ID

33091

Description

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

Keywords

Versions (1)
  1. 11/27/18 11/27/18 -
Copyright Holder

GSK group of companies

Uploaded on

November 27, 2018

DOI

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License

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

English

Diary Card: Local Symptoms

1 forms  
Administrative data
Description

Administrative data

Dose Number
Description

Dose Number

Data type

text

Subject Number
Description

Subject Number

Data type

integer

Local Symptoms (at injection site)
Description

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
Description

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

Data type

text

Local Symptoms
Description

Local Symptoms

Day
Description

Day

Data type

integer

Redness
Description

size

Data type

float

Measurement units
  • mm
mm
Swelling
Description

size

Data type

float

Measurement units
  • mm
mm
Pain
Description

intensity; please measure the greatest diameter

Data type

text

Ongoing after Day 3?
Description

Ongoing after Day 3?

Data type

boolean

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

If Yes, record the date of last day of symptoms

Data type

date

Local Symptoms (Group Priorix)
Description

Local Symptoms (Group Priorix)

Day
Description

Day

Data type

integer

Redness
Description

size

Data type

float

Measurement units
  • mm
mm
Swelling
Description

size

Data type

float

Measurement units
  • mm
mm
Pain
Description

intensity

Data type

integer

Ongoing after Day 3
Description

Ongoing after Day 3

Data type

boolean

If Yes, date of last day of symptoms
Description

If Yes, date of last day of symptoms

Data type

date

for investigator only (Priorix vaccine)
Description

for investigator only (Priorix vaccine)

Side
Description

Side

Data type

text

Site
Description

Site

Data type

text

Local Symptoms (Group Varilrix)
Description

Local Symptoms (Group Varilrix)

Day
Description

Day

Data type

integer

Redness
Description

size

Data type

float

Measurement units
  • mm
mm
Swelling
Description

size

Data type

float

Measurement units
  • mm
mm
Pain
Description

intensity

Data type

integer

Ongoing after day 3?
Description

Ongoing after day 3?

Data type

boolean

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

If Yes, record the date of last day of symptoms

Data type

date

for investigator only (Varilrix vaccine)
Description

for investigator only (Varilrix vaccine)

Side
Description

Side

Data type

integer

Site
Description

Site

Data type

integer

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Similar models

Diary Card: Local Symptoms

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
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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