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ID

33384

Description

Study ID: 104065 Clinical Study ID: 104065 Study Title: Immune memory of GSK's DTPw-HBV/Hib vaccine by giving Plain PRP polysaccharide at 10 mths. Immuno & reacto of a booster dose of DTPw-HBV/Hib or DTPw-HBV or DTPw-HBV+Hib at 15-18 mths in infants previously primed with DTPw-HBV/Hib Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00169442  Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 3 Study Recruitment Status: Completet Generic Name: Combined Diphtheria, Tetanus, Whole Cell Pertussis, Hepatitis B, Haemophilus influenzae Type b Vaccine (KFT) Trade Name: Zilbrix/Hib Study Indication: Diphtheria; Haemophilus influenzae type b; Hepatitis B; Tetanus; Whole Cell Pertussis

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Versions (1)
  1. 12/7/18 12/7/18 -
Copyright Holder

GSK group of companies

Uploaded on

December 7, 2018

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Creative Commons BY-NC 3.0
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    Immune memory of Combined Diphtheria, Tetanus, Whole Cell Pertussis, Hepatitis B, Haemophilus influenzae Type b Vaccine at infants (15 to 18 mths) - 104065

    English

    Study Conclusion

    1 forms  
    1. StudyEvent: ODM
      1. Study Conclusion
    Administrative data
    Description

    Administrative data

    Subject Number
    Description

    Subject Number

    Data type

    integer

    Protocol Number
    Description

    Protocol Number

    Data type

    integer

    Occurrence of Serious Adverse Event
    Description

    Occurrence of Serious Adverse Event

    Did the subject experience any Serious Adverse Event during the study period?
    Description

    Did the subject experience any Serious Adverse Event during the study period?

    Data type

    boolean

    If Yes, specify total number of SAE's
    Description

    If Yes, specify total number of SAE's

    Data type

    integer

    Elimination Criteria
    Description

    Elimination Criteria

    Did any elimination criteria become applicable during the study?
    Description

    Did any elimination criteria become applicable during the study?

    Data type

    boolean

    If Yes, specify
    Description

    If Yes, specify

    Data type

    text

    Subject Withdrawal
    Description

    Subject Withdrawal

    Was the subject withdrawn from study?
    Description

    Was the subject withdrawn from study?

    Data type

    boolean

    If Yes, please tick the ONE most appropriate category for withdrawal
    Description

    If Yes, please tick the ONE most appropriate category for withdrawal

    Data type

    text

    If SAE, please specify SAE number
    Description

    If SAE, please specify SAE number

    Data type

    integer

    If Non-SAE, please specify unsolicited AE number
    Description

    If Non-SAE, please specify unsolicited AE number

    Data type

    integer

    If Protocol violation, please specify below
    Description

    If Protocol violation, please specify below

    Data type

    text

    If Other, please specify
    Description

    If Other, please specify

    Data type

    text

    Please record who took decision
    Description

    Please record who took decision

    Data type

    text

    Date of last contact
    Description

    Date of last contact

    Data type

    date

    Was the subject in good condition at the date of last contact?
    Description

    If No, please give details in the Adverse Events form!

    Data type

    boolean

    Investigator's confirmation
    Description

    Investigator's confirmation

    I confirm that I have reviewed the data in this Case Report Form for this subject. All information entered by myself or my colleagues is, to the best of my knowledge, complete and accurate, as of the date below.
    Description

    I confirm that I have reviewed the data in this Case Report Form for this subject. All information entered by myself or my colleagues is, to the best of my knowledge, complete and accurate, as of the date below.

    Data type

    date

    Investigator's signature
    Description

    Investigator's signature

    Data type

    text

    Investigator's name (Print)
    Description

    Investigator's name (Print)

    Data type

    text

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    Similar models

    Study Conclusion

    1 forms
    1. StudyEvent: ODM
      1. Study Conclusion
    Name
    Type
    Description | Question | Decode (Coded Value)
    Data type
    Alias
    Item Group
    Administrative data
    Subject Number
    Item
    Subject Number
    integer
    Protocol Number
    Item
    Protocol Number
    integer
    Item Group
    Occurrence of Serious Adverse Event
    Did the subject experience any Serious Adverse Event during the study period?
    Item
    Did the subject experience any Serious Adverse Event during the study period?
    boolean
    If Yes, specify total number of SAE's
    Item
    If Yes, specify total number of SAE's
    integer
    Item Group
    Elimination Criteria
    Did any elimination criteria become applicable during the study?
    Item
    Did any elimination criteria become applicable during the study?
    boolean
    If Yes, specify
    Item
    If Yes, specify
    text
    Item Group
    Subject Withdrawal
    Was the subject withdrawn from study?
    Item
    Was the subject withdrawn from study?
    boolean
    Item
    If Yes, please tick the ONE most appropriate category for withdrawal
    text
    If Yes, please tick the ONE most appropriate category for withdrawal
    Code List
    If Yes, please tick the ONE most appropriate category for withdrawal
    CL Item
    Serious Adverse Event (1)
    CL Item
    Non-Serious Adverse Event (2)
    CL Item
    Protocol violation (3)
    CL Item
    Consent withdrawal, not due to adverse event (4)
    CL Item
    Migrated/moved from the study area (5)
    CL Item
    Lost to follow-up (6)
    CL Item
    Other (7)
    If SAE, please specify SAE number
    Item
    If SAE, please specify SAE number
    integer
    If Non-SAE, please specify unsolicited AE number
    Item
    If Non-SAE, please specify unsolicited AE number
    integer
    If Protocol violation, please specify below
    Item
    If Protocol violation, please specify below
    text
    If Other, please specify
    Item
    If Other, please specify
    text
    Item
    Please record who took decision
    text
    Please record who took decision
    Code List
    Please record who took decision
    CL Item
    Investigator (1)
    CL Item
    Parents/Guardians (2)
    Date of last contact
    Item
    Date of last contact
    date
    Was the subject in good condition at the date of last contact?
    Item
    Was the subject in good condition at the date of last contact?
    boolean
    Item Group
    Investigator's confirmation
    I confirm that I have reviewed the data in this Case Report Form for this subject. All information entered by myself or my colleagues is, to the best of my knowledge, complete and accurate, as of the date below.
    Item
    I confirm that I have reviewed the data in this Case Report Form for this subject. All information entered by myself or my colleagues is, to the best of my knowledge, complete and accurate, as of the date below.
    date
    Investigator's signature
    Item
    Investigator's signature
    text
    Investigator's name (Print)
    Item
    Investigator's name (Print)
    text
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