ID
35986
Beskrivning
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
Nyckelord
Versioner (1)
- 2019-04-08 2019-04-08 -
Rättsinnehavare
GlaxoSmithKline
Uppladdad den
8 april 2019
DOI
För en begäran logga in.
Licens
Creative Commons BY-NC 3.0
Modellkommentarer :
Här kan du kommentera modellen. Med hjälp av pratbubblor i Item-grupperna och Item kan du lägga in specifika kommentarer.
Itemgroup-kommentar för :
Item-kommentar för :
Du måste vara inloggad för att kunna ladda ner formulär. Var vänlig logga in eller registrera dig utan kostnad.
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
Beskrivning
Follow-Up Studies
Alias
- UMLS CUI-1
- C0016441
Beskrivning
If No, please specify the most appropriate reason
Datatyp
boolean
Alias
- UMLS CUI [1,1]
- C0016441
- UMLS CUI [1,2]
- C0600109
Beskrivning
If subject would not be willing to participate in a follow-up study, please specify the most appropriate reason
Datatyp
integer
Alias
- UMLS CUI [1,1]
- C0016441
- UMLS CUI [1,2]
- C0558080
- UMLS CUI [1,3]
- C0392360
Beskrivning
If Adverse Event or Serious Adverse Event, please specify
Datatyp
text
Alias
- UMLS CUI [1,1]
- C0877248
- UMLS CUI [1,2]
- C2348235
- UMLS CUI [2,1]
- C1519255
- UMLS CUI [2,2]
- C2348235
Beskrivning
If other, please specify
Datatyp
text
Alias
- UMLS CUI [1,1]
- C0205394
- UMLS CUI [1,2]
- C2348235
Beskrivning
Study Conclusion
Alias
- UMLS CUI-1
- C1707478
- UMLS CUI-2
- C0008972
Beskrivning
If Yes, specify total number of SAE's
Datatyp
boolean
Alias
- UMLS CUI [1]
- C1519255
- UMLS CUI [2]
- C2347804
- UMLS CUI [3]
- C2348563
Beskrivning
Total number of SAE's
Datatyp
integer
Alias
- UMLS CUI [1,1]
- C1519255
- UMLS CUI [1,2]
- C0449788
Beskrivning
If Yes, complete the Pregnancy notification form.
Datatyp
text
Alias
- UMLS CUI [1]
- C0032961
Beskrivning
If Yes, record major reason for withdrawal
Datatyp
boolean
Alias
- UMLS CUI [1]
- C0422727
Beskrivning
Tick one box only
Datatyp
text
Alias
- UMLS CUI [1,1]
- C2349954
- UMLS CUI [1,2]
- C0392360
Beskrivning
Please complete and submit SAE report
Datatyp
integer
Alias
- UMLS CUI [1,1]
- C1519255
- UMLS CUI [1,2]
- C0237753
Beskrivning
Please complete Non-serious Adverse Event section
Datatyp
text
Alias
- UMLS CUI [1,1]
- C1518404
- UMLS CUI [1,2]
- C0237753
- UMLS CUI [2,1]
- C1518404
- UMLS CUI [2,2]
- C0805701
Beskrivning
If protocol violation, please specify
Datatyp
text
Alias
- UMLS CUI [1,1]
- C1709750
- UMLS CUI [1,2]
- C2348235
Beskrivning
If other reason, please specify
Datatyp
text
Alias
- UMLS CUI [1,1]
- C3840932
- UMLS CUI [1,2]
- C2348235
Beskrivning
Who made the decision?
Datatyp
text
Alias
- UMLS CUI [1]
- C0679006
Beskrivning
Date of last contact
Datatyp
date
Alias
- UMLS CUI [1]
- C0805839
Beskrivning
If No, please give details in Adverse Events section.
Datatyp
boolean
Alias
- UMLS CUI [1,1]
- C1142435
- UMLS CUI [1,2]
- C0681850
Beskrivning
Investigator signature
Alias
- UMLS CUI-1
- C2346576
Beskrivning
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.
Datatyp
text
Alias
- UMLS CUI [1]
- C2346576
Beskrivning
Investigator Signature Date
Datatyp
date
Alias
- UMLS CUI [1,1]
- C2346576
- UMLS CUI [1,2]
- C0011008
Beskrivning
Investigator name
Datatyp
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])