ID

33068

Descrizione

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

versioni (1)
  1. 26/11/18 26/11/18 -
Titolare del copyright

GSK group of companies

Caricato su

26 novembre 2018

DOI

Per favore, per richiedere un accesso.

Licenza

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

Inglese

Febrile Convulsions AE Form

1 moduli  
Administrative data
Descrizione

Administrative data

Subject Number
Descrizione

Subject Number

Tipo di dati

integer

Febrile Convulsions - Suspected Signs of Meningitis
Descrizione

Febrile Convulsions - Suspected Signs of Meningitis

Event Number
Descrizione

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

Tipo di dati

integer

Description
Descrizione

Description

Tipo di dati

text

Further Details (For GSK)
Descrizione

Further Details (For GSK)

Event Number
Descrizione

Event Number

Tipo di dati

text

Date started
Descrizione

Date started

Tipo di dati

date

Date stopped
Descrizione

Date stopped

Tipo di dati

date

Intensity
Descrizione

Intensity

Tipo di dati

text

Was a neurological examination performed?
Descrizione

Was a neurological examination performed?

Tipo di dati

boolean

If Yes, was a lumbar puncture performed?
Descrizione

If Yes, was a lumbar puncture performed?

Tipo di dati

boolean

If Yes, date of exam
Descrizione

If Yes, date of exam

Tipo di dati

date

Relationship to investigational products
Descrizione

Relationship to investigational products

Tipo di dati

boolean

Outcome
Descrizione

Outcome

Tipo di dati

text

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Similar models

Febrile Convulsions AE Form

1 moduli
Name
genere
Description | Question | Decode (Coded Value)
Tipo di dati
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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