ID

33061

Beskrivning

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

Nyckelord

Versioner (1)
  1. 2018-11-26 2018-11-26 -
Rättsinnehavare

GSK group of companies

Uppladdad den

26 november 2018

DOI

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Licens

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

Engelsk

Parotid / Salivary Gland Swelling AE Form

1 Formulär  
Administrative data
Beskrivning

Administrative data

Subject Number
Beskrivning

Subject Number

Datatyp

integer

Parotid/Salivary Gland Swelling Events
Beskrivning

Parotid/Salivary Gland Swelling Events

Event Number
Beskrivning

Please report any parotid / salivary gland swelling events occurring during the study period

Datatyp

integer

Description
Beskrivning

Description

Datatyp

text

Further Details (For GSK)
Beskrivning

Further Details (For GSK)

Event Number
Beskrivning

Event Number

Datatyp

integer

Date started
Beskrivning

Date started

Datatyp

date

Date stopped
Beskrivning

Date stopped

Datatyp

date

Intensity
Beskrivning

Intensity

Datatyp

text

Saliva Sample
Beskrivning

Saliva Sample

Event Number
Beskrivning

Event Number

Datatyp

integer

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

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

Datatyp

boolean

If Yes, record date
Beskrivning

If Yes, record date

Datatyp

date

Relationship to Investigational products
Beskrivning

Relationship to Investigational products

Event Number
Beskrivning

Event Number

Datatyp

integer

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

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

Datatyp

boolean

Outcome
Beskrivning

Outcome

Event Number
Beskrivning

Event Number

Datatyp

integer

Outcome
Beskrivning

Outcome

Datatyp

text

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Similar models

Parotid / Salivary Gland Swelling AE Form

1 Formulär
Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
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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