0 Evaluaciones
ID

36623

Descripción

Study ID: 105910 Clinical Study ID: 105910 Study Title: Compare Immunogenicity & Reactogenicity of 2 Formulations of GSK Biologicals' DTPa-HBV-IPV/Hib Vaccine (New vs Current) Given in Healthy Infants. The DTPa-HBV-IPV Vaccine (New Formulation) Will Also be Assessed in a 3rd Group of Subjects Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00320463 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 3 Study Recruitment Status: Completed Generic Name: DTPa-HBV-IPV/Hib vaccine Trade Name: N/A Study Indication: Diphtheria, Hepatitis B, Poliomyelitis, Tetanus, Whooping Cough

Palabras clave

Versiones (1)
  1. 26/05/2019 26/05/2019 -
Titular de derechos de autor

GlaxoSmithKline

Subido en

26 de maio de 2019

DOI

Para solicitar uno, por favor iniciar sesión.

Licencia

Creative Commons BY-NC 3.0
Comentarios del modelo :

Puede comentar sobre el modelo de datos aquí. A través de las burbujas de diálogo en los grupos de elementos y elementos, puede agregar comentarios específicos.

Volver a los comentarios del modelo
Comentarios de grupo de elementos para :

Comentarios del elemento para :

  • El más nuevo
  • Más antiguo
  • Popular
  • El más nuevo
    • El más nuevo
    • Más antiguo
    • Popular

    Sin comentarios

    Para descargar modelos de datos, debe haber iniciado sesión. Por favor iniciar sesión o Registrate gratis.

    DTPa-HBV-IPV/Hib Vaccine Given in Healthy Infants; NCT00320463

    Inglés

    Visit 4

    1 formularios  
    1. StudyEvent: ODM
      1. Visit 4
    Administrative Data
    Descripción

    Administrative Data

    Alias
    UMLS CUI-1
    C1320722
    Date of visit
    Descripción

    Date of visit

    Tipo de datos

    date

    Alias
    UMLS CUI [1]
    C1320303
    Subject Number
    Descripción

    Clinical Trial Subject Unique Identifier

    Tipo de datos

    integer

    Alias
    UMLS CUI [1]
    C2348585
    Check for Study Continuation
    Descripción

    Check for Study Continuation

    Alias
    UMLS CUI-1
    C0805733
    UMLS CUI-2
    C0008976
    Did the subject return for visit 4 ?
    Descripción

    Continuation status, Clinical Trials

    Tipo de datos

    boolean

    Alias
    UMLS CUI [1,1]
    C0805733
    UMLS CUI [1,2]
    C0008976
    If No, Please tick the ONE most appropriate reason and skip the following pages of this visit.
    Descripción

    Continuation status, Clinical Trials, Reason

    Tipo de datos

    text

    Alias
    UMLS CUI [1,1]
    C0805733
    UMLS CUI [1,2]
    C0008976
    UMLS CUI [1,3]
    C0566251
    Specify
    Descripción

    Continuation status, Clinical Trials, Reason

    Tipo de datos

    text

    Alias
    UMLS CUI [1,1]
    C0805733
    UMLS CUI [1,2]
    C0008976
    UMLS CUI [1,3]
    C0566251
    Please tick who made the decision
    Descripción

    Continuation status, Clinical Trials, Decision

    Tipo de datos

    text

    Alias
    UMLS CUI [1,1]
    C0805733
    UMLS CUI [1,2]
    C0008976
    UMLS CUI [1,3]
    C0679006
    Laboratory Tests - Blood Sample
    Descripción

    Laboratory Tests - Blood Sample

    Alias
    UMLS CUI-1
    C0005834
    Has a blood sample been taken ?
    Descripción

    Collection of blood specimen for laboratory procedure

    Tipo de datos

    boolean

    Alias
    UMLS CUI [1]
    C0005834
    Date (Please complete only if different from visit date)
    Descripción

    Collection of blood specimen for laboratory procedure, Date in time

    Tipo de datos

    date

    Alias
    UMLS CUI [1,1]
    C0005834
    UMLS CUI [1,2]
    C0011008
    Volver a la parte superior de la página

    Similar models

    Visit 4

    1 formularios
    1. StudyEvent: ODM
      1. Visit 4
    Name
    Tipo
    Description | Question | Decode (Coded Value)
    Tipo de datos
    Alias
    Item Group
    Administrative Data
    C1320722 (UMLS CUI-1)
    Date of visit
    Item
    Date of visit
    date
    C1320303 (UMLS CUI [1])
    Clinical Trial Subject Unique Identifier
    Item
    Subject Number
    integer
    C2348585 (UMLS CUI [1])
    Item Group
    Check for Study Continuation
    C0805733 (UMLS CUI-1)
    C0008976 (UMLS CUI-2)
    Continuation status, Clinical Trials
    Item
    Did the subject return for visit 4 ?
    boolean
    C0805733 (UMLS CUI [1,1])
    C0008976 (UMLS CUI [1,2])
    Item
    If No, Please tick the ONE most appropriate reason and skip the following pages of this visit.
    text
    C0805733 (UMLS CUI [1,1])
    C0008976 (UMLS CUI [1,2])
    C0566251 (UMLS CUI [1,3])
    Continuation status, Clinical Trials, Reason
    Code List
    If No, Please tick the ONE most appropriate reason and skip the following pages of this visit.
    CL Item
    Serious adverse event (Please specify SAE No.) (1)
    CL Item
    Non-Serious adverse event (Please specify AE No. or solicited AE code) (2)
    CL Item
    Other, please specify (3)
    Item
    Specify
    text
    C0805733 (UMLS CUI [1,1])
    C0008976 (UMLS CUI [1,2])
    C0566251 (UMLS CUI [1,3])
    Continuation status, Clinical Trials, Reason
    Code List
    Specify
    Item
    Please tick who made the decision
    text
    C0805733 (UMLS CUI [1,1])
    C0008976 (UMLS CUI [1,2])
    C0679006 (UMLS CUI [1,3])
    Continuation status, Clinical Trials, Reason
    Code List
    Please tick who made the decision
    CL Item
    Investigator  (1)
    CL Item
    Parents/Guardians (2)
    Item Group
    Laboratory Tests - Blood Sample
    C0005834 (UMLS CUI-1)
    Collection of blood specimen for laboratory procedure
    Item
    Has a blood sample been taken ?
    boolean
    C0005834 (UMLS CUI [1])
    Collection of blood specimen for laboratory procedure, Date in time
    Item
    Date (Please complete only if different from visit date)
    date
    C0005834 (UMLS CUI [1,1])
    C0011008 (UMLS CUI [1,2])
    Volver a la parte superior de la página 

    Ayuda

    Do you need help on how to use the search function? Please watch the corresponding tutorial video for more details and learn how to use the search function most efficiently.

    Watch Tutorial