ID

33061

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

Parotid / Salivary Gland Swelling AE Form

1 formularios  
Administrative data
Descripción

Administrative data

Subject Number
Descripción

Subject Number

Tipo de datos

integer

Parotid/Salivary Gland Swelling Events
Descripción

Parotid/Salivary Gland Swelling Events

Event Number
Descripción

Please report any parotid / salivary gland swelling events 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

integer

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

Saliva Sample
Descripción

Saliva Sample

Event Number
Descripción

Event Number

Tipo de datos

integer

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

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

Tipo de datos

boolean

If Yes, record date
Descripción

If Yes, record date

Tipo de datos

date

Relationship to Investigational products
Descripción

Relationship to Investigational products

Event Number
Descripción

Event Number

Tipo de datos

integer

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

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

Tipo de datos

boolean

Outcome
Descripción

Outcome

Event Number
Descripción

Event Number

Tipo de datos

integer

Outcome
Descripción

Outcome

Tipo de datos

text

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Similar models

Parotid / Salivary Gland Swelling 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
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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