ID
42724
Description
GSK TWINRIX™ Hepatitis A and B Vaccine: Persistence of Immune Response in 0,6 Month vs. 0,1,6 Month Schedule NCT00197119 - Longterm Follow-up VISIT 13 - YEAR 8 - 96 MONTHS + 2 MONTHS Study ID: 100566 Clinical Study ID: 100566 Study Title: Evaluate Persistence of Immune Response of GSK Biologicals’ TWINRIX™ Vaccine Administered According to 0,6 Month Schedule Versus TWINRIX™ JUNIOR Administered According to 0,1,6 Month Schedule, in Subjects Aged 12-15 years at Time of First Vaccine Dose Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00197119 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: phase 3 Study Recruitment Status: Completed Generic Name: Hepatitis A (Inactivated), Hepatitis B (Recombinant) Vaccine Trade Name: BIO HAB; Twinrix Study Indication: Hepatitis A; Hepatitis B
Mots-clés
Versions (2)
- 19/08/2017 19/08/2017 -
- 17/09/2021 17/09/2021 -
Détendeur de droits
glaxoSmithKline
Téléchargé le
17 septembre 2021
DOI
Pour une demande vous connecter.
Licence
Creative Commons BY-NC 3.0
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GSK TWINRIX™ Hepatitis A and B Vaccine: Persistence of Immune Response in 0,6 Month vs. 0,1,6 Month Schedule NCT00197119 - Longterm Follow-up Visit 13
GSK TWINRIX™ Hepatitis A and B Vaccine: Persistence of Immune Response in 0,6 Month vs. 0,1,6 Month Schedule NCT00197119 - Longterm Follow-up Visit 13
Description
Demographics
Alias
- UMLS CUI-1
- C1704791
Description
LONG-TERM FOLLOW-UP PREVIOUS STUDY 208127/106 (EXT HAB-084) – Month 60 Subject number will be the same as in the previous study.
Type de données
text
Alias
- UMLS CUI [1,1]
- C1301943
- UMLS CUI [1,2]
- C0600091
Description
Date of Birth
Type de données
date
Alias
- UMLS CUI [1]
- C0421451
Description
Gender
Type de données
text
Alias
- UMLS CUI [1]
- C0079399
Description
Laboratory Tests
Alias
- UMLS CUI-1
- C0022885
Description
Blood sample taken for testing anti-HAV or anti-HBs
Type de données
boolean
Alias
- UMLS CUI [1,1]
- C1277698
- UMLS CUI [1,2]
- C0201473
- UMLS CUI [2,1]
- C1277698
- UMLS CUI [2,2]
- C0201478
Description
Only answer if blood sample for testing anti-HAV or anti-HBs was taken and if the date the blood sample was taken is different from visit date.
Type de données
date
Alias
- UMLS CUI [1,1]
- C0011008
- UMLS CUI [1,2]
- C0005834
Description
A dose of monovalent or combined Hepatitis A or Hepatitis B vaccine
Type de données
boolean
Alias
- UMLS CUI [1]
- C0170300
- UMLS CUI [2]
- C2240392
- UMLS CUI [3]
- C5397396
Description
Follow-up studies
Alias
- UMLS CUI-1
- C0016441
- UMLS CUI-2
- C0042210
Description
Would the subject be willing to participate in a follow-up study?
Type de données
integer
Alias
- UMLS CUI [1,1]
- C0016441
- UMLS CUI [1,2]
- C2348568
- UMLS CUI [1,3]
- C0600109
Description
I you answered previous question with 'no' please specify the most appropriate reason.
Type de données
text
Alias
- UMLS CUI [1,1]
- C2348568
- UMLS CUI [1,2]
- C0392360
Description
Please specify Adverse Event or Serious adverse event
Type de données
text
Alias
- UMLS CUI [1,1]
- C0559546
- UMLS CUI [1,2]
- C1521902
- UMLS CUI [2,1]
- C1519255
- UMLS CUI [2,2]
- C1521902
Description
other reason for non-participation
Type de données
text
Alias
- UMLS CUI [1,1]
- C3840932
- UMLS CUI [1,2]
- C1521902
Description
Investigator's signature
Alias
- UMLS CUI-1
- C2346576
Description
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.
Type de données
text
Alias
- UMLS CUI [1]
- C2346576
Description
Investigator signature date
Type de données
date
Alias
- UMLS CUI [1,1]
- C2346576
- UMLS CUI [1,2]
- C0011008
Description
Investigator name
Type de données
text
Alias
- UMLS CUI [1]
- C2826892
Description
Tracking Document - Reason for non participation
Alias
- UMLS CUI-1
- C2348568
- UMLS CUI-2
- C0392360
Description
Previous subject number
Type de données
text
Alias
- UMLS CUI [1,1]
- C2348585
- UMLS CUI [1,2]
- C0205156
Description
Date of birth
Type de données
date
Alias
- UMLS CUI [1]
- C0421451
Description
reason for non participation
Type de données
integer
Alias
- UMLS CUI [1,1]
- C2348568
- UMLS CUI [1,2]
- C0392360
Description
If you chose 'Subject not eligible' as reason for non participation, please specify.
Type de données
text
Alias
- UMLS CUI [1,1]
- C3828770
- UMLS CUI [1,2]
- C1521902
Description
Only, answer this question, if you chose 'Subject eligible but not willing to participate' as reason for non participation.
Type de données
integer
Alias
- UMLS CUI [1,1]
- C3846156
- UMLS CUI [1,2]
- C0392360
Description
If you chose 'adverse events or serious adverse event', please specify.
Type de données
text
Alias
- UMLS CUI [1,1]
- C0559546
- UMLS CUI [1,2]
- C1521902
- UMLS CUI [2,1]
- C1519255
- UMLS CUI [2,2]
- C1521902
Description
Please specify 'other' reason for eligible but not-willing to participate in study.
Type de données
text
Alias
- UMLS CUI [1,1]
- C3840932
- UMLS CUI [1,2]
- C1521902
Description
Please fill in Date of death, if you chose 'subject died on' as reason for non participation
Type de données
date
Alias
- UMLS CUI [1]
- C1148348
Description
Date of contact
Type de données
date
Alias
- UMLS CUI [1]
- C0805839
Similar models
GSK TWINRIX™ Hepatitis A and B Vaccine: Persistence of Immune Response in 0,6 Month vs. 0,1,6 Month Schedule NCT00197119 - Longterm Follow-up Visit 13
C0600091 (UMLS CUI [1,2])
C0201473 (UMLS CUI [1,2])
C1277698 (UMLS CUI [2,1])
C0201478 (UMLS CUI [2,2])
C0005834 (UMLS CUI [1,2])
C2240392 (UMLS CUI [2])
C5397396 (UMLS CUI [3])
C2348568 (UMLS CUI [1,2])
C0600109 (UMLS CUI [1,3])
C0392360 (UMLS CUI [1,2])
C1521902 (UMLS CUI [1,2])
C1519255 (UMLS CUI [2,1])
C1521902 (UMLS CUI [2,2])
C1521902 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,2])
C0392360 (UMLS CUI-2)
C0205156 (UMLS CUI [1,2])
C0392360 (UMLS CUI [1,2])
C1521902 (UMLS CUI [1,2])
C0392360 (UMLS CUI [1,2])
C1521902 (UMLS CUI [1,2])
C1519255 (UMLS CUI [2,1])
C1521902 (UMLS CUI [2,2])
C1521902 (UMLS CUI [1,2])