ID

35986

Beschreibung

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

Stichworte

Versionen (1)
  1. 08.04.19 08.04.19 -
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GlaxoSmithKline

Hochgeladen am

8. April 2019

DOI

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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

Englisch

Long-Term Follow Up (Year 11) - Follow-Up Studies; Study Conclusion

1 Formulare  
Administrative
Beschreibung

Administrative

Alias
UMLS CUI-1
C1320722
Subject number
Beschreibung

Subject number

Datentyp

integer

Alias
UMLS CUI [1]
C2348585
Follow-Up Studies
Beschreibung

Follow-Up Studies

Alias
UMLS CUI-1
C0016441
If a follow-up study is offered in the future, would the subject be willing to be contacted and learn more about it?
Beschreibung

If No, please specify the most appropriate reason

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0016441
UMLS CUI [1,2]
C0600109
If subject would not be willing to participate in a follow-up study, please specify the most appropriate reason
Beschreibung

If subject would not be willing to participate in a follow-up study, please specify the most appropriate reason

Datentyp

integer

Alias
UMLS CUI [1,1]
C0016441
UMLS CUI [1,2]
C0558080
UMLS CUI [1,3]
C0392360
If Adverse Event or Serious Adverse Event, please specify
Beschreibung

If Adverse Event or Serious Adverse Event, please specify

Datentyp

text

Alias
UMLS CUI [1,1]
C0877248
UMLS CUI [1,2]
C2348235
UMLS CUI [2,1]
C1519255
UMLS CUI [2,2]
C2348235
If other, please specify
Beschreibung

If other, please specify

Datentyp

text

Alias
UMLS CUI [1,1]
C0205394
UMLS CUI [1,2]
C2348235
Study Conclusion
Beschreibung

Study Conclusion

Alias
UMLS CUI-1
C1707478
UMLS CUI-2
C0008972
Did the subject experience any Serious Adverse Event during the study period as specified in the protocol?
Beschreibung

If Yes, specify total number of SAE's

Datentyp

boolean

Alias
UMLS CUI [1]
C1519255
UMLS CUI [2]
C2347804
UMLS CUI [3]
C2348563
Total number of SAE's
Beschreibung

Total number of SAE's

Datentyp

integer

Alias
UMLS CUI [1,1]
C1519255
UMLS CUI [1,2]
C0449788
Did the subject become pregnant before the end of the study?
Beschreibung

If Yes, complete the Pregnancy notification form.

Datentyp

text

Alias
UMLS CUI [1]
C0032961
Was the subject withdrawn from the study?
Beschreibung

If Yes, record major reason for withdrawal

Datentyp

boolean

Alias
UMLS CUI [1]
C0422727
Major reason for withdrawal
Beschreibung

Tick one box only

Datentyp

text

Alias
UMLS CUI [1,1]
C2349954
UMLS CUI [1,2]
C0392360
If Serious adverse event, please specify SAE No
Beschreibung

Please complete and submit SAE report

Datentyp

integer

Alias
UMLS CUI [1,1]
C1519255
UMLS CUI [1,2]
C0237753
If Non-serious adverse event, please specify AE No or solicited AE code.
Beschreibung

Please complete Non-serious Adverse Event section

Datentyp

text

Alias
UMLS CUI [1,1]
C1518404
UMLS CUI [1,2]
C0237753
UMLS CUI [2,1]
C1518404
UMLS CUI [2,2]
C0805701
If protocol violation, please specify
Beschreibung

If protocol violation, please specify

Datentyp

text

Alias
UMLS CUI [1,1]
C1709750
UMLS CUI [1,2]
C2348235
If other reason, please specify
Beschreibung

If other reason, please specify

Datentyp

text

Alias
UMLS CUI [1,1]
C3840932
UMLS CUI [1,2]
C2348235
Who made the decision?
Beschreibung

Who made the decision?

Datentyp

text

Alias
UMLS CUI [1]
C0679006
Date of last contact
Beschreibung

Date of last contact

Datentyp

date

Alias
UMLS CUI [1]
C0805839
Was the subject in good condition at date of last contact?
Beschreibung

If No, please give details in Adverse Events section.

Datentyp

boolean

Alias
UMLS CUI [1,1]
C1142435
UMLS CUI [1,2]
C0681850
Investigator signature
Beschreibung

Investigator signature

Alias
UMLS CUI-1
C2346576
Investigator Signature
Beschreibung

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.

Datentyp

text

Alias
UMLS CUI [1]
C2346576
Investigator Signature Date
Beschreibung

Investigator Signature Date

Datentyp

date

Alias
UMLS CUI [1,1]
C2346576
UMLS CUI [1,2]
C0011008
Investigator name
Beschreibung

Investigator name

Datentyp

text

Alias
UMLS CUI [1]
C2826892
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Ähnliche Modelle

Long-Term Follow Up (Year 11) - Follow-Up Studies; Study Conclusion

1 Formulare
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
Alias
Item Group
Administrative
C1320722 (UMLS CUI-1)
Subject number
Item
Subject number
integer
C2348585 (UMLS CUI [1])
Item Group
Follow-Up Studies
C0016441 (UMLS CUI-1)
If a follow-up study is offered in the future, would the subject be willing to be contacted and learn more about it?
Item
If a follow-up study is offered in the future, would the subject be willing to be contacted and learn more about it?
boolean
C0016441 (UMLS CUI [1,1])
C0600109 (UMLS CUI [1,2])
Item
If subject would not be willing to participate in a follow-up study, please specify the most appropriate reason
integer
C0016441 (UMLS CUI [1,1])
C0558080 (UMLS CUI [1,2])
C0392360 (UMLS CUI [1,3])
If subject would not be willing to participate in a follow-up study, please specify the reason
Code List
If subject would not be willing to participate in a follow-up study, please specify the most appropriate reason
CL Item
Adverse Events, or Serious Adverse Events (1)
CL Item
Other (2)
If Adverse Event or Serious Adverse Event, please specify
Item
If Adverse Event or Serious Adverse Event, please specify
text
C0877248 (UMLS CUI [1,1])
C2348235 (UMLS CUI [1,2])
C1519255 (UMLS CUI [2,1])
C2348235 (UMLS CUI [2,2])
If other, please specify
Item
If other, please specify
text
C0205394 (UMLS CUI [1,1])
C2348235 (UMLS CUI [1,2])
Item Group
Study Conclusion
C1707478 (UMLS CUI-1)
C0008972 (UMLS CUI-2)
Did the subject experience any Serious Adverse Event during the study period as specified in the protocol?
Item
Did the subject experience any Serious Adverse Event during the study period as specified in the protocol?
boolean
C1519255 (UMLS CUI [1])
C2347804 (UMLS CUI [2])
C2348563 (UMLS CUI [3])
Total number of SAE's
Item
Total number of SAE's
integer
C1519255 (UMLS CUI [1,1])
C0449788 (UMLS CUI [1,2])
Item
Did the subject become pregnant before the end of the study?
text
C0032961 (UMLS CUI [1])
Did the subject become pregnant before the end of the study?
Code List
Did the subject become pregnant before the end of the study?
CL Item
No (N)
CL Item
Yes (Y)
CL Item
Not Applicable (not of childbearing potential or male) (N/A)
Was the subject withdrawn from the study?
Item
Was the subject withdrawn from the study?
boolean
C0422727 (UMLS CUI [1])
Item
Major reason for withdrawal
text
C2349954 (UMLS CUI [1,1])
C0392360 (UMLS CUI [1,2])
Major reason for withdrawal
Code List
Major reason for withdrawal
CL Item
Serious adverse event  (SAE)
CL Item
Non-Serious adverse event  (AEX)
CL Item
Protocol violation, please specify (PTV)
CL Item
Consent withdrawal, not due to an adverse event.  (CWS)
CL Item
Migrated / moved from the study area  (MIG)
CL Item
Lost to follow-up (LFU)
CL Item
Other, please specify (OTH)
If Serious adverse event, please specify SAE No
Item
If Serious adverse event, please specify SAE No
integer
C1519255 (UMLS CUI [1,1])
C0237753 (UMLS CUI [1,2])
If Non-serious adverse event, please specify AE No or solicited AE code.
Item
If Non-serious adverse event, please specify AE No or solicited AE code.
text
C1518404 (UMLS CUI [1,1])
C0237753 (UMLS CUI [1,2])
C1518404 (UMLS CUI [2,1])
C0805701 (UMLS CUI [2,2])
If protocol violation, please specify
Item
If protocol violation, please specify
text
C1709750 (UMLS CUI [1,1])
C2348235 (UMLS CUI [1,2])
If other reason, please specify
Item
If other reason, please specify
text
C3840932 (UMLS CUI [1,1])
C2348235 (UMLS CUI [1,2])
Item
Who made the decision?
text
C0679006 (UMLS CUI [1])
Who made the decision?
Code List
Who made the decision?
CL Item
Investigator (I)
CL Item
Parents/ Guardians (P)
Date of last contact
Item
Date of last contact
date
C0805839 (UMLS CUI [1])
Was the subject in good condition at date of last contact?
Item
Was the subject in good condition at date of last contact?
boolean
C1142435 (UMLS CUI [1,1])
C0681850 (UMLS CUI [1,2])
Item Group
Investigator signature
C2346576 (UMLS CUI-1)
Investigator Signature
Item
Investigator Signature
text
C2346576 (UMLS CUI [1])
Investigator Signature Date
Item
Investigator Signature Date
date
C2346576 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
Investigator name
Item
Investigator name
text
C2826892 (UMLS CUI [1])
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