ID

29433

Description

Long term follow-up Visit 6 Month 30 Study ID: 101695 Ext. Mth30 Clinical Study ID: 101695 Study Title: Long-term study of immune response persistence of GSK Biologicals' 2-dose thiomersal-free Engerix™-B and 3-dose preservative-free Engerix™-B vaccines in subjects aged 11-15 yrs Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00343915 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 3 Study Recruitment Status: Completed Generic Name: Hepatitis B Vaccine, Recombinant Trade Name: BIO HBV; Engerix-B Study Indication: Hepatitis B

Keywords

Versions (1)
  1. 3/24/18 3/24/18 -
Copyright Holder

GlaxoSmithKline (GSK)

Uploaded on

March 24, 2018

DOI

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License

Creative Commons BY-NC 3.0
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GSK Biologicals' 2-dose thiomersal-free Engerix™-B and 3-dose preservative-free Engerix™-B vaccines Study ID: 101695 NCT00343915

English

Long term follow-up Visit 6 Month 30

1 forms  
Patient Administration
Description

Patient Administration

Alias
UMLS CUI-1
C1320722
Protocol
Description

Protocol

Data type

integer

Alias
UMLS CUI [1]
C1507394
Center
Description

Center

Data type

integer

Alias
UMLS CUI [1,1]
C1301943
UMLS CUI [1,2]
C0805701
Date of Visit
Description

Date of Visit

Data type

date

Alias
UMLS CUI [1]
C1320303
Subject Number
Description

Subject Number

Data type

integer

Alias
UMLS CUI [1]
C2348585
Informed Consent
Description

Informed Consent

Alias
UMLS CUI-1
C0021430
I certify that Informed Consent has been obtained prior to any study procedure.
Description

Informed Consent Date

Data type

date

Alias
UMLS CUI [1]
C2985782
Demographics
Description

Demographics

Alias
UMLS CUI-1
C0011298
Subject Initials
Description

Subject Initials

Data type

text

Alias
UMLS CUI [1,1]
C1997894
UMLS CUI [1,2]
C2986440
Date of birth
Description

Date of birth

Data type

date

Alias
UMLS CUI [1]
C0421451
Gender
Description

Gender

Data type

integer

Alias
UMLS CUI [1]
C0079399
Race
Description

Race

Data type

text

Alias
UMLS CUI [1]
C0034510
Laboratory tests
Description

Laboratory tests

Alias
UMLS CUI-1
C0022885
Has a blood sample been taken?
Description

Blood sample

Data type

boolean

Alias
UMLS CUI [1]
C0005834
Vaccination
Description

Vaccination

Alias
UMLS CUI-1
C0042196
Has the subject received since the last visit: A dose of monovalent or combined Hepatitis B vaccine?
Description

Hepatitis B vaccination

Data type

boolean

Alias
UMLS CUI [1]
C0474232
If 'Yes', please specify:
Description

Hepatitis B vaccination

Data type

integer

Alias
UMLS CUI [1]
C0474232
A dose of Hepatitis B immunoglobulins within 6 months prior to bleeding?
Description

Hepatitis B immunoglobulins

Data type

boolean

Alias
UMLS CUI [1]
C0062525
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Similar models

Long term follow-up Visit 6 Month 30

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
Patient Administration
C1320722 (UMLS CUI-1)
Protocol
Item
Protocol
integer
C1507394 (UMLS CUI [1])
Center
Item
Center
integer
C1301943 (UMLS CUI [1,1])
C0805701 (UMLS CUI [1,2])
Date of Visit
Item
Date of Visit
date
C1320303 (UMLS CUI [1])
Subject Number
Item
Subject Number
integer
C2348585 (UMLS CUI [1])
Item Group
Informed Consent
C0021430 (UMLS CUI-1)
Informed Consent Date
Item
I certify that Informed Consent has been obtained prior to any study procedure.
date
C2985782 (UMLS CUI [1])
Item Group
Demographics
C0011298 (UMLS CUI-1)
Subject Initials
Item
Subject Initials
text
C1997894 (UMLS CUI [1,1])
C2986440 (UMLS CUI [1,2])
Date of birth
Item
Date of birth
date
C0421451 (UMLS CUI [1])
Item
Gender
integer
C0079399 (UMLS CUI [1])
Gender
Code List
Gender
CL Item
Male (1)
CL Item
Female (2)
Item
Race
text
C0034510 (UMLS CUI [1])
Race
Code List
Race
CL Item
White ((WH))
CL Item
Black ((BL))
CL Item
Oriental ((OR))
CL Item
Other, please specify: ____________________________________________ ((OT))
Item Group
Laboratory tests
C0022885 (UMLS CUI-1)
Blood sample
Item
Has a blood sample been taken?
boolean
C0005834 (UMLS CUI [1])
Item Group
Vaccination
C0042196 (UMLS CUI-1)
Hepatitis B vaccination
Item
Has the subject received since the last visit: A dose of monovalent or combined Hepatitis B vaccine?
boolean
C0474232 (UMLS CUI [1])
Item
If 'Yes', please specify:
integer
C0474232 (UMLS CUI [1])
Hepatitis B vaccination
Code List
If 'Yes', please specify:
CL Item
Monovalent vaccine (1)
CL Item
Combined Hepatitis B vaccine (2)
Hepatitis B immunoglobulins
Item
A dose of Hepatitis B immunoglobulins within 6 months prior to bleeding?
boolean
C0062525 (UMLS CUI [1])
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