ID

33871

Description

Study ID:103860/269 Clinical Study ID:103860/269 (HBV-269) Study Title: Phase II study to evaluate the immunogenicity of GSK Biologicals' preservative-free Engerix-B and thiomersal-free Engerix-B vaccines compared to Engerix™-B and evaluate safety and reactogenicity of each vaccine when administered intramuscularly according to a 0, 1, 6 month schedule in healthy volunteers Patient Level Data:Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: N/A Sponsor: GlaxoSmithKline Collaborators: N/A Phase: phase 2 Study Recruitment Status: Completed Generic Name: Hepatitis B Vaccine, Recombinant Trade Name: Engerix-B Study Indication: Hepatitis B

Keywords

Versions (1)
  1. 1/4/19 1/4/19 -
Copyright Holder

GlaxoSmithKline

Uploaded on

January 4, 2019

DOI

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License

Creative Commons BY-NC 3.0
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    Immunogenicity, safety and reactogenicity of preservative-free Engerix-B and thiomersal-free Engerix-B vaccines compared to Engerix™️-B

    English

    Informed Consent

    1 forms  
    1. StudyEvent: ODM
      1. Informed Consent
    Informed Consent
    Description

    Informed Consent

    Alias
    UMLS CUI-1
    C0021430
    UMLS CUI-2
    C0030705
    Subject’s first name and family name
    Description

    The aims and procedures of this study have been clearly explained to me and I have read the preceding information sheet and understood the information provided. I agree to be enrolled in the study. I understand that I have the right to decline to enter the study and to withdraw from it at any time for any reasons, without consequence to my present or future health care and attention which I receive from my healthcare provider. I have been made aware of my right to access and request correction of my personal data. I acknowledge that I have received a copy of this form for future reference. I hereby freely give my consent to take part in this study.

    Data type

    text

    Alias
    UMLS CUI [1]
    C1299487
    Participant’s signature
    Description

    Participant, Signature

    Data type

    text

    Alias
    UMLS CUI [1,1]
    C0679646
    UMLS CUI [1,2]
    C1519316
    Participant’s main address
    Description

    Patient address

    Data type

    text

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

    Participant, Telephone Number

    Data type

    integer

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

    Informed Consent, Date in time

    Data type

    date

    Alias
    UMLS CUI [1,1]
    C0021430
    UMLS CUI [1,2]
    C0011008
    Time
    Description

    Informed Consent, Time

    Data type

    time

    Alias
    UMLS CUI [1,1]
    C0021430
    UMLS CUI [1,2]
    C0040223
    Witness
    Description

    Informed Consent, Witnesses

    Data type

    text

    Alias
    UMLS CUI [1,1]
    C0021430
    UMLS CUI [1,2]
    C0682356
    Statement by Doctor, Nurse or Project Assistant who conducted the informed consent discussion
    Description

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

    Alias
    UMLS CUI-1
    C0021430
    UMLS CUI-2
    C0035173
    Name
    Description

    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.

    Data type

    text

    Alias
    UMLS CUI [1,1]
    C0021430
    UMLS CUI [1,2]
    C0035173
    UMLS CUI [1,3]
    C0027365
    Signature
    Description

    Informed Consent, Research Personnel, Signature

    Data type

    text

    Alias
    UMLS CUI [1,1]
    C0021430
    UMLS CUI [1,2]
    C0035173
    UMLS CUI [1,3]
    C1519316
    Designation
    Description

    Informed Consent, Research Personnel, Occupations

    Data type

    text

    Alias
    UMLS CUI [1,1]
    C0021430
    UMLS CUI [1,2]
    C0035173
    UMLS CUI [1,3]
    C0028811
    Date
    Description

    Informed Consent, Research Personnel, Date in time

    Data type

    date

    Alias
    UMLS CUI [1,1]
    C0021430
    UMLS CUI [1,2]
    C0035173
    UMLS CUI [1,3]
    C0011008
    Time
    Description

    Informed Consent, Research Personnel, Time

    Data type

    time

    Alias
    UMLS CUI [1,1]
    C0021430
    UMLS CUI [1,2]
    C0035173
    UMLS CUI [1,3]
    C0040223
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    Similar models

    Informed Consent

    1 forms
    1. StudyEvent: ODM
      1. Informed Consent
    Name
    Type
    Description | Question | Decode (Coded Value)
    Data type
    Alias
    Item Group
    Informed Consent
    C0021430 (UMLS CUI-1)
    C0030705 (UMLS CUI-2)
    Patient Name
    Item
    Subject’s first name and family name
    text
    C1299487 (UMLS CUI [1])
    Participant, Signature
    Item
    Participant’s signature
    text
    C0679646 (UMLS CUI [1,1])
    C1519316 (UMLS CUI [1,2])
    Patient address
    Item
    Participant’s main address
    text
    C0421449 (UMLS CUI [1])
    Participant, Telephone Number
    Item
    Participant’s phone number
    integer
    C0679646 (UMLS CUI [1,1])
    C1515258 (UMLS CUI [1,2])
    Informed Consent, Date in time
    Item
    Date
    date
    C0021430 (UMLS CUI [1,1])
    C0011008 (UMLS CUI [1,2])
    Informed Consent, Time
    Item
    Time
    time
    C0021430 (UMLS CUI [1,1])
    C0040223 (UMLS CUI [1,2])
    Informed Consent, Witnesses
    Item
    Witness
    text
    C0021430 (UMLS CUI [1,1])
    C0682356 (UMLS CUI [1,2])
    Item Group
    Statement by Doctor, Nurse or Project Assistant who conducted the informed consent discussion
    C0021430 (UMLS CUI-1)
    C0035173 (UMLS CUI-2)
    Informed Consent, Research Personnel, Name
    Item
    Name
    text
    C0021430 (UMLS CUI [1,1])
    C0035173 (UMLS CUI [1,2])
    C0027365 (UMLS CUI [1,3])
    Informed Consent, Research Personnel, Signature
    Item
    Signature
    text
    C0021430 (UMLS CUI [1,1])
    C0035173 (UMLS CUI [1,2])
    C1519316 (UMLS CUI [1,3])
    Informed Consent, Research Personnel, Occupations
    Item
    Designation
    text
    C0021430 (UMLS CUI [1,1])
    C0035173 (UMLS CUI [1,2])
    C0028811 (UMLS CUI [1,3])
    Informed Consent, Research Personnel, Date in time
    Item
    Date
    date
    C0021430 (UMLS CUI [1,1])
    C0035173 (UMLS CUI [1,2])
    C0011008 (UMLS CUI [1,3])
    Informed Consent, Research Personnel, Time
    Item
    Time
    time
    C0021430 (UMLS CUI [1,1])
    C0035173 (UMLS CUI [1,2])
    C0040223 (UMLS CUI [1,3])
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