ID

33091

Descripción

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

Palabras clave

Versiones (1)
  1. 27/11/18 27/11/18 -
Titular de derechos de autor

GSK group of companies

Subido en

27 de noviembre de 2018

DOI

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Licencia

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

Inglés

Diary Card: Local Symptoms

1 formularios  
Administrative data
Descripción

Administrative data

Dose Number
Descripción

Dose Number

Tipo de datos

text

Subject Number
Descripción

Subject Number

Tipo de datos

integer

Local Symptoms (at injection site)
Descripción

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
Descripción

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

Tipo de datos

text

Local Symptoms
Descripción

Local Symptoms

Day
Descripción

Day

Tipo de datos

integer

Redness
Descripción

size

Tipo de datos

float

Unidades de medida
  • mm
mm
Swelling
Descripción

size

Tipo de datos

float

Unidades de medida
  • mm
mm
Pain
Descripción

intensity; please measure the greatest diameter

Tipo de datos

text

Ongoing after Day 3?
Descripción

Ongoing after Day 3?

Tipo de datos

boolean

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

If Yes, record the date of last day of symptoms

Tipo de datos

date

Local Symptoms (Group Priorix)
Descripción

Local Symptoms (Group Priorix)

Day
Descripción

Day

Tipo de datos

integer

Redness
Descripción

size

Tipo de datos

float

Unidades de medida
  • mm
mm
Swelling
Descripción

size

Tipo de datos

float

Unidades de medida
  • mm
mm
Pain
Descripción

intensity

Tipo de datos

integer

Ongoing after Day 3
Descripción

Ongoing after Day 3

Tipo de datos

boolean

If Yes, date of last day of symptoms
Descripción

If Yes, date of last day of symptoms

Tipo de datos

date

for investigator only (Priorix vaccine)
Descripción

for investigator only (Priorix vaccine)

Side
Descripción

Side

Tipo de datos

text

Site
Descripción

Site

Tipo de datos

text

Local Symptoms (Group Varilrix)
Descripción

Local Symptoms (Group Varilrix)

Day
Descripción

Day

Tipo de datos

integer

Redness
Descripción

size

Tipo de datos

float

Unidades de medida
  • mm
mm
Swelling
Descripción

size

Tipo de datos

float

Unidades de medida
  • mm
mm
Pain
Descripción

intensity

Tipo de datos

integer

Ongoing after day 3?
Descripción

Ongoing after day 3?

Tipo de datos

boolean

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

If Yes, record the date of last day of symptoms

Tipo de datos

date

for investigator only (Varilrix vaccine)
Descripción

for investigator only (Varilrix vaccine)

Side
Descripción

Side

Tipo de datos

integer

Site
Descripción

Site

Tipo de datos

integer

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Similar models

Diary Card: Local Symptoms

1 formularios
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de datos
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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