0 Ratings
ID

24845

Description

Study ID: 100571 (M138) Clinical Study ID: 100571 Study Title: Double-blind randomized study to evaluate the immunogenicity and reactogenicity of two different lots of GlaxoSmithKline Biologicals' inactivated hepatitis A vaccine containing 1440 EL.U of antigen per mL and injected according to a 0, 12 month schedule in healthy adult volunteers Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00291876 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: phase 4 Study Recruitment Status: Completed Generic Name: Hepatitis A Vaccine, Inactivated Trade Name: Havrix Study Indication: Hepatitis A https://clinicaltrials.gov/ct2/show/NCT00291876

Link

https://clinicaltrials.gov/ct2/show/NCT00291876

Keywords

Versions (1)
  1. 8/19/17 8/19/17 -
Copyright Holder

GlaxoSmithKline

Uploaded on

August 19, 2017

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.

    GSK Hepatitis A Vaccine Month 162 VISIT 20 LONG TERM FOLLOW UP NCT00291876

    English

    GSK Hepatitis A Vaccine Month 162 VISIT 20 LONG TERM FOLLOW UP NCT00291876

    1 forms  
    Study administration
    Description

    Study administration

    Subject Number
    Description

    Subject Identifier

    Data type

    integer

    Alias
    UMLS CUI [1]
    C2348585
    FOLLOW-UP STUDIES
    Description

    FOLLOW-UP STUDIES

    Would the subject be willing to participate in a follow-up study?
    Description

    participation status study subject

    Data type

    integer

    Alias
    UMLS CUI [1]
    C2348568
    Adverse Events, or Serious Adverse Events:
    Description

    participation status study subject adverse event

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C2348568
    UMLS CUI [1,2]
    C0877248
    please specify
    Description

    participation status study subject adverse event specify

    Data type

    text

    Alias
    UMLS CUI [1,1]
    C2348568
    UMLS CUI [1,2]
    C0877248
    Other
    Description

    participation status study subject other reason

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C2348568
    UMLS CUI [1,2]
    C0566251
    please specify:
    Description

    participation status study subject specify other reason

    Data type

    text

    Alias
    UMLS CUI [1,1]
    C2348568
    UMLS CUI [1,2]
    C0566251
    INVESTIGATOR SIGNATURE
    Description

    INVESTIGATOR SIGNATURE

    Date
    Description

    Signature date

    Data type

    date

    Alias
    UMLS CUI [1]
    C0807937
    Investigators signature
    Description

    signature

    Data type

    text

    Alias
    UMLS CUI [1]
    C1519316
    Back to the top of the page

    Similar models

    GSK Hepatitis A Vaccine Month 162 VISIT 20 LONG TERM FOLLOW UP NCT00291876

    1 forms
    Name
    Type
    Description | Question | Decode (Coded Value)
    Data type
    Alias
    Item Group
    Study administration
    Subject Identifier
    Item
    Subject Number
    integer
    C2348585 (UMLS CUI [1])
    Item Group
    FOLLOW-UP STUDIES
    Item
    Would the subject be willing to participate in a follow-up study?
    integer
    C2348568 (UMLS CUI [1])
    participation status study subject
    Code List
    Would the subject be willing to participate in a follow-up study?
    CL Item
    Yes (1)
    CL Item
    No, please specify the reason (2)
    participation status study subject adverse event
    Item
    Adverse Events, or Serious Adverse Events:
    boolean
    C2348568 (UMLS CUI [1,1])
    C0877248 (UMLS CUI [1,2])
    participation status study subject adverse event specify
    Item
    please specify
    text
    C2348568 (UMLS CUI [1,1])
    C0877248 (UMLS CUI [1,2])
    participation status study subject other reason
    Item
    Other
    boolean
    C2348568 (UMLS CUI [1,1])
    C0566251 (UMLS CUI [1,2])
    participation status study subject specify other reason
    Item
    please specify:
    text
    C2348568 (UMLS CUI [1,1])
    C0566251 (UMLS CUI [1,2])
    Item Group
    INVESTIGATOR SIGNATURE
    Signature date
    Item
    Date
    date
    C0807937 (UMLS CUI [1])
    signature
    Item
    Investigators signature
    text
    C1519316 (UMLS CUI [1])
    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