ID

33091

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. 2018-11-27 2018-11-27 -
Rättsinnehavare

GSK group of companies

Uppladdad den

27 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

Diary Card: Local Symptoms

1 Formulär  
Administrative data
Beskrivning

Administrative data

Dose Number
Beskrivning

Dose Number

Datatyp

text

Subject Number
Beskrivning

Subject Number

Datatyp

integer

Local Symptoms (at injection site)
Beskrivning

Local Symptoms (at injection site)

please fill in below and assess the occurrence of any of the following signs or symptoms according to the criteria listed hereafter
Beskrivning

please fill in below and assess the occurrence of any of the following signs or symptoms according to the criteria listed hereafter

Datatyp

text

Local Symptoms
Beskrivning

Local Symptoms

Day
Beskrivning

Day

Datatyp

integer

Redness
Beskrivning

size

Datatyp

float

Måttenheter
  • mm
mm
Swelling
Beskrivning

size

Datatyp

float

Måttenheter
  • mm
mm
Pain
Beskrivning

intensity; please measure the greatest diameter

Datatyp

text

Ongoing after Day 3?
Beskrivning

Ongoing after Day 3?

Datatyp

boolean

If Yes, record the date of last day of symptoms
Beskrivning

If Yes, record the date of last day of symptoms

Datatyp

date

Local Symptoms (Group Priorix)
Beskrivning

Local Symptoms (Group Priorix)

Day
Beskrivning

Day

Datatyp

integer

Redness
Beskrivning

size

Datatyp

float

Måttenheter
  • mm
mm
Swelling
Beskrivning

size

Datatyp

float

Måttenheter
  • mm
mm
Pain
Beskrivning

intensity

Datatyp

integer

Ongoing after Day 3
Beskrivning

Ongoing after Day 3

Datatyp

boolean

If Yes, date of last day of symptoms
Beskrivning

If Yes, date of last day of symptoms

Datatyp

date

for investigator only (Priorix vaccine)
Beskrivning

for investigator only (Priorix vaccine)

Side
Beskrivning

Side

Datatyp

text

Site
Beskrivning

Site

Datatyp

text

Local Symptoms (Group Varilrix)
Beskrivning

Local Symptoms (Group Varilrix)

Day
Beskrivning

Day

Datatyp

integer

Redness
Beskrivning

size

Datatyp

float

Måttenheter
  • mm
mm
Swelling
Beskrivning

size

Datatyp

float

Måttenheter
  • mm
mm
Pain
Beskrivning

intensity

Datatyp

integer

Ongoing after day 3?
Beskrivning

Ongoing after day 3?

Datatyp

boolean

If Yes, record the date of last day of symptoms
Beskrivning

If Yes, record the date of last day of symptoms

Datatyp

date

for investigator only (Varilrix vaccine)
Beskrivning

for investigator only (Varilrix vaccine)

Side
Beskrivning

Side

Datatyp

integer

Site
Beskrivning

Site

Datatyp

integer

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Similar models

Diary Card: Local Symptoms

1 Formulär
Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
Alias
Item Group
Administrative data
Item
Dose Number
text
Dose Number
Code List
Dose Number
CL Item
Dose 1 (1)
Subject Number
Item
Subject Number
integer
Item Group
Local Symptoms (at injection site)
please fill in below and assess the occurrence of any of the following signs or symptoms according to the criteria listed hereafter
Item
please fill in below and assess the occurrence of any of the following signs or symptoms according to the criteria listed hereafter
text
Item Group
Local Symptoms
Item
Day
integer
Day
Code List
Day
CL Item
Day 0 (1)
CL Item
Day 1 (Evening) (2)
CL Item
Day 2 (Evening) (3)
CL Item
Day 3 (Evening) (4)
Redness
Item
Redness
float
Swelling
Item
Swelling
float
Item
Pain
text
Pain
Code List
Pain
CL Item
Absent (1)
CL Item
Minor reaction to touch (2)
CL Item
Cries/protests on touch (3)
CL Item
Cries when limb is moved/spontaneously painful (4)
Ongoing after Day 3?
Item
Ongoing after Day 3?
boolean
If Yes, record the date of last day of symptoms
Item
If Yes, record the date of last day of symptoms
date
Item Group
Local Symptoms (Group Priorix)
Item
Day
integer
Day
Code List
Day
CL Item
Day 0 (1)
CL Item
Day 1 (Evening) (2)
CL Item
Day 2 (Evening) (3)
CL Item
Day 3 (Evening) (4)
Redness
Item
Redness
float
Swelling
Item
Swelling
float
Item
Pain
integer
Pain
Code List
Pain
CL Item
Absent (1)
CL Item
Minor reaction to touch (2)
CL Item
Cries/protests on touch (3)
CL Item
Cries when limb is moved/spontaneously painful (4)
Ongoing after Day 3
Item
Ongoing after Day 3
boolean
If Yes, date of last day of symptoms
Item
If Yes, date of last day of symptoms
date
Item Group
for investigator only (Priorix vaccine)
Item
Side
text
Side
Code List
Side
CL Item
Upper left (1)
CL Item
Lower left (2)
CL Item
Upper right (3)
CL Item
Lower right (4)
Item
Site
text
Site
Code List
Site
CL Item
Arm (1)
CL Item
Thigh (2)
CL Item
Buttock (3)
Item Group
Local Symptoms (Group Varilrix)
Item
Day
integer
Day
Code List
Day
CL Item
Day 0 (1)
CL Item
Day 1 (Evening) (2)
CL Item
Day 2 (Evening) (3)
CL Item
Day 3 (Evening) (4)
Redness
Item
Redness
float
Swelling
Item
Swelling
float
Item
Pain
integer
Pain
Code List
Pain
CL Item
Absent (1)
CL Item
Minor reaction to touch (2)
CL Item
Cries/protests on touch (3)
CL Item
Cries when limb is moved/spontaneously painful (4)
Ongoing after day 3?
Item
Ongoing after day 3?
boolean
If Yes, record the date of last day of symptoms
Item
If Yes, record the date of last day of symptoms
date
Item Group
for investigator only (Varilrix vaccine)
Item
Side
integer
Side
Code List
Side
CL Item
Upper left (1)
CL Item
Lower left (2)
CL Item
Upper right (3)
CL Item
Lower right (4)
Item
Site
integer
Site
Code List
Site
CL Item
Arm (1)
CL Item
Thigh (2)
CL Item
Buttock (3)
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