ID

35691

Description

Study ID: 100565 Clinical Study ID: 100565 Study Title: An open study to evaluate the immunogenicity, safety and reactogenicity of GlaxoSmithKline Biologicals' commercially available combined hepatitis A / hepatitis B vaccine (TWINRIX ADULT) containing 720 ELISA units of hepatitis A antigen and 20 µg of hepatitis B surface antigen, administered following a two-dose (0, 6 months) schedule in healthy children between the ages of 1 and 11 years Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: 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

Keywords

Versions (1)
  1. 3/15/19 3/15/19 -
Copyright Holder

GlaxoSmithKline

Uploaded on

March 15, 2019

DOI

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License

Creative Commons BY-NC 3.0
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Immunogenicity, safety and reactogenicity of combined hepatitis A / hepatitis B vaccine (TWINRIX ADULT) in healthy children (100565)

English

Visit 2, 3 and 5 - Laboratory Tests

1 forms  
Administration
Description

Administration

Alias
UMLS CUI-1
C1320722
Visit
Description

Visit

Data type

date

Alias
UMLS CUI [1]
C1320303
Subject number
Description

Subject number

Data type

integer

Alias
UMLS CUI [1]
C2348585
Laboratory Tests - Visit 2
Description

Laboratory Tests - Visit 2

Alias
UMLS CUI-1
C0022885
UMLS CUI-2
C0545082
Has a blood sample been taken ?
Description

Has a blood sample been taken ?

Data type

boolean

Alias
UMLS CUI [1]
C0005834
Laboratory Tests - Visit 3
Description

Laboratory Tests - Visit 3

Alias
UMLS CUI-1
C0022885
UMLS CUI-2
C0545082
Has a blood sample been taken ?
Description

Has a blood sample been taken ?

Data type

boolean

Alias
UMLS CUI [1]
C0005834
Laboratory Tests - Visit 5
Description

Laboratory Tests - Visit 5

Alias
UMLS CUI-1
C0022885
UMLS CUI-2
C0545082
Has a blood sample been taken ?
Description

Subjects who fail to exhibit a satisfactory immune response following the two-dose candidate vaccine course, as evidenced by anti-HBs titre ≥ 10mIU/ml and/or seropositivity for anti-HAV, will be p rovided an additional dose of the appropriate commercial vaccine.

Data type

boolean

Alias
UMLS CUI [1]
C0005834
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Similar models

Visit 2, 3 and 5 - Laboratory Tests

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
Administration
C1320722 (UMLS CUI-1)
Visit
Item
Visit
date
C1320303 (UMLS CUI [1])
Subject number
Item
Subject number
integer
C2348585 (UMLS CUI [1])
Item Group
Laboratory Tests - Visit 2
C0022885 (UMLS CUI-1)
C0545082 (UMLS CUI-2)
Has a blood sample been taken ?
Item
Has a blood sample been taken ?
boolean
C0005834 (UMLS CUI [1])
Item Group
Laboratory Tests - Visit 3
C0022885 (UMLS CUI-1)
C0545082 (UMLS CUI-2)
Has a blood sample been taken ?
Item
Has a blood sample been taken ?
boolean
C0005834 (UMLS CUI [1])
Item Group
Laboratory Tests - Visit 5
C0022885 (UMLS CUI-1)
C0545082 (UMLS CUI-2)
Has a blood sample been taken ?
Item
Has a blood sample been taken ?
boolean
C0005834 (UMLS CUI [1])
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