ID

33068

Descripción

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

Palabras clave

Versiones (1)
  1. 26/11/18 26/11/18 -
Titular de derechos de autor

GSK group of companies

Subido en

26 de noviembre de 2018

DOI

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Licencia

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

Inglés

Febrile Convulsions AE Form

1 formularios  
Administrative data
Descripción

Administrative data

Subject Number
Descripción

Subject Number

Tipo de datos

integer

Febrile Convulsions - Suspected Signs of Meningitis
Descripción

Febrile Convulsions - Suspected Signs of Meningitis

Event Number
Descripción

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

Tipo de datos

integer

Description
Descripción

Description

Tipo de datos

text

Further Details (For GSK)
Descripción

Further Details (For GSK)

Event Number
Descripción

Event Number

Tipo de datos

text

Date started
Descripción

Date started

Tipo de datos

date

Date stopped
Descripción

Date stopped

Tipo de datos

date

Intensity
Descripción

Intensity

Tipo de datos

text

Was a neurological examination performed?
Descripción

Was a neurological examination performed?

Tipo de datos

boolean

If Yes, was a lumbar puncture performed?
Descripción

If Yes, was a lumbar puncture performed?

Tipo de datos

boolean

If Yes, date of exam
Descripción

If Yes, date of exam

Tipo de datos

date

Relationship to investigational products
Descripción

Relationship to investigational products

Tipo de datos

boolean

Outcome
Descripción

Outcome

Tipo de datos

text

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Similar models

Febrile Convulsions AE Form

1 formularios
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de datos
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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