Flag of the European Union EU Clinical Trials Register Help

Clinical trials

The European Union Clinical Trials Register allows you to search for protocol and results information on:
  • interventional clinical trials that are conducted in the European Union (EU) and the European Economic Area (EEA);
  • clinical trials conducted outside the EU / EEA that are linked to European paediatric-medicine development.
  • Learn   more about the EU Clinical Trials Register   including the source of the information and the legal basis.


    The EU Clinical Trials Register currently displays   35525   clinical trials with a EudraCT protocol, of which   5839   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).
     
    Examples: Cancer AND drug name. Pneumonia AND sponsor name.
    How to search [pdf]
    Search Tips: Under advanced search you can use filters for Country, Age Group, Gender, Trial Phase, Trial Status, Date Range, Rare Diseases and Orphan Designation. For these items you should use the filters and not add them to your search terms in the text field.
    Advanced Search: Search tools
     

    < Back to search results

    Print Download

    Summary
    EudraCT Number:2014-001117-41
    Sponsor's Protocol Code Number:201330
    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:2015-05-08
    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 number2014-001117-41
    A.3Full title of the trial
    A phase IV, open-label, non-randomised, multi-centre study to assess the immunogenicity and safety of Infanrix hexa? administered as primary vaccination in healthy infants born to mothers given Boostrix? during pregnancy or post-delivery in 116945 [DTPA (BOOSTRIX)-047].
    Estudio multicéntrico de fase IV, abierto, no aleatorizado para evaluar la inmunogenicidad y seguridad de Infanrix hexa® administrada como vacunación primaria en niños sanos, nacidos de madres que recibieron Boostrix® durante el embarazo o en el postparto inmediato en el estudio 116945 [DTPA (BOOSTRIX)-047].
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Immunogenicity and safety study of Infanrix hexa in healthy infants born to mothers vaccinated with Boostrix? during pregnancy or immediately post-delivery.
    Estudio de inmunogenicidad y seguridad Infanrix hexa® (217744) en niños sanos nacidos de madres vacunadas con Boostrix® en el embarazo o en el postparto inmediato.
    A.3.2Name or abbreviated title of the trial where available
    DTPA (BOOSTRIX)-048 PRI
    DTPA (BOOSTRIX)-048 PRI
    A.4.1Sponsor's protocol code number201330
    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 number+34902202700
    B.5.5Fax number+34918070479
    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 INFANRIX HEXA
    D.2.1.1.2Name of the Marketing Authorisation holderGlaxoSmithKline Biologicals S.A.
    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.3.9.3Other 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.3.9.3Other 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.3.9.3Other 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.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 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.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
    Healthy volunteers [Primary immunisation of infants against diphtheria, tetanus, pertussis, hepatitis B, poliomyelitis and disease caused by Haemophilus influenzae type b (Hib)].
    Primovacunación de lactantes 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
    Diphtheria
    Lock jaw
    Whopping cough
    Hepatitis B
    Polio
    Influenza
    Difteria
    Bloqueo de mandíbula
    Tos pertúsica
    Hepatitis B
    Polio
    Gripe
    E.1.1.2Therapeutic area Diseases [C] - Bacterial Infections and Mycoses [C01]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 18.0
    E.1.2Level LLT
    E.1.2Classification code 10006025
    E.1.2Term Bordetella pertussis laryngotracheobronchitis
    E.1.2System Organ Class 100000004862
    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 DTPa-HBV-IPV/Hib in terms of seroprotection status for diphtheria, tetanus, hepatitis B, poliovirus and Hib antigens, and in terms of vaccine response to the pertussis antigens, one month after the last dose of the primary vaccination in infants born to mothers vaccinated with Boostrix during pregnancy or immediately post-delivery.
    Evaluar la respuesta inmunitaria a DTPa-HBV-IPV/Hib a juzgar por las tasas de seroprotección frente a los antígenos de difteria, tétanos, hepatitis B, poliovirus y Hib, y por las tasas de seropositividad frente a los antígenos pertussis, un mes después de la última dosis de la primovacunación de los niños de madres vacunadas con Boostrix durante el embarazo o inmediatamente después del parto.
    E.2.2Secondary objectives of the trial
    ?To assess persistence of antibodies against diphtheria, tetanus and pertussis antigens, before the first dose of DTPa-HBV-IPV/Hib in infants born to mothers vaccinated with Boostrix during pregnancy or immediately post-delivery.
    ?To assess the immunological response to DTPa-HBV-IPV/Hib and 13Pn in terms of antibody concentrations or titres against all antigens, one month* after the last dose of the primary vaccination in infants born to mothers vaccinated with Boostrix during pregnancy or immediately post-delivery.
    ?To assess the immunological response to DTPa-HBV-IPV/Hib in terms of seropositivity rates against pertussis antigens, one month after the last dose of the primary vaccination in infants born to mothers vaccinated with Boostrix during pregnancy or immediately post-delivery.
    ?To assess the safety and reactogenicity of DTPa-HBV-IPV/Hib and 13Pn in terms of solicited and unsolicited symptoms and serious adverse events (SAEs).
    -Evaluar la persistencia de anticuerpos frente a los antígenos de difteria, tétanos y tosferina, antes de administrar la 1ª dosis de DTPa-HBV-IPV/Hib a niños nacidos de madres vacunadas con Boostrix durante el embarazo o postparto inmediato.
    -Evaluar la respuesta inmunitaria a DTPa-HBV-IPV/Hib y 13Pn a juzgar por las concentraciones o títulos de anticuerpos frente a todos los antígenos, un mes después de la última dosis de la primovacunación de los niños de madres vacunadas con Boostrix durante el embarazo o en el postparto inmediato.
    -Evaluar la respuesta inmunitaria a DTPa-HBV-IPV/Hib a juzgar por las tasas de seropositividad frente a los antígenos pertussis, un mes después de la última dosis de la primovacunación de los niños de madres vacunadas con Boostrix durante el embarazo o en el postparto inmediato.
    - Evaluar la seguridad y reactogenicidad de DTPa-HBV-IPV/Hib y 13Pn a juzgar por los síntomas solicitados y no solicitados y los acontecimientos adversos graves (AAG).
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    ?Subjects? parent(s)/Legally Acceptable Representative(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 between, 6 and 12 weeks of age (including 6 weeks and up to but not including 12 weeks) at the time of the first vaccination.
    ?Healthy subjects as established by medical history and clinical examination before entering into the study.
    ?Born to a mother enrolled in study 116945 [DTPA (BOOSTRIX)-047].
    ?Medically stable* prematurely born infants, born after a gestation period of 27-36 weeks may be enrolled in the study at the discretion of the investigator.
    *Medically stable refers to the condition of premature infants who do not require significant medical support or ongoing management for debilitating disease and who have demonstrated a clinical course of sustained recovery by the time they receive the first dose of study vaccine.
    -Padres/representantes legales aceptables (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.
    - Niño ó niña, con una edad de 6 a 12 semanas, (Incluyendo 6 semanas y hasta 12 semanas exclusive), en el momento de la primera vacunación.
    - Sujetos sanos, según lo establecido en la historia clínica y exploración física previas a la entrada en el estudio.
    - Niño nacido de una madre reclutada en el estudio 116945 [DTPA (BOOSTRIX)-047].
    - A criterio del investigador, se podrá reclutar para el estudio a niños prematuros médicamente estables*, nacidos tras un período de gestación de 27-36 semanas.
    *Médicamente estable se refiere al estado de un niño prematuro que no precise asistencia médica importante o tratamiento continuado de una enfermedad debilitante y que haya manifestado una evolución clínica con recuperación sostenida en el momento de recibir la primera dosis de la vacuna del estudio.
    E.4Principal exclusion criteria
    ?Child in care
    ?Chronic administration (defined as more than 14 days in total) of immunosuppressants or other immune-modifying drugs during the period starting at birth prior to the first vaccine dose. For corticosteroids, this will mean predni-sone ?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).
    ?Administration of any chronic drug therapy to be continued during the study period.
    ?A vaccine not foreseen by the study protocol administered during the period starting from 30 days before each dose of 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 package insert (PI) and according to the local governmental recommendations and provided a written approval of the Sponsor is obtained.
    ?Concurrently participating in another clinical study, at any time during the study period, in which the subject has been or will be exposed to an investigational or a non-investigational vaccine/product (pharmaceutical product or device).
    ?Previous vaccination against Hib, diphtheria, tetanus, pertussis, pneumococcus, and/or poliovirus since birth.
    ?History of Hib, diphtheria, tetanus, pertussis, pneumococcal, poliovirus and hepatitis B diseases.
    ?Any confirmed or suspected immunosuppressive or immunodeficient condition including severe combined immunodeficiency disease (SCID), based on medical history and physical examination (no laboratory testing required).
    ?Family history of congenital or hereditary immunodeficiency.
    ?History of any reaction or hypersensitivity likely to be exacerbated by any component of the vaccine.
    ?Major congenital defects
    ?Serious chronic illness.
    ?History of any neurological disorders or seizures.
    ?Acute disease and/or fever at the time of enrolment.
    - Fever is defined as temperature ? 37.5°C/99.5°F for oral, axillary or tympanic route, or ? 38.0°C/100.4°F for 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.
    ?Administration of immunoglobulins and/or any blood products during the period starting at birth before the first dose of study vaccines or planned administration during the study period.
    ?Hypersensitivity to latex.
    -Niño en acogida.
    Por favor, consulte la definición niño en acogida en el glosario de términos.
    - Administración crónica (definida por una duración mayor de 14 días en total) de inmunosupresores o de otros medicamentos inmunomoduladores, a contar desde el nacimiento hasta la administración de la primera dosis de 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).
    ? Administración durante el período de estudio de un tratamiento farmacológico crónico.
    ? Vacuna no prevista en el protocolo del estudio que se administre desde 30 días antes de cada dosis de la vacuna 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.
    ? Participación simultánea en otro ensayo clínico, 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 período de estudio.
    ? Vacunación previa frente a Hib, difteria, tétanos, tos ferina, neumococo y/o polio desde el nacimiento.
    ? Antecedentes de Hib, difteria, tétanos, tos ferina, enfermedad por neumococo o polio o hepatitis B.
    ? Cualquier trastorno confirmado o sospechado de inmunosupresión o inmunodeficiencia, incluida la inmunodeficiencia combinada grave (ICG), de acuerdo con la historia clínica y la exploración física (no se exigirá ninguna prueba de laboratorio).
    ? Antecedentes familiares de inmunodeficiencia congénita o hereditaria.
    ? Antecedentes de reacción o de hipersensibilidad que se pueda exacerbar por algún componente de la vacuna.
    ? Defectos congénitos mayores.
    ? Enfermedad crónica grave.
    ? Antecedentes de enfermedades neurológicas o de crisis convulsivas.
    ? Enfermedad aguda o fiebre o ambas en el momento del reclutamiento.
    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 (del tipo de diarrea o infección respiratoria alta leve) sin fiebre podrán ser reclutados, si el investigador lo cree oportuno.
    ? Administración de inmunoglobulinas y/o hemoderivados desde el nacimiento hasta antes de la administración de la primera dosis de las vacunas del estudio o de su administración programada durante el período de estudio.
    ? Hipersensibilidad al látex.?
    E.5 End points
    E.5.1Primary end point(s)
    Immunogenicity with respect to components of DTPa-HBV-IPV/Hib.
    - Anti-diphtheria, anti-tetanus, anti-HBs, anti poliovirus type 1, anti-poliovirus type 2, anti-poliovirus type 3 and anti-polyribosyl-ribitol phosphate (anti-PRP) seroprotection status.
    - Vaccine response to PT, FHA and PRN antigens.
    Inmunogenicidad con respecto a los componentes de DTPa-HBV-IPV/Hib.
    - 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))
    -Respuesta a los antígenos TP, FHA y PRN de la vacuna,
    E.5.1.1Timepoint(s) of evaluation of this end point
    Month 3 or Month 5 (depending on vaccination schedule of the country).
    Mes 3 o mes 5 (dependiendo del esquema de vacunación del país). En España será mes 5.
    E.5.2Secondary end point(s)
    Persistence of antibodies before the first dose of DTPa-HBV-IPV/Hib- Anti-diphtheria and anti-tetanus seroprotection status, anti-PT, anti-FHA, anti-PRN seropositivity status and antibody concentrations.
    Immunogenicity with respect to components of DTPa-HBV-IPV/Hib and 13Pn - Anti-diphtheria, anti-tetanus, anti-poliovirus type 1, anti-poliovirus type 2, anti-poliovirus type 3, anti-HBs, anti-PRP, anti-PT, anti-FHA, anti-PRN and anti-pneumococcal serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, 23F) antibody concentrations or titres.
    Immunogenicity with respect to components of DTPa-HBV-IPV/Hib-Anti-PT, anti-FHA, anti-PRN antibody seropositivity status.
    Occurrence of solicited local/general symptoms.
    Occurrence of unsolicited symptoms.
    Occurrence of serious adverse events.
    Persistencia de los anticuerpos antes de la primera dosis de DTPa-HBV-IPV/Hib- Estado de seroprotección (anticuerpos antidiftéricos y antitetánicos), estado de seropositividad anti-PT, anti-FHA y anti-PRN y concentraciones de anticuerpos.
    - Inmunogenicidad con respecto a los componentes de DTPa-HBV-IPV/Hib y 13Pn- Concentraciones o títulos de anticuerpos antidiftéricos, antitetánicos, anti-poliovirus tipo 1, anti-poliovirus tipo 2, anti-poliovirus tipo 3, anti-HBs, anti-PRP, anti-PT, anti-FHA, anti-PRN y anti-serotipos neumocócicos (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, 23F)
    -Inmunogenicidad con respecto a los componentes de DTPa-HBV-IPV/Hib
    - Estado de seropositividad (anticuerpos anti-PT, anti-FHA, anti-PRN)
    - Síntomas locales y generales solicitados.
    - Frecuencia de síntomas solicitados locales/generales -
    - Acontecimientos adversos no solicitados.
    - Acontecimientos adversos graves.
    ?
    E.5.2.1Timepoint(s) of evaluation of this end point
    Persistence of antibodies before the first dose of DTPa-HBV-IPV/Hib- Month 0.
    Immunogenicity with respect to components of DTPa-HBV-IPV/Hib and 13Pn - Month 3 or Month 5 (depending on vaccination schedule of the country).
    Immunogenicity with respect to components of DTPa-HBV-IPV/Hib- Month 3 or Month 5 (depending on vaccination schedule of the country) .
    Occurrence of solicited local/general symptoms- During 4 day (Day 0-Day 3) after each dose of study vaccines.
    Occurrence of unsolicited symptoms- During the 31-day (Day 0-Day 30) follow-up period after each dose of study vaccines.
    Occurrence of serious adverse events- From Month 0 up to Month 3 or Month 5 (depending on vaccination schedule of the country).
    Persistencia de anticuerpos antes de la primera dosis de DTPa-HBV-IPV/Hib: mes 0.
    Inmunogenicidad respecto a los componentes de DTPa-HBV-IPV/Hib y 13Pn: mes 3 o mes 5 (dependiendo del esquema de vacunación del país). En España mes 5
    Inmunogenicidad respecto a los componentes de DTPa-HBV-IPV/Hib: mes 3 o mes 5 (dependiendo del esquema de vacunación del país). En España mes 5
    Aparición de acontecimientos adversos locales/generales durante 4 días (día 0-3 tras cada dosis de vacunas de estudio)
    Aparición de acontecimientos adversos no solicitados durante 31 días (día 0-30 tras cada dosis de vacunas de estudio)
    Aparición de acontecimientos adversos graves desde el mes 0 hasta el mes 3 o 5 (dependiendo del esquema de vacunación del país).En España mes 5.
    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 No
    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.8.2.4Number of treatment arms in the trial2
    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
    LVLS
    Última visita del último sujeto
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years2
    E.8.9.1In the Member State concerned months0
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years2
    E.8.9.2In all countries concerned by the trial months0
    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 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 Decision2015-11-13
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2015-11-09
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2018-03-07
    EU Clinical Trials Register Service Desk: https://servicedesk.ema.europa.eu
    European Medicines Agency © 1995-2019 | Domenico Scarlattilaan 6, 1083 HS Amsterdam, The Netherlands
    Legal notice
    EMA HMA