ID

29354

Description

Tracking Document Safety Follow-Up 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

Keywords

Versions (1)
  1. 3/20/18 3/20/18 -
Copyright Holder

GlaxoSmithKline (GSK)

Uploaded on

March 20, 2018

DOI

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License

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

English

Tracking Document Safety Follow-Up

1 forms  
Tracking Document Safety Follow-Up
Description

Tracking Document Safety Follow-Up

Alias
UMLS CUI-1
C3889409
Tracking Document Safety Follow-Up
Description

Tracking Document Safety Follow-Up

Data type

integer

Alias
UMLS CUI [1]
C3889409
Subject number
Description

Subject number

Data type

integer

Alias
UMLS CUI [1]
C2348585
Subject initials first name family name
Description

Subject initials

Data type

text

Alias
UMLS CUI [1,1]
C1997894
UMLS CUI [1,2]
C2986440
Date of birth (day month year)
Description

Date of birth

Data type

date

Alias
UMLS CUI [1]
C0421451
Did the subject experience any SAE(s) since the last contact?
Description

SAE(s)

Data type

integer

Alias
UMLS CUI [1]
C1519255
Date of Contact
Description

Date of Contact

Data type

date

Alias
UMLS CUI [1,1]
C0011008
UMLS CUI [1,2]
C1705415
Administrative documentation
Description

Administrative documentation

Alias
UMLS CUI-1
C1320722
Investigator signature:
Description

Signature

Data type

text

Alias
UMLS CUI [1]
C2346576
Investigator name
Description

Name of Investigator

Data type

text

Alias
UMLS CUI [1]
C2826892
Date
Description

Date

Data type

date

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

Tracking Document Safety Follow-Up

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
Tracking Document Safety Follow-Up
C3889409 (UMLS CUI-1)
Item
Tracking Document Safety Follow-Up
integer
C3889409 (UMLS CUI [1])
Tracking Document Safety Follow-Up
Code List
Tracking Document Safety Follow-Up
CL Item
Prospective Follow-Up for all subjects (1)
(Comment:en)
CL Item
Retrospective Safety Follow-Up (time elapsed between the last contact of the preceding study and the new study contact as specified in the protocol.) (2)
(Comment:en)
Subject number
Item
Subject number
integer
C2348585 (UMLS CUI [1])
Subject initials
Item
Subject initials first name family name
text
C1997894 (UMLS CUI [1,1])
C2986440 (UMLS CUI [1,2])
Date of birth
Item
Date of birth (day month year)
date
C0421451 (UMLS CUI [1])
Item
Did the subject experience any SAE(s) since the last contact?
integer
C1519255 (UMLS CUI [1])
SAE(s)
Code List
Did the subject experience any SAE(s) since the last contact?
CL Item
Yes, please complete the Safety Follow-up Serious Adverse Event (SAE) form (1)
CL Item
No (2)
CL Item
Unknown (subject lost to follow-up or could not be reached) (3)
Date of Contact
Item
Date of Contact
date
C0011008 (UMLS CUI [1,1])
C1705415 (UMLS CUI [1,2])
Item Group
Administrative documentation
C1320722 (UMLS CUI-1)
Signature
Item
Investigator signature:
text
C2346576 (UMLS CUI [1])
Name of Investigator
Item
Investigator name
text
C2826892 (UMLS CUI [1])
Date
Item
Date
date
C2346576 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
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