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    Summary
    EudraCT Number:2012-004221-25
    Sponsor's Protocol Code Number:PRI02C
    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:2013-01-14
    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 number2012-004221-25
    A.3Full title of the trial
    A phase 3 open-label study to evaluate the immunogenicity and safety of a mixed (HEXA/PENTA/HEXA) primary series schedule that includes V419 (PR5I) at 2 and 6 months of age and Pediacel® at 4 months of age.
    Estudio abierto fase III para evaluar la inmunogenicidad y seguridad de un esquema de primovacunación alternado (HEXA/PENTA/HEXA) que incluye V419 (PR5I) a los 2 y 6 meses de edad y Pediacel® a los 4 meses de edad.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A phase 3 open-label study to evaluate the immune response and the safety of a primary series schedule that includes V419 (PR5I: hexavalent vaccine) at 2 and 6 months of age and Pediacel® (pentavalent vaccine) at 4 months of age
    Estudio abierto fase III para evaluar la respuesta inmune y la seguridad de un esquema de primovacunación que incluye V419 (PR5I: vacuna hexavalente) a los 2 y 6 meses de edad y Pediacel® (vacuna pentavalente) a los 4 meses de edad.
    A.3.2Name or abbreviated title of the trial where available
    Spanish mixed HEXA/PENTA/HEXA schedule
    A.4.1Sponsor's protocol code numberPRI02C
    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 SponsorSanofi Pasteur MSD
    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 MSD-SNC
    B.4.2CountryFrance
    B.4.1Name of organisation providing supportSanofi Pasteur
    B.4.2CountryFrance
    B.4.1Name of organisation providing supportMerck & Co. Inc
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationSanofi Pasteur MSD S.N.C.
    B.5.2Functional name of contact pointClinical Development Director
    B.5.3 Address:
    B.5.3.1Street Address8, rue Jonas Salk
    B.5.3.2Town/ cityLyon Cedex 07
    B.5.3.3Post code69367
    B.5.3.4CountryFrance
    B.5.4Telephone number+33437284000
    B.5.5Fax number+33437284451
    B.5.6E-mailclinicaldevelopment@spmsd.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 No
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.1Product namePR5I
    D.3.2Product code V419
    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 INNPERTUSSIS TOXOID
    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 number20
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNPertactin
    D.3.9.3Other descriptive namePertactin
    D.3.9.4EV Substance CodeSUB38399
    D.3.10 Strength
    D.3.10.1Concentration unit µg microgram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number3
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNHepatitis B Surface Antigen
    D.3.9.3Other descriptive nameHEPATITIS B SURFACE ANTIGEN (RDNA)
    D.3.9.4EV Substance CodeSUB20082
    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 INNInactivated Type 1 poliovirus (Mahoney)
    D.3.9.3Other descriptive namePOLIOVIRUS (INACTIVATED) TYPE 1 (MAHONEY STRAIN)
    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 number29
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNInactivated Type 2 poliovirus (MEF-1)
    D.3.9.3Other descriptive namePOLIOVIRUS (INACTIVATED) TYPE 2 (MEF-1 STRAIN)
    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 number7
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNInactivated Type 3 poliovirus (Saukett)
    D.3.9.3Other descriptive namePOLIOVIRUS (INACTIVATED) TYPE 3 (SAUKETT STRAIN)
    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 number26
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNDiphteria 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 INNFilamentous Haemagglutinin
    D.3.9.3Other descriptive nameFilamentous Haemagglutinin
    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 number20
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNHib conjugate to meningococcal outer membrane protein complex
    D.3.9.3Other descriptive nameHAEMOPHILUS TYPE B POLYSACCHARIDE CONJUGATED TO NEISSERIA MENINGITIDIS (B11 STRAIN) OUTER MEMBRANE PROTEIN COMPLEX (OMPC)
    D.3.9.4EV Substance CodeSUB25334
    D.3.10 Strength
    D.3.10.1Concentration unit µg microgram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number3
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNTETANUS 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 INNFIM
    D.3.9.3Other descriptive namePERTUSSIS FIMBRIAL AGGLUTINOGENS (FIM) 2 AND 3
    D.3.9.4EV Substance CodeSUB25272
    D.3.10 Strength
    D.3.10.1Concentration unit µg microgram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number5
    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 Pediacel®
    D.2.1.1.2Name of the Marketing Authorisation holderSanofi Pasteur MSD, SA
    D.2.1.2Country which granted the Marketing AuthorisationSpain
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.1Product namePediacel ®
    D.3.4Pharmaceutical form Suspension for injection
    D.3.4.1Specific paediatric formulation Yes
    D.3.7Routes of administration for this IMPIntramuscular use
    D.3.11 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: 3
    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 NeisVac-C®
    D.2.1.1.2Name of the Marketing Authorisation holderBaxter Healthcare Limited
    D.2.1.2Country which granted the Marketing AuthorisationSpain
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.4Pharmaceutical form Suspension for injection
    D.3.4.1Specific paediatric formulation Yes
    D.3.7Routes of administration for this IMPIntramuscular use
    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: 4
    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 RotaTeq®
    D.2.1.1.2Name of the Marketing Authorisation holderSanofi Pasteur MSD, SNC
    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 Oral solution
    D.3.4.1Specific paediatric formulation Yes
    D.3.7Routes of administration for this IMPOral use
    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: 5
    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.3.11 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 infants greater than or equal to 46 days and less than or equal to 74 days of age on the day of inclusion
    E.1.1.1Medical condition in easily understood language
    Healthy infants greater than or equal to 46 days and less than or equal to 74 days of age on the day of inclusion
    E.1.1.2Therapeutic area Body processes [G] - Immune system processes [G12]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 16.0
    E.1.2Level LLT
    E.1.2Classification code 10054187
    E.1.2Term Polio immunization
    E.1.2System Organ Class 100000004865
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 16.0
    E.1.2Level LLT
    E.1.2Classification code 10069543
    E.1.2Term Hemophilus influenzae type b immunization
    E.1.2System Organ Class 100000004865
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 16.0
    E.1.2Level LLT
    E.1.2Classification code 10069593
    E.1.2Term Pertussis immunization
    E.1.2System Organ Class 100000004865
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 16.0
    E.1.2Level LLT
    E.1.2Classification code 10054181
    E.1.2Term Hepatitis B immunization
    E.1.2System Organ Class 100000004865
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 16.0
    E.1.2Level LLT
    E.1.2Classification code 10054180
    E.1.2Term Diphtheria immunization
    E.1.2System Organ Class 100000004865
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 16.0
    E.1.2Level LLT
    E.1.2Classification code 10054183
    E.1.2Term Tetanus immunization
    E.1.2System Organ Class 100000004865
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    The two co-primary objectives for the study are:
    -To demonstrate that the mixed schedule induces acceptable responses for Hepatitis B (% of subjects with an anti-HBs titre ≥10 mIU/mL ) one month after the third dose of the mixed schedule (i.e. at Month 7)
    -To demonstrate that the mixed schedule induces acceptable responses for Hib (% of subjects with an anti-PRP titre ≥0.15 µg/mL ) one month after the third dose of the mixed schedule (i.e. at Month 7).
    Los dos objetivos principales del estudio son:
    − Demostrar que el esquema alternado induce respuestas aceptables frente
    a la hepatitis B (porcentaje de pacientes con un título de anticuerpos
    frente al antígeno de superficie de la hepatitis B [anti-HBs] ≥ 10 mUI/ml)
    un mes después de la tercera dosis del esquema alternado (p. ej., al
    séptimo mes)
    − Demostrar que el esquema alternado induce respuestas aceptables frente
    a Hib (porcentaje de pacientes con un título de anticuerpos de PRP ≥
    0,15 μg/ml) un mes después de la tercera dosis del esquema alternado
    (p. ej., al séptimo mes)
    E.2.2Secondary objectives of the trial
    Immunogenicity:
    -To describe the antibody response to all PR5I antigens: hepatitis B, Hib, diphtheria (D) and tetanus (T) toxoids, pertussis (PT, FHA, PRN, FIM 2&3) and inactivated poliovirus antigens (IPV1, IPV2, IPV3) one month after completion of the mixed schedule (i.e. at Month 7).
    -To describe the antibody response to meningococcal serogroup C conjugate (MenC) vaccine one month after the second dose of MenC vaccine when used concomitantly with the mixed schedule.
    Safety:
    - To describe the safety profile after each dose of study vaccines administered.
    Inmunogenicidad:
    -Describir la respuesta de los anticuerpos a todos los antígenos de PR5I:
    hepatitis B, Hib, difteria (D) y toxoides tétanicos (T), tosferina (TP, HAF,
    PRN, FIM 2 y 3) y antígenos del virus de la poliomelitis inactivado (IPV1,
    IPV2, IPV3) un mes después de completar el esquema alternado (es decir, en
    el mes 7).
    -Describir la respuesta de los anticuerpos a la vacuna antimeningocócica del
    serogrupo C conjugada (MenC) un mes después de la segunda dosis de la
    vacuna MenC, cuando se usa de manera concomitante con un esquema
    alternado.
    Seguridad:
    -Describir el perfil de seguridad después de cada dosis de las vacunas
    administradas en el estudio.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1.Subject is a healthy infant greater than or equal to 46 days and less than or equal to 74 days of age on the day of inclusion.
    2.Subject has received only one dose of monovalent hepatitis B vaccine, within the 3 days after birth, outside of the study context and it is documented in subject´s medical history.
    3.Informed consent has been signed by the subject's parent(s) or legal representative.
    4.Subject's parent(s) or legal representative able to comply with the study procedures such as adherence to study visits and completion of the Vaccination Report Cards.
    1. El paciente es un bebé sano de 46 o más días de edad y que no tiene más de
    74 días de edad el día de la inclusión.
    2. El paciente ha recibido solo una dosis de la vacuna monovalente contra la
    hepatitis B en los 3 días siguientes al nacimiento, fuera del contexto del
    estudio, y esta vacunación está registrada en la historia clínica del paciente.
    3. Los padres o el representante legal del paciente han firmado el
    consentimiento informado
    4. Los padres o el representante legal del paciente son capaces de cumplir con
    los procedimientos del estudio, como la asistencia a las visitas y la
    cumplimentación de las Tarjetas de Registro de Vacunación.
    E.4Principal exclusion criteria
    1.Participation in any study with an investigational compound or device since birth
    2.Subject´s parent(s)/legal representative plans to enrol the subject in another clinical study during the present study period
    3.History of congenital or acquired immunodeficiency (e.g. HIV)
    4.Chronic illness that could interfere with study conduct or completion, or significant findings on review of systems (by medical history) such as development delay or neurological disorder
    5.Known or suspected hypersensitivity to any of the study vaccines' components or history of a life-threatening reaction to a vaccine containing the same substances as the study vaccines
    6.Contraindication to Pediacel®, NeisVac-C®, Prevenar 13®, and RotaTeq® as per their Summary of Product Characteristics
    7.History or maternal history of HBsAg seropositivity
    8.Coagulation disorder that contraindicate intramuscular injection
    9.History of vaccination with a Haemophilus influenzae type b conjugate, diphtheria, tetanus, pertussis (acelullar or whole-cell), poliovirus, meningococcal serogroup C conjugate, pneumococcal conjugate containing vaccine(s)
    10.History of hepatitis B, Haemophilus influenzae type b, diphtheria, tetanus, pertussis, poliomyelitis, or serogroup C meningococcal infection
    11.Receipt of immune globulin, blood or blood-derived products since birth
    12.Receipt of systemic corticosteroids (greater than the equivalent of 2 mg/kg total daily dose of prednisone) for more than 14 consecutive days within one month of the study start
    13.Subjects expected to require systemic corticosteroids (greater than the equivalent of 2 mg/kg total daily dose of prednisone) for more than 14 consecutive days from the time of study start through the end of the safety follow-up period following the last dose. Subjects using non-systemic corticosteroids (e.g. topical, ophthalmic, and inhaled) will be eligible for vaccination.
    14.Identified as a natural or adopted child of the Investigator or employee with direct involvement in the proposed study.
    1. Participación en un estudio con un compuesto o un producto sanitario en fase
    de investigación desde el nacimiento.
    2. Los padres o el representante legal del paciente tienen previsto incluirlo en
    otro estudio clínico durante el periodo de este estudio.
    3. Antecedentes de inmunodeficiencia congénita o adquirida (p.ej., VIH)
    4. Enfermedad crónica que pudiera interferir en la realización o finalización del
    estudio, o resultados relevantes en la revisión de sistemas orgánicos
    (mediante anamnesis), como por ejemplo retraso en el desarrollo o trastorno
    neurológico.
    5. Hipersensibilidad conocida o sospechada a cualquiera de los componentes de
    las vacunas del estudio, o antecedentes de una reacción potencialmente
    mortal a una vacuna que contiene los mismos principios activos que las
    vacunas del estudio.
    6. Contraindicación a Pediacel®, NeisVac-C®, Prevenar 13® y RotaTeq® según
    sus Fichas Técnicas.
    7. Antecedentes o antecedentes maternos de seropositividad al HBsAg
    8. Trastorno de coagulación por el cual la inyección intramuscular esté
    contraindicada.
    9. Antecedentes de vacunación con vacunas contra Haemophilus influenzae tipo
    b conjugado, difteria, tétanos, tosferina (acelular o de células enteras), virus
    de la poliomelitis, antimeningocócica del serogrupo C conjugada,
    antineumocócica conjugada.
    10. Antecedentes de infección por hepatitis B, Haemophilus influenzae tipo b,
    difteria, tétanos, tosferina, virus de la poliomielitis, o infección meningocócica
    del serogrupo C.
    11. Pacientes que hayan recibido inmunoglobulina, sangre o hemoderivados desde el nacimiento.
    12. Pacientes que hayan recibido corticoesteroides sistémicos (en cantidades
    superiores al equivalente a una dosis diaria total de prednisona de 2 mg/kg)
    durante más de 14 días consecutivos en el mes previo al del inicio del
    estudio.
    13. Pacientes que se espera que requieran corticoesteroides sistémicos (más que
    lo equivalente a una dosis diaria total de prednisona de 2 mg/kg) durante
    más de 14 días consecutivos desde el momento de inicio del estudio hasta el
    final del periodo de seguimiento de la seguridad posterior a la última dosis.
    Los pacientes que usen corticoesteroides no sistémicos (p. ej., tópicos,
    oftálmicos e inhalados) serán aptos para la vacunación.
    14. Pacientes que sean hijos naturales o adoptados del investigador o de un
    empleado directamente implicado en el estudio.
    E.5 End points
    E.5.1Primary end point(s)
    -Proportion of subjects with an anti-HBs titre ≥10 mIU/mL
    -Proportion of subjects with an anti-PRP titre ≥0.15 µg/mL
    E.5.1.1Timepoint(s) of evaluation of this end point
    One month after the complete mixed schedule PR5I/Pediacel/PR5I
    E.5.2Secondary end point(s)
    Immunogenicity:

    -Anti-HBs Geometric Mean Titers (GMT)
    -Anti-PRP GMT
    -Proportion of subjects with an anti-PRP titre ≥1 µg/mL
    -Proportion of subjects with an anti-diphtheria concentration ≥0.01 IU/mL
    -Proportion of subjects with an anti-diphtheria concentration ≥0.1 IU/mL
    -Anti-diphtheria Geometric Mean Concentrations (GMC)
    -Proportion of subjects with an anti-tetanus concentration ≥0.01 IU/mL
    -Proportion of subjects with an anti-tetanus concentration ≥0.1 IU/mL
    -Anti-tetanus GMC
    -Proportion of subjects with an anti-IPV1 titre ≥1:8 dil
    -Proportion of subjects with an anti-IPV2 titre ≥1:8 dil
    -Proportion of subjects with an anti-IPV3 titre ≥1:8 dil
    -Anti-IPV1, anti-IPV2 and anti-IPV3 GMTs
    -Anti-PT , anti-FHA, anti-PRN and anti-FIM 2&3 GMCs
    -Proportion of subjects with an anti-MenC titre ≥ 1:8dil
    -Anti-MenC GMT

    Safety:

    Incidence of solicited injection-sites reactions and solicited systemic adverse event.
    Incidence of unsolicited injection-site reactions, unsolicited systemic adverse events and all serious adverse events.
    E.5.2.1Timepoint(s) of evaluation of this end point
    Immunogenicity: one month after the complete mixed schedule PR5I/Pediacel/PR5I and one month after the second dose of MenC vaccine.
    Safety: from Visit 1 to Visit 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 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 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.8.3 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 concerned6
    E.8.5The trial involves multiple Member States No
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA No
    E.8.6.2Trial being conducted completely outside of the EEA No
    E.8.7Trial has a data monitoring committee No
    E.8.8 Definition of the end of the trial and justification where it is not the last visit of the last subject undergoing the trial
    End of data collection including availability of last serololgy results
    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 months1
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years1
    E.8.9.2In all countries concerned by the trial months1
    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: 385
    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: 385
    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 No
    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
    Healthy infants greater than or equal to 46 days and less than or equal to 74 days of age on the day of inclusion
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state385
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 385
    F.4.2.2In the whole clinical trial 385
    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)
    A plan for treatment or care after the subject has ended his/her participation in the trial is not provided for prophylactic vaccine studies as the subjects are healthy and do not need any treatment or care after the end of the study.
    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 Decision2013-03-12
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2013-03-06
    P. End of Trial
    P.End of Trial StatusCompleted
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