ID

25202

Description

Medication form Study ID: 208127/125 Clinical Study ID: 208127/125 (Ext-HAB-038 Month 90) Study Title: A double-blind, randomized study to evaluate the immunogenicity and reactogenicity of two different lots of GlaxoSmithKline Biologicals' combined hepatitis A / hepatitis B vaccine in healthy children between 6 and 15 years of age. Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: N/A Sponsor:GlaxoSmithKline Collaborators: N/A 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. 8/28/17 8/28/17 -
Copyright Holder

GlaxoSmithKline

Uploaded on

August 28, 2017

DOI

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License

Creative Commons BY-NC 3.0
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Medication Biologicals HepA/HepB vaccine 208127/125

English

Medication Biologicals HepA/HepB vaccine 208127/125

1 forms  
Header
Description

Header

Alias
UMLS CUI-1
C1320722
Protocol
Description

Protocol

Data type

text

Alias
UMLS CUI [1]
C1507394
Subject number
Description

Subject number

Data type

text

Alias
UMLS CUI [1]
C2348585
Medication
Description

Medication

Alias
UMLS CUI-1
C0013227
Trade name
Description

Trade name

Data type

text

Alias
UMLS CUI [1]
C2360065
Total Daily Dose
Description

Total daily dose

Data type

text

Alias
UMLS CUI [1]
C2348070
Route
Description

Route

Data type

text

Alias
UMLS CUI [1]
C0013153
Medical indication
Description

Where appropriate, medical indication should be recorded using the same terminology in the Adverse Experience Section.

Data type

text

Alias
UMLS CUI [1,1]
C3146298
UMLS CUI [1,2]
C0013227
Code
Description

Please indicate the corresponding "code" of tbe reported. adverse experience if applicable (eg. "VO", "AE.2"), or code as "P" if used prophylactically in anticipation of vaccine reactions.

Data type

text

Alias
UMLS CUI [1,1]
C0805701
UMLS CUI [1,2]
C3146298
UMLS CUI [1,3]
C0013227
Start Date
Description

day/month/year

Data type

date

Alias
UMLS CUI [1]
C0808070
End date, or tick box if continuing at end of study
Description

day/month/year

Data type

date

Alias
UMLS CUI [1]
C0806020
tick box if continuing at end of study
Description

Continuing at end of study

Data type

boolean

Alias
UMLS CUI [1,1]
C1553904
UMLS CUI [1,2]
C2983670
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Similar models

Medication Biologicals HepA/HepB vaccine 208127/125

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
Header
C1320722 (UMLS CUI-1)
Protocol
Item
Protocol
text
C1507394 (UMLS CUI [1])
Subject number
Item
Subject number
text
C2348585 (UMLS CUI [1])
Item Group
Medication
C0013227 (UMLS CUI-1)
Trade name
Item
Trade name
text
C2360065 (UMLS CUI [1])
Total daily dose
Item
Total Daily Dose
text
C2348070 (UMLS CUI [1])
Route
Item
Route
text
C0013153 (UMLS CUI [1])
Medical indication
Item
Medical indication
text
C3146298 (UMLS CUI [1,1])
C0013227 (UMLS CUI [1,2])
Code for medical indication
Item
Code
text
C0805701 (UMLS CUI [1,1])
C3146298 (UMLS CUI [1,2])
C0013227 (UMLS CUI [1,3])
Start date
Item
Start Date
date
C0808070 (UMLS CUI [1])
End date
Item
End date, or tick box if continuing at end of study
date
C0806020 (UMLS CUI [1])
Continuing at end of study
Item
tick box if continuing at end of study
boolean
C1553904 (UMLS CUI [1,1])
C2983670 (UMLS CUI [1,2])
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