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ID

36609

Description

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

Keywords

Versions (1)
  1. 5/26/19 5/26/19 -
Copyright Holder

GlaxoSmithKline

Uploaded on

May 26, 2019

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License

Creative Commons BY-NC 3.0
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    DTPa-HBV-IPV/Hib Vaccine Given in Healthy Infants; NCT00320463

    English

    Study Conclusion

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

    Administrative Data

    Alias
    UMLS CUI-1
    C1320722
    Subject Number
    Description

    Clinical Trial Subject Unique Identifier

    Data type

    integer

    Alias
    UMLS CUI [1]
    C2348585
    Follow-Up Studies
    Description

    Follow-Up Studies

    Alias
    UMLS CUI-1
    C0016441
    If a booster study or a follow-up study is offered in the future, would the subject/parents/guardians be willing to be contacted and learn more about it?
    Description

    Follow-Up Studies, Contact with, parent, Legal Guardians

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C0016441
    UMLS CUI [1,2]
    C0332158
    UMLS CUI [1,3]
    C0030551
    UMLS CUI [1,4]
    C0023226
    If No, please specify the most appropriate reason
    Description

    Follow-Up Studies, Contact with, parent, Legal Guardians, Reason

    Data type

    text

    Alias
    UMLS CUI [1,1]
    C0016441
    UMLS CUI [1,2]
    C0332158
    UMLS CUI [1,3]
    C0030551
    UMLS CUI [1,4]
    C0023226
    UMLS CUI [1,5]
    C0016441
    UMLS CUI [1,6]
    C0566251
    Occurrence of Serious Adverse Event
    Description

    Occurrence of Serious Adverse Event

    Alias
    UMLS CUI-1
    C1519255
    Did the subject experience any Serious Adverse Event during the study period?
    Description

    Serious Adverse Event

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C1519255
    If Yes, specify total number of SAE's
    Description

    Serious Adverse Event, Count of entities

    Data type

    integer

    Alias
    UMLS CUI [1,1]
    C1519255
    UMLS CUI [1,2]
    C0449788
    Status of Treatment Blind
    Description

    Status of Treatment Blind

    Alias
    UMLS CUI-1
    C0749659
    UMLS CUI-2
    C2347038
    Was the treatment blind broken during the study?
    Description

    Subject Unblinding Event Record

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C3897431
    Complete Date
    Description

    Subject Unblinding Event Record, Date in time

    Data type

    date

    Alias
    UMLS CUI [1,1]
    C3897431
    UMLS CUI [1,2]
    C0011008
    Tick one reason below
    Description

    Subject Unblinding Event Record, Indication

    Data type

    text

    Alias
    UMLS CUI [1,1]
    C3897431
    UMLS CUI [1,2]
    C0392360
    Elimination Criteria
    Description

    Elimination Criteria

    Alias
    UMLS CUI-1
    C0680251
    Did any elimination criteria become applicable during the study?
    Description

    Exclusion Criteria

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0680251
    Specify
    Description

    Exclusion Criteria

    Data type

    text

    Alias
    UMLS CUI [1]
    C0680251
    Withdraw
    Description

    Withdraw

    Alias
    UMLS CUI-1
    C2349954
    Was the subject withdrawn from the study?
    Description

    Withdraw

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C2349954
    Major reason for withdrawal (tick one box only).
    Description

    Withdraw, Indication

    Data type

    text

    Alias
    UMLS CUI [1,1]
    C2349954
    UMLS CUI [1,2]
    C3146298
    UMLS CUI [1,3]
    C1522508
    Specifications
    Description

    Withdraw, Indication, Details

    Data type

    text

    Alias
    UMLS CUI [1,1]
    C2349954
    UMLS CUI [1,2]
    C3146298
    UMLS CUI [1,3]
    C1522508
    Who made the decision
    Description

    Withdraw, Decision

    Data type

    text

    Alias
    UMLS CUI [1,1]
    C2349954
    UMLS CUI [1,2]
    C0679006
    Date of last contact
    Description

    Withdraw, Date last contact

    Data type

    date

    Alias
    UMLS CUI [1,1]
    C2349954
    UMLS CUI [1,2]
    C0805839
    Was the subject in good condition at date of last contact?
    Description

    Withdraw, Date last contact, General physical condition

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C2349954
    UMLS CUI [1,2]
    C0805839
    UMLS CUI [1,3]
    C1142435
    Investigator's Signature
    Description

    Investigator's Signature

    Alias
    UMLS CUI-1
    C2346576
    Investigator's signature
    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

    text

    Alias
    UMLS CUI [1]
    C2346576
    Date
    Description

    Investigator Signature, Date in time

    Data type

    date

    Alias
    UMLS CUI [1,1]
    C2346576
    UMLS CUI [1,2]
    C0011008
    Printed Investigator's name
    Description

    Investigator Name

    Data type

    text

    Alias
    UMLS CUI [1]
    C2826892
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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
    C1320722 (UMLS CUI-1)
    Clinical Trial Subject Unique Identifier
    Item
    Subject Number
    integer
    C2348585 (UMLS CUI [1])
    Item Group
    Follow-Up Studies
    C0016441 (UMLS CUI-1)
    Follow-Up Studies, Contact with, parent, Legal Guardians
    Item
    If a booster study or a follow-up study is offered in the future, would the subject/parents/guardians be willing to be contacted and learn more about it?
    boolean
    C0016441 (UMLS CUI [1,1])
    C0332158 (UMLS CUI [1,2])
    C0030551 (UMLS CUI [1,3])
    C0023226 (UMLS CUI [1,4])
    Item
    If No, please specify the most appropriate reason
    text
    C0016441 (UMLS CUI [1,1])
    C0332158 (UMLS CUI [1,2])
    C0030551 (UMLS CUI [1,3])
    C0023226 (UMLS CUI [1,4])
    C0016441 (UMLS CUI [1,5])
    C0566251 (UMLS CUI [1,6])
    Follow-Up Studies, Contact with, parent, Legal Guardians, Reason
    Code List
    If No, please specify the most appropriate reason
    CL Item
    Adverse Events, or Serious Adverse Events (please specify) (1)
    CL Item
    Other (please specify) (2)
    Item Group
    Occurrence of Serious Adverse Event
    C1519255 (UMLS CUI-1)
    Serious Adverse Event
    Item
    Did the subject experience any Serious Adverse Event during the study period?
    boolean
    C1519255 (UMLS CUI [1])
    Serious Adverse Event, Count of entities
    Item
    If Yes, specify total number of SAE's
    integer
    C1519255 (UMLS CUI [1,1])
    C0449788 (UMLS CUI [1,2])
    Item Group
    Status of Treatment Blind
    C0749659 (UMLS CUI-1)
    C2347038 (UMLS CUI-2)
    Subject Unblinding Event Record
    Item
    Was the treatment blind broken during the study?
    boolean
    C3897431 (UMLS CUI [1])
    Subject Unblinding Event Record, Date in time
    Item
    Complete Date
    date
    C3897431 (UMLS CUI [1,1])
    C0011008 (UMLS CUI [1,2])
    Item
    Tick one reason below
    text
    C3897431 (UMLS CUI [1,1])
    C0392360 (UMLS CUI [1,2])
    Withdraw, Decision
    Code List
    Tick one reason below
    CL Item
    Medical emergency requiring identification of investigational product for further treatments. (1)
    CL Item
    Other, specify (2)
    Item Group
    Elimination Criteria
    C0680251 (UMLS CUI-1)
    Exclusion Criteria
    Item
    Did any elimination criteria become applicable during the study?
    boolean
    C0680251 (UMLS CUI [1])
    Exclusion Criteria
    Item
    Specify
    text
    C0680251 (UMLS CUI [1])
    Item Group
    Withdraw
    C2349954 (UMLS CUI-1)
    Withdraw
    Item
    Was the subject withdrawn from the study?
    boolean
    C2349954 (UMLS CUI [1])
    Item
    Major reason for withdrawal (tick one box only).
    text
    C2349954 (UMLS CUI [1,1])
    C3146298 (UMLS CUI [1,2])
    C1522508 (UMLS CUI [1,3])
    Withdraw, Indication
    Code List
    Major reason for withdrawal (tick one box only).
    CL Item
    Serious adverse event (Please specify SAE N°) (1)
    CL Item
    Non-Serious adverse event (Please specify unsolicited AE N° or solicited AE code) (2)
    CL Item
    Protocol violation, please specify (3)
    CL Item
    Consent withdrawal, not due to an adverse event. (4)
    CL Item
    Migrated / moved from the study area (5)
    CL Item
    Lost to follow-up. (6)
    CL Item
    Other, please specify (7)
    Withdraw, Indication, Details
    Item
    Specifications
    text
    C2349954 (UMLS CUI [1,1])
    C3146298 (UMLS CUI [1,2])
    C1522508 (UMLS CUI [1,3])
    Item
    Who made the decision
    text
    C2349954 (UMLS CUI [1,1])
    C0679006 (UMLS CUI [1,2])
    Withdraw, Decision
    Code List
    Who made the decision
    CL Item
    Investigator  (1)
    CL Item
    Parents/Guardians (2)
    Withdraw, Date last contact
    Item
    Date of last contact
    date
    C2349954 (UMLS CUI [1,1])
    C0805839 (UMLS CUI [1,2])
    Withdraw, Date last contact, General physical condition
    Item
    Was the subject in good condition at date of last contact?
    boolean
    C2349954 (UMLS CUI [1,1])
    C0805839 (UMLS CUI [1,2])
    C1142435 (UMLS CUI [1,3])
    Item Group
    Investigator's Signature
    C2346576 (UMLS CUI-1)
    Investigator Signature
    Item
    Investigator's signature
    text
    C2346576 (UMLS CUI [1])
    Investigator Signature, Date in time
    Item
    Date
    date
    C2346576 (UMLS CUI [1,1])
    C0011008 (UMLS CUI [1,2])
    Investigator Name
    Item
    Printed Investigator's name
    text
    C2826892 (UMLS CUI [1])
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