ID

33061

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

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License

Creative Commons BY-NC 3.0
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Immunogenicity of Combined Measles, Mumps, Rubella, Varicella Vaccine for healthy 2 y.o children - 104020

English

Parotid / Salivary Gland Swelling AE Form

1 forms  
Administrative data
Description

Administrative data

Subject Number
Description

Subject Number

Data type

integer

Parotid/Salivary Gland Swelling Events
Description

Parotid/Salivary Gland Swelling Events

Event Number
Description

Please report any parotid / salivary gland swelling events occurring during the study period

Data type

integer

Description
Description

Description

Data type

text

Further Details (For GSK)
Description

Further Details (For GSK)

Event Number
Description

Event Number

Data type

integer

Date started
Description

Date started

Data type

date

Date stopped
Description

Date stopped

Data type

date

Intensity
Description

Intensity

Data type

text

Saliva Sample
Description

Saliva Sample

Event Number
Description

Event Number

Data type

integer

Has a saliva sample been taken for mumps virus detection, strain identification and for viral culture?
Description

Has a saliva sample been taken for mumps virus detection, strain identification and for viral culture?

Data type

boolean

If Yes, record date
Description

If Yes, record date

Data type

date

Relationship to Investigational products
Description

Relationship to Investigational products

Event Number
Description

Event Number

Data type

integer

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

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

Data type

boolean

Outcome
Description

Outcome

Event Number
Description

Event Number

Data type

integer

Outcome
Description

Outcome

Data type

text

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Similar models

Parotid / Salivary Gland Swelling 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
Parotid/Salivary Gland Swelling Events
Item
Event Number
integer
Event Number
Code List
Event Number
CL Item
PS. 1 (1)
CL Item
PS. 2 (2)
Description
Item
Description
text
Item Group
Further Details (For GSK)
Item
Event Number
integer
Event Number
Code List
Event Number
CL Item
PS. 1 (1)
CL Item
PS. 2 (2)
Date started
Item
Date started
date
Date stopped
Item
Date stopped
date
Item
Intensity
text
Intensity
Code List
Intensity
CL Item
Swelling without difficulties to move the jaw (1)
CL Item
Swelling with difficulties to move the jaw (2)
CL Item
Swelling and additional general symptoms (3)
Item Group
Saliva Sample
Item
Event Number
integer
Event Number
Code List
Event Number
CL Item
PS. 1 (1)
CL Item
PS. 2 (2)
Has a saliva sample been taken for mumps virus detection, strain identification and for viral culture?
Item
Has a saliva sample been taken for mumps virus detection, strain identification and for viral culture?
boolean
If Yes, record date
Item
If Yes, record date
date
Item Group
Relationship to Investigational products
Item
Event Number
integer
Event Number
Code List
Event Number
CL Item
PS. 1 (1)
CL Item
PS. 2 (2)
Is there a reasonable possibility that the AE may have been caused by the investigational product?
Item
Is there a reasonable possibility that the AE may have been caused by the investigational product?
boolean
Item Group
Outcome
Item
Event Number
integer
Event Number
Code List
Event Number
CL Item
PS. 1 (1)
CL Item
PS. 2 (2)
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)
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