ID
35986
Description
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
Keywords
Versions (1)
- 4/8/19 4/8/19 -
Copyright Holder
GlaxoSmithKline
Uploaded on
April 8, 2019
DOI
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License
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
Description
Follow-Up Studies
Alias
- UMLS CUI-1
- C0016441
Description
If No, please specify the most appropriate reason
Data type
boolean
Alias
- UMLS CUI [1,1]
- C0016441
- UMLS CUI [1,2]
- C0600109
Description
If subject would not be willing to participate in a follow-up study, please specify the most appropriate reason
Data type
integer
Alias
- UMLS CUI [1,1]
- C0016441
- UMLS CUI [1,2]
- C0558080
- UMLS CUI [1,3]
- C0392360
Description
If Adverse Event or Serious Adverse Event, please specify
Data type
text
Alias
- UMLS CUI [1,1]
- C0877248
- UMLS CUI [1,2]
- C2348235
- UMLS CUI [2,1]
- C1519255
- UMLS CUI [2,2]
- C2348235
Description
If other, please specify
Data type
text
Alias
- UMLS CUI [1,1]
- C0205394
- UMLS CUI [1,2]
- C2348235
Description
Study Conclusion
Alias
- UMLS CUI-1
- C1707478
- UMLS CUI-2
- C0008972
Description
If Yes, specify total number of SAE's
Data type
boolean
Alias
- UMLS CUI [1]
- C1519255
- UMLS CUI [2]
- C2347804
- UMLS CUI [3]
- C2348563
Description
Total number of SAE's
Data type
integer
Alias
- UMLS CUI [1,1]
- C1519255
- UMLS CUI [1,2]
- C0449788
Description
If Yes, complete the Pregnancy notification form.
Data type
text
Alias
- UMLS CUI [1]
- C0032961
Description
If Yes, record major reason for withdrawal
Data type
boolean
Alias
- UMLS CUI [1]
- C0422727
Description
Tick one box only
Data type
text
Alias
- UMLS CUI [1,1]
- C2349954
- UMLS CUI [1,2]
- C0392360
Description
Please complete and submit SAE report
Data type
integer
Alias
- UMLS CUI [1,1]
- C1519255
- UMLS CUI [1,2]
- C0237753
Description
Please complete Non-serious Adverse Event section
Data type
text
Alias
- UMLS CUI [1,1]
- C1518404
- UMLS CUI [1,2]
- C0237753
- UMLS CUI [2,1]
- C1518404
- UMLS CUI [2,2]
- C0805701
Description
If protocol violation, please specify
Data type
text
Alias
- UMLS CUI [1,1]
- C1709750
- UMLS CUI [1,2]
- C2348235
Description
If other reason, please specify
Data type
text
Alias
- UMLS CUI [1,1]
- C3840932
- UMLS CUI [1,2]
- C2348235
Description
Who made the decision?
Data type
text
Alias
- UMLS CUI [1]
- C0679006
Description
Date of last contact
Data type
date
Alias
- UMLS CUI [1]
- C0805839
Description
If No, please give details in Adverse Events section.
Data type
boolean
Alias
- UMLS CUI [1,1]
- C1142435
- UMLS CUI [1,2]
- C0681850
Description
Investigator 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.
Data type
text
Alias
- UMLS CUI [1]
- C2346576
Description
Investigator Signature Date
Data type
date
Alias
- UMLS CUI [1,1]
- C2346576
- UMLS CUI [1,2]
- C0011008
Description
Investigator name
Data type
text
Alias
- UMLS CUI [1]
- C2826892
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Long-Term Follow Up (Year 11) - Follow-Up Studies; Study Conclusion
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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])
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C0237753 (UMLS CUI [1,2])
C0237753 (UMLS CUI [1,2])
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C2348235 (UMLS CUI [1,2])
C0681850 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,2])