ID

33061

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

Parotid / Salivary Gland Swelling AE Form

1 moduli  
Administrative data
Descrizione

Administrative data

Subject Number
Descrizione

Subject Number

Tipo di dati

integer

Parotid/Salivary Gland Swelling Events
Descrizione

Parotid/Salivary Gland Swelling Events

Event Number
Descrizione

Please report any parotid / salivary gland swelling events 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

integer

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

Saliva Sample
Descrizione

Saliva Sample

Event Number
Descrizione

Event Number

Tipo di dati

integer

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

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

Tipo di dati

boolean

If Yes, record date
Descrizione

If Yes, record date

Tipo di dati

date

Relationship to Investigational products
Descrizione

Relationship to Investigational products

Event Number
Descrizione

Event Number

Tipo di dati

integer

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

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

Tipo di dati

boolean

Outcome
Descrizione

Outcome

Event Number
Descrizione

Event Number

Tipo di dati

integer

Outcome
Descrizione

Outcome

Tipo di dati

text

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Similar models

Parotid / Salivary Gland Swelling 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
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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