0 Ratings
ID

30022

Description

Study ID: 100480, 759346/004 & 100791 Clinical Study ID: 100480, 759346/004 & 100791 Study Title: Study to assess immunogenicity and non-inferiority of investigational vaccination regimen as compared to Tritanrix-HepB/Hiberix and as compared to Meningitec when administered to healthy infants Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: Sponsor: GlaxoSmithKline Collaborators: N/A Phase: phase 3 Study Recruitment Status: Completed Generic Name: Combined Diphtheria, Tetanus, Whole Cell Pertussis, Hepatitis B, Haemophilus influenzae Type b Vaccine Trade Name: Tritanrix HepB/Hiberix Study Indication: Diphtheria; Haemophilus influenzae type b; Hepatitis B; Tetanus; Whole Cell Pertussis Documentation part: Study Conclusion

Keywords

Versions (3)
  1. 7/10/17 7/10/17 -
  2. 7/10/17 7/10/17 -
  3. 5/4/18 5/4/18 - Sarah Riepenhausen
Copyright Holder

GlaxoSmithKline

Uploaded on

May 4, 2018

DOI

To request one please log in.

License

Creative Commons BY-NC 3.0
Model comments :

You can comment on the data model here. Via the speech bubbles at the itemgroups and items you can add comments to those specificially.

Back to model comments
Itemgroup comments for :

Item comments for :

  • Newest
  • Oldest
  • Popular
  • Newest
    • Newest
    • Oldest
    • Popular

    No comments

    In order to download data models you must be logged in. Please log in or register for free.

    Investigational vaccination compared to Tritanrix-HepB/Hiberix and Meningitec Study Conclusion 100480

    English

    Study Conclusion Investigational vaccination compared to Tritanrix-HepB/Hiberix and Meningitec 100480

    1 forms  
    Study Conclusion
    Description

    Study Conclusion

    Alias
    UMLS CUI-1
    C1707478
    UMLS CUI-2
    C0008976
    UMLS CUI-3
    C0042210
    Did the subject experience any Serious Adverse Event during the study period ?
    Description

    Serious Adverse Event

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C1519255
    Total number of SAE's:
    Description

    If yes, please give the total number of SAE's:

    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

    boolean

    Alias
    UMLS CUI [1,1]
    C2349954
    UMLS CUI [1,2]
    C0008976
    Please tick the ONE most appropriate category for drop out
    Description

    If Yes, 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, Who made the decision?
    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
    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

    treatment blind broken

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C0749659
    UMLS CUI [1,2]
    C2347038
    If Yes, complete the date
    Description

    Was the treatment blind broken during the study?

    Data type

    date

    Alias
    UMLS CUI [1,1]
    C3897431
    UMLS CUI [1,2]
    C0011008
    If Yes, tick one reason below:
    Description

    Was the treatment blind broken during the study?

    Data type

    integer

    Alias
    UMLS CUI [1,1]
    C3897431
    UMLS CUI [1,2]
    C0392360
    Reason treatment blind broken. If other, specify:
    Description

    reason treatment blind broken

    Data type

    text

    Alias
    UMLS CUI [1,1]
    C3897431
    UMLS CUI [1,2]
    C0392360
    Back to the top of the page

    Similar models

    Study Conclusion Investigational vaccination compared to Tritanrix-HepB/Hiberix and Meningitec 100480

    1 forms
    Name
    Type
    Description | Question | Decode (Coded Value)
    Data type
    Alias
    Item Group
    Study Conclusion
    C1707478 (UMLS CUI-1)
    C0008976 (UMLS CUI-2)
    C0042210 (UMLS CUI-3)
    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
    Total 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])
    withdrawn
    Item
    Was the subject withdrawn from study?
    boolean
    C2349954 (UMLS CUI [1,1])
    C0008976 (UMLS CUI [1,2])
    Item
    Please tick the ONE most appropriate category for drop out
    integer
    C2349954 (UMLS CUI [1,1])
    C0392360 (UMLS CUI [1,2])
    C0008976 (UMLS CUI [1,3])
    reason for withdrawal
    Code List
    Please tick the ONE most appropriate category for drop out
    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, Who made the decision?
    integer
    C2349954 (UMLS CUI [1,1])
    C0392360 (UMLS CUI [1,2])
    C0008976 (UMLS CUI [1,3])
    reason for withdrawal
    Code List
    reason for withdrawal, Who made the decision?
    CL Item
    Investigator’s decision (1)
    CL Item
    Parents/Guardian’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])
    Item Group
    Status of Treatment Blind
    C0749659 (UMLS CUI-1)
    C2347038 (UMLS CUI-2)
    treatment blind broken
    Item
    Was the treatment blind broken during the study?
    boolean
    C0749659 (UMLS CUI [1,1])
    C2347038 (UMLS CUI [1,2])
    date treatment blind broken
    Item
    If Yes, complete the date
    date
    C3897431 (UMLS CUI [1,1])
    C0011008 (UMLS CUI [1,2])
    Item
    If Yes, tick one reason below:
    integer
    C3897431 (UMLS CUI [1,1])
    C0392360 (UMLS CUI [1,2])
    reason treatment blind broken
    Code List
    If Yes, tick one reason below:
    CL Item
    Medical emergency requiring identification of investigational product for further treatments (1)
    CL Item
    Other (2)
    reason treatment blind broken
    Item
    Reason treatment blind broken. If other, specify:
    text
    C3897431 (UMLS CUI [1,1])
    C0392360 (UMLS CUI [1,2])
    Back to the top of the page 

    Help

    Do you need help on how to use the search function? Please watch the corresponding tutorial video for more details and learn how to use the search function most efficiently.

    Watch Tutorial