ID
24775
Descripción
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 12 - YEAR 7 - 84 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
Palabras clave
Versiones (2)
- 16/8/17 16/8/17 -
- 17/9/21 17/9/21 -
Titular de derechos de autor
glaxoSmithKline
Subido en
16 de agosto de 2017
DOI
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Licencia
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 12
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 12
Descripción
Demographics
Alias
- UMLS CUI-1
- C1704791
Descripción
LONG-TERM FOLLOW-UP PREVIOUS STUDY 208127/106 (EXT HAB-084) – Month 60 Subject number will be the same as in the previous study.
Tipo de datos
text
Alias
- UMLS CUI [1,1]
- C1301943
- UMLS CUI [1,2]
- C0600091
Descripción
Date of Birth
Tipo de datos
date
Alias
- UMLS CUI [1]
- C0421451
Descripción
Gender
Tipo de datos
text
Alias
- UMLS CUI [1]
- C0079399
Descripción
Laboratory Tests
Alias
- UMLS CUI-1
- C0022885
Descripción
Blood sample taken for testing anti-HAV or anti-HBs
Tipo de datos
boolean
Alias
- UMLS CUI [1,1]
- C1277698
- UMLS CUI [1,2]
- C0201473
- UMLS CUI [2,1]
- C1277698
- UMLS CUI [2,2]
- C0201478
Descripción
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.
Tipo de datos
date
Alias
- UMLS CUI [1,1]
- C0011008
- UMLS CUI [1,2]
- C0005834
Descripción
A dose of monovalent or combined Hepatitis A or Hepatitis B vaccine
Tipo de datos
boolean
Alias
- UMLS CUI [1]
- C0170300
- UMLS CUI [2]
- C2240392
- UMLS CUI [3]
- C0593947
Descripción
Follow-up studies
Alias
- UMLS CUI-1
- C0016441
- UMLS CUI-2
- C0042210
Descripción
Would the subject be willing to participate in a follow-up study?
Tipo de datos
integer
Alias
- UMLS CUI [1,1]
- C0016441
- UMLS CUI [1,2]
- C2348568
- UMLS CUI [1,3]
- C0600109
Descripción
I you answered previous question with 'no' please specify the most appropriate reason.
Tipo de datos
text
Alias
- UMLS CUI [1,1]
- C2348568
- UMLS CUI [1,2]
- C0392360
Descripción
Please specify Adverse Event or Serious adverse event
Tipo de datos
text
Alias
- UMLS CUI [1,1]
- C0559546
- UMLS CUI [1,2]
- C1521902
- UMLS CUI [2,1]
- C1519255
- UMLS CUI [2,2]
- C1521902
Descripción
other reason for non-participation
Tipo de datos
text
Alias
- UMLS CUI [1,1]
- C3840932
- UMLS CUI [1,2]
- C1521902
Descripción
Investigator's signature
Alias
- UMLS CUI-1
- C2346576
Descripción
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.
Tipo de datos
text
Alias
- UMLS CUI [1]
- C2346576
Descripción
Investigator signature date
Tipo de datos
date
Alias
- UMLS CUI [1,1]
- C2346576
- UMLS CUI [1,2]
- C0011008
Descripción
Investigator name
Tipo de datos
text
Alias
- UMLS CUI [1]
- C2826892
Descripción
Tracking Document - Reason for non participation
Alias
- UMLS CUI-1
- C2348568
- UMLS CUI-2
- C0392360
Descripción
Previous subject number
Tipo de datos
text
Alias
- UMLS CUI [1,1]
- C2348585
- UMLS CUI [1,2]
- C0205156
Descripción
Date of birth
Tipo de datos
date
Alias
- UMLS CUI [1]
- C0421451
Descripción
reason for non participation
Tipo de datos
integer
Alias
- UMLS CUI [1,1]
- C2348568
- UMLS CUI [1,2]
- C0392360
Descripción
If you chose 'Subject not eligible' as reason for non participation, please specify.
Tipo de datos
text
Alias
- UMLS CUI [1,1]
- C3828770
- UMLS CUI [1,2]
- C1521902
Descripción
Only, answer this question, if you chose 'Subject eligible but not willing to participate' as reason for non participation.
Tipo de datos
integer
Alias
- UMLS CUI [1,1]
- C3846156
- UMLS CUI [1,2]
- C0392360
Descripción
If you chose 'adverse events or serious adverse event', please specify.
Tipo de datos
text
Alias
- UMLS CUI [1,1]
- C0559546
- UMLS CUI [1,2]
- C1521902
- UMLS CUI [2,1]
- C1519255
- UMLS CUI [2,2]
- C1521902
Descripción
Please specify 'other' reason for eligible but not-willing to participate in study.
Tipo de datos
text
Alias
- UMLS CUI [1,1]
- C3840932
- UMLS CUI [1,2]
- C1521902
Descripción
Please fill in Date of death, if you chose 'subject died on' as reason for non participation
Tipo de datos
date
Alias
- UMLS CUI [1]
- C1148348
Descripción
Date of contact
Tipo de datos
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 12
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C0201473 (UMLS CUI [1,2])
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C0392360 (UMLS CUI [1,2])
C1521902 (UMLS CUI [1,2])
C0392360 (UMLS CUI [1,2])
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C1519255 (UMLS CUI [2,1])
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