ID

25109

Description

GSK Study: Evaluation of safety and efficacy of VarilrixTM and of Combined Measles-Mumps-Rubella-Varicella Vaccine NCT00226499 - Concomitant Vaccination, Medication and Non SAE 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

Keywords

Versions (1)
  1. 8/26/17 8/26/17 -
Copyright Holder

glaxoSmithKline

Uploaded on

August 26, 2017

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License

Creative Commons BY-NC 3.0
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GSK Study: Evaluation of safety and efficacy of VarilrixTM and of Combined Measles-Mumps-Rubella-Varicella Vaccine NCT00226499 - Concomitant Vaccination,Medication and Non SAE

English

GSK Study: Evaluation of safety and efficacy of VarilrixTM and of Combined Measles-Mumps-Rubella-Varicella Vaccine NCT00226499 - Concomitant Vaccination,Medication and Non SAE

1 forms  
Concomitant Vaccination
Description

Concomitant Vaccination

Alias
UMLS CUI-1
C0042196
UMLS CUI-2
C2347852
Has any vaccine other than the study vaccine(s) been administered during the timeframe as specified in the Protocol?
Description

If yes, please record concomitant vaccination with trade name and/or generic name, route and vaccine administration date.

Data type

boolean

Alias
UMLS CUI [1,1]
C0042196
UMLS CUI [1,2]
C2347852
Concomitant vaccination
Description

Concomitant vaccination

Alias
UMLS CUI-1
C0042196
UMLS CUI-2
C2347852
Trade / (Generic) Name
Description

Trade name of vaccine

Data type

text

Alias
UMLS CUI [1,1]
C0592503
UMLS CUI [1,2]
C0042196
Route
Description

Administration route of vaccine

Data type

text

Alias
UMLS CUI [1,1]
C0013153
UMLS CUI [1,2]
C0042210
Administration date
Description

Vaccine administration date

Data type

date

Alias
UMLS CUI [1,1]
C1533734
UMLS CUI [1,2]
C0011008
UMLS CUI [1,3]
C0042210
Medication
Description

Medication

Alias
UMLS CUI-1
C0013227
Have any medications/treatments been administered during study period according to protocol?
Description

Medication

Data type

boolean

Alias
UMLS CUI [1]
C0013227
Medication
Description

Medication

Alias
UMLS CUI-1
C0013227
Trade / Generic name
Description

Trade name of medication

Data type

text

Alias
UMLS CUI [1,1]
C0592503
UMLS CUI [1,2]
C0013227
Medical indication
Description

Medical indication for medication

Data type

text

Alias
UMLS CUI [1,1]
C0013227
UMLS CUI [1,2]
C3146298
Prophylactic
Description

Prophylactic medication

Data type

boolean

Alias
UMLS CUI [1]
C0420172
Total daily dose
Description

Total daily dose

Data type

text

Alias
UMLS CUI [1,1]
C2348070
UMLS CUI [1,2]
C0013227
Route
Description

Route of administration

Data type

text

Alias
UMLS CUI [1]
C0013153
Start Date
Description

Start Date of medication

Data type

date

Alias
UMLS CUI [1,1]
C0013227
UMLS CUI [1,2]
C0808070
End date
Description

End Date of Medication

Data type

date

Alias
UMLS CUI [1,1]
C0013227
UMLS CUI [1,2]
C0806020
Continuous medication
Description

Medication continuing

Data type

boolean

Alias
UMLS CUI [1,1]
C0013227
UMLS CUI [1,2]
C0549178
Non-serious adverse event
Description

Non-serious adverse event

Alias
UMLS CUI-1
C1518404
Has any non-serious adverse events occurred within 42 days after the vaccinations, excluding those recorded on the Solicited Adverse Events pages?
Description

Please report all serious adverse events only on the Serious Adverse Event (SAE) form

Data type

boolean

Alias
UMLS CUI [1]
C1518404
Non-serious adverse event
Description

Non-serious adverse event

Alias
UMLS CUI-1
C1518404
Non-serious adverse event No.
Description

Non-serious adverse event number

Data type

integer

Alias
UMLS CUI [1,1]
C1518404
UMLS CUI [1,2]
C0449788
Description
Description

Description of non-serious adverse event

Data type

text

Alias
UMLS CUI [1,1]
C1518404
UMLS CUI [1,2]
C0678257
Anatomic site of non-serious adverse event
Description

Anatomic site of non-serious adverse event

Data type

text

Alias
UMLS CUI [1,1]
C1518404
UMLS CUI [1,2]
C0678257
UMLS CUI [1,3]
C1515974
Date started
Description

Start date of non-serious adverse event

Data type

date

Alias
UMLS CUI [1,1]
C1518404
UMLS CUI [1,2]
C0808070
Did the non-serious adverse event start during immediate post-vaccination period (30 minutes)?
Description

Non-serious adverse event start time vaccination

Data type

boolean

Alias
UMLS CUI [1,1]
C1518404
UMLS CUI [1,2]
C0808070
UMLS CUI [1,3]
C0042196
UMLS CUI [1,4]
C0205253
Date stopped
Description

End Date of non-serious adverse event

Data type

date

Alias
UMLS CUI [1,1]
C0806020
UMLS CUI [1,2]
C1518404
Intensity
Description

Intensity of non-serious adverse event

Data type

integer

Alias
UMLS CUI [1,1]
C1518404
UMLS CUI [1,2]
C0518690
Is there a reasonable possibility that the AE may have been caused by the investigational product?
Description

Relationship to investigational products

Data type

boolean

Alias
UMLS CUI [1,1]
C0009952
UMLS CUI [1,2]
C0085978
UMLS CUI [1,3]
C0042210
Outcome
Description

Outcome

Data type

integer

Alias
UMLS CUI [1]
C1547647
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Similar models

GSK Study: Evaluation of safety and efficacy of VarilrixTM and of Combined Measles-Mumps-Rubella-Varicella Vaccine NCT00226499 - Concomitant Vaccination,Medication and Non SAE

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
Concomitant Vaccination
C0042196 (UMLS CUI-1)
C2347852 (UMLS CUI-2)
Concomitant vaccination
Item
Has any vaccine other than the study vaccine(s) been administered during the timeframe as specified in the Protocol?
boolean
C0042196 (UMLS CUI [1,1])
C2347852 (UMLS CUI [1,2])
Item Group
Concomitant vaccination
C0042196 (UMLS CUI-1)
C2347852 (UMLS CUI-2)
Trade name of vaccine
Item
Trade / (Generic) Name
text
C0592503 (UMLS CUI [1,1])
C0042196 (UMLS CUI [1,2])
Item
Route
text
C0013153 (UMLS CUI [1,1])
C0042210 (UMLS CUI [1,2])
Administration route of vaccine
Code List
Route
CL Item
Intradermal  (ID)
CL Item
Inhalation (IH)
CL Item
Intramuscular  (IM)
CL Item
Intravenous  (IV)
CL Item
Intranasal  (NA)
CL Item
Other (OTH)
CL Item
Parenteral (PE)
CL Item
Oral (PO)
CL Item
Subcutaneous  (SC)
CL Item
Sublingual (SL)
CL Item
Transdermal  (TD)
CL Item
Unknown (UNK)
Vaccine administration date
Item
Administration date
date
C1533734 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
C0042210 (UMLS CUI [1,3])
Item Group
Medication
C0013227 (UMLS CUI-1)
Medication
Item
Have any medications/treatments been administered during study period according to protocol?
boolean
C0013227 (UMLS CUI [1])
Item Group
Medication
C0013227 (UMLS CUI-1)
Trade name of medication
Item
Trade / Generic name
text
C0592503 (UMLS CUI [1,1])
C0013227 (UMLS CUI [1,2])
Medical indication for medication
Item
Medical indication
text
C0013227 (UMLS CUI [1,1])
C3146298 (UMLS CUI [1,2])
Prophylactic medication
Item
Prophylactic
boolean
C0420172 (UMLS CUI [1])
Total daily dose
Item
Total daily dose
text
C2348070 (UMLS CUI [1,1])
C0013227 (UMLS CUI [1,2])
Item
Route
text
C0013153 (UMLS CUI [1])
Route of administration
Code List
Route
CL Item
External (EXT)
CL Item
Intradermal (ID)
CL Item
Inhalation (IH)
CL Item
Intramuscular (IM)
CL Item
Intraarticular (IR)
CL Item
Intrathecal (IT)
CL Item
Intravenous (IV)
CL Item
Intranasal (NA)
CL Item
Other (OTH)
CL Item
Parenteral (PE)
CL Item
Oral (PO)
CL Item
Rectal  (PR)
CL Item
Subcutaneous (SC)
CL Item
Sublingual (SL)
CL Item
Transdermal (TD)
CL Item
Topical (TO)
CL Item
Unknown (UNK)
CL Item
Vaginal (VA)
Start Date of medication
Item
Start Date
date
C0013227 (UMLS CUI [1,1])
C0808070 (UMLS CUI [1,2])
End Date of Medication
Item
End date
date
C0013227 (UMLS CUI [1,1])
C0806020 (UMLS CUI [1,2])
Medication continuing
Item
Continuous medication
boolean
C0013227 (UMLS CUI [1,1])
C0549178 (UMLS CUI [1,2])
Item Group
Non-serious adverse event
C1518404 (UMLS CUI-1)
Non-serious adverse event
Item
Has any non-serious adverse events occurred within 42 days after the vaccinations, excluding those recorded on the Solicited Adverse Events pages?
boolean
C1518404 (UMLS CUI [1])
Item Group
Non-serious adverse event
C1518404 (UMLS CUI-1)
Non-serious adverse event number
Item
Non-serious adverse event No.
integer
C1518404 (UMLS CUI [1,1])
C0449788 (UMLS CUI [1,2])
Description of non-serious adverse event
Item
Description
text
C1518404 (UMLS CUI [1,1])
C0678257 (UMLS CUI [1,2])
Item
Anatomic site of non-serious adverse event
text
C1518404 (UMLS CUI [1,1])
C0678257 (UMLS CUI [1,2])
C1515974 (UMLS CUI [1,3])
Anatomic site of non-serious adverse event
Code List
Anatomic site of non-serious adverse event
CL Item
Administration site (L)
CL Item
Non-administration site (G)
Start date of non-serious adverse event
Item
Date started
date
C1518404 (UMLS CUI [1,1])
C0808070 (UMLS CUI [1,2])
Non-serious adverse event start time vaccination
Item
Did the non-serious adverse event start during immediate post-vaccination period (30 minutes)?
boolean
C1518404 (UMLS CUI [1,1])
C0808070 (UMLS CUI [1,2])
C0042196 (UMLS CUI [1,3])
C0205253 (UMLS CUI [1,4])
End Date of non-serious adverse event
Item
Date stopped
date
C0806020 (UMLS CUI [1,1])
C1518404 (UMLS CUI [1,2])
Item
Intensity
integer
C1518404 (UMLS CUI [1,1])
C0518690 (UMLS CUI [1,2])
Intensity of non-serious adverse event
Code List
Intensity
CL Item
mild (1)
CL Item
moderate (2)
CL Item
severe (3)
Relationship to investigational products
Item
Is there a reasonable possibility that the AE may have been caused by the investigational product?
boolean
C0009952 (UMLS CUI [1,1])
C0085978 (UMLS CUI [1,2])
C0042210 (UMLS CUI [1,3])
Item
Outcome
integer
C1547647 (UMLS CUI [1])
Outcome
Code List
Outcome
CL Item
Recovered / resolved  (1)
CL Item
Recovering / resolving  (2)
CL Item
Not recovered / not resolved  (3)
CL Item
Recovered with sequelae / resolved with sequelae (4)
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