ID

33068

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. 2018-11-26 2018-11-26 -
Copyright Holder

GSK group of companies

Uploaded on

26 november 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

Febrile Convulsions AE Form

1 forms  
Administrative data
Description

Administrative data

Subject Number
Description

Subject Number

Data type

integer

Febrile Convulsions - Suspected Signs of Meningitis
Description

Febrile Convulsions - Suspected Signs of Meningitis

Event Number
Description

Please report any febrile convulsion and any suspected signs of meningitis 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

text

Date started
Description

Date started

Data type

date

Date stopped
Description

Date stopped

Data type

date

Intensity
Description

Intensity

Data type

text

Was a neurological examination performed?
Description

Was a neurological examination performed?

Data type

boolean

If Yes, was a lumbar puncture performed?
Description

If Yes, was a lumbar puncture performed?

Data type

boolean

If Yes, date of exam
Description

If Yes, date of exam

Data type

date

Relationship to investigational products
Description

Relationship to investigational products

Data type

boolean

Outcome
Description

Outcome

Data type

text

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Similar models

Febrile Convulsions 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
Febrile Convulsions - Suspected Signs of Meningitis
Item
Event Number
integer
Event Number
Code List
Event Number
CL Item
FC. 1 (1)
CL Item
FC. 2 (2)
Description
Item
Description
text
Item Group
Further Details (For GSK)
Item
Event Number
text
Event Number
Code List
Event Number
CL Item
FC. 1 (1)
CL Item
FC. 2 (2)
Date started
Item
Date started
date
Date stopped
Item
Date stopped
date
Item
Intensity
text
Intensity
Code List
Intensity
CL Item
Mild (1)
CL Item
Moderate (2)
CL Item
Severe (3)
Was a neurological examination performed?
Item
Was a neurological examination performed?
boolean
If Yes, was a lumbar puncture performed?
Item
If Yes, was a lumbar puncture performed?
boolean
If Yes, date of exam
Item
If Yes, date of exam
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)
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