ID
24773
Beschrijving
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 11 - YEAR 6 - 72 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
Trefwoorden
Versies (3)
- 16-08-17 16-08-17 -
- 16-08-17 16-08-17 -
- 17-09-21 17-09-21 -
Houder van rechten
glaxoSmithKline
Geüploaded op
16 augustus 2017
DOI
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Licentie
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 11
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 11
Beschrijving
Demographics
Alias
- UMLS CUI-1
- C1704791
Beschrijving
LONG-TERM FOLLOW-UP PREVIOUS STUDY 208127/106 (EXT HAB-084) – Month 60 Subject number will be the same as in the previous study.
Datatype
text
Alias
- UMLS CUI [1,1]
- C1301943
- UMLS CUI [1,2]
- C0600091
Beschrijving
Date of Birth
Datatype
date
Alias
- UMLS CUI [1]
- C0421451
Beschrijving
Gender
Datatype
text
Alias
- UMLS CUI [1]
- C0079399
Beschrijving
Laboratory Tests
Alias
- UMLS CUI-1
- C0022885
Beschrijving
Blood sample taken for testing anti-HAV or anti-HBs
Datatype
boolean
Alias
- UMLS CUI [1,1]
- C1277698
- UMLS CUI [1,2]
- C0201473
- UMLS CUI [2,1]
- C1277698
- UMLS CUI [2,2]
- C0201478
Beschrijving
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.
Datatype
date
Alias
- UMLS CUI [1,1]
- C0011008
- UMLS CUI [1,2]
- C0005834
Beschrijving
A dose of monovalent or combined Hepatitis A or Hepatitis B vaccine
Datatype
boolean
Alias
- UMLS CUI [1]
- C0170300
- UMLS CUI [2]
- C2240392
- UMLS CUI [3]
- C0593947
Beschrijving
Tracking Document - Reason for non participation
Alias
- UMLS CUI-1
- C2348568
- UMLS CUI-2
- C0392360
Beschrijving
Previous subject number
Datatype
text
Alias
- UMLS CUI [1,1]
- C2348585
- UMLS CUI [1,2]
- C0205156
Beschrijving
Date of birth
Datatype
date
Alias
- UMLS CUI [1]
- C0421451
Beschrijving
reason for non participation
Datatype
integer
Alias
- UMLS CUI [1,1]
- C2348568
- UMLS CUI [1,2]
- C0392360
Beschrijving
If you chose 'Subject not eligible' as reason for non participation, please specify.
Datatype
text
Alias
- UMLS CUI [1,1]
- C3828770
- UMLS CUI [1,2]
- C1521902
Beschrijving
Only, answer this question, if you chose 'Subject eligible but not willing to participate' as reason for non participation.
Datatype
integer
Alias
- UMLS CUI [1,1]
- C3846156
- UMLS CUI [1,2]
- C0392360
Beschrijving
If you chose 'adverse events or serious adverse event', please specify.
Datatype
text
Alias
- UMLS CUI [1,1]
- C0559546
- UMLS CUI [1,2]
- C1521902
- UMLS CUI [2,1]
- C1519255
- UMLS CUI [2,2]
- C1521902
Beschrijving
Please specify 'other' reason for eligible but not-willing to participate in study.
Datatype
text
Alias
- UMLS CUI [1,1]
- C3840932
- UMLS CUI [1,2]
- C1521902
Beschrijving
Please fill in Date of death, if you chose 'subject died on' as reason for non participation
Datatype
date
Alias
- UMLS CUI [1]
- C1148348
Beschrijving
Date of contact
Datatype
date
Alias
- UMLS CUI [1]
- C0805839
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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 11
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C0201473 (UMLS CUI [1,2])
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