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)
  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

English

Visit 2 Eligibility Checklist 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
Activity
Description

Activity

Data type

text

Alias
UMLS CUI [1]
C1512346
Subject number
Description

Subject number

Data type

text

Alias
UMLS CUI [1]
C2348585
Criteria for study participation
Description

Criteria for study participation

Alias
UMLS CUI-1
C1512693
Age: between 6 to 15 years old.
Description

Age

Data type

boolean

Alias
UMLS CUI [1]
C0001779
Good physical condition as established by clinical examination and history taking at the time of entry
Description

Good physical condition

Data type

boolean

Alias
UMLS CUI [1]
C1142435
Female participants who are at risk to become pregnant will be on a contraceptive programme if necessary during the study period. (Intrauterine device, oral contraceptives, diaphragm or condom in combination with contraceptive cream or foam).
Description

NA = no answer

Data type

boolean

Alias
UMLS CUI [1]
C0700589
Has the written informed consent been signed ?
Description

Written informed consent

Data type

boolean

Alias
UMLS CUI [1]
C0021430
if Yes, date of signature :
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
Criteria for exclusion of the study
Description

Criteria for exclusion of the study

Alias
UMLS CUI-1
C0680251
Positive titres for anti-HAV, anti-HBs, anti-HBc antibodies and/or HBsAg (screening)
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
Elevated serum liver enzymes : ALT (SGPT), AST (SGOT) : higher than 2.5 fold the upper normal laboratory values
Description

Elevated ALT or AST

Data type

boolean

Alias
UMLS CUI [1]
C0201836
UMLS CUI [2]
C0201899
History of significant and persisting hematologic, hepatic, renal, cardiac or respiratory disease
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
Any acute disease at the moment of entry
Description

Acute disease

Data type

boolean

Alias
UMLS CUI [1]
C0001314
Chronic alcohol consumption
Description

Chronic alcohol consumption

Data type

boolean

Alias
UMLS CUI [1,1]
C0205191
UMLS CUI [1,2]
C0001948
Hepatomegaly, right upper quadrant abdominal pain or tenderness
Description

Hepatomegaly or right upper quadrant adominal pain

Data type

boolean

Alias
UMLS CUI [1]
C0019209
UMLS CUI [2]
C0235299
Any chronic drug treatment, including any treatment with immunosuppressive drugs, which in the investigator's opinion, precludes inclusion into the study
Description

Chronic drug treatment

Data type

boolean

Alias
UMLS CUI [1,1]
C0205191
UMLS CUI [1,2]
C0013216
UMLS CUI [2]
C0021081
History of allergic disease likely to be stimulated by any component of the vaccine
Description

Allergy stimulated by the vaccine

Data type

boolean

Alias
UMLS CUI [1]
C0571550
Simultaneous participation in any other clinical trial
Description

Participation in another clinical trial

Data type

boolean

Alias
UMLS CUI [1]
C2348568
Previous vaccination against hepatitis A and B
Description

Previous vaccination against hepatitis

Data type

boolean

Alias
UMLS CUI [1]
C0419735
UMLS CUI [2]
C0474232
Administrative Data
Description

Administrative Data

Alias
UMLS CUI-1
C1320722
Date :
Description

day/month/year

Data type

date

Alias
UMLS CUI [1]
C0011008
Investigator Signature :
Description

Signature

Data type

text

Alias
UMLS CUI [1]
C2346576
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Similar models

Visit 2 Eligibility Checklist 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])
Activity
Item
Activity
text
C1512346 (UMLS CUI [1])
Subject number
Item
Subject number
text
C2348585 (UMLS CUI [1])
Item Group
Criteria for study participation
C1512693 (UMLS CUI-1)
Age
Item
Age: between 6 to 15 years old.
boolean
C0001779 (UMLS CUI [1])
Good physical condition
Item
Good physical condition as established by clinical examination and history taking at the time of entry
boolean
C1142435 (UMLS CUI [1])
Contraception
Item
Female participants who are at risk to become pregnant will be on a contraceptive programme if necessary during the study period. (Intrauterine device, oral contraceptives, diaphragm or condom in combination with contraceptive cream or foam).
boolean
C0700589 (UMLS CUI [1])
Written informed consent
Item
Has the written informed consent been signed ?
boolean
C0021430 (UMLS CUI [1])
Date of written informed consent
Item
if Yes, date of signature :
date
C2985782 (UMLS CUI [1])
Item Group
Criteria for exclusion of the study
C0680251 (UMLS CUI-1)
Positive titres for hepatitis antibodies
Item
Positive titres for anti-HAV, anti-HBs, anti-HBc antibodies and/or HBsAg (screening)
boolean
C0201473 (UMLS CUI [1,1])
C0201478 (UMLS CUI [1,2])
C0201480 (UMLS CUI [1,3])
C0201477 (UMLS CUI [2])
Elevated ALT or AST
Item
Elevated serum liver enzymes : ALT (SGPT), AST (SGOT) : higher than 2.5 fold the upper normal laboratory values
boolean
C0201836 (UMLS CUI [1])
C0201899 (UMLS CUI [2])
History of diseases
Item
History of significant and persisting hematologic, hepatic, renal, cardiac or respiratory disease
boolean
C0018939 (UMLS CUI [1])
C0023895 (UMLS CUI [2])
C0022658 (UMLS CUI [3])
C0018799 (UMLS CUI [4])
C0035204 (UMLS CUI [5])
Acute disease
Item
Any acute disease at the moment of entry
boolean
C0001314 (UMLS CUI [1])
Chronic alcohol consumption
Item
Chronic alcohol consumption
boolean
C0205191 (UMLS CUI [1,1])
C0001948 (UMLS CUI [1,2])
Hepatomegaly or right upper quadrant adominal pain
Item
Hepatomegaly, right upper quadrant abdominal pain or tenderness
boolean
C0019209 (UMLS CUI [1])
C0235299 (UMLS CUI [2])
Chronic drug treatment
Item
Any chronic drug treatment, including any treatment with immunosuppressive drugs, which in the investigator's opinion, precludes inclusion into the study
boolean
C0205191 (UMLS CUI [1,1])
C0013216 (UMLS CUI [1,2])
C0021081 (UMLS CUI [2])
Allergy stimulated by the vaccine
Item
History of allergic disease likely to be stimulated by any component of the vaccine
boolean
C0571550 (UMLS CUI [1])
Participation in another clinical trial
Item
Simultaneous participation in any other clinical trial
boolean
C2348568 (UMLS CUI [1])
Previous vaccination against hepatitis
Item
Previous vaccination against hepatitis A and B
boolean
C0419735 (UMLS CUI [1])
C0474232 (UMLS CUI [2])
Item Group
Administrative Data
C1320722 (UMLS CUI-1)
Date
Item
Date :
date
C0011008 (UMLS CUI [1])
Signature
Item
Investigator Signature :
text
C2346576 (UMLS CUI [1])
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