ID

33091

Beschrijving

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

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Versies (1)
  1. 27-11-18 27-11-18 -
Houder van rechten

GSK group of companies

Geüploaded op

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

Engels

Diary Card: Local Symptoms

1 Formulieren  
Administrative data
Beschrijving

Administrative data

Dose Number
Beschrijving

Dose Number

Datatype

text

Subject Number
Beschrijving

Subject Number

Datatype

integer

Local Symptoms (at injection site)
Beschrijving

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
Beschrijving

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

Datatype

text

Local Symptoms
Beschrijving

Local Symptoms

Day
Beschrijving

Day

Datatype

integer

Redness
Beschrijving

size

Datatype

float

Maateenheden
  • mm
mm
Swelling
Beschrijving

size

Datatype

float

Maateenheden
  • mm
mm
Pain
Beschrijving

intensity; please measure the greatest diameter

Datatype

text

Ongoing after Day 3?
Beschrijving

Ongoing after Day 3?

Datatype

boolean

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

If Yes, record the date of last day of symptoms

Datatype

date

Local Symptoms (Group Priorix)
Beschrijving

Local Symptoms (Group Priorix)

Day
Beschrijving

Day

Datatype

integer

Redness
Beschrijving

size

Datatype

float

Maateenheden
  • mm
mm
Swelling
Beschrijving

size

Datatype

float

Maateenheden
  • mm
mm
Pain
Beschrijving

intensity

Datatype

integer

Ongoing after Day 3
Beschrijving

Ongoing after Day 3

Datatype

boolean

If Yes, date of last day of symptoms
Beschrijving

If Yes, date of last day of symptoms

Datatype

date

for investigator only (Priorix vaccine)
Beschrijving

for investigator only (Priorix vaccine)

Side
Beschrijving

Side

Datatype

text

Site
Beschrijving

Site

Datatype

text

Local Symptoms (Group Varilrix)
Beschrijving

Local Symptoms (Group Varilrix)

Day
Beschrijving

Day

Datatype

integer

Redness
Beschrijving

size

Datatype

float

Maateenheden
  • mm
mm
Swelling
Beschrijving

size

Datatype

float

Maateenheden
  • mm
mm
Pain
Beschrijving

intensity

Datatype

integer

Ongoing after day 3?
Beschrijving

Ongoing after day 3?

Datatype

boolean

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

If Yes, record the date of last day of symptoms

Datatype

date

for investigator only (Varilrix vaccine)
Beschrijving

for investigator only (Varilrix vaccine)

Side
Beschrijving

Side

Datatype

integer

Site
Beschrijving

Site

Datatype

integer

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Similar models

Diary Card: Local Symptoms

1 Formulieren
Name
Type
Description | Question | Decode (Coded Value)
Datatype
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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