ID
24852
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 14 - YEAR 9 - 108 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 (2)
- 19-08-17 19-08-17 -
- 17-09-21 17-09-21 -
Houder van rechten
glaxoSmithKline
Geüploaded op
19 augustus 2017
DOI
Voor een aanvraag inloggen.
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 14
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 14
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
Follow-up studies
Alias
- UMLS CUI-1
- C0016441
- UMLS CUI-2
- C0042210
Beschrijving
Would the subject be willing to participate in a follow-up study?
Datatype
integer
Alias
- UMLS CUI [1,1]
- C0016441
- UMLS CUI [1,2]
- C2348568
- UMLS CUI [1,3]
- C0600109
Beschrijving
I you answered previous question with 'no' please specify the most appropriate reason.
Datatype
text
Alias
- UMLS CUI [1,1]
- C2348568
- UMLS CUI [1,2]
- C0392360
Beschrijving
Please specify Adverse Event or Serious adverse event
Datatype
text
Alias
- UMLS CUI [1,1]
- C0559546
- UMLS CUI [1,2]
- C1521902
- UMLS CUI [2,1]
- C1519255
- UMLS CUI [2,2]
- C1521902
Beschrijving
other reason for non-participation
Datatype
text
Alias
- UMLS CUI [1,1]
- C3840932
- UMLS CUI [1,2]
- C1521902
Beschrijving
serious adverse event since last visit
Datatype
boolean
Alias
- UMLS CUI [1,1]
- C1519255
- UMLS CUI [1,2]
- C2047944
Beschrijving
Investigator's signature
Alias
- UMLS CUI-1
- C2346576
Beschrijving
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.
Datatype
text
Alias
- UMLS CUI [1]
- C2346576
Beschrijving
Investigator signature date
Datatype
date
Alias
- UMLS CUI [1,1]
- C2346576
- UMLS CUI [1,2]
- C0011008
Beschrijving
Investigator name
Datatype
text
Alias
- UMLS CUI [1]
- C2826892
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 14
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C0201473 (UMLS CUI [1,2])
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