ID
35986
Beschrijving
Study ID: 100556 (Y11) Clinical Study ID: 100556 Study Title: Long-Term Persistence Follow-up Study to Evaluate the Immune Persistence of GSK Biologicals' Combined Hepatitis A / Hepatitis B Vaccine in Healthy Adult Volunteers Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00289718 Sponsor: GlaxoSmithKline Phase: phase 3 Study Recruitment Status: Completed Generic Name: Hepatitis A (Inactivated), Hepatitis B (Recombinant) Vaccine Trade Name: Twinrix Study Indication: Hepatitis A; Hepatitis B
Trefwoorden
Versies (1)
- 08-04-19 08-04-19 -
Houder van rechten
GlaxoSmithKline
Geüploaded op
8 april 2019
DOI
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Licentie
Creative Commons BY-NC 3.0
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Immune Persistence of GSK Biologicals' Combined Hepatitis A / Hepatitis B Vaccine in Healthy Adult Volunteers NCT00289718
Long-Term Follow Up (Year 11) - Follow-Up Studies; Study Conclusion
Beschrijving
Follow-Up Studies
Alias
- UMLS CUI-1
- C0016441
Beschrijving
If No, please specify the most appropriate reason
Datatype
boolean
Alias
- UMLS CUI [1,1]
- C0016441
- UMLS CUI [1,2]
- C0600109
Beschrijving
If subject would not be willing to participate in a follow-up study, please specify the most appropriate reason
Datatype
integer
Alias
- UMLS CUI [1,1]
- C0016441
- UMLS CUI [1,2]
- C0558080
- UMLS CUI [1,3]
- C0392360
Beschrijving
If Adverse Event or Serious Adverse Event, please specify
Datatype
text
Alias
- UMLS CUI [1,1]
- C0877248
- UMLS CUI [1,2]
- C2348235
- UMLS CUI [2,1]
- C1519255
- UMLS CUI [2,2]
- C2348235
Beschrijving
If other, please specify
Datatype
text
Alias
- UMLS CUI [1,1]
- C0205394
- UMLS CUI [1,2]
- C2348235
Beschrijving
Study Conclusion
Alias
- UMLS CUI-1
- C1707478
- UMLS CUI-2
- C0008972
Beschrijving
If Yes, specify total number of SAE's
Datatype
boolean
Alias
- UMLS CUI [1]
- C1519255
- UMLS CUI [2]
- C2347804
- UMLS CUI [3]
- C2348563
Beschrijving
Total number of SAE's
Datatype
integer
Alias
- UMLS CUI [1,1]
- C1519255
- UMLS CUI [1,2]
- C0449788
Beschrijving
If Yes, complete the Pregnancy notification form.
Datatype
text
Alias
- UMLS CUI [1]
- C0032961
Beschrijving
If Yes, record major reason for withdrawal
Datatype
boolean
Alias
- UMLS CUI [1]
- C0422727
Beschrijving
Tick one box only
Datatype
text
Alias
- UMLS CUI [1,1]
- C2349954
- UMLS CUI [1,2]
- C0392360
Beschrijving
Please complete and submit SAE report
Datatype
integer
Alias
- UMLS CUI [1,1]
- C1519255
- UMLS CUI [1,2]
- C0237753
Beschrijving
Please complete Non-serious Adverse Event section
Datatype
text
Alias
- UMLS CUI [1,1]
- C1518404
- UMLS CUI [1,2]
- C0237753
- UMLS CUI [2,1]
- C1518404
- UMLS CUI [2,2]
- C0805701
Beschrijving
If protocol violation, please specify
Datatype
text
Alias
- UMLS CUI [1,1]
- C1709750
- UMLS CUI [1,2]
- C2348235
Beschrijving
If other reason, please specify
Datatype
text
Alias
- UMLS CUI [1,1]
- C3840932
- UMLS CUI [1,2]
- C2348235
Beschrijving
Who made the decision?
Datatype
text
Alias
- UMLS CUI [1]
- C0679006
Beschrijving
Date of last contact
Datatype
date
Alias
- UMLS CUI [1]
- C0805839
Beschrijving
If No, please give details in Adverse Events section.
Datatype
boolean
Alias
- UMLS CUI [1,1]
- C1142435
- UMLS CUI [1,2]
- C0681850
Beschrijving
Investigator 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
Similar models
Long-Term Follow Up (Year 11) - Follow-Up Studies; Study Conclusion
C0600109 (UMLS CUI [1,2])
C0558080 (UMLS CUI [1,2])
C0392360 (UMLS CUI [1,3])
C2348235 (UMLS CUI [1,2])
C1519255 (UMLS CUI [2,1])
C2348235 (UMLS CUI [2,2])
C2348235 (UMLS CUI [1,2])
C2347804 (UMLS CUI [2])
C2348563 (UMLS CUI [3])
C0449788 (UMLS CUI [1,2])
C0392360 (UMLS CUI [1,2])
C0237753 (UMLS CUI [1,2])
C0237753 (UMLS CUI [1,2])
C1518404 (UMLS CUI [2,1])
C0805701 (UMLS CUI [2,2])
C2348235 (UMLS CUI [1,2])
C2348235 (UMLS CUI [1,2])
C0681850 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,2])