ID
43848
Beschreibung
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
Stichworte
Versionen (2)
- 11.10.17 11.10.17 -
- 20.09.21 20.09.21 -
Rechteinhaber
Glaxo Smith Kline
Hochgeladen am
20. September 2021
DOI
Für eine Beantragung loggen Sie sich ein.
Lizenz
Creative Commons BY-NC 3.0
Modell Kommentare :
Hier können Sie das Modell kommentieren. Über die Sprechblasen an den Itemgruppen und Items können Sie diese spezifisch kommentieren.
Itemgroup Kommentare für :
Item Kommentare für :
Um Formulare herunterzuladen müssen Sie angemeldet sein. Bitte loggen Sie sich ein oder registrieren Sie sich kostenlos.
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
Beschreibung
Demographics
Alias
- UMLS CUI-1
- C0011298
Beschreibung
Date of birth
Datentyp
date
Alias
- UMLS CUI [1]
- C0421451
Beschreibung
Gender
Datentyp
integer
Alias
- UMLS CUI [1]
- C0079399
Beschreibung
Race
Datentyp
integer
Alias
- UMLS CUI [1]
- C0034510
Beschreibung
Race
Datentyp
text
Alias
- UMLS CUI [1]
- C0034510
Beschreibung
Serious adverse event
Datentyp
boolean
Alias
- UMLS CUI [1]
- C1519255
Beschreibung
Check SAE form(s) have been submitted to GSK Biologicals
Datentyp
integer
Alias
- UMLS CUI [1]
- C1519255
Beschreibung
Laboratory Tests
Alias
- UMLS CUI-1
- C0022885
Beschreibung
Blood sample
Datentyp
boolean
Alias
- UMLS CUI [1]
- C0005834
Beschreibung
Please complete only if different from visit date
Datentyp
date
Alias
- UMLS CUI [1]
- C1302413
Beschreibung
Vaccination since last visit
Datentyp
boolean
Alias
- UMLS CUI [1,1]
- C3543421
- UMLS CUI [1,2]
- C0589121
Beschreibung
Hepatitis vaccines
Datentyp
integer
Alias
- UMLS CUI [1]
- C3543421
Beschreibung
Hepatitis A and/or Hepatitis B immunoglobulins past 6 months
Datentyp
boolean
Alias
- UMLS CUI [1,1]
- C3652495
- UMLS CUI [1,2]
- C0062525
- UMLS CUI [1,3]
- C3828652
Beschreibung
Hepatitis A and/or Hepatitis B immunoglobulins
Datentyp
integer
Alias
- UMLS CUI [1,1]
- C3652495
- UMLS CUI [1,2]
- C0062525
Beschreibung
Blood sample conclusion
Alias
- UMLS CUI-1
- C0178913
- UMLS CUI-2
- C1254595
Beschreibung
Seronegativity anti-HAV antibodies
Datentyp
boolean
Alias
- UMLS CUI [1,1]
- C0521144
- UMLS CUI [1,2]
- C0062524
Beschreibung
seroprotective titres anti-HBs antibodies
Datentyp
boolean
Alias
- UMLS CUI [1,1]
- C0312543
- UMLS CUI [1,2]
- C0201478
Beschreibung
Additional Vaccination consent
Datentyp
boolean
Alias
- UMLS CUI [1,1]
- C2713304
- UMLS CUI [1,2]
- C0021430
Beschreibung
Investigator Signature
Alias
- UMLS CUI-1
- C2346576
Beschreibung
Confirmation
Datentyp
boolean
Alias
- UMLS CUI [1]
- C0750484
Beschreibung
Investigator Signature
Datentyp
text
Alias
- UMLS CUI [1]
- C2346576
Beschreibung
Investigator name
Datentyp
text
Alias
- UMLS CUI [1]
- C2826892
Beschreibung
Date of completion
Datentyp
date
Alias
- UMLS CUI [1]
- C1549507
Ähnliche Modelle
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])