs).
    8. Neurodevelopmental status will be assessed at 9 and 18 months of age adjusted for prematurity.
    1. Estado de seroprotección frrente a anticuerpos antidiftéricos, antitetánicos, anti-poliovirus tipo 1, anti-poliovirus tipo 2, anti-poliovirus tipo 3, anti-HBs y anti-PRP.
    2. Tasas de seropositividad de los anticuerpos anti-PT, anti-FHA, anti-PRN y anti-serotipos neumocócicos (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, 23F).
    3.Concentraciones o títulos de anticuerpos antidiftéricos, antitetánicos, anti-PT, anti-FHA, anti-PRN, anti-poliovirus tipo 1, anti-poliovirus tipo 2, anti-poliovirus tipo 3, anti-HBs, anti-serotipos neumocócicos (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, 23F) y anti-PRP.
    4.Tasas de seropositividad de los anticuerpos anti-PT, anti-FHA y anti-PRN.
    5.Frecuencia de síntomas solicitados locales/generales
    6.Frecuencia de síntomas no solicitados
    7.Frecuencia de AAG notificados
    8.Estado de desarrollo neurológico evaluado a los 9 y a los 18 meses de edad,tras el ajuste de la prematuridad
    E.5.2.1Timepoint(s) of evaluation of this end point
    1. One month before booster dose
    2. One month before booster dose
    3. One month before and after booster dose
    4. One month after booster dose
    5. During the 4-day (Day 0-Day 3) follow-up period after booster vaccination
    6. During the 31-day (Day 0-Day 30) follow-up period after booster vaccination
    7. From booster dose up to study end
    8. At 9 and 18 months of age
    1. Un mes antes de la dosis de recuerdo
    2. Un mes antes de la dosis de recuerdo
    3. Un mes antes y despues de la dosis de recuerdo
    4. Un mes tras la dosis de recuerdo
    5. Durante el periodo de seguimiento de 4 días (día 0 a día 3) tras la vacunación de recuerdo
    6. Durante el periodo de seguimiento de 31 días (día 0 a día 30) tras la vacunación de recuerdo
    7. Desde la dosis de recuerdo hasta la finalización del ensayo
    8. A los 9 y 18 meses de edad
    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
    Immunogenicity
    Inmunogenicidad
    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 No
    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 Information not present in EudraCT
    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 No
    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 concerned9
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA15
    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 No
    E.8.6.3If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned
    Australia
    Canada
    Czech Republic
    Spain
    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
    LSLV
    Última visita del último sujeto
    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 months9
    E.8.9.1In the Member State concerned days13
    E.8.9.2In all countries concerned by the trial years1
    E.8.9.2In all countries concerned by the trial months9
    E.8.9.2In all countries concerned by the trial days13
    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: 680
    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) Yes
    F.1.1.4.1Number of subjects for this age range: 680
    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) 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 No
    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 state230
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 330
    F.4.2.2In the whole clinical trial 680
    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
    Ninguno
    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 Decision2016-05-29
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2016-05-10
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2019-07-11
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