ID

33888

Description

Study ID:103860/269 Clinical Study ID:103860/269 (HBV-269) Study Title: Phase II study to evaluate the immunogenicity of GSK Biologicals' preservative-free Engerix-B and thiomersal-free Engerix-B vaccines compared to Engerix™-B and evaluate safety and reactogenicity of each vaccine when administered intramuscularly according to a 0, 1, 6 month schedule in healthy volunteers Patient Level Data:Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: N/A Sponsor: GlaxoSmithKline Collaborators: N/A Phase: phase 2 Study Recruitment Status: Completed Generic Name: Hepatitis B Vaccine, Recombinant Trade Name: Engerix-B Study Indication: Hepatitis B

Keywords

Versions (1)
  1. 1/5/19 1/5/19 -
Copyright Holder

GlaxoSmithKline

Uploaded on

January 5, 2019

DOI

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License

Creative Commons BY-NC 3.0
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Immunogenicity, safety and reactogenicity of preservative-free Engerix-B and thiomersal-free Engerix-B vaccines compared to Engerix™️-B

English

Visit 5

1 forms  
  1. StudyEvent: ODM
    1. Visit 5
Administration data
Description

Administration data

Alias
UMLS CUI-1
C1320722
Date of visit
Description

Date of visit

Data type

date

Alias
UMLS CUI [1]
C1320303
Subject number
Description

Clinical Trial Subject Unique Identifier

Data type

integer

Alias
UMLS CUI [1]
C2348585
Laboratory Tests
Description

Laboratory Tests

Alias
UMLS CUI-1
C0022885
Has a blood sample been taken?
Description

Collection of blood specimen for laboratory procedure

Data type

boolean

Alias
UMLS CUI [1]
C0005834
Has a blood sample been taken for RF1-like antibodies testing (only for 50 subjects per group)?
Description

Collection of blood specimen for laboratory procedure, Antibodies

Data type

text

Alias
UMLS CUI [1,1]
C0005834
UMLS CUI [1,2]
C0003241
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Similar models

Visit 5

1 forms
  1. StudyEvent: ODM
    1. Visit 5
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
Administration data
C1320722 (UMLS CUI-1)
Date of visit
Item
Date of visit
date
C1320303 (UMLS CUI [1])
Clinical Trial Subject Unique Identifier
Item
Subject number
integer
C2348585 (UMLS CUI [1])
Item Group
Laboratory Tests
C0022885 (UMLS CUI-1)
Collection of blood specimen for laboratory procedure
Item
Has a blood sample been taken?
boolean
C0005834 (UMLS CUI [1])
Item
Has a blood sample been taken for RF1-like antibodies testing (only for 50 subjects per group)?
text
C0005834 (UMLS CUI [1,1])
C0003241 (UMLS CUI [1,2])
Collection of blood specimen for laboratory procedure, Antibodies
Code List
Has a blood sample been taken for RF1-like antibodies testing (only for 50 subjects per group)?
CL Item
Yes (1)
CL Item
No (2)
CL Item
NA (3)
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