ID

25193

Descrição

Phase A - Year 1 - Telephone contact 6 - 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

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Versões (1)
  1. 28/08/2017 28/08/2017 -
Titular dos direitos

glaxoSmithKline

Transferido a

28 de agosto de 2017

DOI

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Licença

Creative Commons BY-NC 3.0
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Phase A - Year 1 - Telephone contact 6 - GSK Study: Evaluation of safety and efficacy of VarilrixTM and of Combined Measles-Mumps-Rubella-Varicella Vaccine NCT00226499

Inglês

Phase A - Year 1 - Telephone contact 6 - GSK Study: Evaluation of safety and efficacy of VarilrixTM and of Combined Measles-Mumps-Rubella-Varicella Vaccine NCT00226499

1 Formulários  
Subject's contact
Descrição

Subject's contact

Alias
UMLS CUI-1
C0332158 (Contact with)
SNOMED
11723008
UMLS CUI-2
C0681850 (Study Subject)
Was the subject successfully contacted at scheduled Telephone Contact 6?
Descrição

telephone contact

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0420309 (Planned telephone contact)
SNOMED
183631005
Has the subject been seen or contacted between the previous contact and this contact?
Descrição

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

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0332158 (Contact with)
SNOMED
11723008
UMLS CUI [1,2]
C0681850 (Study Subject)
Last date
Descrição

Date of last contact

Tipo de dados

date

Alias
UMLS CUI [1]
C0805839 (Date last contact)
LOINC
MTHU010432
Household exposure
Descrição

Household exposure

Alias
UMLS CUI-1
C0332157 (Exposure to)
SNOMED
24932003
UMLS CUI-2
C0020052 (Households)
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?
Descrição

Exposure in household to varicella/zoster

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0008049 (Chickenpox)
SNOMED
38907003
LOINC
LA10517-3
UMLS CUI [1,2]
C0332157 (Exposure to)
SNOMED
24932003
UMLS CUI [1,3]
C0020052 (Households)
UMLS CUI [2,1]
C0740380 (Varicella zoster)
UMLS CUI [2,2]
C0332157 (Exposure to)
SNOMED
24932003
UMLS CUI [2,3]
C0020052 (Households)
Household exposure number
Descrição

Household exposure number

Alias
UMLS CUI-1
C0332157 (Exposure to)
SNOMED
24932003
UMLS CUI-2
C0020052 (Households)
UMLS CUI-3
C0449788 (Count of entities)
SNOMED
410681005
Household Exposure No
Descrição

Household Exposure No

Tipo de dados

integer

Alias
UMLS CUI [1,1]
C0332157 (Exposure to)
SNOMED
24932003
UMLS CUI [1,2]
C0020052 (Households)
UMLS CUI [1,3]
C0449788 (Count of entities)
SNOMED
410681005
Date of onset exposure
Descrição

Date of onset exposure

Tipo de dados

date

Alias
UMLS CUI [1,1]
C0574845 (Date of onset)
SNOMED
298059007
LOINC
MTHU048807
UMLS CUI [1,2]
C0332157 (Exposure to)
SNOMED
24932003
Type of exposure
Descrição

Type of exposure

Tipo de dados

integer

Alias
UMLS CUI [1]
C0332157 (Exposure to)
SNOMED
24932003
Varicella or zoster
Descrição

Varicella or zoster

Alias
UMLS CUI-1
C0008049 (Chickenpox)
SNOMED
38907003
LOINC
LA10517-3
UMLS CUI-3
C0740380 (Varicella zoster)
Did the subject present any signs of varicella or zoster symptoms between the previous contact and this contact ?
Descrição

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

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0037088 (Signs and Symptoms)
SNOMED
404684003
LOINC
LP185402-7
UMLS CUI [1,2]
C0740380 (Varicella zoster)
UMLS CUI [2,1]
C0037088 (Signs and Symptoms)
SNOMED
404684003
LOINC
LP185402-7
UMLS CUI [2,2]
C0008049 (Chickenpox)
SNOMED
38907003
LOINC
LA10517-3
How many episodes?
Descrição

Number of episodes of varicella/zoster signs and symptoms

Tipo de dados

integer

Alias
UMLS CUI [1,1]
C0037088 (Signs and Symptoms)
SNOMED
404684003
LOINC
LP185402-7
UMLS CUI [1,2]
C0740380 (Varicella zoster)
UMLS CUI [2,1]
C0037088 (Signs and Symptoms)
SNOMED
404684003
LOINC
LP185402-7
UMLS CUI [2,2]
C0008049 (Chickenpox)
SNOMED
38907003
LOINC
LA10517-3
Serious adverse event
Descrição

Serious adverse event

Alias
UMLS CUI-1
C1519255 (Serious Adverse Event)
Did the subject experience any serious adverse event between the previous contact and this contact?
Descrição

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

Tipo de dados

boolean

Alias
UMLS CUI [1]
C1519255 (Serious Adverse Event)
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Similar models

Phase A - Year 1 - Telephone contact 6 - GSK Study: Evaluation of safety and efficacy of VarilrixTM and of Combined Measles-Mumps-Rubella-Varicella Vaccine NCT00226499

1 Formulários
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de dados
Alias
Item Group
Subject's contact
C0332158 (UMLS CUI-1)
C0681850 (UMLS CUI-2)
telephone contact
Item
Was the subject successfully contacted at scheduled Telephone Contact 6?
boolean
C0420309 (UMLS CUI [1])
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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