ID

33068

Beschrijving

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

Trefwoorden

Versies (1)
  1. 26-11-18 26-11-18 -
Houder van rechten

GSK group of companies

Geüploaded op

26 november 2018

DOI

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Licentie

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

Engels

Febrile Convulsions AE Form

1 Formulieren  
Administrative data
Beschrijving

Administrative data

Subject Number
Beschrijving

Subject Number

Datatype

integer

Febrile Convulsions - Suspected Signs of Meningitis
Beschrijving

Febrile Convulsions - Suspected Signs of Meningitis

Event Number
Beschrijving

Please report any febrile convulsion and any suspected signs of meningitis occurring during the study period

Datatype

integer

Description
Beschrijving

Description

Datatype

text

Further Details (For GSK)
Beschrijving

Further Details (For GSK)

Event Number
Beschrijving

Event Number

Datatype

text

Date started
Beschrijving

Date started

Datatype

date

Date stopped
Beschrijving

Date stopped

Datatype

date

Intensity
Beschrijving

Intensity

Datatype

text

Was a neurological examination performed?
Beschrijving

Was a neurological examination performed?

Datatype

boolean

If Yes, was a lumbar puncture performed?
Beschrijving

If Yes, was a lumbar puncture performed?

Datatype

boolean

If Yes, date of exam
Beschrijving

If Yes, date of exam

Datatype

date

Relationship to investigational products
Beschrijving

Relationship to investigational products

Datatype

boolean

Outcome
Beschrijving

Outcome

Datatype

text

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Similar models

Febrile Convulsions AE Form

1 Formulieren
Name
Type
Description | Question | Decode (Coded Value)
Datatype
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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