ID

44093

Description

Study ID: 100565 Clinical Study ID: 100565 Study Title: An open study to evaluate the immunogenicity, safety and reactogenicity of GlaxoSmithKline Biologicals' commercially available combined hepatitis A / hepatitis B vaccine (TWINRIX ADULT) containing 720 ELISA units of hepatitis A antigen and 20 µg of hepatitis B surface antigen, administered following a two-dose (0, 6 months) schedule in healthy children between the ages of 1 and 11 years Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: Sponsor: GlaxoSmithKline 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 (3)
  1. 3/20/19 3/20/19 -
  2. 4/4/19 4/4/19 -
  3. 9/20/21 9/20/21 -
Copyright Holder

GlaxoSmithKline

Uploaded on

September 20, 2021

DOI

To request one please log in.

License

Creative Commons BY-NC 3.0
Model comments :

You can comment on the data model here. Via the speech bubbles at the itemgroups and items you can add comments to those specificially.

Back to model comments
Itemgroup comments for :

Item comments for :

In order to download data models you must be logged in. Please log in or register for free.

Immunogenicity, safety and reactogenicity of combined hepatitis A / hepatitis B vaccine (TWINRIX ADULT) in healthy children (100565)

English

Long-Term Follow-Up (Visit 13, Year 10) - Informed Consent; Demographics; Laboratory Tests; Serology Conclusion Before Booster

1 forms  
Administrative
Description

Administrative

Alias
UMLS CUI-1
C1320722
Subject number
Description

Subject number

Data type

integer

Alias
UMLS CUI [1]
C2348585
Date of visit
Description

Date of visit

Data type

date

Alias
UMLS CUI [1]
C1320303
Informed Consent
Description

Informed Consent

Alias
UMLS CUI-1
C0021430
Informed Consent Date
Description

I certify that Informed Consent has been obtained prior to any study procedure.

Data type

date

Alias
UMLS CUI [1]
C2985782
Demographics
Description

Demographics

Alias
UMLS CUI-1
C1704791
Center Number
Description

Center Number

Data type

integer

Alias
UMLS CUI [1,1]
C1301943
UMLS CUI [1,2]
C0600091
Date of birth
Description

Date of birth

Data type

date

Alias
UMLS CUI [1]
C0421451
Gender
Description

Gender

Data type

text

Alias
UMLS CUI [1]
C0079399
Laboratory Tests
Description

Laboratory Tests

Alias
UMLS CUI-1
C0022885
Has a blood sample been taken for testing anti-HAV and anti-HBs antibodies?
Description

Has a blood sample been taken for testing anti-HAV and anti-HBs antibodies?

Data type

boolean

Alias
UMLS CUI [1,1]
C0005834
UMLS CUI [1,2]
C0201473
UMLS CUI [2,1]
C0005834
UMLS CUI [2,2]
C0201478
Date blood sample taken
Description

Please complete only if different from visit date

Data type

date

Alias
UMLS CUI [1,1]
C1277698
UMLS CUI [1,2]
C0011008
Has the subject received since the last visit - A dose of monovalent or combined Hepatitis A or Hepatitis B vaccine?
Description

Has the subject received since the last visit - A dose of monovalent or combined Hepatitis A or Hepatitis B vaccine?

Data type

boolean

Alias
UMLS CUI [1,1]
C0170300
UMLS CUI [1,2]
C2240392
If subject has received Hepatitis A or Hepatitis B vaccine, please specify
Description

If subject has received Hepatitis A or Hepatitis B vaccine, please specify

Data type

integer

Alias
UMLS CUI [1,1]
C0170300
UMLS CUI [1,2]
C2348235
UMLS CUI [2,1]
C2240392
UMLS CUI [2,2]
C2348235
Has the subject received since the last visit - A dose of Hepatitis A or Hepatitis B immunoglobulins within 6 months prior to bleeding?
Description

Has the subject received since the last visit - A dose of Hepatitis A or Hepatitis B immunoglobulins within 6 months prior to bleeding?

Data type

boolean

Alias
UMLS CUI [1,1]
C3652495
UMLS CUI [1,2]
C0019080
UMLS CUI [1,3]
C0332152
UMLS CUI [2,1]
C0062525
UMLS CUI [2,2]
C0019080
UMLS CUI [2,3]
C0332152
If the subject received Hepatitis A or Hepatitis B immunoglobulins since the last visit, please specify.
Description

If the subject received Hepatitis A or Hepatitis B immunoglobulins since the last visit, please specify.

Data type

integer

Alias
UMLS CUI [1,1]
C3652495
UMLS CUI [1,2]
C2348235
UMLS CUI [2,1]
C0062525
UMLS CUI [2,2]
C2348235
Serology Conclusion Before Booster
Description

Serology Conclusion Before Booster

Alias
UMLS CUI-1
C0036743
UMLS CUI-2
C1707478
UMLS CUI-3
C0419739
UMLS CUI-4
C0419731
Has the subject lost HBs antibodies at any of the 4 following time points: Y6 or Y7or Y8or Y9 or Y10 (= visit 13 included)?
Description

If YES, subject will receive either ENGERIX™, HAVRIX™ or TWINRIX™ as appropriate. Please complete the entire Case Report Form. If NO to both questions, please complete the SAE section and study conclusion section only.

Data type

boolean

Alias
UMLS CUI [1,1]
C0201478
UMLS CUI [1,2]
C2348792
Has the subject lost HAV antibodies at any of the 4 following time points: Y6 or Y7or Y8or Y9 or Y10 (= visit 13 included)?
Description

If YES, subject will receive either ENGERIX™, HAVRIX™ or TWINRIX™ as appropriate. Please complete the entire Case Report Form. If NO to both questions, please complete the SAE section and study conclusion section only.

Data type

boolean

Alias
UMLS CUI [1,1]
C0201473
UMLS CUI [1,2]
C2348792
Back to the top of the page

Similar models

Long-Term Follow-Up (Visit 13, Year 10) - Informed Consent; Demographics; Laboratory Tests; Serology Conclusion Before Booster

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
Administrative
C1320722 (UMLS CUI-1)
Subject number
Item
Subject number
integer
C2348585 (UMLS CUI [1])
Date of visit
Item
Date of visit
date
C1320303 (UMLS CUI [1])
Item Group
Informed Consent
C0021430 (UMLS CUI-1)
Informed Consent Date
Item
Informed Consent Date
date
C2985782 (UMLS CUI [1])
Item Group
Demographics
C1704791 (UMLS CUI-1)
Center Number
Item
Center Number
integer
C1301943 (UMLS CUI [1,1])
C0600091 (UMLS CUI [1,2])
Date of birth
Item
Date of birth
date
C0421451 (UMLS CUI [1])
Item
Gender
text
C0079399 (UMLS CUI [1])
Gender
Code List
Gender
CL Item
Female (F)
CL Item
Male (M)
Item Group
Laboratory Tests
C0022885 (UMLS CUI-1)
Has a blood sample been taken for testing anti-HAV and anti-HBs antibodies?
Item
Has a blood sample been taken for testing anti-HAV and anti-HBs antibodies?
boolean
C0005834 (UMLS CUI [1,1])
C0201473 (UMLS CUI [1,2])
C0005834 (UMLS CUI [2,1])
C0201478 (UMLS CUI [2,2])
Date blood sample taken
Item
Date blood sample taken
date
C1277698 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
Has the subject received since the last visit - A dose of monovalent or combined Hepatitis A or Hepatitis B vaccine?
Item
Has the subject received since the last visit - A dose of monovalent or combined Hepatitis A or Hepatitis B vaccine?
boolean
C0170300 (UMLS CUI [1,1])
C2240392 (UMLS CUI [1,2])
Item
If subject has received Hepatitis A or Hepatitis B vaccine, please specify
integer
C0170300 (UMLS CUI [1,1])
C2348235 (UMLS CUI [1,2])
C2240392 (UMLS CUI [2,1])
C2348235 (UMLS CUI [2,2])
If subject has received Hepatitis A or Hepatitis B vaccine, please specify
Code List
If subject has received Hepatitis A or Hepatitis B vaccine, please specify
CL Item
Hepatitis A vaccine (1)
CL Item
Hepatitis B vaccine (2)
CL Item
Combined Hepatitis A and B vaccine (3)
Has the subject received since the last visit - A dose of Hepatitis A or Hepatitis B immunoglobulins within 6 months prior to bleeding?
Item
Has the subject received since the last visit - A dose of Hepatitis A or Hepatitis B immunoglobulins within 6 months prior to bleeding?
boolean
C3652495 (UMLS CUI [1,1])
C0019080 (UMLS CUI [1,2])
C0332152 (UMLS CUI [1,3])
C0062525 (UMLS CUI [2,1])
C0019080 (UMLS CUI [2,2])
C0332152 (UMLS CUI [2,3])
Item
If the subject received Hepatitis A or Hepatitis B immunoglobulins since the last visit, please specify.
integer
C3652495 (UMLS CUI [1,1])
C2348235 (UMLS CUI [1,2])
C0062525 (UMLS CUI [2,1])
C2348235 (UMLS CUI [2,2])
undefined item
Code List
If the subject received Hepatitis A or Hepatitis B immunoglobulins since the last visit, please specify.
CL Item
Hepatitis A immunoglobulins (1)
CL Item
Hepatitis B immunoglobulins (2)
Item Group
Serology Conclusion Before Booster
C0036743 (UMLS CUI-1)
C1707478 (UMLS CUI-2)
C0419739 (UMLS CUI-3)
C0419731 (UMLS CUI-4)
Has the subject lost HBs antibodies at any of the 4 following time points: Y6 or Y7or Y8or Y9 or Y10?
Item
Has the subject lost HBs antibodies at any of the 4 following time points: Y6 or Y7or Y8or Y9 or Y10 (= visit 13 included)?
boolean
C0201478 (UMLS CUI [1,1])
C2348792 (UMLS CUI [1,2])
Has the subject lost HAV antibodies at any of the 4 following time points: Y6 or Y7or Y8or Y9 or Y10?
Item
Has the subject lost HAV antibodies at any of the 4 following time points: Y6 or Y7or Y8or Y9 or Y10 (= visit 13 included)?
boolean
C0201473 (UMLS CUI [1,1])
C2348792 (UMLS CUI [1,2])
Back to the top of the page 

Contact

Please use this form for feedback, questions and suggestions for improvements.

Fields marked with * are required.

Help

Do you need help on how to use the search function? Please watch the corresponding tutorial video for more details and learn how to use the search function most efficiently.

Watch Tutorial