ID

33064

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 (2)
  1. 2018-11-23 2018-11-23 -
  2. 2018-11-26 2018-11-26 -
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GSK group of companies

Uppladdad den

26 november 2018

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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

Solicited Adverse Events (Group Priorix+Varilrix)

1 Formulär  
Administrative data
Beskrivning

Administrative data

Visit Number
Beskrivning

Visit Number

Datatyp

text

Date of Visit
Beskrivning

Date of Visit

Datatyp

date

Subject Number
Beskrivning

Subject Number

Datatyp

integer

Local Symptoms
Beskrivning

Local Symptoms

Has the subject experienced any of the following signs/symptoms at the administration site during the solicited period?
Beskrivning

Has the subject experienced any of the following signs/symptoms at the administration site during the solicited period?

Datatyp

text

Local Symptoms
Beskrivning

Local Symptoms

Redness
Beskrivning

If YES is ticked, please complete all items

Datatyp

boolean

Size - Day 0
Beskrivning

Size - Day 0

Datatyp

float

Måttenheter
  • mm
mm
Size - Day 1
Beskrivning

Size - Day 1

Datatyp

float

Måttenheter
  • mm
mm
Size - Day 2
Beskrivning

Size - Day 2

Datatyp

float

Måttenheter
  • mm
mm
Size - Day 3
Beskrivning

Size - Day 3

Datatyp

float

Måttenheter
  • mm
mm
Ongoing after Day 3?
Beskrivning

Ongoing after Day 3?

Datatyp

boolean

If YES, record date of last day of symptoms
Beskrivning

If YES, record date of last day of symptoms

Datatyp

date

Priorix Vaccine - Local Symptoms
Beskrivning

Priorix Vaccine - Local Symptoms

Swelling
Beskrivning

If YES is ticked, please complete all items

Datatyp

boolean

Size - Day 0
Beskrivning

Size - Day 0

Datatyp

float

Måttenheter
  • mm
mm
Size - Day 1
Beskrivning

Size - Day 1

Datatyp

float

Måttenheter
  • mm
mm
Size - Day 2
Beskrivning

Size - Day 2

Datatyp

float

Måttenheter
  • mm
mm
Size - Day 3
Beskrivning

Size - Day 3

Datatyp

float

Måttenheter
  • mm
mm
Ongoing after Day 3?
Beskrivning

Ongoing after Day 3?

Datatyp

boolean

If YES, record date of last day of symptoms
Beskrivning

If YES, record date of last day of symptoms

Datatyp

date

Priorix Vaccine - Local Symptoms
Beskrivning

Priorix Vaccine - Local Symptoms

Pain
Beskrivning

If YES is ticked, please complete all items

Datatyp

boolean

Intensity - Day 0
Beskrivning

Intensity - Day 0

Datatyp

integer

Intensity - Day 1
Beskrivning

Intensity - Day 1

Datatyp

integer

Intensity - Day 2
Beskrivning

Intensity - Day 2

Datatyp

integer

Intensity - Day 3
Beskrivning

Intensity - Day 3

Datatyp

integer

Ongoing after Day 3?
Beskrivning

Ongoing after Day 3?

Datatyp

boolean

If YES, record date of last day of symptoms
Beskrivning

If YES, record date of last day of symptoms

Datatyp

date

Varilrix Vaccine - Local Symptoms
Beskrivning

Varilrix Vaccine - Local Symptoms

Redness
Beskrivning

If YES is ticked, please complete all items

Datatyp

boolean

Size - Day 0
Beskrivning

Size - Day 0

Datatyp

float

Måttenheter
  • mm
mm
Size - Day 1
Beskrivning

Size - Day 1

Datatyp

float

Måttenheter
  • mm
mm
Size - Day 2
Beskrivning

Size - Day 2

Datatyp

float

Måttenheter
  • mm
mm
Size - Day 3
Beskrivning

Size - Day 3

Datatyp

float

Måttenheter
  • mm
mm
Ongoing after Day 3?
Beskrivning

Ongoing after Day 3?

Datatyp

boolean

If YES, record date of last day of symptoms
Beskrivning

If YES, record date of last day of symptoms

Datatyp

date

Varilrix Vaccine - Local Symptoms
Beskrivning

Varilrix Vaccine - Local Symptoms

Swelling
Beskrivning

If YES is ticked, please complete all items

Datatyp

boolean

Size - Day 0
Beskrivning

Size - Day 0

Datatyp

float

Måttenheter
  • mm
mm
Size - Day 1
Beskrivning

Size - Day 1

Datatyp

float

Måttenheter
  • mm
mm
Size - Day 2
Beskrivning

Size - Day 2

Datatyp

float

Måttenheter
  • mm
mm
Size - Day 3
Beskrivning

Size - Day 3

Datatyp

float

Måttenheter
  • mm
mm
Ongoing after Day 3?
Beskrivning

Ongoing after Day 3?

Datatyp

boolean

If YES, record date of last day of symptoms
Beskrivning

If YES, record date of last day of symptoms

Datatyp

date

Varilrix Vaccine - Local Symptoms
Beskrivning

Varilrix Vaccine - Local Symptoms

Pain
Beskrivning

If YES is ticked, please complete all items

Datatyp

boolean

Intensity - Day 0
Beskrivning

Intensity - Day 0

Datatyp

integer

Intensity - Day 1
Beskrivning

Intensity - Day 1

Datatyp

integer

Intensity - Day 2
Beskrivning

Intensity - Day 2

Datatyp

integer

Intensity - Day 3
Beskrivning

Intensity - Day 3

Datatyp

integer

Ongoing after Day 3?
Beskrivning

Ongoing after Day 3?

Datatyp

boolean

If YES, record date of last day of symptoms
Beskrivning

If YES, record date of last day of symptoms

Datatyp

date

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Similar models

Solicited Adverse Events (Group Priorix+Varilrix)

1 Formulär
Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
Alias
Item Group
Administrative data
Item
Visit Number
text
Visit Number
Code List
Visit Number
CL Item
Visit 1 (1)
Date of Visit
Item
Date of Visit
date
Subject Number
Item
Subject Number
integer
Item Group
Local Symptoms
Item
Has the subject experienced any of the following signs/symptoms at the administration site during the solicited period?
text
Has the subject experienced any serious or non-serious unsolicited adverse events within minimum 43 days post-vaccination?
Code List
Has the subject experienced any of the following signs/symptoms at the administration site during the solicited period?
CL Item
Information not available (1)
CL Item
No vaccine administered (2)
CL Item
No (3)
CL Item
Yes, please tick NO/YES for each symptom.  (4)
Item Group
Local Symptoms
Redness
Item
Redness
boolean
Size - Day 0
Item
Size - Day 0
float
Size - Day 1
Item
Size - Day 1
float
Size - Day 2
Item
Size - Day 2
float
Size - Day 3
Item
Size - Day 3
float
Ongoing after Day 3?
Item
Ongoing after Day 3?
boolean
If YES, record date of last day of symptoms
Item
If YES, record date of last day of symptoms
date
Item Group
Priorix Vaccine - Local Symptoms
Swelling
Item
Swelling
boolean
Size - Day 0
Item
Size - Day 0
float
Size - Day 1
Item
Size - Day 1
float
Size - Day 2
Item
Size - Day 2
float
Size - Day 3
Item
Size - Day 3
float
Ongoing after Day 3?
Item
Ongoing after Day 3?
boolean
If YES, record date of last day of symptoms
Item
If YES, record date of last day of symptoms
date
Item Group
Priorix Vaccine - Local Symptoms
Pain
Item
Pain
boolean
Item
Intensity - Day 0
integer
Intensity - Day 0
Code List
Intensity - Day 0
CL Item
None (1)
CL Item
Mild (2)
CL Item
Moderate (3)
CL Item
Severe (4)
Item
Intensity - Day 1
integer
Intensity - Day 1
Code List
Intensity - Day 1
CL Item
None (1)
CL Item
Mild (2)
CL Item
Moderate (3)
CL Item
Severe (4)
Item
Intensity - Day 2
integer
Intensity - Day 2
Code List
Intensity - Day 2
CL Item
None (1)
CL Item
Mild (2)
CL Item
Moderate (3)
CL Item
Severe (4)
Item
Intensity - Day 3
integer
Intensity - Day 3
Code List
Intensity - Day 3
CL Item
None (1)
CL Item
Mild (2)
CL Item
Moderate (3)
CL Item
Severe (4)
Ongoing after Day 3?
Item
Ongoing after Day 3?
boolean
If YES, record date of last day of symptoms
Item
If YES, record date of last day of symptoms
date
Item Group
Varilrix Vaccine - Local Symptoms
Redness
Item
Redness
boolean
Size - Day 0
Item
Size - Day 0
float
Size - Day 1
Item
Size - Day 1
float
Size - Day 2
Item
Size - Day 2
float
Size - Day 3
Item
Size - Day 3
float
Ongoing after Day 3?
Item
Ongoing after Day 3?
boolean
If YES, record date of last day of symptoms
Item
If YES, record date of last day of symptoms
date
Item Group
Varilrix Vaccine - Local Symptoms
Swelling
Item
Swelling
boolean
Size - Day 0
Item
Size - Day 0
float
Size - Day 1
Item
Size - Day 1
float
Size - Day 2
Item
Size - Day 2
float
Size - Day 3
Item
Size - Day 3
float
Ongoing after Day 3?
Item
Ongoing after Day 3?
boolean
If YES, record date of last day of symptoms
Item
If YES, record date of last day of symptoms
date
Item Group
Varilrix Vaccine - Local Symptoms
Pain
Item
Pain
boolean
Item
Intensity - Day 0
integer
Intensity - Day 0
Code List
Intensity - Day 0
CL Item
None (1)
CL Item
Mild (2)
CL Item
Moderate (3)
CL Item
Severe (4)
Item
Intensity - Day 1
integer
Intensity - Day 1
Code List
Intensity - Day 1
CL Item
None (1)
CL Item
Mild (2)
CL Item
Moderate (3)
CL Item
Severe (4)
Item
Intensity - Day 2
integer
Intensity - Day 2
Code List
Intensity - Day 2
CL Item
None (1)
CL Item
Mild (2)
CL Item
Moderate (3)
CL Item
Severe (4)
Item
Intensity - Day 3
integer
Intensity - Day 3
Code List
Intensity - Day 3
CL Item
None (1)
CL Item
Mild (2)
CL Item
Moderate (3)
CL Item
Severe (4)
Ongoing after Day 3?
Item
Ongoing after Day 3?
boolean
If YES, record date of last day of symptoms
Item
If YES, record date of last day of symptoms
date
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