ID

25396

Beschreibung

Phase A - Year 2 Extension - Telephone contact 30 - GSK Study: Evaluation of safety and efficacy of VarilrixTM and of Combined Measles-Mumps-Rubella-Varicella Vaccine NCT00226499 Study ID: 100388 Clinical Study ID: 100388 Study Title: Study in Healthy Children (<2 Years) to Evaluate the Safety and Efficacy of GSK Biologicals' Live Attenuated Varicella Vaccine (VarilrixTM) and of GSK Biologicals' Combined Measles-Mumps-Rubella-Varicella Vaccine Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00226499 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: phase 3 Study Recruitment Status: Completed Generic Name: Varicella Vaccine Trade Name: BIO OKAH; Varilrix Study Indication: Varicella

Stichworte

Versionen (1)
  1. 02/09/17 02/09/17 -
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glaxoSmithKline

Hochgeladen am

2 settembre 2017

DOI

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Creative Commons BY-NC 3.0
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Phase A - Year 2 Extension - Telephone contact 30 - GSK Study: Evaluation of safety and efficacy of VarilrixTM and of Combined Measles-Mumps-Rubella-Varicella Vaccine NCT00226499

Englisch

Phase A - Year 2 Extension - Telephone contact 30 - GSK Study: Evaluation of safety and efficacy of VarilrixTM and of Combined Measles-Mumps-Rubella-Varicella Vaccine NCT00226499

1 Formulare  
Subject's contact
Beschreibung

Subject's contact

Alias
UMLS CUI-1
C0332158
UMLS CUI-2
C0681850
Was the subject successfully contacted at scheduled Telephone Contact 30?
Beschreibung

telephone contact

Datentyp

integer

Alias
UMLS CUI [1]
C0420309
Has the subject been seen or contacted between the previous contact and this contact?
Beschreibung

Only fill in, if you answered previous question with 'no'.

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0332158
UMLS CUI [1,2]
C0681850
Last date
Beschreibung

Date of last contact

Datentyp

date

Alias
UMLS CUI [1]
C0805839
Household exposure
Beschreibung

Household exposure

Alias
UMLS CUI-1
C0332157
UMLS CUI-2
C0020052
Irrespective of whether the subject developed/develops varicella/zoster, was the subject exposed for more than one day to any varicella or zoster case presented by a household member or another person living temporarily within the household between the previous contact and this contact?
Beschreibung

Exposure in household to varicella/zoster

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0008049
UMLS CUI [1,2]
C0332157
UMLS CUI [1,3]
C0020052
UMLS CUI [2,1]
C0740380
UMLS CUI [2,2]
C0332157
UMLS CUI [2,3]
C0020052
Household exposure number
Beschreibung

Household exposure number

Alias
UMLS CUI-1
C0332157
UMLS CUI-2
C0020052
UMLS CUI-3
C0449788
Household Exposure No
Beschreibung

Household Exposure No

Datentyp

integer

Alias
UMLS CUI [1,1]
C0332157
UMLS CUI [1,2]
C0020052
UMLS CUI [1,3]
C0449788
Date of onset exposure
Beschreibung

Date of onset exposure

Datentyp

date

Alias
UMLS CUI [1,1]
C0574845
UMLS CUI [1,2]
C0332157
Type of exposure
Beschreibung

Type of exposure

Datentyp

integer

Alias
UMLS CUI [1]
C0332157
Varicella or zoster
Beschreibung

Varicella or zoster

Alias
UMLS CUI-1
C0008049
UMLS CUI-3
C0740380
Did the subject present any signs of varicella or zoster symptoms between the previous contact and this contact?
Beschreibung

if 'yes', please complete the Varicella or Zoster Case section.

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0037088
UMLS CUI [1,2]
C0740380
UMLS CUI [2,1]
C0037088
UMLS CUI [2,2]
C0008049
How many episodes?
Beschreibung

Number of episodes of varicella/zoster signs and symptoms

Datentyp

integer

Alias
UMLS CUI [1,1]
C0037088
UMLS CUI [1,2]
C0740380
UMLS CUI [2,1]
C0037088
UMLS CUI [2,2]
C0008049
Serious adverse event
Beschreibung

Serious adverse event

Alias
UMLS CUI-1
C1519255
Did the subject experience any serious adverse event between the previous contact and this contact?
Beschreibung

If 'yes, please complete the Serious Adverse Event form.

Datentyp

boolean

Alias
UMLS CUI [1]
C1519255
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Ähnliche Modelle

Phase A - Year 2 Extension - Telephone contact 30 - GSK Study: Evaluation of safety and efficacy of VarilrixTM and of Combined Measles-Mumps-Rubella-Varicella Vaccine NCT00226499

1 Formulare
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
Alias
Item Group
Subject's contact
C0332158 (UMLS CUI-1)
C0681850 (UMLS CUI-2)
Item
Was the subject successfully contacted at scheduled Telephone Contact 30?
integer
C0420309 (UMLS CUI [1])
telephone contact
Code List
Was the subject successfully contacted at scheduled Telephone Contact 30?
CL Item
Yes (1)
CL Item
No (2)
CL Item
NA: Not applicable, please complete if there is no need to perform this telephone contact due to the end of Phase A. (3)
contact with subject
Item
Has the subject been seen or contacted between the previous contact and this contact?
boolean
C0332158 (UMLS CUI [1,1])
C0681850 (UMLS CUI [1,2])
Date of last contact
Item
Last date
date
C0805839 (UMLS CUI [1])
Item Group
Household exposure
C0332157 (UMLS CUI-1)
C0020052 (UMLS CUI-2)
Exposure in household to varicella/zoster
Item
Irrespective of whether the subject developed/develops varicella/zoster, was the subject exposed for more than one day to any varicella or zoster case presented by a household member or another person living temporarily within the household between the previous contact and this contact?
boolean
C0008049 (UMLS CUI [1,1])
C0332157 (UMLS CUI [1,2])
C0020052 (UMLS CUI [1,3])
C0740380 (UMLS CUI [2,1])
C0332157 (UMLS CUI [2,2])
C0020052 (UMLS CUI [2,3])
Item Group
Household exposure number
C0332157 (UMLS CUI-1)
C0020052 (UMLS CUI-2)
C0449788 (UMLS CUI-3)
Household Exposure No
Item
Household Exposure No
integer
C0332157 (UMLS CUI [1,1])
C0020052 (UMLS CUI [1,2])
C0449788 (UMLS CUI [1,3])
Date of onset exposure
Item
Date of onset exposure
date
C0574845 (UMLS CUI [1,1])
C0332157 (UMLS CUI [1,2])
Item
Type of exposure
integer
C0332157 (UMLS CUI [1])
Type of exposure
Code List
Type of exposure
CL Item
Varicella (1)
CL Item
Zoster (2)
Item Group
Varicella or zoster
C0008049 (UMLS CUI-1)
C0740380 (UMLS CUI-3)
signs or symptoms of varicella or zoster
Item
Did the subject present any signs of varicella or zoster symptoms between the previous contact and this contact?
boolean
C0037088 (UMLS CUI [1,1])
C0740380 (UMLS CUI [1,2])
C0037088 (UMLS CUI [2,1])
C0008049 (UMLS CUI [2,2])
Number of episodes of varicella/zoster signs and symptoms
Item
How many episodes?
integer
C0037088 (UMLS CUI [1,1])
C0740380 (UMLS CUI [1,2])
C0037088 (UMLS CUI [2,1])
C0008049 (UMLS CUI [2,2])
Item Group
Serious adverse event
C1519255 (UMLS CUI-1)
serious adverse event
Item
Did the subject experience any serious adverse event between the previous contact and this contact?
boolean
C1519255 (UMLS CUI [1])
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