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ID

22997

Description

Study ID: 100484 Clinical Study ID: 100484 (DTPa) Study Title: An open prospective study of immunogenicity and reactogenicity of DTPa vaccine (Infanrix) given as a booster to healthy school children 10 to 12 years of age Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: Sponsor: GlaxoSmithKline Collaborators: N/A Phase: phase 4 Study Recruitment Status: Completed Generic Name: Diphtheria, Tetanus, Acellular Pertussis Vaccine Adsorbed Trade Name: BIO DTPA (INFANRIX); Infanrix Study Indication: Acellular Pertussis; Diphtheria; Tetanus; acellular pertussis Documentation: Study Conclusion

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Versions (1)
  1. 6/19/17 6/19/17 -
Copyright Holder

GlaxoSmithKline

Uploaded on

June 19, 2017

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Creative Commons BY-NC 3.0
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    Study Conclusion: GSK DTPa vaccine (Infanrix) 100484

    English

    Study ID: 100484 Study Conclusion

    1 forms  
    Study Conclusion
    Description

    Study Conclusion

    Alias
    UMLS CUI-1
    C1707478
    UMLS CUI-2
    C0008976
    Did the subject experience any Serious Adverse Event during the study period ?
    Description

    Serious Adverse Event

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C1519255
    Number of SAE's
    Description

    Serious Adverse Event? If Yes, please specify

    Data type

    integer

    Alias
    UMLS CUI [1,1]
    C0449788
    UMLS CUI [1,2]
    C1519255
    Did any elimination criteria become applicable during the study?
    Description

    elimination criteria

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0680251
    Did any elimination criteria become applicable during the study? If Yes, please specify
    Description

    elimination criteria

    Data type

    text

    Alias
    UMLS CUI [1]
    C0680251
    Was the subject withdrawn from study?
    Description

    withdrawn

    Data type

    integer

    Alias
    UMLS CUI [1,1]
    C2349954
    UMLS CUI [1,2]
    C0008976
    Please tick the ONE most appropriate reason and skip the following pages of this visit.
    Description

    If No, please specify

    Data type

    integer

    Alias
    UMLS CUI [1,1]
    C2349954
    UMLS CUI [1,2]
    C0392360
    UMLS CUI [1,3]
    C0008976
    SAE Number
    Description

    If Serious adverse event, please specify

    Data type

    integer

    Alias
    UMLS CUI [1,1]
    C1519255
    UMLS CUI [1,2]
    C0237753
    AE Number or Code
    Description

    If Non-serious adverse event, please specify

    Data type

    integer

    Alias
    UMLS CUI [1,1]
    C1518404
    UMLS CUI [1,2]
    C0237753
    If Protocol violation, please specify
    Description

    Protocol violation

    Data type

    text

    Alias
    UMLS CUI [1]
    C1709750
    Other reason for withdrawal
    Description

    If Other, please specify

    Data type

    text

    Alias
    UMLS CUI [1,1]
    C2349954
    UMLS CUI [1,2]
    C0392360
    UMLS CUI [1,3]
    C0008976
    reason for withdrawal
    Description

    reason for withdrawal

    Data type

    integer

    Alias
    UMLS CUI [1,1]
    C2349954
    UMLS CUI [1,2]
    C0392360
    UMLS CUI [1,3]
    C0008976
    Date of last contact
    Description

    Date of last contact

    Data type

    date

    Alias
    UMLS CUI [1,1]
    C0011008
    UMLS CUI [1,2]
    C1705415
    Was the subject in good condition at date of last contact?
    Description

    subject condition

    Data type

    integer

    Alias
    UMLS CUI [1,1]
    C1142435
    UMLS CUI [1,2]
    C0681850
    Investigators signature
    Description

    Investigators signature

    Data type

    text

    Alias
    UMLS CUI [1]
    C2346576
    Investigators signature Date
    Description

    Investigators signature Date

    Data type

    date

    Alias
    UMLS CUI [1,1]
    C0011008
    UMLS CUI [1,2]
    C2346576
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    Similar models

    Study ID: 100484 Study Conclusion

    1 forms
    Name
    Type
    Description | Question | Decode (Coded Value)
    Data type
    Alias
    Item Group
    Study Conclusion
    C1707478 (UMLS CUI-1)
    C0008976 (UMLS CUI-2)
    Serious Adverse Event
    Item
    Did the subject experience any Serious Adverse Event during the study period ?
    boolean
    C1519255 (UMLS CUI [1])
    Number of SAEs
    Item
    Number of SAE's
    integer
    C0449788 (UMLS CUI [1,1])
    C1519255 (UMLS CUI [1,2])
    elimination criteria
    Item
    Did any elimination criteria become applicable during the study?
    boolean
    C0680251 (UMLS CUI [1])
    elimination criteria
    Item
    Did any elimination criteria become applicable during the study? If Yes, please specify
    text
    C0680251 (UMLS CUI [1])
    Item
    Was the subject withdrawn from study?
    integer
    C2349954 (UMLS CUI [1,1])
    C0008976 (UMLS CUI [1,2])
    subject come at visit 2
    Code List
    Was the subject withdrawn from study?
    CL Item
    No (1)
    CL Item
    Yes, Please tick the ONE most appropriate category for drop out. (2)
    Item
    Please tick the ONE most appropriate reason and skip the following pages of this visit.
    integer
    C2349954 (UMLS CUI [1,1])
    C0392360 (UMLS CUI [1,2])
    C0008976 (UMLS CUI [1,3])
    reason for study discontinuation
    Code List
    Please tick the ONE most appropriate reason and skip the following pages of this visit.
    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 an adverse event. (4)
    CL Item
    Migrated / moved from the study area (5)
    CL Item
    Lost to follow-up (6)
    CL Item
    Other (7)
    SAE Number
    Item
    SAE Number
    integer
    C1519255 (UMLS CUI [1,1])
    C0237753 (UMLS CUI [1,2])
    AE Number
    Item
    AE Number or Code
    integer
    C1518404 (UMLS CUI [1,1])
    C0237753 (UMLS CUI [1,2])
    Protocol violation
    Item
    If Protocol violation, please specify
    text
    C1709750 (UMLS CUI [1])
    Other reason for withdrawal
    Item
    Other reason for withdrawal
    text
    C2349954 (UMLS CUI [1,1])
    C0392360 (UMLS CUI [1,2])
    C0008976 (UMLS CUI [1,3])
    Item
    reason for withdrawal
    integer
    C2349954 (UMLS CUI [1,1])
    C0392360 (UMLS CUI [1,2])
    C0008976 (UMLS CUI [1,3])
    reason for study discontinuation
    Code List
    reason for withdrawal
    CL Item
    Investigator’s decision (1)
    CL Item
    Subject’s decision (2)
    Date of last contact
    Item
    Date of last contact
    date
    C0011008 (UMLS CUI [1,1])
    C1705415 (UMLS CUI [1,2])
    Item
    Was the subject in good condition at date of last contact?
    integer
    C1142435 (UMLS CUI [1,1])
    C0681850 (UMLS CUI [1,2])
    subject condition
    Code List
    Was the subject in good condition at date of last contact?
    CL Item
    No, please give details within the Adverse Events section (1)
    CL Item
    Yes (2)
    Investigators signature
    Item
    Investigators signature
    text
    C2346576 (UMLS CUI [1])
    Investigators signature Date
    Item
    Investigators signature Date
    date
    C0011008 (UMLS CUI [1,1])
    C2346576 (UMLS CUI [1,2])
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