ID

33066

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 CRF Seiten: 268-336; 870-938

Keywords

Versions (2)
  1. 11/23/18 11/23/18 -
  2. 11/26/18 11/26/18 -
Copyright Holder

GSK group of companies

Uploaded on

November 26, 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

Visit 2: Solicited Adverse Events (All Groups)

1 forms  
Administrative data
Description

Administrative data

Visit Number
Description

Visit Number

Data type

text

Date of Visit
Description

Date of Visit

Data type

date

Subject Number
Description

Subject Number

Data type

integer

Local Symptoms
Description

Local Symptoms

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

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

Data type

text

Local Symptoms
Description

Local Symptoms

Redness
Description

If YES is ticked, please complete all items

Data type

boolean

Size - Day 0
Description

Size - Day 0

Data type

float

Measurement units
  • mm
mm
Size - Day 1
Description

Size - Day 1

Data type

float

Measurement units
  • mm
mm
Size - Day 2
Description

Size - Day 2

Data type

float

Measurement units
  • mm
mm
Size - Day 3
Description

Size - Day 3

Data type

float

Measurement units
  • mm
mm
Ongoing after Day 3?
Description

Ongoing after Day 3?

Data type

boolean

If YES, record date of last day of symptoms
Description

If YES, record date of last day of symptoms

Data type

date

Local Symptoms
Description

Local Symptoms

Swelling
Description

If YES is ticked, please complete all items

Data type

boolean

Size - Day 0
Description

Size - Day 0

Data type

float

Measurement units
  • mm
mm
Size - Day 1
Description

Size - Day 1

Data type

float

Measurement units
  • mm
mm
Size - Day 2
Description

Size - Day 2

Data type

float

Measurement units
  • mm
mm
Size - Day 3
Description

Size - Day 3

Data type

float

Measurement units
  • mm
mm
Ongoing after Day 3?
Description

Ongoing after Day 3?

Data type

boolean

If YES, record date of last day of symptoms
Description

If YES, record date of last day of symptoms

Data type

date

Local Symptoms
Description

Local Symptoms

Pain
Description

If YES is ticked, please complete all items

Data type

boolean

Intensity - Day 0
Description

Intensity - Day 0

Data type

integer

Intensity - Day 1
Description

Intensity - Day 1

Data type

integer

Intensity - Day 2
Description

Intensity - Day 2

Data type

integer

Intensity - Day 3
Description

Intensity - Day 3

Data type

integer

Ongoing after Day 3?
Description

Ongoing after Day 3?

Data type

boolean

If YES, record date of last day of symptoms
Description

If YES, record date of last day of symptoms

Data type

date

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Similar models

Visit 2: Solicited Adverse Events (All Groups)

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