ID

29435

Description

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

Keywords

Versions (1)
  1. 3/24/18 3/24/18 -
Copyright Holder

GlaxoSmithKline (GSK)

Uploaded on

March 24, 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

Study conclusion (Long term Follow-up)

1 forms  
Follow-up studies
Description

Follow-up studies

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

Follow-up studies

Data type

boolean

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

Follow-up studies

Data type

integer

Alias
UMLS CUI [1]
C0016441
Administrative documentation
Description

Administrative documentation

Alias
UMLS CUI-1
C1320722
Investigator signature:
Description

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.

Data type

text

Alias
UMLS CUI [1]
C2346576
Date
Description

Date

Data type

date

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

Study conclusion (Long term Follow-up)

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
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
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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