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   39587   clinical trials with a EudraCT protocol, of which   6490   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:2012-001055-39
    Sponsor's Protocol Code Number:A3L39
    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:2013-12-05
    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 number2012-001055-39
    A.3Full title of the trial
    Phase III, multi-center trial in 795 infants in the Czech Republic, Germany, and Spain. Subjects from the Czech Republic and Germany will be randomized in Groups 1 and 2 to receive in a blind-observer manner, the investigational DTaP IPV HB Hib vaccine or the control vaccine, Infanrix? hexa, concomitantly with the administration of Prevenar® 13 at 2, 3, and 4 months of age; the subjects from Spain (in Group 3) who had received a first dose of hepatitis B vaccine prior to the study will be allocated to receive in an open-label manner, the investigational DTaP IPV HB Hib vaccine at 2 and 6 months of age, and Pentavac? vaccine at 4 months of age, concomitantly with Prevenar 13 at 2 and 4 months of age and RotaTeq® at 2, 4 and 6 months of age.
    Ensayo de fase III, multicéntrico en 795 lactantes de la República Checa, Alemania y España. Los sujetos de la República Checa y Alemania se asignarán aleatoriamente a los grupos 1 y 2 para recibir, con observador ciego, la vacuna en investigación DTaP-IPV-HB-Hib o la vacuna de control, Infanrix? hexa, concomitantemente con la administración de Prevenar® 13, a los 2, 3 y 4 meses de edad; los sujetos de España (en el grupo 3), que habían recibido una primera dosis de la vacuna contra la hepatitis B antes del estudio, se asignarán para recibir de forma abierta, la vacuna en investigación DTaP-IPV-HB-Hib a los 2 y 6 meses de edad y la vacuna Pentavac? a los 4 meses de edad, concomitantemente con Prevenar 13 a los 2 y 4 meses de edad y RotaTeq® a los 2, 4 y 6 meses de edad.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Immunogenicity and Safety Study of a Hexavalent DTaP-IPV-HB-Hib Combined Vaccine in a 3-dose Primary Series in Healthy Infants in Europe
    Estudio de inmunogenicidad y de seguridad de una vacuna combinada hexavalente DTaP-IPV-HB-Hib en una serie primaria de 3 dosis en lactantes sanos en Europa.
    A.4.1Sponsor's protocol code numberA3L39
    A.5.3WHO Universal Trial Reference Number (UTRN)U1111-1122-2329
    A.7Trial is part of a Paediatric Investigation Plan Yes
    A.8EMA Decision number of Paediatric Investigation PlanP/229/2013
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorSanofi Pasteur SA
    B.1.3.4CountryFrance
    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 supportSanofi Pasteur SA
    B.4.2CountryFrance
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationSanofi Pasteur SA
    B.5.2Functional name of contact pointClinical Development
    B.5.3 Address:
    B.5.3.1Street Address1541, avenue Marcel Merieux
    B.5.3.2Town/ cityMarcy L'Etoile
    B.5.3.3Post code69280
    B.5.3.4CountryFrance
    B.5.4Telephone number33(0)4 37 37 58 43
    B.5.5Fax number33(0)4 37 37 74 38
    B.5.6E-mailemmanuel.feroldi@sanofipasteur.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 Hexacima
    D.2.1.1.2Name of the Marketing Authorisation holderSanofi Pasteur
    D.2.1.2Country which granted the Marketing AuthorisationEuropean Union
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.1Product nameHexacima
    D.3.2Product code DTaP-IPV-HB-Hib
    D.3.4Pharmaceutical form Suspension for injection
    D.3.4.1Specific paediatric formulation Yes
    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 INNPurified Diphtheria Toxoid
    D.3.9.2Current sponsor codeD
    D.3.9.3Other descriptive nameDIPHTHERIA TOXOID
    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 number20
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNPurified Tetanus Toxoid
    D.3.9.2Current sponsor codeT
    D.3.9.3Other descriptive nameTETANUS TOXOID
    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 INNPERTUSSIS TOXOID
    D.3.9.2Current sponsor codePT
    D.3.9.3Other descriptive namePERTUSSIS TOXOID
    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 INNPERTUSSIS FILAMENTOUS HAEMAGGLUTININ
    D.3.9.2Current sponsor codeFHA
    D.3.9.3Other descriptive namePERTUSSIS FILAMENTOUS HAEMAGGLUTININ
    D.3.9.4EV Substance CodeSUB20298
    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 INNPOLIOVIRUS (INACTIVATED) TYPE 1
    D.3.9.2Current sponsor codeIPV
    D.3.9.3Other descriptive namePOLIOVIRUS (INACTIVATED) TYPE 1 (MAHONEY STRAIN) PRODUCED ON VERO CELLS
    D.3.9.4EV Substance CodeSUB25669
    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 (INACTIVATED) TYPE 2
    D.3.9.2Current sponsor codeIPV
    D.3.9.3Other descriptive namePOLIOVIRUS (INACTIVATED) TYPE 2 (MEF-1 STRAIN) PRODUCED ON VERO CELLS
    D.3.9.4EV Substance CodeSUB25670
    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 (INACTIVATED) TYPE 3
    D.3.9.2Current sponsor codeIPV
    D.3.9.3Other descriptive namePOLIOVIRUS (INACTIVATED) TYPE 3 (SAUKETT STRAIN) PRODUCED ON VERO CELLS
    D.3.9.4EV Substance CodeSUB25671
    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 INNHepatitis B (rDNA)
    D.3.9.2Current sponsor codeHep B
    D.3.9.3Other descriptive nameHEPATITIS B SURFACE ANTIGEN
    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 INNHaemophilus Influenzae type b conjugate
    D.3.9.3Other descriptive nameHAEMOPHILUS TYPE B POLYSACCHARIDE CONJUGATED TO TETANUS TOXOID
    D.3.9.4EV Substance CodeSUB25275
    D.3.10 Strength
    D.3.10.1Concentration unit µg microgram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number12
    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 RoleComparator
    D.2 Status of the IMP to be used in the clinical trial
    D.2.1IMP to be used in the trial has a marketing authorisation Yes
    D.2.1.1.1Trade name Infanrix hexa
    D.2.1.1.2Name of the Marketing Authorisation holderGlaxoSmithKline (GSK)
    D.2.1.2Country which granted the Marketing AuthorisationEuropean Union
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.1Product nameInfanrix hexa
    D.3.4Pharmaceutical form Powder and suspension for suspension for injection
    D.3.4.1Specific paediatric formulation Yes
    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 INNPurified Diphtheria Toxoid
    D.3.9.3Other descriptive nameDIPHTHERIA TOXOID
    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 INNPurified Tetanus Toxoid
    D.3.9.3Other descriptive nameTETANUS TOXOID
    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 INNPERTUSSIS TOXOID
    D.3.9.2Current sponsor codePT
    D.3.9.3Other descriptive namePERTUSSIS TOXOID
    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 INNPERTUSSIS FILAMENTOUS HAEMAGGLUTININ
    D.3.9.2Current sponsor codeFHA
    D.3.9.3Other descriptive namePERTUSSIS FILAMENTOUS HAEMAGGLUTININ
    D.3.9.4EV Substance CodeSUB20298
    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 INNPERTUSSIS PERTACTIN
    D.3.9.3Other descriptive namePERTUSSIS PERTACTIN
    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 INNPOLIOVIRUS (INACTIVATED) TYPE 1
    D.3.9.3Other descriptive namePOLIOVIRUS (INACTIVATED) TYPE 1 (MAHONEY STRAIN) PRODUCED ON VERO CELLS
    D.3.9.4EV Substance CodeSUB25669
    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 (INACTIVATED) TYPE 2
    D.3.9.3Other descriptive namePOLIOVIRUS (INACTIVATED) TYPE 2 (MEF-1 STRAIN) PRODUCED ON VERO CELLS
    D.3.9.4EV Substance CodeSUB25670
    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 (INACTIVATED) TYPE 3
    D.3.9.3Other descriptive namePOLIOVIRUS (INACTIVATED) TYPE 3 (SAUKETT STRAIN) PRODUCED ON VERO CELLS
    D.3.9.4EV Substance CodeSUB25671
    D.3.10 Strength
    D.3.10.1Concentration unit DAgU/ml D antigen unit(s)/millilitre
    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 INNHepatitis B (rDNA)
    D.3.9.3Other descriptive nameHEPATITIS B SURFACE ANTIGEN
    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 INNHaemophilus Influenzae type b conjugate
    D.3.9.3Other descriptive nameHAEMOPHILUS TYPE B POLYSACCHARIDE CONJUGATED TO TETANUS TOXOID
    D.3.9.4EV Substance CodeSUB25275
    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 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
    Prevention of infections caused by Corynebacterium diphtheriae, Clostridium tetani, Bordetella pertussis, poliovirus type 1, 2 and 3, prevention against invasive infections caused by Haemophilus influenzae type b and infection caused by hepatitis B virus
    Prevención de infecciones provocadas por Corynebacterium diphtheriae, Clostridium tetani, Bordetella pertussis, poliovirus tipo 1, 2 y 3; prevención de infecciones invasivas provocadas por Haemophilus influenzae tipo b e infección provocada por el virus de la hepatitis B.
    E.1.1.1Medical condition in easily understood language
    Active immunisation against diphtheriae, tetanus, pertussis, hepatitis B, poliomyelitis and invasive infections caused by Haemophilus influenzae type b
    Inmunización activa contra difteria, tétanos, tos ferina, hepatitis B, poliomielitis e infecciones invasivas provocadas por Haemophilus influenzae tipo b.
    E.1.1.2Therapeutic area Diseases [C] - Virus Diseases [C02]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 14.1
    E.1.2Level LLT
    E.1.2Classification code 10036897
    E.1.2Term Prophylactic vaccination
    E.1.2System Organ Class 10042613 - Surgical and medical procedures
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 14.1
    E.1.2Level HLGT
    E.1.2Classification code 10043413
    E.1.2Term Therapeutic procedures and supportive care NEC
    E.1.2System Organ Class 10042613 - Surgical and medical procedures
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 14.1
    E.1.2Level PT
    E.1.2Classification code 10021430
    E.1.2Term Immunisation
    E.1.2System Organ Class 10042613 - Surgical and medical procedures
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 14.1
    E.1.2Level HLT
    E.1.2Classification code 10021431
    E.1.2Term Immunisations
    E.1.2System Organ Class 10042613 - Surgical and medical procedures
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    Groups 1 and 2 only
    To demonstrate the non-inferiority of the DTaP-IPV-HB-Hib vaccine to the control Infanrix hexa vaccine, both co-administered with Prevenar 13, in terms of seroprotection or vaccine response rates to PT, FHA, Hep B, and PRP antigens, 1 month after a 3-dose primary series.
    Grupos 1 y 2 solamente
    Demostrar la no inferioridad de la vacuna DTaP-IPV-HB-Hib respecto a la vacuna Infanrix hexa de control, ambas administradas conjuntamente con Prevenar 13, en cuanto a los índices de seroprotección o respuesta vacunal a los antígenos PT, FHA, Hep B y PRP, 1 mes después de una serie primaria de 3 dosis.
    E.2.2Secondary objectives of the trial
    Immunogenicity
    Groups 1 and 2
    ? To describe in each group the immunogenicity parameters before the first vaccination for PT and FHA antigens and 1 month after the third dose of the primary series for all antigens contained in the investigational and control vaccines
    ? To describe in each group the immune response to Prevenar 13 serotypes 1 month after the 3rd dose of the primary series
    Group 3
    ? To describe the immunogenicity parameters before the first vaccination and 1 month after the 3rd dose of the primary series for all antigens contained in the investigational and Pentavac vaccines
    ? To describe the immune response to RotaTeq vaccine before the first vaccination and 1 month after the 3rd dose

    Safety (all Groups)
    To describe the safety profile after each and any injection for each of the study groups.
    Inmunogenicidad
    Grupos 1 y 2
    ? Describir en cada grupo los parámetros de inmunogenicidad antes de la primera vacunación para los antígenos PT y de FHA y 1 mes después de la tercera dosis de la serie primaria para todos los antígenos que contienen las vacunas en investigación y de control.
    ? Describir en cada grupo la respuesta inmunitaria a los serotipos de Prevenar 13 un mes después de la 3ª dosis de la serie primaria
    Grupo 3
    ? Describir los parámetros de inmunogenicidad antes de la primera vacunación y 1 mes después de la tercera dosis de la serie primaria para todos los antígenos que contienen las vacunas en investigación y de control.
    ? Describir la respuesta inmunitaria a la vacuna RotaTeq antes de la primera vacunación y 1 mes después de la tercera dosis

    Seguridad (todos los grupos)
    Describir el perfil de seguridad después de cada inyección para cada uno de los grupos de estudio.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    An individual must fulfill all of the following criteria in order to be eligible for trial enrollment:
    All Groups
    1) Aged 55 to 75 days on the day of the first study visit
    2) Born at full term of pregnancy (? 37 weeks) and/or with a birth weight ? 2.5 kg
    3) Informed consent form has been signed and dated by the parent(s) or other legally acceptable representative (and by an independent witness if required by local regulations)
    4) Subject and parent/legally acceptable representative are able to attend all scheduled visits and to comply with all trial procedures
    5) Covered by health insurance, if applicable
    Group 3 only
    6) Previously vaccinated with one dose of hepatitis B vaccine
    Un individuo debe cumplir todos los criterios siguientes para poder participar en el ensayo:
    Todos los grupos
    1) De 55 a 75 días de edad el día de la primera visita del estudio.
    2) Nacido de embarazo a término (?37 semanas) o con un peso al nacer ?2,5 kg.
    3) El formulario de consentimiento informado ha sido firmado y fechado por su padre/madre o por otro representante legal (y por un testigo independiente si así lo exige la normativa local).
    4) El sujeto y su padre/madre/representante legal tienen la posibilidad de asistir a todas las visitas programadas y de cumplir todos los procedimientos del ensayo.
    5) Cubiertos por un seguro médico, si aplicase.
    Solo el grupo 3
    6) Vacunado previamente con una dosis de la vacuna contra la hepatitis B
    E.4Principal exclusion criteria
    An individual fulfilling any of the following criteria is to be excluded from trial enrollment:
    1) Participation at the time of study enrollment (or in the 4 weeks preceding the first trial vaccination) or planned participation during the present trial period in another clinical trial investigating a vaccine, drug, medical device, or medical procedure
    2) Receipt of any vaccine in the 4 weeks preceding the first trial vaccination or planned receipt of any vaccine in the 4 weeks following any trial vaccination, except in case of routine vaccines to be administered as per the National Immunization schedule and for influenza vaccination. This exception includes monovalent pandemic influenza vaccines and multivalent influenza vaccines
    3) Groups 1 and 2 only: Previous vaccination against diphtheria, tetanus, pertussis, poliomyelitis, hepatitis B, or Haemophilus influenzae type b, pneumococcal infections, and rotavirus with another vaccine(s)
    4) Group 3 only: Previous vaccination against diphtheria, tetanus, pertussis, poliomyelitis, Haemophilus influenzae type b, pneumococcal and meningococcal infections, and rotavirus with another vaccine(s)
    5) Receipt of immune globulins, blood or blood-derived products since birth
    6) Known or suspected congenital or acquired immunodeficiency; or receipt of immunosuppressive therapy, such as anti-cancer chemotherapy or radiation therapy, since birth; or long-term systemic corticosteroid therapy (prednisone or equivalent for more than 2 consecutive weeks since birth)
    7) Known personal or maternal history of hepatitis B (HBsAg) or hepatitis C seropositivity
    8) History of diphtheria, tetanus, pertussis, poliomyelitis, hepatitis B, or Haemophilus influenzae type b and pneumococcal infections, confirmed either clinically, serologically, or microbiologically
    9) Known systemic hypersensitivity to any of the vaccine components, or history of a life-threatening reaction to the vaccine(s) used in the trial or to a vaccine containing any of the same substances
    10) Known thrombocytopenia, as reported by the parent/legally acceptable representative
    11) Bleeding disorder, or receipt of anticoagulants in the 3 weeks preceding inclusion, contraindicating intramuscular vaccination
    12) History of seizures
    13) Subjects in an emergency setting, or hospitalized involuntarily
    14) Chronic illness that, in the opinion of the Investigator, is at a stage where it might interfere with trial conduct or completion
    15) Moderate or severe acute illness/infection (according to Investigator judgment) on the day of vaccination or febrile illness (temperature ? 38.0°C). A prospective subject should not be included in the study until the condition has resolved or the febrile event has subsided.
    16) Identified as a natural or adopted child of the Investigator or employee with direct involvement in the proposed study
    Un individuo que cumpla cualquiera de los siguientes criterios no podrá participar en el ensayo:
    1) Participación al momento de la inclusión en el estudio (o en las 4 semanas anteriores a la primera vacunación del estudio) o participación planificada durante el período de este estudio en otro ensayo clínico en el cual se investigue una vacuna, un medicamento, un dispositivo médico o un procedimiento médico.
    2) Haber recibido cualquier vacuna durante las 4 semanas previas a la primera vacunación del ensayo o recepción prevista de cualquier vacuna durante las 4 semanas posteriores a cualquier vacunación del ensayo, excepto en el caso de las vacunas incluidas en el plan nacional de vacunación y la vacunación contra la gripe. Esta excepción incluye las vacunas monovalentes contra la gripe pandémica y las vacunas antigripales polivalentes
    3) Grupos 1 y 2 solamente: Vacunación previa contra las infecciones por difteria, tétanos, tos ferina, poliomielitis, hepatitis B o Haemophilus influenzae tipo b y neumocócicas con otra/s vacuna/s.
    4) Solo el grupo 3: Vacunación previa contra las infecciones por difteria, tétanos, tos ferina, poliomielitis, Haemophilus influenzae tipo b, neumocócicas y meningocócicas y rotavirus con otra/s vacuna/s.
    5) Haber recibido inmunoglobulinas, sangre o derivados sanguíneos desde el nacimiento.
    6) Inmunodeficiencia congénita o adquirida, conocida o sospechada, o haber recibido terapias inmunosupresoras, tales como quimioterapia o radioterapia anticancerosa, desde el nacimiento; o terapia con corticoides sistémicos de largo plazo (prednisona o equivalente durante más de 2 semanas consecutivas desde el nacimiento).
    7) Antecedentes personales o maternos conocidos de seropositividad a la hepatitis B (HBsAg) o a la hepatitis C.
    8) Antecedentes de infecciones por difteria, tétanos, tos ferina, poliomielitis, Hep B o Haemophilus influenzae tipo b y neumocócicas, confirmadas de forma clínica, serológica o microbiológica.
    9) Hipersensibilidad sistémica conocida a cualquiera de los componentes de la vacuna, o antecedentes de reacciones que ponen en peligro la vida a la/s vacuna/s utilizada/s en el ensayo o a una vacuna que contenga las mismas sustancias.
    10) Trombocitopenia conocida, informada por el padre/madre/representante legal.
    11) Trastorno hemorrágico o haber recibido anticoagulantes en las 3 semanas anteriores a la inclusión, por los que resulte contraindicada la vacunación intramuscular.
    12) Antecedentes de convulsiones
    13) Sujetos en situación de urgencia u hospitalizados involuntariamente.
    14) Enfermedad crónica que, en opinión del investigador, se encuentre en una etapa en la que pudiese interferir con la realización o la finalización del ensayo.
    15) Enfermedad/infección aguda moderada o grave (a criterio del investigador) el día de la vacunación o enfermedad febril (temperatura ? 38,0 °C). No se debe incluir en el estudio a un posible sujeto hasta que la afección se haya resuelto o el episodio febril haya cedido.
    16) Identificado como hijo natural o adoptado del investigador o de un empleado con participación directa en el estudio propuesto.
    E.5 End points
    E.5.1Primary end point(s)
    Groups 1 and 2 only
    The following serological endpoints will be assessed 1 month after the third dose of the primary series (i.e., at V04 = 5 MoA) with seroprotection and vaccine response being respectively defined as:
    Seroprotection for Hep B and PRP:
    ? Anti-Hep B antibody (Ab) concentrations ? 10 mIU/mL
    ? Anti-PRP Ab concentrations ? 0.15 µg/mL
    Vaccine response for PT and FHA:
    ? Post-Dose 3 Ab concentrations ? 4 x lower level of quantitation (LLOQ), if pre-Dose 1 Ab concentrations < 4 x LLOQ
    ? Post-Dose 3 Ab concentrations ? pre-Dose 1 Ab concentrations, if pre-Dose 1 Ab concentrations ? 4 x LLOQ
    Grupos 1 y 2 solamente
    Se evaluarán los siguientes criterios de valoración serológicos 1 mes después de la tercera dosis de la serie primaria (es decir, en la V04 = 5 meses de edad) con la seroprotección y la respuesta vacunal definidas respectivamente como:
    Seroprotección para Hep B y PRP:
    ? Concentraciones del anticuerpo (Ac) anti-Hep B ? 10 mUI/mL
    ? Concentraciones de Ac anti-PRP ? 0,15 µg/mL
    Respuesta a la vacuna en relación con PT y FHA:
    ? Concentraciones de Ac después de la dosis 3 ? 4 x nivel inferior de cuantificación (LLOQ), si las concentraciones de Ac antes de la dosis 1 < 4 x LLOQ
    ? Concentraciones de Ac posteriores a la dosis 3 ? concentraciones de Ac previas a la dosis 1, si las concentraciones de Ac previas a la dosis 1 ? 4 x LLOQ
    E.5.1.1Timepoint(s) of evaluation of this end point
    Vaccination
    Groups 1 and 2: subjects will receive 3 doses of either DTaP-IPV-HB-Hib or Infanrix hexa, both co-administered with Prevenar 13 and RotaTeq on Day 0, Day 30, and Day 60.
    Group 3: subjects will receive 2 doses of DTaP-IPV-HB-Hib vaccine on Day 0 and Day 120 and 1 dose of Pentavac on Day 60. Investigational vaccine and Pentavac will be co-administered with Prevenar 13 on Day 0 and Day 60, with NeisVac-C on Day 0, and with RotaTeq on Day 0, Day 60 and Day 120.

    Blood sampling
    All subjects will provide a pre-vaccination blood sample at Day 0 and one post-vaccination sample at Day 90 for Groups 1 and 2 and at Day 150 for Group 3.
    Vacunación
    Grupos 1 y 2: los sujetos recibirán 3 dosis de DTaP-IPV-HB-Hib o Infanrix hexa, ambas administradas junto con Prevenar 13 y RotaTeq el día 0, el día 30 y el día 60.
    Grupo 3: los sujetos recibirán 2 dosis de la vacuna DTaP-IPV-HB-Hib el día 0 y el día 120 y 1 dosis de Pentavac el día 60. La vacuna en investigación y Pentavac se administrarán junto con Prevenar 13 el día 0 y el día 60, NeisVac-C el día 0 y RotaTeq el día 0, el día 60 y el día 120.

    Extracción de muestras de sangre
    Todos los sujetos suministrarán una muestra de sangre antes de la vacunación el día 0 y otra después de la vacunación el día 90 para los grupos 1 y 2 el día 150 para el grupo 3.
    E.5.2Secondary end point(s)
    Immunogenicity
    Groups 1 and 2
    Endpoints for the immune response (descriptive) will include:
    V01 at 2 MoA:
    ? Ab concentrations for PT and FHA antigens
    ? Ab concentrations above a cut-off:
    ? Anti-PT Ab concentrations ? LLOQ
    ? Anti-FHA Ab concentrations ? LLOQ
    V04 at 5 MoA:
    ? Ab concentrations/titers for each valence
    ? Ab concentrations /titers above a cut-off:
    ? Anti-D Ab concentrations ? 0.01 IU/mL, ? 0.1 IU/mL and ? 1.0 IU/mL
    ? Anti-T Ab concentrations ? 0.01 IU/mL, ? 0.1 IU/mL and ? 1.0 IU/mL
    ? Anti-PT Ab concentrations ? 4 EU/mL
    ? Anti-FHA Ab concentrations ? 4 EU/mL
    ? Anti-poliovirus 1, 2, and 3 Ab titers ? 8 (1/dil)
    ? Anti-Hep B Ab concentrations ? 100 mIU/mL
    ? Anti-PRP Ab concentrations ? 1.0 µg/mL
    ? Anti-pneumococcal serotype 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F and 23F concentrations ? 0.35 µg/mL
    ? Ab individual concentrations ratios for anti-PT and FHA (V04 at 5MoA/V01 at 2MoA)
    ? Seroconversion for anti PT and anti FHA, defined as anti PT and anti FHA ? 4 fold Ab concentrations increase from V01 (at 2 MoA) to V04 (at 5 MoA)

    Group 3
    V01 at 2 MoA:
    ? Ab concentrations /titers for each valence (except Prevenar 13)
    ? Ab concentrations /titers above a cut-off:
    ? Anti-D Ab concentrations ? 0.01 IU/mL and ? 0.1 IU/mL
    ? Anti-T Ab concentrations ? 0.01 IU/mL and ? 0.1 IU/mL
    ? Anti-PT Ab concentrations ? LLOQ
    ? Anti-FHA Ab concentrations ? LLOQ
    ? Anti-poliovirus 1, 2, and 3 Ab titers ? 8 (1/dil)
    ? Anti-Hep B Ab concentrations ? 10 mIU/mL
    ? Anti- PRP Ab concentrations ? 0.15 µg/mL
    ? Anti-RV IgA ? 20 U/mL
    V04 at 7 MoA:
    ? Ab concentrations /titers for each valence (except Prevenar 13)
    ? Ab concentrations /titers above a cut-off:
    ? Anti-D Ab concentrations ? 0.01 IU/mL, ? 0.1 IU/mL and ? 1.0 IU/mL
    ? Anti-T Ab concentrations ? 0.01 IU/mL, ? 0.1 IU/mL and ? 1.0 IU/mL
    ? Anti-PT Ab concentrations ? 4 EU/mL
    ? Anti-FHA Ab concentrations ? 4 EU/mL
    ? Anti-poliovirus 1, 2, and 3 Ab titers ? 8 (1/dil)
    ? Anti-Hep B Ab concentrations ? 10 mIU/mL and ? 100 mIU/mL
    ? Anti-PRP Ab concentrations ? 0.15 µg/mL and ? 1.0 µg/mL
    ? Anti-RV IgA ? 20 U/mL
    ? Ab individual concentrations /titer ratios for all antigens (V04/V01) (except Prevenar 13)
    ? Seroconversion for anti PT and anti FHA, defined as anti PT and anti FHA ? 4 fold Ab concentration increase from V01 (at 2 MoA) to V04 (at 7 MoA)
    ? Seroconversion for anti-RV IgA defined as anti-RV IgA ? 20 U/mL, in subject seronegative at pre-Dose 1)

    Vaccine response for PT and FHA:
    ? Post-Dose 3 Ab concentrations ? 4 x lower level of quantitation (LLOQ), if pre-Dose 1 Ab concentrations < 4 x LLOQ
    ? Post-Dose 3 Ab concentrations ? pre-Dose 1 Ab concentrations, if pre-Dose 1 Ab concentrations ? 4 x LLOQ

    Safety (all Groups)
    ? Occurrence of any unsolicited systemic adverse events (AEs) reported in the 30 minutes after each and any dose
    ? Occurrence of solicited, i.e., pre-listed in the subject?s diary and electronic case report form (eCRF), injection site and systemic reactions occurring up to 7 days after each and any dose
    ? Occurrence of unsolicited (spontaneously reported) AEs up to 30 days after each and any dose
    ? Occurrence of SAEs, including AESIs, throughout the trial period
    ? Other endpoints recorded or derived as described in the statistical analysis plan. Depending on the item, these could include: nature (MedDRA preferred term), time of onset, duration, number of days of occurrence, Grade of severity, relationship to vaccine, action taken, whether the AE led to early termination from the study, seriousness, or outcome.
    Inmunogenicidad
    Grupos 1 y 2
    Los criterios de valoración para la respuesta inmunitaria (descriptivos) incluirán:
    V01 a los 2 MdE:
    ? Concentraciones de Ac contra los antígenos PT y FHA
    ? Concentraciones de Ac por encima de un valor de corte:
    ? Concentraciones de Ac anti-PT ? LLOQ
    ? Concentraciones de Ac anti-FHA ?LLOQ
    V04 a los 5 MdE:
    ? Concentraciones/títulos de Ac por cada valencia
    ? Concentraciones/títulos de Ac por encima de un valor de corte:
    ? Concentraciones de Ac anti-D ?0,01 UI/mL, ?0,1 UI/mL y ?1,0 UI/mL
    ? Concentraciones de Ac anti-T ?0,01 UI/mL, ?0,1 UI/mL y ?1,0 UI/mL
    ? Concentraciones de Ac anti-PT ? 4 UE/mL
    ? Concentraciones de Ac anti-FHA ? 4 UE/mL
    ? Títulos de Ac contra los poliovirus 1, 2 y 3 ?8 (1/dil)
    ? Concentraciones de Ac anti-Hep B ? 100 mUI/mL
    ? Concentraciones de Ac anti-PRP ? 1,0 µg/mL
    ? Concentraciones contra los neumococos de los serotipos 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F y 23F ? 0,35 µg/mL.
    ? Índices de concentraciones individuales de Ac anti-PT y anti-FHA (V04 a los 5 MdE/V01 a los 2 MdE)
    ? Seroconversión para anti-PT y anti-FHA, definida como un incremento ?4 veces de las concentraciones de Ac anti-PT y anti-FHA desde la V01 (a los 2 MdE) hasta la V04 (a los 5 MdE).

    Grupo 3
    V01 a los 2 MdE:
    ? Concentraciones/títulos de Ac para cada valencia (salvo Prevenar 13)
    ? Concentraciones/títulos de Ac por encima de un valor de corte:
    ? Concentraciones de Ac anti-D ? 0,01 UI/mL y ? 0,1 UI/mL
    ? Concentraciones de Ac anti-T ? 0,01 UI/mL y ? 0,1 UI/mL
    ? Concentraciones de Ac anti-PT ? LLOQ
    ? Concentraciones de Ac anti-FHA ?LLOQ
    ? Títulos de Ac contra los poliovirus 1, 2 y 3 ?8 (1/dil)
    ? Concentraciones de Ac anti-Hep B ? 10 mUI/mL
    ? Concentraciones de Ac anti-PRP ? 0,15 µg/mL
    ? IgA anti-RV ? 20 U/mL
    V04 a los 7 MdE:
    ? Concentraciones/títulos de Ac para cada valencia (salvo Prevenar 13)
    ? Concentraciones/títulos de Ac por encima de un valor de corte:
    ? Concentraciones de Ac anti-D ? 0,01 UI/mL, ? 0,1 UI/mL y ? 1,0 UI/mL
    ? Concentraciones de Ac anti-T ? 0,01 UI/mL, ? 0,1 UI/mL y ? 1,0 UI/mL
    ? Concentraciones de Ac anti-PT ? 4 UE/mL
    ? Concentraciones de Ac anti-FHA ? 4 UE/mL
    ? Títulos de Ac contra los poliovirus 1, 2 y 3 ?8 (1/dil)
    ? Concentraciones de Ac anti-Hep B ? 10 mUI/mL y ? 100 mUI/mL
    ? Concentraciones de Ac anti-PRP ? 0,15 µg/mL y ? 1,0 µg/mL
    ? IgA anti-RV ? 20 U/mL
    ? Índice de concentraciones/títulos individuales de Ac para todos los antígenos (V04/V01) (excepto Prevenar 13)
    ? Seroconversión para anti-PT y anti-FHA, definida como un incremento ? 4 veces de la concentración de Ac anti-PT y anti-FHA desde V01 (a los 2 MdE) hasta V04 (a los 7 MdE).
    ? Seroconversión para la IgA anti-RV definida como IgA anti-RV ? 20 U/mL, en sujetos seronegativos antes de la dosis uno.

    Respuesta a la vacuna en relación con PT y FHA:
    ? Concentraciones de Ac después de la dosis 3 ? 4 x nivel inferior de cuantificación (LLOQ), si las concentraciones de Ac antes de la dosis 1 < 4 x LLOQ
    ? Concentraciones de Ac posteriores a la dosis 3 ? concentraciones de Ac previas a la dosis 1, si las concentraciones de Ac previas a la dosis 1 ? 4 x LLOQ

    Seguridad (todos los grupos)
    ? Aparición de cualquier acontecimiento adverso (AA) sistémico no solicitado informado en los 30 minutos posteriores a cada dosis.
    ? Aparición de reacciones solicitadas (es decir, las enumeradas en el diario y en el formulario electrónico de recogida de datos (eCRF) del sujeto) en el lugar de la inyección y de reacciones sistémicas hasta 7 días después de cada dosis.
    ? Aparición de AA no solicitados (informados espontáneamente) hasta 30 días después de cada dosis.
    ? Aparición de AAG, incluidos AAIE, durante todo el período del ensayo.
    ? Otros criterios de valoración registrados o derivados descritos en el plan de análisis estadístico. En función del elemento, podrían incluir: naturaleza (término preferido de MedDRA), momento de inicio, duración, número de días que ha ocurrido, grado de gravedad, relación con la vacuna, acción tomada, si el AA ocasionó el abandono prematuro del estudio, gravedad o resultado.
    E.5.2.1Timepoint(s) of evaluation of this end point
    Vaccination
    Groups 1 and 2: subjects will receive 3 doses of either DTaP-IPV-HB-Hib or Infanrix hexa, both co-administered with Prevenar 13 and RotaTeq on Day 0, Day 30, and Day 60.
    Group 3: subjects will receive 2 doses of DTaP-IPV-HB-Hib vaccine on Day 0 and Day 120 and 1 dose of Pentavac on Day 60. Investigational vaccine and Pentavac will be co-administered with Prevenar 13 on Day 0 and Day 60, with NeisVac-C on Day 0, and with RotaTeq on Day 0, Day 60 and Day 120.

    Blood sampling
    All subjects will provide a pre-vaccination blood sample at Day 0 and one post-vaccination sample at Day 90 for Groups 1 and 2 and at Day 150 for Group 3.
    Vacunación
    Grupos 1 y 2: los sujetos recibirán 3 dosis de DTaP-IPV-HB-Hib o Infanrix hexa, ambas administradas junto con Prevenar 13 y RotaTeq el día 0, el día 30 y el día 60.
    Grupo 3: los sujetos recibirán 2 dosis de la vacuna DTaP-IPV-HB-Hib el día 0 y el día 120 y 1 dosis de Pentavac el día 60. La vacuna en investigación y Pentavac se administrarán junto con Prevenar 13 el día 0 y el día 60, NeisVac-C el día 0 y RotaTeq el día 0, el día 60 y el día 120.

    Extracción de muestras de sangre
    Todos los sujetos suministrarán una muestra de sangre antes de la vacunación el día 0 y otra después de la vacunación el día 90 para los grupos 1 y 2 el día 150 para el grupo 3.
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis No
    E.6.2Prophylaxis Yes
    E.6.3Therapy No
    E.6.4Safety Yes
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic No
    E.6.7Pharmacodynamic No
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic No
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic No
    E.6.13Others No
    E.7Trial type and phase
    E.7.1Human pharmacology (Phase I) No
    E.7.1.1First administration to humans No
    E.7.1.2Bioequivalence study No
    E.7.1.3Other No
    E.7.1.3.1Other trial type description
    E.7.2Therapeutic exploratory (Phase II) No
    E.7.3Therapeutic confirmatory (Phase III) Yes
    E.7.4Therapeutic use (Phase IV) No
    E.8 Design of the trial
    E.8.1Controlled Yes
    E.8.1.1Randomised Yes
    E.8.1.2Open No
    E.8.1.3Single blind No
    E.8.1.4Double blind No
    E.8.1.5Parallel group No
    E.8.1.6Cross over No
    E.8.1.7Other Yes
    E.8.1.7.1Other trial design description
    blind-observer (group 1 and group 2) and open-label (group 3)
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) Yes
    E.8.2.2Placebo No
    E.8.2.3Other No
    E.8.2.4Number of treatment arms in the trial3
    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 concerned4
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA44
    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 No
    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
    end of the trial = LVLS
    final del estudio = 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 years
    E.8.9.1In the Member State concerned months10
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial months10
    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: 795
    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: 795
    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 Yes
    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 Yes
    F.3.3.6.1Details of subjects incapable of giving consent
    Vulnerable pop (infants): ICF signed by the subject's the parent(s)/legal representative (and by an independent witness if required by local regulations)
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state265
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 795
    F.4.2.2In the whole clinical trial 795
    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
    G.4 Investigator Network to be involved in the Trial: 1
    G.4.1Name of Organisation Center for Public Health Research (CSISP )
    G.4.3.4Network Country Spain
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2014-01-16
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2014-01-07
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2014-11-27
    The status of studies in GB is no longer updated from 1.1.2021
    For the UK, as from 1.1.2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI
    EU Clinical Trials Register Service Desk: https://servicedesk.ema.europa.eu
    European Medicines Agency © 1995-2021 | Domenico Scarlattilaan 6, 1083 HS Amsterdam, The Netherlands
    Legal notice
    EMA HMA