ID
43848
Description
Phase III, open, randomized study, in two centres, to demonstrate the equivalence of the 0, 12 month schedule to the 0, 6 month schedule with respect to the immunogenicity and to evaluate the safety and reactogenicity of GlaxoSmithKline Biologicals’ combined hepatitis A/ hepatitis B vaccine TWINRIX™ ADULT (720 EL. U. of hepatitis A antigen/ 20 μg of recombinant hepatitis B surface antigen) in healthy volunteers aged from 12 to 15 years inclusive. NCT00197171
Keywords
Versions (2)
- 10/11/17 10/11/17 -
- 9/20/21 9/20/21 -
Copyright Holder
Glaxo Smith Kline
Uploaded on
September 20, 2021
DOI
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License
Creative Commons BY-NC 3.0
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GSK Study ID 100386 & 100387 Persistence of immune response to TWINRIX™ ADULT Long Term Follow up Year 6
Long Term Follow up Year 6
- StudyEvent: ODM
Description
Demographics
Alias
- UMLS CUI-1
- C0011298
Description
Date of birth
Data type
date
Alias
- UMLS CUI [1]
- C0421451
Description
Gender
Data type
integer
Alias
- UMLS CUI [1]
- C0079399
Description
Race
Data type
integer
Alias
- UMLS CUI [1]
- C0034510
Description
Race
Data type
text
Alias
- UMLS CUI [1]
- C0034510
Description
Serious adverse event
Data type
boolean
Alias
- UMLS CUI [1]
- C1519255
Description
Check SAE form(s) have been submitted to GSK Biologicals
Data type
integer
Alias
- UMLS CUI [1]
- C1519255
Description
Laboratory Tests
Alias
- UMLS CUI-1
- C0022885
Description
Blood sample
Data type
boolean
Alias
- UMLS CUI [1]
- C0005834
Description
Please complete only if different from visit date
Data type
date
Alias
- UMLS CUI [1]
- C1302413
Description
Vaccination since last visit
Data type
boolean
Alias
- UMLS CUI [1,1]
- C3543421
- UMLS CUI [1,2]
- C0589121
Description
Hepatitis vaccines
Data type
integer
Alias
- UMLS CUI [1]
- C3543421
Description
Hepatitis A and/or Hepatitis B immunoglobulins past 6 months
Data type
boolean
Alias
- UMLS CUI [1,1]
- C3652495
- UMLS CUI [1,2]
- C0062525
- UMLS CUI [1,3]
- C3828652
Description
Hepatitis A and/or Hepatitis B immunoglobulins
Data type
integer
Alias
- UMLS CUI [1,1]
- C3652495
- UMLS CUI [1,2]
- C0062525
Description
Blood sample conclusion
Alias
- UMLS CUI-1
- C0178913
- UMLS CUI-2
- C1254595
Description
Seronegativity anti-HAV antibodies
Data type
boolean
Alias
- UMLS CUI [1,1]
- C0521144
- UMLS CUI [1,2]
- C0062524
Description
seroprotective titres anti-HBs antibodies
Data type
boolean
Alias
- UMLS CUI [1,1]
- C0312543
- UMLS CUI [1,2]
- C0201478
Description
Additional Vaccination consent
Data type
boolean
Alias
- UMLS CUI [1,1]
- C2713304
- UMLS CUI [1,2]
- C0021430
Description
Investigator Signature
Alias
- UMLS CUI-1
- C2346576
Description
Confirmation
Data type
boolean
Alias
- UMLS CUI [1]
- C0750484
Description
Investigator Signature
Data type
text
Alias
- UMLS CUI [1]
- C2346576
Description
Investigator name
Data type
text
Alias
- UMLS CUI [1]
- C2826892
Description
Date of completion
Data type
date
Alias
- UMLS CUI [1]
- C1549507
Similar models
Long Term Follow up Year 6
- StudyEvent: ODM
C0589121 (UMLS CUI [1,2])
C0062525 (UMLS CUI [1,2])
C3828652 (UMLS CUI [1,3])
C0062525 (UMLS CUI [1,2])
C1254595 (UMLS CUI-2)
C0062524 (UMLS CUI [1,2])
C0201478 (UMLS CUI [1,2])
C0021430 (UMLS CUI [1,2])