ID

33015

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 CRF Seiten: 268-336; 870-938

Trefwoorden

Versies (2)
  1. 23-11-18 23-11-18 -
  2. 26-11-18 26-11-18 -
Houder van rechten

GSK group of companies

Geüploaded op

23 november 2018

DOI

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Creative Commons BY-NC 3.0
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Immogenicity of Combined Measles, Mumps, Rubella, Varicella Vaccine for healthy 2 y.o children - 104020

Engels

Visit 2: Solicited Adverse Events (All Groups)

1 Formulieren  
Administrative data
Beschrijving

Administrative data

Visit Number
Beschrijving

Visit Number

Datatype

text

Date of Visit
Beschrijving

Date of Visit

Datatype

date

Subject Number
Beschrijving

Subject Number

Datatype

integer

Local Symptoms
Beschrijving

Local Symptoms

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

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

Datatype

text

Local Symptoms
Beschrijving

Local Symptoms

Redness
Beschrijving

If YES is ticked, please complete all items

Datatype

boolean

Size - Day 0
Beschrijving

Size - Day 0

Datatype

float

Maateenheden
  • mm
mm
Size - Day 1
Beschrijving

Size - Day 1

Datatype

float

Maateenheden
  • mm
mm
Size - Day 2
Beschrijving

Size - Day 2

Datatype

float

Maateenheden
  • mm
mm
Size - Day 3
Beschrijving

Size - Day 3

Datatype

float

Maateenheden
  • mm
mm
Ongoing after Day 3?
Beschrijving

Ongoing after Day 3?

Datatype

boolean

If YES, record date of last day of symptoms
Beschrijving

If YES, record date of last day of symptoms

Datatype

date

Local Symptoms
Beschrijving

Local Symptoms

Swelling
Beschrijving

If YES is ticked, please complete all items

Datatype

boolean

Size - Day 0
Beschrijving

Size - Day 0

Datatype

float

Maateenheden
  • mm
mm
Size - Day 1
Beschrijving

Size - Day 1

Datatype

float

Maateenheden
  • mm
mm
Size - Day 2
Beschrijving

Size - Day 2

Datatype

float

Maateenheden
  • mm
mm
Size - Day 3
Beschrijving

Size - Day 3

Datatype

float

Maateenheden
  • mm
mm
Ongoing after Day 3?
Beschrijving

Ongoing after Day 3?

Datatype

boolean

If YES, record date of last day of symptoms
Beschrijving

If YES, record date of last day of symptoms

Datatype

date

Local Symptoms
Beschrijving

Local Symptoms

Pain
Beschrijving

If YES is ticked, please complete all items

Datatype

boolean

Intensity - Day 0
Beschrijving

Intensity - Day 0

Datatype

integer

Intensity - Day 1
Beschrijving

Intensity - Day 1

Datatype

integer

Intensity - Day 2
Beschrijving

Intensity - Day 2

Datatype

integer

Intensity - Day 3
Beschrijving

Intensity - Day 3

Datatype

integer

Ongoing after Day 3?
Beschrijving

Ongoing after Day 3?

Datatype

boolean

If YES, record date of last day of symptoms
Beschrijving

If YES, record date of last day of symptoms

Datatype

date

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Similar models

Visit 2: Solicited Adverse Events (All Groups)

1 Formulieren
Name
Type
Description | Question | Decode (Coded Value)
Datatype
Alias
Item Group
Administrative data
Item
Visit Number
text
Visit Number
Code List
Visit Number
CL Item
Visit 2 (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
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
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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