ID
43848
Beskrivning
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
Nyckelord
Versioner (2)
- 2017-10-11 2017-10-11 -
- 2021-09-20 2021-09-20 -
Rättsinnehavare
Glaxo Smith Kline
Uppladdad den
20 september 2021
DOI
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Licens
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
Beskrivning
Demographics
Alias
- UMLS CUI-1
- C0011298
Beskrivning
Date of birth
Datatyp
date
Alias
- UMLS CUI [1]
- C0421451
Beskrivning
Gender
Datatyp
integer
Alias
- UMLS CUI [1]
- C0079399
Beskrivning
Race
Datatyp
integer
Alias
- UMLS CUI [1]
- C0034510
Beskrivning
Race
Datatyp
text
Alias
- UMLS CUI [1]
- C0034510
Beskrivning
Serious adverse event
Datatyp
boolean
Alias
- UMLS CUI [1]
- C1519255
Beskrivning
Check SAE form(s) have been submitted to GSK Biologicals
Datatyp
integer
Alias
- UMLS CUI [1]
- C1519255
Beskrivning
Laboratory Tests
Alias
- UMLS CUI-1
- C0022885
Beskrivning
Blood sample
Datatyp
boolean
Alias
- UMLS CUI [1]
- C0005834
Beskrivning
Please complete only if different from visit date
Datatyp
date
Alias
- UMLS CUI [1]
- C1302413
Beskrivning
Vaccination since last visit
Datatyp
boolean
Alias
- UMLS CUI [1,1]
- C3543421
- UMLS CUI [1,2]
- C0589121
Beskrivning
Hepatitis vaccines
Datatyp
integer
Alias
- UMLS CUI [1]
- C3543421
Beskrivning
Hepatitis A and/or Hepatitis B immunoglobulins past 6 months
Datatyp
boolean
Alias
- UMLS CUI [1,1]
- C3652495
- UMLS CUI [1,2]
- C0062525
- UMLS CUI [1,3]
- C3828652
Beskrivning
Hepatitis A and/or Hepatitis B immunoglobulins
Datatyp
integer
Alias
- UMLS CUI [1,1]
- C3652495
- UMLS CUI [1,2]
- C0062525
Beskrivning
Blood sample conclusion
Alias
- UMLS CUI-1
- C0178913
- UMLS CUI-2
- C1254595
Beskrivning
Seronegativity anti-HAV antibodies
Datatyp
boolean
Alias
- UMLS CUI [1,1]
- C0521144
- UMLS CUI [1,2]
- C0062524
Beskrivning
seroprotective titres anti-HBs antibodies
Datatyp
boolean
Alias
- UMLS CUI [1,1]
- C0312543
- UMLS CUI [1,2]
- C0201478
Beskrivning
Additional Vaccination consent
Datatyp
boolean
Alias
- UMLS CUI [1,1]
- C2713304
- UMLS CUI [1,2]
- C0021430
Beskrivning
Investigator Signature
Alias
- UMLS CUI-1
- C2346576
Beskrivning
Confirmation
Datatyp
boolean
Alias
- UMLS CUI [1]
- C0750484
Beskrivning
Investigator Signature
Datatyp
text
Alias
- UMLS CUI [1]
- C2346576
Beskrivning
Investigator name
Datatyp
text
Alias
- UMLS CUI [1]
- C2826892
Beskrivning
Date of completion
Datatyp
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])