ID

43930

Description

Visit 1 Laboratory Tests Screening form Study ID: 208127/125 Clinical Study ID: 208127/125 (Ext-HAB-038 Month 90) Study Title: A double-blind, randomized study to evaluate the immunogenicity and reactogenicity of two different lots of GlaxoSmithKline Biologicals' combined hepatitis A / hepatitis B vaccine in healthy children between 6 and 15 years of age. Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: N/A Sponsor:GlaxoSmithKline Collaborators: N/A Phase: Phase 3 Study Recruitment Status: Completed Generic Name: Hepatitis A (Inactivated), Hepatitis B (Recombinant) Vaccine Trade Name: Twinrix Study Indication: Hepatitis A; Hepatitis B

Keywords

Versions (2)
  1. 7/30/17 7/30/17 -
  2. 9/20/21 9/20/21 -
Copyright Holder

GlaxoSmithKline

Uploaded on

September 20, 2021

DOI

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License

Creative Commons BY-NC 3.0
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Visit 1 Laboratory Tests Biologicals HepA/HepB vaccine 208127/125

English

Visit 1 Laboratory Tests Biologicals HepA/HepB vaccine 208127/125

1 forms  
Header
Description

Header

Alias
UMLS CUI-1
C1320722
Protocol
Description

Protocol

Data type

text

Alias
UMLS CUI [1]
C1507394
Activity
Description

Activity

Data type

text

Alias
UMLS CUI [1]
C1512346
Date of activity
Description

day/month/year

Data type

date

Alias
UMLS CUI [1]
C1320303
Subject number
Description

Subject number

Data type

text

Alias
UMLS CUI [1]
C2348585
Laboratory tests - Screening
Description

Laboratory tests - Screening

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

if yes, enter all results or attach individual laboratory report behind this page

Data type

boolean

Alias
UMLS CUI [1]
C0005834
Date of blood sampling :
Description

day/month/year

Data type

date

Alias
UMLS CUI [1,1]
C0178913
UMLS CUI [1,2]
C0011008
Please comment :
Description

blood sample has not been taken

Data type

text

Alias
UMLS CUI [1]
C0005834
Biochemistry
Description

Biochemistry

Alias
UMLS CUI-1
C0005477
result of the ALT measurement
Description

ND = not done

Data type

integer

Alias
UMLS CUI [1]
C0201836
abnormalities of the ALT measurement
Description

if the result is outside the normal range, please repeat the blood sample

Data type

integer

Alias
UMLS CUI [1,1]
C1704258
UMLS CUI [1,2]
C0201836
results of the AST measurement
Description

ND = not done

Data type

integer

Alias
UMLS CUI [1]
C0201899
abnormalities of the AST measurement
Description

if the result is outside the normal range, please repeat the blood sample

Data type

integer

Alias
UMLS CUI [1,1]
C1704258
UMLS CUI [1,2]
C0201899
Serology
Description

Serology

Alias
UMLS CUI-1
C0036743
result of the anti-HAV measurement
Description

ND = not done

Data type

integer

Alias
UMLS CUI [1]
C0062524
result of the anti-HBs measurement
Description

ND = not done

Data type

integer

Alias
UMLS CUI [1]
C0201478
result of the anti-HBc measurement
Description

ND = not done

Data type

integer

Alias
UMLS CUI [1]
C0312631
result of the HBsAg measurement
Description

ND = not done

Data type

integer

Alias
UMLS CUI [1]
C0019168
Administrative Data
Description

Administrative Data

Alias
UMLS CUI-1
C1320722
Comments, if any
Description

Comments

Data type

text

Alias
UMLS CUI [1]
C0947611
Date :
Description

day/month/year

Data type

date

Alias
UMLS CUI [1]
C0011008
Investigator Signature :
Description

Signature

Data type

text

Alias
UMLS CUI [1]
C2346576
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Similar models

Visit 1 Laboratory Tests Biologicals HepA/HepB vaccine 208127/125

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
Header
C1320722 (UMLS CUI-1)
Protocol
Item
Protocol
text
C1507394 (UMLS CUI [1])
Activity
Item
Activity
text
C1512346 (UMLS CUI [1])
Date of activity
Item
Date of activity
date
C1320303 (UMLS CUI [1])
Subject number
Item
Subject number
text
C2348585 (UMLS CUI [1])
Item Group
Laboratory tests - Screening
C0022885 (UMLS CUI-1)
Blood sample
Item
Has blood sample been taken ?
boolean
C0005834 (UMLS CUI [1])
Date of blood sampling
Item
Date of blood sampling :
date
C0178913 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
No blood sample taken
Item
Please comment :
text
C0005834 (UMLS CUI [1])
Item Group
Biochemistry
C0005477 (UMLS CUI-1)
ALT measurement result
Item
result of the ALT measurement
integer
C0201836 (UMLS CUI [1])
Item
abnormalities of the ALT measurement
integer
C1704258 (UMLS CUI [1,1])
C0201836 (UMLS CUI [1,2])
ALT measurement abnormalities
Code List
abnormalities of the ALT measurement
CL Item
laboratory error (1)
CL Item
preexisting/concomitant medical condition (2)
CL Item
prior/concomitant medication (3)
CL Item
unknown (4)
Item
results of the AST measurement
integer
C0201899 (UMLS CUI [1])
AST measurement
Code List
results of the AST measurement
Item
abnormalities of the AST measurement
integer
C1704258 (UMLS CUI [1,1])
C0201899 (UMLS CUI [1,2])
AST measurement abnormalities
Code List
abnormalities of the AST measurement
CL Item
laboratory error (1)
CL Item
preexisting/concomitant medical condition (2)
CL Item
prior/concomitant medication (3)
CL Item
unknown (4)
Item Group
Serology
C0036743 (UMLS CUI-1)
anti-HAV measurement result
Item
result of the anti-HAV measurement
integer
C0062524 (UMLS CUI [1])
anti-HBs measurement result
Item
result of the anti-HBs measurement
integer
C0201478 (UMLS CUI [1])
Item
result of the anti-HBc measurement
integer
C0312631 (UMLS CUI [1])
anti-HBc measurement
Code List
result of the anti-HBc measurement
HBsAg measurement result
Item
result of the HBsAg measurement
integer
C0019168 (UMLS CUI [1])
Item Group
Administrative Data
C1320722 (UMLS CUI-1)
Comments
Item
Comments, if any
text
C0947611 (UMLS CUI [1])
Date
Item
Date :
date
C0011008 (UMLS CUI [1])
Signature
Item
Investigator Signature :
text
C2346576 (UMLS CUI [1])
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