ID
24379
Description
Visit 2 Eligibility Checklist 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)
- 7/30/17 7/30/17 -
Copyright Holder
GlaxoSmithKline
Uploaded on
July 30, 2017
DOI
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License
Creative Commons BY-NC 3.0
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Visit 2 Eligibility Checklist Biologicals HepA/HepB vaccine 208127/125
Visit 2 Eligibility Checklist Biologicals HepA/HepB vaccine 208127/125
Description
Criteria for study participation
Alias
- UMLS CUI-1
- C1512693
Description
Age
Data type
boolean
Alias
- UMLS CUI [1]
- C0001779
Description
Good physical condition
Data type
boolean
Alias
- UMLS CUI [1]
- C1142435
Description
NA = no answer
Data type
boolean
Alias
- UMLS CUI [1]
- C0700589
Description
Written informed consent
Data type
boolean
Alias
- UMLS CUI [1]
- C0021430
Description
if the written informed consent has been signed, enter the date of signature day/month/year
Data type
date
Alias
- UMLS CUI [1]
- C2985782
Description
Criteria for exclusion of the study
Alias
- UMLS CUI-1
- C0680251
Description
Positive titres for hepatitis antibodies
Data type
boolean
Alias
- UMLS CUI [1,1]
- C0201473
- UMLS CUI [1,2]
- C0201478
- UMLS CUI [1,3]
- C0201480
- UMLS CUI [2]
- C0201477
Description
Elevated ALT or AST
Data type
boolean
Alias
- UMLS CUI [1]
- C0201836
- UMLS CUI [2]
- C0201899
Description
History of diseases
Data type
boolean
Alias
- UMLS CUI [1]
- C0018939
- UMLS CUI [2]
- C0023895
- UMLS CUI [3]
- C0022658
- UMLS CUI [4]
- C0018799
- UMLS CUI [5]
- C0035204
Description
Acute disease
Data type
boolean
Alias
- UMLS CUI [1]
- C0001314
Description
Chronic alcohol consumption
Data type
boolean
Alias
- UMLS CUI [1,1]
- C0205191
- UMLS CUI [1,2]
- C0001948
Description
Hepatomegaly or right upper quadrant adominal pain
Data type
boolean
Alias
- UMLS CUI [1]
- C0019209
- UMLS CUI [2]
- C0235299
Description
Chronic drug treatment
Data type
boolean
Alias
- UMLS CUI [1,1]
- C0205191
- UMLS CUI [1,2]
- C0013216
- UMLS CUI [2]
- C0021081
Description
Allergy stimulated by the vaccine
Data type
boolean
Alias
- UMLS CUI [1]
- C0571550
Description
Participation in another clinical trial
Data type
boolean
Alias
- UMLS CUI [1]
- C2348568
Description
Previous vaccination against hepatitis
Data type
boolean
Alias
- UMLS CUI [1]
- C0419735
- UMLS CUI [2]
- C0474232
Description
Administrative Data
Alias
- UMLS CUI-1
- C1320722
Similar models
Visit 2 Eligibility Checklist Biologicals HepA/HepB vaccine 208127/125
C0201478 (UMLS CUI [1,2])
C0201480 (UMLS CUI [1,3])
C0201477 (UMLS CUI [2])
C0201899 (UMLS CUI [2])
C0023895 (UMLS CUI [2])
C0022658 (UMLS CUI [3])
C0018799 (UMLS CUI [4])
C0035204 (UMLS CUI [5])
C0001948 (UMLS CUI [1,2])
C0235299 (UMLS CUI [2])
C0013216 (UMLS CUI [1,2])
C0021081 (UMLS CUI [2])
C0474232 (UMLS CUI [2])