ID

33184

Description

Study ID: 104021 Clinical Study ID: 104021 Study Title: A phase III, partially blind, randomized study to evaluate the immunogenicity, safety and reactogenicity of GlaxoSmithKline (GSK) Biologicals’ Tritanrix™-HepB and GSK Biologicals Kft’s DTPw-HBV vaccines as compared to concomitant administration of Commonwealth Serum Laboratory’s (CSL’s) DTPw (Triple Antigen™) and GSK Biologicals’ HBV (Engerix™-B), when co-administered with GSK Biologicals’ oral live attenuated human rotavirus (HRV) vaccine, to healthy infants at 3, 4½ and 6 months of age, after a birth dose of hepatitis B vaccine. Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00158756 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 3 Study Recruitment Status: Completed Generic Name: Hepatitis B Vaccine, Recombinant Trade Name: Engerix B Study Indication: Hepatitis B

Keywords

Versions (2)
  1. 11/30/18 11/30/18 -
  2. 11/30/18 11/30/18 -
Copyright Holder

GSK group of companies

Uploaded on

November 30, 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.

    Immunogenicity of co-administration of Tritanrix™-HepB and DTPw-HBV vaccines or Triple Antigen™ and Engerix™-B with HRV vaccine to infants (3, 4½ and 6 month) - 104021

    English

    Visit 3: Study Continuation Check

    1 forms  
    Administrative data
    Description

    Administrative data

    Subject Number
    Description

    Subject Number

    Data type

    integer

    Check for Study Continuation
    Description

    Check for Study Continuation

    Did the subject return for visit 3?
    Description

    Did the subject return for visit 3?

    Data type

    boolean

    If yes, please complete all forms for Visit 3
    Description

    If yes, please complete all forms for Visit 3

    Data type

    text

    If No, record ONE most appropriate reason and skip the following pages of this visit
    Description

    If No, record ONE most appropriate reason and skip the following pages of this visit

    Data type

    text

    If SAE, record the SAE number
    Description

    If SAE, record the SAE number

    Data type

    integer

    If Non-SAE, record the unsolicited AE number
    Description

    If Non-SAE, record the unsolicited AE number

    Data type

    integer

    If Other, specify
    Description

    e.g., consent withdrawal, protocol violation, etc.

    Data type

    text

    Who took the decision?
    Description

    Who took the decision?

    Data type

    text

    Back to the top of the page

    Similar models

    Visit 3: Study Continuation Check

    1 forms
    Name
    Type
    Description | Question | Decode (Coded Value)
    Data type
    Alias
    Item Group
    Administrative data
    Subject Number
    Item
    Subject Number
    integer
    Item Group
    Check for Study Continuation
    Did the subject return for visit 3?
    Item
    Did the subject return for visit 3?
    boolean
    If yes, please complete all forms for Visit 3
    Item
    If yes, please complete all forms for Visit 3
    text
    Item
    If No, record ONE most appropriate reason and skip the following pages of this visit
    text
    If No, record ONE most appropriate reason and skip the following pages of this visit
    Code List
    If No, record 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
    Other (3)
    If SAE, record the SAE number
    Item
    If SAE, record the SAE number
    integer
    If Non-SAE, record the unsolicited AE number
    Item
    If Non-SAE, record the unsolicited AE number
    integer
    If Other, specify
    Item
    If Other, specify
    text
    Item
    Who took the decision?
    text
    Who took the decision?
    Code List
    Who took the decision?
    CL Item
    Investigator (1)
    CL Item
    Parents/Guardians (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