0 Evaluaciones
ID

35700

Descripción

Study ID: 100565 Clinical Study ID: 100565 Study Title: An open study to evaluate the immunogenicity, safety and reactogenicity of GlaxoSmithKline Biologicals' commercially available combined hepatitis A / hepatitis B vaccine (TWINRIX ADULT) containing 720 ELISA units of hepatitis A antigen and 20 µg of hepatitis B surface antigen, administered following a two-dose (0, 6 months) schedule in healthy children between the ages of 1 and 11 years Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: Sponsor: GlaxoSmithKline Phase: phase 3 Study Recruitment Status: Completed Generic Name: Hepatitis A (Inactivated), Hepatitis B (Recombinant) Vaccine Trade Name: Twinrix Study Indication: Hepatitis A; Hepatitis B

Palabras clave

Versiones (1)
  1. 16/3/19 16/3/19 -
Titular de derechos de autor

GlaxoSmithKline

Subido en

16 de marzo de 2019

DOI

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Licencia

Creative Commons BY-NC 3.0
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    Immunogenicity, safety and reactogenicity of combined hepatitis A / hepatitis B vaccine (TWINRIX ADULT) in healthy children (100565)

    Inglés

    Informed Consent for the long-term follow-up

    1 formularios  
    Informed Consent for the long-term follow-up
    Descripción

    Informed Consent for the long-term follow-up

    Alias
    UMLS CUI-1
    C0021430
    UMLS CUI-2
    C1517942
    Subject’s parent or legal guardian’s first name and family name
    Descripción

    I Hereby freely give my consent for my child/ward to take part in this study.

    Tipo de datos

    text

    Alias
    UMLS CUI [1,1]
    C1443235
    UMLS CUI [1,2]
    C0030551
    UMLS CUI [2,1]
    C1301584
    UMLS CUI [2,2]
    C0030551
    UMLS CUI [3,1]
    C1443235
    UMLS CUI [3,2]
    C0085537
    UMLS CUI [4,1]
    C1301584
    UMLS CUI [4,2]
    C0085537
    Participant's Firs Name, Family Name
    Descripción

    Participant's Firs Name, Family Name

    Tipo de datos

    text

    Alias
    UMLS CUI [1,1]
    C0679646
    UMLS CUI [1,2]
    C1443235
    UMLS CUI [2,1]
    C0679646
    UMLS CUI [2,2]
    C1301584
    Participant's Signature (where applicable)
    Descripción

    Participant's Signature (where applicable)

    Tipo de datos

    text

    Alias
    UMLS CUI [1,1]
    C0679646
    UMLS CUI [1,2]
    C1519316
    Parent/ Guardian's First Name, Family Name
    Descripción

    Parent/ Guardian's First Name, Family Name

    Tipo de datos

    text

    Alias
    UMLS CUI [1,1]
    C0030551
    UMLS CUI [1,2]
    C1443235
    UMLS CUI [2,1]
    C0030551
    UMLS CUI [2,2]
    C1301584
    UMLS CUI [3,1]
    C0023226
    UMLS CUI [3,2]
    C1443235
    UMLS CUI [4,1]
    C0023226
    UMLS CUI [4,2]
    C1301584
    Parent/ Guardian's siganture
    Descripción

    Parent/ Guardian's siganture

    Tipo de datos

    text

    Alias
    UMLS CUI [1,1]
    C0030551
    UMLS CUI [1,2]
    C1519316
    UMLS CUI [2,1]
    C0023226
    UMLS CUI [2,2]
    C1519316
    Relationship to participant
    Descripción

    Relationship to participant

    Tipo de datos

    text

    Alias
    UMLS CUI [1,1]
    C0439849
    UMLS CUI [1,2]
    C0679646
    Participant's main address
    Descripción

    Participant's main address

    Tipo de datos

    text

    Alias
    UMLS CUI [1]
    C0421449
    Participant’s phone number:
    Descripción

    Participant’s phone number:

    Tipo de datos

    integer

    Alias
    UMLS CUI [1,1]
    C0679646
    UMLS CUI [1,2]
    C1515258
    Date
    Descripción

    Date

    Tipo de datos

    date

    Alias
    UMLS CUI [1]
    C0011008
    Time
    Descripción

    Time

    Tipo de datos

    time

    Alias
    UMLS CUI [1]
    C0040223
    Witness
    Descripción

    Witness

    Tipo de datos

    text

    Alias
    UMLS CUI [1]
    C0682356
    Administrative
    Descripción

    Administrative

    Alias
    UMLS CUI-1
    C1320722
    Subject No.
    Descripción

    Subject No.

    Tipo de datos

    integer

    Alias
    UMLS CUI [1]
    C2348585
    Statement by Doctor, Nurse or Project Assistant who conducted the informed consent discussion:
    Descripción

    Statement by Doctor, Nurse or Project Assistant who conducted the informed consent discussion:

    Alias
    UMLS CUI-1
    C1710187
    UMLS CUI-2
    C0031831
    UMLS CUI-3
    C0028661
    UMLS CUI-4
    C1709701
    UMLS CUI-5
    C0401893
    UMLS CUI-6
    C0021430
    Name
    Descripción

    I have carefully explained the nature, demands and foreseeable risks and benefits of the vaccination study to the person named above and witnessed the completion of the written consent form.

    Tipo de datos

    text

    Alias
    UMLS CUI [1]
    C0027365
    Signature
    Descripción

    Signature

    Tipo de datos

    text

    Alias
    UMLS CUI [1]
    C1519316
    Designation
    Descripción

    Designation

    Tipo de datos

    text

    Alias
    UMLS CUI [1]
    C0442504
    Date
    Descripción

    Date

    Tipo de datos

    date

    Alias
    UMLS CUI [1]
    C0011008
    Time
    Descripción

    Time

    Tipo de datos

    time

    Alias
    UMLS CUI [1]
    C0040223
    Volver a la parte superior de la página

    Similar models

    Informed Consent for the long-term follow-up

    1 formularios
    Name
    Tipo
    Description | Question | Decode (Coded Value)
    Tipo de datos
    Alias
    Item Group
    Informed Consent for the long-term follow-up
    C0021430 (UMLS CUI-1)
    C1517942 (UMLS CUI-2)
    Subject’s parent or legal guardian’s first name and family name
    Item
    Subject’s parent or legal guardian’s first name and family name
    text
    C1443235 (UMLS CUI [1,1])
    C0030551 (UMLS CUI [1,2])
    C1301584 (UMLS CUI [2,1])
    C0030551 (UMLS CUI [2,2])
    C1443235 (UMLS CUI [3,1])
    C0085537 (UMLS CUI [3,2])
    C1301584 (UMLS CUI [4,1])
    C0085537 (UMLS CUI [4,2])
    Participant's Firs Name, Family Name
    Item
    Participant's Firs Name, Family Name
    text
    C0679646 (UMLS CUI [1,1])
    C1443235 (UMLS CUI [1,2])
    C0679646 (UMLS CUI [2,1])
    C1301584 (UMLS CUI [2,2])
    Participant's Signature (where applicable)
    Item
    Participant's Signature (where applicable)
    text
    C0679646 (UMLS CUI [1,1])
    C1519316 (UMLS CUI [1,2])
    Parent/ Guardian's First Name, Family Name
    Item
    Parent/ Guardian's First Name, Family Name
    text
    C0030551 (UMLS CUI [1,1])
    C1443235 (UMLS CUI [1,2])
    C0030551 (UMLS CUI [2,1])
    C1301584 (UMLS CUI [2,2])
    C0023226 (UMLS CUI [3,1])
    C1443235 (UMLS CUI [3,2])
    C0023226 (UMLS CUI [4,1])
    C1301584 (UMLS CUI [4,2])
    Parent/ Guardian's siganture
    Item
    Parent/ Guardian's siganture
    text
    C0030551 (UMLS CUI [1,1])
    C1519316 (UMLS CUI [1,2])
    C0023226 (UMLS CUI [2,1])
    C1519316 (UMLS CUI [2,2])
    Relationship to participant
    Item
    Relationship to participant
    text
    C0439849 (UMLS CUI [1,1])
    C0679646 (UMLS CUI [1,2])
    Participant's main address
    Item
    Participant's main address
    text
    C0421449 (UMLS CUI [1])
    Participant’s phone number:
    Item
    Participant’s phone number:
    integer
    C0679646 (UMLS CUI [1,1])
    C1515258 (UMLS CUI [1,2])
    Date
    Item
    Date
    date
    C0011008 (UMLS CUI [1])
    Time
    Item
    Time
    time
    C0040223 (UMLS CUI [1])
    Witness
    Item
    Witness
    text
    C0682356 (UMLS CUI [1])
    Item Group
    Administrative
    C1320722 (UMLS CUI-1)
    Subject No.
    Item
    Subject No.
    integer
    C2348585 (UMLS CUI [1])
    Item Group
    Statement by Doctor, Nurse or Project Assistant who conducted the informed consent discussion:
    C1710187 (UMLS CUI-1)
    C0031831 (UMLS CUI-2)
    C0028661 (UMLS CUI-3)
    C1709701 (UMLS CUI-4)
    C0401893 (UMLS CUI-5)
    C0021430 (UMLS CUI-6)
    Name
    Item
    Name
    text
    C0027365 (UMLS CUI [1])
    Signature
    Item
    Signature
    text
    C1519316 (UMLS CUI [1])
    Designation
    Item
    Designation
    text
    C0442504 (UMLS CUI [1])
    Date
    Item
    Date
    date
    C0011008 (UMLS CUI [1])
    Time
    Item
    Time
    time
    C0040223 (UMLS CUI [1])
    Volver a la parte superior de la página 

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