ID

33064

Beschreibung

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

Stichworte

Versionen (2)
  1. 2018-11-23 2018-11-23 -
  2. 2018-11-26 2018-11-26 -
Rechteinhaber

GSK group of companies

Hochgeladen am

26 november 2018

DOI

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Immunogenicity of Combined Measles Mumps Rubella Varicella Vaccine for healthy 2 y.o children - 104020

Englisch

Solicited Adverse Events (Group Priorix+Varilrix)

1 Formulare  
Administrative data
Beschreibung

Administrative data

Visit Number
Beschreibung

Visit Number

Datentyp

text

Date of Visit
Beschreibung

Date of Visit

Datentyp

date

Subject Number
Beschreibung

Subject Number

Datentyp

integer

Local Symptoms
Beschreibung

Local Symptoms

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

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

Datentyp

text

Local Symptoms
Beschreibung

Local Symptoms

Redness
Beschreibung

If YES is ticked, please complete all items

Datentyp

boolean

Size - Day 0
Beschreibung

Size - Day 0

Datentyp

float

Maßeinheiten
  • mm
mm
Size - Day 1
Beschreibung

Size - Day 1

Datentyp

float

Maßeinheiten
  • mm
mm
Size - Day 2
Beschreibung

Size - Day 2

Datentyp

float

Maßeinheiten
  • mm
mm
Size - Day 3
Beschreibung

Size - Day 3

Datentyp

float

Maßeinheiten
  • mm
mm
Ongoing after Day 3?
Beschreibung

Ongoing after Day 3?

Datentyp

boolean

If YES, record date of last day of symptoms
Beschreibung

If YES, record date of last day of symptoms

Datentyp

date

Priorix Vaccine - Local Symptoms
Beschreibung

Priorix Vaccine - Local Symptoms

Swelling
Beschreibung

If YES is ticked, please complete all items

Datentyp

boolean

Size - Day 0
Beschreibung

Size - Day 0

Datentyp

float

Maßeinheiten
  • mm
mm
Size - Day 1
Beschreibung

Size - Day 1

Datentyp

float

Maßeinheiten
  • mm
mm
Size - Day 2
Beschreibung

Size - Day 2

Datentyp

float

Maßeinheiten
  • mm
mm
Size - Day 3
Beschreibung

Size - Day 3

Datentyp

float

Maßeinheiten
  • mm
mm
Ongoing after Day 3?
Beschreibung

Ongoing after Day 3?

Datentyp

boolean

If YES, record date of last day of symptoms
Beschreibung

If YES, record date of last day of symptoms

Datentyp

date

Priorix Vaccine - Local Symptoms
Beschreibung

Priorix Vaccine - Local Symptoms

Pain
Beschreibung

If YES is ticked, please complete all items

Datentyp

boolean

Intensity - Day 0
Beschreibung

Intensity - Day 0

Datentyp

integer

Intensity - Day 1
Beschreibung

Intensity - Day 1

Datentyp

integer

Intensity - Day 2
Beschreibung

Intensity - Day 2

Datentyp

integer

Intensity - Day 3
Beschreibung

Intensity - Day 3

Datentyp

integer

Ongoing after Day 3?
Beschreibung

Ongoing after Day 3?

Datentyp

boolean

If YES, record date of last day of symptoms
Beschreibung

If YES, record date of last day of symptoms

Datentyp

date

Varilrix Vaccine - Local Symptoms
Beschreibung

Varilrix Vaccine - Local Symptoms

Redness
Beschreibung

If YES is ticked, please complete all items

Datentyp

boolean

Size - Day 0
Beschreibung

Size - Day 0

Datentyp

float

Maßeinheiten
  • mm
mm
Size - Day 1
Beschreibung

Size - Day 1

Datentyp

float

Maßeinheiten
  • mm
mm
Size - Day 2
Beschreibung

Size - Day 2

Datentyp

float

Maßeinheiten
  • mm
mm
Size - Day 3
Beschreibung

Size - Day 3

Datentyp

float

Maßeinheiten
  • mm
mm
Ongoing after Day 3?
Beschreibung

Ongoing after Day 3?

Datentyp

boolean

If YES, record date of last day of symptoms
Beschreibung

If YES, record date of last day of symptoms

Datentyp

date

Varilrix Vaccine - Local Symptoms
Beschreibung

Varilrix Vaccine - Local Symptoms

Swelling
Beschreibung

If YES is ticked, please complete all items

Datentyp

boolean

Size - Day 0
Beschreibung

Size - Day 0

Datentyp

float

Maßeinheiten
  • mm
mm
Size - Day 1
Beschreibung

Size - Day 1

Datentyp

float

Maßeinheiten
  • mm
mm
Size - Day 2
Beschreibung

Size - Day 2

Datentyp

float

Maßeinheiten
  • mm
mm
Size - Day 3
Beschreibung

Size - Day 3

Datentyp

float

Maßeinheiten
  • mm
mm
Ongoing after Day 3?
Beschreibung

Ongoing after Day 3?

Datentyp

boolean

If YES, record date of last day of symptoms
Beschreibung

If YES, record date of last day of symptoms

Datentyp

date

Varilrix Vaccine - Local Symptoms
Beschreibung

Varilrix Vaccine - Local Symptoms

Pain
Beschreibung

If YES is ticked, please complete all items

Datentyp

boolean

Intensity - Day 0
Beschreibung

Intensity - Day 0

Datentyp

integer

Intensity - Day 1
Beschreibung

Intensity - Day 1

Datentyp

integer

Intensity - Day 2
Beschreibung

Intensity - Day 2

Datentyp

integer

Intensity - Day 3
Beschreibung

Intensity - Day 3

Datentyp

integer

Ongoing after Day 3?
Beschreibung

Ongoing after Day 3?

Datentyp

boolean

If YES, record date of last day of symptoms
Beschreibung

If YES, record date of last day of symptoms

Datentyp

date

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Ähnliche Modelle

Solicited Adverse Events (Group Priorix+Varilrix)

1 Formulare
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
Alias
Item Group
Administrative data
Item
Visit Number
text
Visit Number
Code List
Visit Number
CL Item
Visit 1 (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
Priorix Vaccine - 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
Priorix Vaccine - 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
Item Group
Varilrix Vaccine - 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
Varilrix Vaccine - 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
Varilrix Vaccine - 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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