0 Ratings
ID

33316

Description

Study ID: 104065 Clinical Study ID: 104065 Study Title: Immune memory of GSK's DTPw-HBV/Hib vaccine by giving Plain PRP polysaccharide at 10 mths. Immuno & reacto of a booster dose of DTPw-HBV/Hib or DTPw-HBV or DTPw-HBV+Hib at 15-18 mths in infants previously primed with DTPw-HBV/Hib Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00169442  Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 3 Study Recruitment Status: Completet Generic Name: Combined Diphtheria, Tetanus, Whole Cell Pertussis, Hepatitis B, Haemophilus influenzae Type b Vaccine (KFT) Trade Name: Zilbrix/Hib Study Indication: Diphtheria; Haemophilus influenzae type b; Hepatitis B; Tetanus; Whole Cell Pertussis

Keywords

Versions (2)
  1. 12/5/18 12/5/18 -
  2. 12/5/18 12/5/18 -
Copyright Holder

GSK group of companies

Uploaded on

December 5, 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.

    Immune memory of Combined Diphtheria, Tetanus, Whole Cell Pertussis, Hepatitis B, Haemophilus influenzae Type b Vaccine at infants (15 to 18 mths) - 104065

    English

    Visit 1: Inclusion Criteria

    1 forms  
    Administrative data
    Description

    Administrative data

    Date of Visit
    Description

    Date of Visit

    Data type

    date

    Subject Number
    Description

    Subject Number

    Data type

    integer

    Eligibility check
    Description

    Eligibility check

    Did the subject meet all the entry criteria?
    Description

    Did the subject meet all the entry criteria?

    Data type

    boolean

    If No, please tick all boxes corresponding to violations of any inclusion/exclusion criteria
    Description

    Do not enter the subject into the study if he/she failed any inclusion or exclusion criteria listed below

    Data type

    text

    Inclusion Criteria
    Description

    Inclusion Criteria

    For subjects receiving Plain PRP followed by DTPw-HBV Kft:
    Description

    For subjects receiving Plain PRP followed by DTPw-HBV Kft:

    Data type

    text

    Back to the top of the page

    Similar models

    Visit 1: Inclusion Criteria

    1 forms
    Name
    Type
    Description | Question | Decode (Coded Value)
    Data type
    Alias
    Item Group
    Administrative data
    Date of Visit
    Item
    Date of Visit
    date
    Subject Number
    Item
    Subject Number
    integer
    Item Group
    Eligibility check
    Did the subject meet all the entry criteria?
    Item
    Did the subject meet all the entry criteria?
    boolean
    If No, please tick all boxes corresponding to violations of any inclusion/exclusion criteria
    Item
    If No, please tick all boxes corresponding to violations of any inclusion/exclusion criteria
    text
    Item Group
    Inclusion Criteria
    Item
    For subjects receiving Plain PRP followed by DTPw-HBV Kft:
    text
    For subjects receiving Plain PRP followed by DTPw-HBV Kft:
    Code List
    For subjects receiving Plain PRP followed by DTPw-HBV Kft:
    CL Item
    A male or female infant, 10 to 11 months of age (40-44 weeks), who completed the primary vaccination course in the study DTPw-HBV=Hib Kft-001 (1)
    CL Item
    Subject who the investigator believes that their parent/guardian can and will comply with the requirements of the protocol (e.g. completion of the diary cards, return for follow-up visits) should be enrolled in the study (2)
    CL Item
    Written informed consent obtained from the parent or guardian of the subject (3)
    CL Item
    Free of obvious health problems as established by medical history and clinical examination before entering into the study (4)
    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