ID

33060

Description

Study ID: 104020 Clinical Study ID: 104020 Study Title: Blinded, randomised study to assess the immunogenicity and safety of GlaxoSmithKline (GSK) Biologicals’ live attenuated measles-mumps-rubella-varicella candidate vaccine when given to healthy children in their second year of life Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00126997 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 4 Study Recruitment Status: Completed Generic Name: Combined Measles, Mumps, Rubella, Varicella Vaccine Trade Name: Priorix Tetra Study Indication: Measles; Mumps; Rubella; Varicella CRF Seiten: 268-336; 870-938

Keywords

Versions (1)
  1. 11/26/18 11/26/18 -
Copyright Holder

GSK group of companies

Uploaded on

November 26, 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 Combined Measles, Mumps, Rubella, Varicella Vaccine for healthy 2 y.o children - 104020

English

Rash / Exanthem AE Form

1 forms  
Administrative data
Description

Administrative data

Subject Number
Description

Subject Number

Data type

integer

Rash/Exanthem
Description

Rash/Exanthem

Event Number
Description

Please report any rash event that occurred during the study period

Data type

integer

Description
Description

Description

Data type

text

Administration sites
Description

Administration sites

Data type

text

Non-administration site
Description

Non-administration site

Data type

text

Further Event Details (For GSK)
Description

Further Event Details (For GSK)

Event Number
Description

Event Number

Data type

integer

Category
Description

Category

Data type

text

If Other, specify
Description

If Other, specify

Data type

text

Date started
Description

Date started

Data type

date

Date stopped
Description

Date stopped

Data type

date

Intensity
Description

Intensity

Data type

text

Has a vesicular fluid sample been taken?
Description

Has a vesicular fluid sample been taken?

Data type

boolean

If Yes, record date
Description

If Yes, record date

Data type

date

Relationship to investigational products
Description

is there a reasonable possibility that the AE may have been caused by the investigational product?

Data type

boolean

Outcome
Description

Outcome

Data type

text

Back to the top of the page

Similar models

Rash / Exanthem AE Form

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
Administrative data
Subject Number
Item
Subject Number
integer
Item Group
Rash/Exanthem
Item
Event Number
integer
Event Number
Code List
Event Number
CL Item
RA. 1 (1)
CL Item
RA. 2 (2)
Description
Item
Description
text
Item
Administration sites
text
Administration sites
Code List
Administration sites
CL Item
MemURu-OKA vaccine (1)
CL Item
Priorix vaccine (2)
CL Item
Varilirix vaccine (3)
Item
Non-administration site
text
Non-administration site
Code List
Non-administration site
CL Item
Generalized (1)
CL Item
Localized (2)
Item Group
Further Event Details (For GSK)
Item
Event Number
integer
Event Number
Code List
Event Number
CL Item
RA. 1 (1)
CL Item
RA. 2 (2)
Item
Category
text
Category
Code List
Category
CL Item
Varicella rash (1)
CL Item
Measles / rubella-rash (2)
CL Item
Other (3)
If Other, specify
Item
If Other, specify
text
Date started
Item
Date started
date
Date stopped
Item
Date stopped
date
Item
Intensity
text
Intensity
Code List
Intensity
CL Item
1 - 50 lesions (1)
CL Item
51 - 150 lesions (2)
CL Item
> 150 lesions (3)
Has a vesicular fluid sample been taken?
Item
Has a vesicular fluid sample been taken?
boolean
If Yes, record date
Item
If Yes, record date
date
Relationship to investigational products
Item
Relationship to investigational products
boolean
Item
Outcome
text
Outcome
Code List
Outcome
CL Item
Recovered/Resolved (1)
CL Item
Recovering/Resolving (2)
CL Item
Not recovered/Not resolved (3)
CL Item
Recovered with sequelae/Resolved with sequelae (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