ID

29353

Beschrijving

Study conclusion Study ID: 101695 Ext. Mth30 Clinical Study ID: 101695 Study Title: Long-term study of immune response persistence of GSK Biologicals' 2-dose thiomersal-free Engerix™-B and 3-dose preservative-free Engerix™-B vaccines in subjects aged 11-15 yrs Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00343915 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 3 Study Recruitment Status: Completed Generic Name: Hepatitis B Vaccine, Recombinant Trade Name: BIO HBV; Engerix-B Study Indication: Hepatitis B

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Versies (1)
  1. 20-03-18 20-03-18 -
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GlaxoSmithKline (GSK)

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20 maart 2018

DOI

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Creative Commons BY-NC 3.0
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GSK Biologicals' 2-dose thiomersal-free Engerix™-B and 3-dose preservative-free Engerix™-B vaccines Study ID: 101695 NCT00343915

Engels

Study conclusion

1 Formulieren  
  1. StudyEvent: ODM
    1. Study conclusion
Follow-up studies
Beschrijving

Follow-up studies

Alias
UMLS CUI-1
C0016441
Would the subject be willing to participate in a follow-up study?
Beschrijving

Follow-up studies

Datatype

boolean

Alias
UMLS CUI [1]
C0016441
If you answered the previous question with 'No', please specify the reason:
Beschrijving

Follow-up studies

Datatype

integer

Alias
UMLS CUI [1]
C0016441
Study conclusion
Beschrijving

Study conclusion

Alias
UMLS CUI-1
C1707478
UMLS CUI-2
C0008972
Has the subject become pregnant during the study?
Beschrijving

Pregnancy

Datatype

integer

Alias
UMLS CUI [1]
C0032961
Did any elimination criteria become applicable during the study?
Beschrijving

Elimination

Datatype

integer

Alias
UMLS CUI [1,1]
C0680251
UMLS CUI [1,2]
C1521902
Has the subject dropped out of the study? (a drop out is a subject who did not come back for the concluding visit foreseen in the protocol.)
Beschrijving

Drop out

Datatype

boolean

Alias
UMLS CUI [1]
C2348568
If you answered the previous question with Yes, please mark the ONE most appropriate category for drop out.
Beschrijving

Drop out reason

Datatype

text

Alias
UMLS CUI [1,1]
C2348568
UMLS CUI [1,2]
C0457454
Date of last contact:
Beschrijving

Date of last contact

Datatype

date

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

Subject condition

Datatype

integer

Alias
UMLS CUI [1,1]
C1142435
UMLS CUI [1,2]
C0681850
Administrative documentation
Beschrijving

Administrative documentation

Alias
UMLS CUI-1
C1320722
Investigator signature:
Beschrijving

I certify that I have reviewed the data in this case report form, the Non-Serious Adverse Events and Serious Adverse Event sections including any laboratory data (if appropriate) and that all information is complete and accurate.

Datatype

text

Alias
UMLS CUI [1]
C2346576
Date
Beschrijving

Date

Datatype

date

Alias
UMLS CUI [1,1]
C2346576
UMLS CUI [1,2]
C0011008
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Similar models

Study conclusion

1 Formulieren
  1. StudyEvent: ODM
    1. Study conclusion
Name
Type
Description | Question | Decode (Coded Value)
Datatype
Alias
Item Group
Follow-up studies
C0016441 (UMLS CUI-1)
Follow-up studies
Item
Would the subject be willing to participate in a follow-up study?
boolean
C0016441 (UMLS CUI [1])
Item
If you answered the previous question with 'No', please specify the reason:
integer
C0016441 (UMLS CUI [1])
Follow-up studies
Code List
If you answered the previous question with 'No', please specify the reason:
CL Item
Adverse Events, or Serious Adverse Events: please specify: --------------------------------------------------------------- (1)
CL Item
<Other: please specify: --------------------------------------------------------------- (2)
Item Group
Study conclusion
C1707478 (UMLS CUI-1)
C0008972 (UMLS CUI-2)
Item
Has the subject become pregnant during the study?
integer
C0032961 (UMLS CUI [1])
Pregnancy
Code List
Has the subject become pregnant during the study?
CL Item
No (1)
CL Item
Yes, please compete the Pregnancy Report Form. (2)
CL Item
NA (3)
Item
Did any elimination criteria become applicable during the study?
integer
C0680251 (UMLS CUI [1,1])
C1521902 (UMLS CUI [1,2])
Elimination
Code List
Did any elimination criteria become applicable during the study?
CL Item
No (1)
CL Item
Yes, please specify: _____________________________________________________________________ (2)
Drop out
Item
Has the subject dropped out of the study? (a drop out is a subject who did not come back for the concluding visit foreseen in the protocol.)
boolean
C2348568 (UMLS CUI [1])
Item
If you answered the previous question with Yes, please mark the ONE most appropriate category for drop out.
text
C2348568 (UMLS CUI [1,1])
C0457454 (UMLS CUI [1,2])
Drop out reason
Code List
If you answered the previous question with Yes, please mark the ONE most appropriate category for drop out.
CL Item
Serious adverse event (complete the Serious Adverse Event form). ((SAE))
CL Item
Non-Serious adverse event (complete the Non-serious Adverse Event form). Please specify AE N°: ___________________________________________________________ ((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))
Date of last contact
Item
Date of last contact:
date
C0805839 (UMLS CUI [1])
Item
Was the subject in good condition at date of last contact?
integer
C1142435 (UMLS CUI [1,1])
C0681850 (UMLS CUI [1,2])
Subject condition
Code List
Was the subject in good condition at date of last contact?
CL Item
No, please give details within the Adverse Events section. (1)
CL Item
Yes (2)
Item Group
Administrative documentation
C1320722 (UMLS CUI-1)
Signature
Item
Investigator signature:
text
C2346576 (UMLS CUI [1])
Date
Item
Date
date
C2346576 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
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