ID

24379

Beskrivning

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

Nyckelord

Versioner (1)
  1. 2017-07-30 2017-07-30 -
Rättsinnehavare

GlaxoSmithKline

Uppladdad den

30 juli 2017

DOI

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Licens

Creative Commons BY-NC 3.0
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Visit 2 Eligibility Checklist Biologicals HepA/HepB vaccine 208127/125

Engelsk

Visit 2 Eligibility Checklist Biologicals HepA/HepB vaccine 208127/125

1 Formulär  
Header
Beskrivning

Header

Alias
UMLS CUI-1
C1320722
Protocol
Beskrivning

Protocol

Datatyp

text

Alias
UMLS CUI [1]
C1507394
Activity
Beskrivning

Activity

Datatyp

text

Alias
UMLS CUI [1]
C1512346
Subject number
Beskrivning

Subject number

Datatyp

text

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

Criteria for study participation

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

Age

Datatyp

boolean

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

Good physical condition

Datatyp

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).
Beskrivning

NA = no answer

Datatyp

boolean

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

Written informed consent

Datatyp

boolean

Alias
UMLS CUI [1]
C0021430
if Yes, date of signature :
Beskrivning

if the written informed consent has been signed, enter the date of signature day/month/year

Datatyp

date

Alias
UMLS CUI [1]
C2985782
Criteria for exclusion of the study
Beskrivning

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)
Beskrivning

Positive titres for hepatitis antibodies

Datatyp

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
Beskrivning

Elevated ALT or AST

Datatyp

boolean

Alias
UMLS CUI [1]
C0201836
UMLS CUI [2]
C0201899
History of significant and persisting hematologic, hepatic, renal, cardiac or respiratory disease
Beskrivning

History of diseases

Datatyp

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
Beskrivning

Acute disease

Datatyp

boolean

Alias
UMLS CUI [1]
C0001314
Chronic alcohol consumption
Beskrivning

Chronic alcohol consumption

Datatyp

boolean

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

Hepatomegaly or right upper quadrant adominal pain

Datatyp

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
Beskrivning

Chronic drug treatment

Datatyp

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
Beskrivning

Allergy stimulated by the vaccine

Datatyp

boolean

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

Participation in another clinical trial

Datatyp

boolean

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

Previous vaccination against hepatitis

Datatyp

boolean

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

Administrative Data

Alias
UMLS CUI-1
C1320722
Date :
Beskrivning

day/month/year

Datatyp

date

Alias
UMLS CUI [1]
C0011008
Investigator Signature :
Beskrivning

Signature

Datatyp

text

Alias
UMLS CUI [1]
C2346576
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Similar models

Visit 2 Eligibility Checklist Biologicals HepA/HepB vaccine 208127/125

1 Formulär
Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
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])
Tillbaka till toppen 

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