ID

33082

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

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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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

Non-Serious Adverse Event Form

1 Formulär  
Administrative data
Beskrivning

Administrative data

Subject Number
Beskrivning

Subject Number

Datatyp

integer

Non-Serious Adverse Events
Beskrivning

Non-Serious Adverse Events

Has any non-serious adverse events occurred within minimum 43 days post-vaccination?
Beskrivning

Please exclude those recorded on the SAE form

Datatyp

boolean

If Yes, please complete the following table
Beskrivning

If Yes, please complete the following table

Datatyp

text

AE Details
Beskrivning

AE Details

AE Number
Beskrivning

AE Number

Datatyp

integer

Description
Beskrivning

Description

Datatyp

text

Administration sites
Beskrivning

Administration sites

Datatyp

text

Date started
Beskrivning

Date started

Datatyp

date

Date stopped
Beskrivning

Date stopped

Datatyp

date

Intensity
Beskrivning

Intensity

Datatyp

text

Relationship to investigational products
Beskrivning

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

Datatyp

boolean

Outcome
Beskrivning

Outcome

Datatyp

text

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Similar models

Non-Serious Adverse Event Form

1 Formulär
Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
Alias
Item Group
Administrative data
Subject Number
Item
Subject Number
integer
Item Group
Non-Serious Adverse Events
Has any non-serious adverse events occurred within minimum 43 days post-vaccination?
Item
Has any non-serious adverse events occurred within minimum 43 days post-vaccination?
boolean
If Yes, please complete the following table
Item
If Yes, please complete the following table
text
Item Group
AE Details
Item
AE Number
integer
AE Number
Code List
AE Number
CL Item
Event 1 (1)
CL Item
Event 2 (2)
CL Item
Event 3 (3)
CL Item
Event 4 (4)
Description
Item
Description
text
Item
Administration sites
text
Administration sites
Code List
Administration sites
CL Item
MeMuRu-OKA vaccine (1)
CL Item
Priorix vaccine (2)
CL Item
Varilrix vaccine (3)
CL Item
Non-administration site (4)
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)
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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