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    Summary
    EudraCT Number:2006-002898-47
    Sponsor's Protocol Code Number:107737
    National Competent Authority:Spain - AEMPS
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2012-06-08
    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 number2006-002898-47
    A.3Full title of the trial
    A phase IIIb open study to assess the safety and immunogenicity of GlaxoSmithKline (GSK) Biologicals´ 10-valent pneumococcal conjugate vaccine when co-administered with DTPa-HBV-IPV/Hib (Infanrix hexa) vaccine in preterm infants as a 3-dose primary immunisation course during the first 6 months of life
    Ensayo clínico en fase IIIb, abierto para evaluar la seguridad y la inmunogenicidad de la vacuna antineumocócica decavalente conjugada de GlaxoSmithKline (GSK) Biologicals, coadministrada con la vacuna DTPa-HBV-IPV/Hib (Infanrix hexa) en niños prematuros como pauta de primovacunación en los 6 primeros meses de vida.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Study to Evaluate the Safety and Immunogenicity of a 10-valent Pneumococcal Conjugate Vaccine in Preterm Infants
    Estudio para evaluar la seguridad y la inmunogenicidad de la vacuna antineumocócica decavalente conjugada en niños prematuros
    A.3.2Name or abbreviated title of the trial where available
    10PN-PD-DIT-015
    A.4.1Sponsor's protocol code number107737
    A.5.2US NCT (ClinicalTrials.gov registry) numberNCT00390910
    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 Biologicals
    B.5.2Functional name of contact pointClinical Disclosure Advisor
    B.5.3 Address:
    B.5.3.1Street AddressRue de l?Institut, 89
    B.5.3.2Town/ cityRixensart
    B.5.3.3Post code1330
    B.5.3.4CountryBelgium
    B.5.4Telephone number442089904466
    B.5.5Fax number----
    B.5.6E-mailGSKClinicalSupportHD@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 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 nameVacuna antineumocócica decavalente conjugada con la proteína D y los toxoides diftérico y tetánico
    D.3.2Product code 10Pn-PD-DiT
    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.3.9.3Other descriptive namePNEUMOCOCCAL POLYSACCHARIDE SEROTYPE 1 CONJ. TO PROTEIN D (NON-TYPEABLE H. INFLUENZAE DERIVED)
    D.3.9.4EV Substance CodeSUB30335
    D.3.10 Strength
    D.3.10.1Concentration unit µg microgram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number1
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.9.3Other descriptive namePNEUMOCOCCAL POLYSACCHARIDE SEROTYPE 4 CONJ. TO PROTEIN D (NON-TYPEABLE H. INFLUENZAE DERIVED)
    D.3.9.4EV Substance CodeSUB30336
    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.3.9.3Other descriptive namePNEUMOCOCCAL POLYSACCHARIDE SEROTYPE 5 CONJ. PROTEIN D (NON-TYPEABLE H. INFLUENZAE DERIVED)
    D.3.9.4EV Substance CodeSUB30337
    D.3.10 Strength
    D.3.10.1Concentration unit µg microgram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number1
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.9.3Other descriptive namePNEUMOCOCCAL POLYSACCHARIDE SEROTYPE 6B CONJ. TO PROTEIN D (NON-TYPEABLE H. INFLUENZAE DERIVED)
    D.3.9.4EV Substance CodeSUB30338
    D.3.10 Strength
    D.3.10.1Concentration unit µg microgram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number1
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.9.3Other descriptive namePNEUMOCOCCAL POLYSACCHARIDE SEROTYPE 7F CONJ. TO PROTEIN D (NON-TYPEABLE H. INFLUENZAE DERIVED)
    D.3.9.4EV Substance CodeSUB30339
    D.3.10 Strength
    D.3.10.1Concentration unit µg microgram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number1
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.9.3Other descriptive namePNEUMOCOCCAL POLYSACCHARIDE SEROTYPE 9V CONJ. TO PROTEIN D (NON-TYPEABLE H. INFLUENZAE DERIVED)
    D.3.9.4EV Substance CodeSUB30340
    D.3.10 Strength
    D.3.10.1Concentration unit µg microgram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number1
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.9.3Other descriptive namePNEUMOCOCCAL POLYSACCHARIDE SEROTYPE 14 CONJ. TO PROTEIN D (NON-TYPEABLE H. INFLUENZAE DERIVED)
    D.3.9.4EV Substance CodeSUB30341
    D.3.10 Strength
    D.3.10.1Concentration unit µg microgram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number1
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.9.3Other descriptive namePNEUMOCOCCAL POLYSACCHARIDE SEROTYPE 23 F CONJ. TO PROTEIN D (NON-TYPEABLE H. INFLUENZAE DERIVED)
    D.3.9.4EV Substance CodeSUB30342
    D.3.10 Strength
    D.3.10.1Concentration unit µg microgram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number1
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.9.3Other descriptive namePNEUMOCOCCAL POLYSACCHARIDE SEROTYPE 18C CONJ. TO TETANUS TOXOID
    D.3.9.4EV Substance CodeSUB30343
    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.3.9.3Other descriptive namePNEUMOCOCCAL POLYSACCHARIDE SEROTYPE 19F CONJ. TO DIPHTHERIA TOXOID
    D.3.9.4EV Substance CodeSUB30344
    D.3.10 Strength
    D.3.10.1Concentration unit µg microgram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number3
    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 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.3.1Product nameInfanrix Hexa
    D.3.2Product code DTPa HBV IPV + Hib
    D.3.4Pharmaceutical form Powder and solvent 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.3.9.3Other descriptive namePurified diphtheria toxoid (D)
    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.3.9.3Other descriptive namePurified tetanus toxoid (T)
    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.3.9.3Other descriptive namePurified pertussis toxoid (PT)
    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.3.9.3Other descriptive namePurified filamentous haemagglutinin (FHA)
    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.3.9.3Other descriptive namePurified pertactin (PRN)
    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.3.9.3Other descriptive namePurified hepatitis B surface antigen (HBsAg)
    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.3.9.3Other descriptive nameHaemophilus influenzae type b polysaccharide (PRP) conjugated to tetanus toxoid
    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.3.9.3Other descriptive nameInactivated poliovirus type 1
    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.3.9.3Other descriptive nameInactivated poliovirus type 2
    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.3.9.3Other descriptive nameInactivated poliovirus type 3
    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.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin No
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) Yes
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) No
    D.3.11.3.1Somatic cell therapy medicinal product No
    D.3.11.3.2Gene therapy medical product No
    D.3.11.3.3Tissue Engineered Product No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) Yes
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product Yes
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product No
    D.8 Information on Placebo
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Three dose primary vaccination of preterm infants between 8-16 weeks (56-118 days) of age at the time of first vaccination against Streptococcus pneumoniae.
    Pauta de primovacunación en niños prematuros entre 8 y 16 semanas (56-118 días) de edad en el momento de recibir la primera dosis de vacuna antineumocócica
    E.1.1.1Medical condition in easily understood language
    Immunization against certain infections caused by the Streptococcus pneumoniae bacterium. This bacterium can cause ear infection, lung infection or meningitis
    Inmunización frente a ciertas infecciones casusadas por la bacteria Streptococcus pneumoniae. Esta bacteria puede causar infección de oído, infección pulmonar o meningitis
    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 14.1
    E.1.2Level LLT
    E.1.2Classification code 10018953
    E.1.2Term Haemophilus influenzae meningitis
    E.1.2System Organ Class 10021881 - Infections and infestations
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 14.1
    E.1.2Level LLT
    E.1.2Classification code 10042194
    E.1.2Term Streptococcus pneumoniae meningitis
    E.1.2System Organ Class 10021881 - Infections and infestations
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 14.1
    E.1.2Level LLT
    E.1.2Classification code 10042196
    E.1.2Term Streptococcus pneumoniae secondary bacterial infection of acute bronchitis
    E.1.2System Organ Class 10021881 - Infections and infestations
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 14.1
    E.1.2Level LLT
    E.1.2Classification code 10018954
    E.1.2Term Haemophilus influenzae secondary bacterial infection of acute bronchitis
    E.1.2System Organ Class 10021881 - Infections and infestations
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 14.1
    E.1.2Level LLT
    E.1.2Classification code 10018952
    E.1.2Term Haemophilus influenzae infection
    E.1.2System Organ Class 10021881 - Infections and infestations
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 14.1
    E.1.2Level LLT
    E.1.2Classification code 10035680
    E.1.2Term Pneumonia due to Haemophilus influenzae (H. influenzae)
    E.1.2System Organ Class 10021881 - Infections and infestations
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 14.1
    E.1.2Level LLT
    E.1.2Classification code 10054642
    E.1.2Term Streptococcus pneumoniae septicemia
    E.1.2System Organ Class 10021881 - Infections and infestations
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 14.1
    E.1.2Level LLT
    E.1.2Classification code 10042195
    E.1.2Term Streptococcus pneumoniae pneumonia
    E.1.2System Organ Class 10021881 - Infections and infestations
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 14.1
    E.1.2Level LLT
    E.1.2Classification code 10058214
    E.1.2Term Septicaemia due to haemophilus influenzae (H. influenzae)
    E.1.2System Organ Class 10021881 - Infections and infestations
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 14.1
    E.1.2Level LLT
    E.1.2Classification code 10042197
    E.1.2Term Streptococcus pneumoniae septicaemia
    E.1.2System Organ Class 10021881 - Infections and infestations
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To evaluate the safety and reactogenicity of GSK Biologicals´ 10-valent pneumococcal conjugate vaccine when administered as a 3-dose primary vaccination course and co-administered with DTPa-HBV-IPV/Hib vaccine in preterm infants.
    Evaluar la seguridad y la reactogenicidad de la vacuna antineumocócica decavalente conjugada de GSK Biologicals, administrada como pauta de vacunación primaria de 3 dosis y coadministrada con la vacuna DTPa-HBV-IPV/Hib en niños prematuros
    E.2.2Secondary objectives of the trial
    To assess the immunogenicity of GSK Biologicals´ 10-valent pneumococcal conjugate vaccine when co-administered with DTPa-HBV-IPV/Hib vaccine in preterm infants, one month post dose III vaccination.
    Para evaluar la inmunogenicidad de la vacuna antineumocócica conjugada 10-valente de GSK Biologicals, cuando se administra conjuntamente con la vacuna DTPa-HBV-IPV/Hib en prematuros, un mes después de la dosis III de vacunación.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    All subjects:
    ?Subjects who the investigator believes that their parents/guardians can and will comply with the requirements of the protocol (e.g. completion of the diary cards, return for follow-up visits) should be enrolled in the study.
    ?A male or female between, and including, 8-16 weeks (56-118 days) of age at the time of the first vaccination.
    ?Written informed consent obtained from the parent or guardian of the subject.
    ?Born after a gestation period of >27 weeks (at least 189 days).
    Subjects of the Preterm I and Preterm II group:
    ?Medically stable* prematurely born infants, born after a gestation period of 27-36 weeks.
    *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.
    Subjects of the Full term group:
    ?Healthy subjects as established by medical history and clinical examination before entering into the study.
    Todos los sujetos deberán reunir los criterios siguientes al inicio del estudio:
    ?Sujetos cuyos padres/tutores puedan y quieran cumplir, en opinión del investigador, los requisitos del protocolo (p. ej., cumplimentación de las tarjetas diario, acudir a las visitas de seguimiento).
    ?Niños o niñas con una edad comprendida entre 8 y 16 semanas (56-118 días), ambas inclusive, en el momento de la primera vacunación.
    ?Consentimiento informado firmado por el padre, madre o tutor del sujeto.
    ?Nacimiento tras un periodo de gestación >27 semanas (como mínimo, 189 días).
    Los sujetos de los grupos I y II de prematuros :
    ?Prematuros médicamente estables* nacidos tras un período de gestación de 27 a 36 semanas.
    * Médicamente estables se refiere a la situación clínica de los prematuros que no precisen medidas importantes de soporte médico ni tratamiento continuado por enfermedad invalidante y que hayan presentado una recuperación clínica sostenida.
    Los sujetos del grupo de nacidos a término :
    ?Lactantes sanos, de acuerdo con la historia clínica y la exploración física realizada antes de iniciar el estudio.
    E.4Principal exclusion criteria
    ?Use of any investigational or non-registered product (drug or vaccine) other than the study vaccines within 30 days preceding the first dose of study vaccines, or planned use during the study period (active phase and 5 months extended safety follow-up)
    ?Chronic administration (defined as more than 14 days) of immunosuppressants or other immune-modifying drugs from birth to the first vaccine dose. (For corticosteroids, this will mean prednisone, or equivalent, >= 0.5 mg/kg/day. Inhaled and topical steroids are allowed).
    ?Planned administration/administration of a vaccine not foreseen by the study protocol, during the period starting from one month (30 days) before the first dose of vaccines (Visit 1) and up to Visit 6.
    ?Previous vaccination against diphtheria, tetanus, pertussis, polio, hepatitis B, Haemophilus influenzae type b, Neisseria meningitidis and/or Streptococcus pneumoniae with the exception of vaccines where the first dose can be given within the first two weeks of life according to the national recommendations (for example hepatitis B vaccination, BGC vaccination)
    ?History of or intercurrent diphtheria, tetanus, pertussis, hepatitis B, polio, Haemophilus influenzae type b disease, Neisseria meningitidis.
    ?History of allergic disease or reactions likely to be exacerbated by any component of the vaccines.
    ?History of any neurologic disorders or seizures.
    ?Acute disease at the time of enrolment. (Acute disease is defined as the presence of a moderate or severe illness with or without fever. All vaccines can be administered to persons with a minor illness such as diarrhoea, mild upper respiratory infection with or without temperature increase, i.e. oral/axillary/tympanic temperature <37.5°C / rectal temperature <38°C )
    ?Any confirmed or suspected immunosuppressive or immunodeficient condition based on medical history and physical examination (no laboratory testing required).
    ?A family history of congenital or hereditary immunodeficiency.
    ?Major congenital defects or serious chronic illness.
    ?Administration of immunoglobulins, with the exception of monoclonal antibodies against RSV, and/or any blood products within one month (30 days) preceding the first dose of study vaccines or planned administration during the active phase of the study.
    ?Uso de algún producto (fármaco o vacuna) en fase de investigación o no registrado, distinto de la o las vacunas del estudio en los 30 días anteriores a la administración de la primera dosis de la vacuna del estudio, o uso previsto durante el período de estudio (fase activa y fase ampliada de seguimiento de la seguridad durante 5 meses).
    ?Administración crónica (definida como aquella superior a 14 días) de inmunosupresores o inmunomoduladores desde el nacimiento hasta la primera dosis de la vacuna. (En el caso de los corticosteroides, equivale a una cantidad de prednisona o equivalente, >= 0,5 mg/kg.día. Se permitirá el uso inhalatorio y tópico de esteroides.)
    ?Administración prevista/administración de una vacuna no contemplada en el protocolo del estudio desde un mes (30 días) antes de la primera dosis de las vacunas (1ª visita) y hasta la 6ª visita.
    ?Vacunación previa frente a difteria, tétanos, tos ferina, poliomielitis, hepatitis B, Haemophilus influenzae de tipo b, Neisseria meningitidisy y/o Streptococcus pneumoniae, con excepción de las vacunas cuya primera dosis se administre en las dos primeras semanas de vida de acuerdo con las recomendaciones nacionales (por ejemplo, vacunación frente a hepatitis B, vacunación BGC).
    ?Antecedentes o enfermedad intercurrente de difteria, tétanos, tos ferina, hepatitis B, poliomielitis, enfermedad por Haemophilus influenzae tipo b, Neisseria meningitidis.
    ?Antecedentes de enfermedades o reacciones alérgicas que pudieran exacerbarse por algún componente de las vacunas.
    ?Antecedente de trastornos neurológicos o crisis convulsivas.
    ?Enfermedad aguda en el momento de la selección. (Se define como enfermedad aguda la presencia de enfermedad moderada o severa, con fiebre o sin ella. Se pueden administrar todas las vacunas a personas con una enfermedad leve, como diarrea, enfermedad respiratoria alta con o sin aumento de la temperatura, es decir, con temperatura oral/axilar/timpánica <37,5°C / temperatura rectal <38°C)
    ?Estado de inmunosupresión o inmunodeficiencia, confirmado o sospechado sobre la base de la anamnesis o exploración física (no se exigirá ninguna prueba de laboratorio).
    ?Antecedentes familiares de inmunodeficiencia congénita o hereditaria.
    ?Malformaciones congénitas importantes o enfermedades crónicas graves.
    ?Administración de inmunoglobulinas, con la excepción de anticuerpos monoclonales contra el VRS (virus respiratorio sincitial), y/o hemoderivados durante el mes (30 días) anterior a la primera dosis de las vacunas del estudio o administración prevista durante la fase activa del estudio.
    E.5 End points
    E.5.1Primary end point(s)
    Occurrence of core fever >39°C (rectal temperature) or >38.5°C (oral, axillary or tympanic temperature) .
    Aparición de fiebre > 39 ° C (temperatura rectal) o> 38,5 ºC (temperatura oral, axilar o timpánica)
    E.5.1.1Timepoint(s) of evaluation of this end point
    Within 4 days (day 0-day 3) after at least one vaccination
    En el periodo comprendido dentro de 4 días (día 0-día 3) después de, al menos, una vacunanción.
    E.5.2Secondary end point(s)
    Occurrence of solicited local symptoms. Occurrence of solicited general symptoms. Occurrence of unsolicited adverse events. Occurrence of serious adverse events. Concentrations of antibodies against vaccine pneumococcal serotypes. Opsonophagocytic activity against vaccine pneumococcal serotypes. Concentrations of antibodies against cross-reactive pneumococcal serotypes. Opsonophagocytic activity against cross-reactive pneumococcal serotypes. Concentrations of antibodies against protein D. Anti-diphtheria and anti-tetanus toxoids, anti-, anti-Pertussis, anti-Hepatitis B antibody concentrations, and anti-polio type 1, 2 and 3 antibody titres.
    ?Aparición de síntomas locales solicitados
    ?Aparición de síntomas generales
    ?Aparición de acontecimientos adversos no solicitados
    ?Aparición de acontecimientos adversos graves
    ?Concentraciones de anticuerpos contra los serotipos neumocócicos
    ?Actividad opsonofagocítica contra los serotipos neumocócicos
    ?Concentraciones de anticuerpos contra los serotipos neumocócicos de reacción cruzada
    ?Actividad opsonofagocítica contra los serotipos neumocócicos de reacción cruzada
    ?Concentraciones de anticuerpos contra la proteína D, contra los toxoides diftérico y tetánico, contra PRP, contra PT, contra FHA y PRN y contra HBs y títulos de anticuerpos contra los virus de la poliomielitis 1, 2 y
    E.5.2.1Timepoint(s) of evaluation of this end point
    Solicited AEs: within 4 days after each vaccination. Unsolicited AEs: within 31 days after each vaccination. Serious AEs: throughout the active phase of the study and during the extended safety follow-up. Immunogenicity: one month after the administration of the 3rd dose of the primary vaccination course with pneumococcal conjugate vaccine GSK1024850A co-administered with DTPa-HBV-IPV/Hib vaccine
    Síntomas locales y generales solicitados: en los 4 primeros días (día 0-día 3) después de cada vacunación.
    Acontecimientos adversos no solicitados: en los 31 primeros días (día 0-día 30) después de cada vacuna.
    Acontecimientos adversos graves durante la fase activa del estudio y durante el período de seguimiento ampliado de la seguridad
    Inmunogenicidad: Un mes después de administrar la 3ª dosis de un esquema de vacunación primaria con la vacuna antineumocócica decavalente conjugada de GSK Biologicals, coadministrada con la vacuna DTPa-HBV-IPV/Hib:
    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) Yes
    E.7.4Therapeutic use (Phase IV) No
    E.8 Design of the trial
    E.8.1Controlled Yes
    E.8.1.1Randomised No
    E.8.1.2Open Yes
    E.8.1.3Single blind No
    E.8.1.4Double blind No
    E.8.1.5Parallel group 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 Yes
    E.8.2.3.1Comparator description
    Full term group
    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 concerned3
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA8
    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
    Last subject/last visit (end of active phase) and last subject/last contact (end of safety follow-up)
    Último sujeto / última visita (final de la fase activa) y último sujeto / último contacto (fin de seguimiento de seguridad)
    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 months4
    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 months4
    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: 300
    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: 300
    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 state175
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 300
    F.4.2.2In the whole clinical trial 300
    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 the participation in this trial is not provided for prophylactic vaccine studies as the subjects are healthy and do not need any treatment or care after end of the study
    No está previsto por los estudios de vacunas profilácticas, un plan para el tratamiento o el cuidado después de que el sujeto haya finalizado su participación en este estudio, debido a que los sujetos son pacientes sanos y no necesitan ningún tratamiento o cuidado después de la finalización del estudio.
    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 Decision2006-09-29
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2006-08-04
    P. End of Trial
    P.End of Trial StatusOngoing
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