Informações:
Falhas:
ID
43848
Descrição
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
Palavras-chave
Versões (2)
- 11/10/2017 11/10/2017 -
- 20/09/2021 20/09/2021 -
Titular dos direitos
Glaxo Smith Kline
Transferido a
20 de setembro de 2021
DOI
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Licença
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
Similar models
Long Term Follow up Year 6
- StudyEvent: ODM
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de dados
Alias
Study site identifier
Item
Center
text
C2826692 (UMLS CUI [1])
Subject number
Item
Subject number
text
C2348585 (UMLS CUI [1])
Treatment Number
Item
Treatment Number
text
C1522541 (UMLS CUI [1])
Date of visit
Item
Date of visit
date
C1320303 (UMLS CUI [1])
Informed consent
Item
I certify that Informed Consent has been obtained prior to any study procedure.
boolean
C0021430 (UMLS CUI [1])
Informed Consent Date
Item
Informed Consent Date
date
C2985782 (UMLS CUI [1])
CL Item
100386 (HAB-158 EXT:082 Y5) (1)
Date of birth
Item
Date of birth
date
C0421451 (UMLS CUI [1])
CL Item
Male (1)
CL Item
Female (2)
CL Item
Black (1)
CL Item
Arabic/North African (4)
CL Item
White/Caucasian (2)
CL Item
East & South East Asian (5)
CL Item
South Asian (6)
CL Item
Other,please specify (9)
Race
Item
Race, if other please specify
text
C0034510 (UMLS CUI [1])
Serious adverse event
Item
Has the subject had any serious adverse event since the end of the primary phase and before the start of this additional vaccination ?
boolean
C1519255 (UMLS CUI [1])
Serious adverse event
Item
Specify number of SAEs
integer
C1519255 (UMLS CUI [1])
Blood sample
Item
Has a blood sample been taken for testing anti-HAV and anti-HBs antibodies?
boolean
C0005834 (UMLS CUI [1])
Sample Collection Date
Item
Sample Collection Date
date
C1302413 (UMLS CUI [1])
Vaccination since last visit
Item
Has the subject received a dose of monovalent or combined Hepatitis A or Hepatitis B vaccine?
boolean
C3543421 (UMLS CUI [1,1])
C0589121 (UMLS CUI [1,2])
C0589121 (UMLS CUI [1,2])
CL Item
Hepatitis A vaccine (1)
CL Item
Hepatitis B vaccine (2)
CL Item
Combined Hepatitis A and B vaccine (3)
Hepatitis A and/or Hepatitis B immunoglobulins past 6 months
Item
Has the subject received a dose of Hepatitis A and/or Hepatitis B immunoglobulins within 6 months prior to bleeding?
boolean
C3652495 (UMLS CUI [1,1])
C0062525 (UMLS CUI [1,2])
C3828652 (UMLS CUI [1,3])
C0062525 (UMLS CUI [1,2])
C3828652 (UMLS CUI [1,3])
Item
If yes, please specify
integer
C3652495 (UMLS CUI [1,1])
C0062525 (UMLS CUI [1,2])
C0062525 (UMLS CUI [1,2])
CL Item
Hepatitis A immunoglobulins (1)
CL Item
Hepatitis B immunoglobulins (2)
Item Group
Blood sample conclusion
C0178913 (UMLS CUI-1)
C1254595 (UMLS CUI-2)
C1254595 (UMLS CUI-2)
Seronegativity anti-HAV antibodies
Item
Has the patient become seronegative for anti-HAV antibodies
boolean
C0521144 (UMLS CUI [1,1])
C0062524 (UMLS CUI [1,2])
C0062524 (UMLS CUI [1,2])
seroprotective titres anti-HBs antibodies
Item
Has the patient lost seroprotective titres for anti-HBs antibodies
boolean
C0312543 (UMLS CUI [1,1])
C0201478 (UMLS CUI [1,2])
C0201478 (UMLS CUI [1,2])
Additional Vaccination consent
Item
If at least one answer is YES, is the subject than willing to receive an Additional Vaccination?
boolean
C2713304 (UMLS CUI [1,1])
C0021430 (UMLS CUI [1,2])
C0021430 (UMLS CUI [1,2])
Confirmation
Item
I confirm that I have reviewed the data in this Case Report Form for this subject. All information entered by myself or my colleagues is, to the best of my knowledge, complete and accurate, as of the date below.
boolean
C0750484 (UMLS CUI [1])
Investigator Signature
Item
Investigator Signature
text
C2346576 (UMLS CUI [1])
Investigator name
Item
Investigator name
text
C2826892 (UMLS CUI [1])
Date of completion
Item
Date
date
C1549507 (UMLS CUI [1])