ID

24005

Description

Study ID: 101377 Clinical Study ID: 101377 Study Title: A phase III, open, randomized, multicentre study to demonstrate the non-inferiority of GSK Biologicals' combined hepatitis A and hepatitis B vaccine according to a 0-1-6 month schedule, to the monovalent hepatitis A vaccine Havrix and hepatitis B vaccine Engerix separately administered, in healthy adults Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: Sponsor: GlaxoSmithKline Collaborators: N/A Phase: phase 3 Study Recruitment Status: Completed Generic Name: Hepatitis A (Inactivated), Hepatitis B (Recombinant) Vaccine Trade Name:BIO HAB; Twinrix Study Indication: Hepatitis A; Hepatitis B Documentation part: Screening (Day – 21 To Day 0)

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  1. 21/07/2017 21/07/2017 -
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21 juillet 2017

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Creative Commons BY-NC 3.0
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Non-inferiority of GSK Biologicals' combined hepatitis A and hepatitis B vaccine to Havrix and Engerix in healthy adults Screening 101377

Anglais

Screening Non-inferiority of GSK Biologicals' combined hepatitis A and hepatitis B vaccine to Havrix and Engerix in healthy adults 101377

1 Formulaires  
Informed Consent
Description

Informed Consent

Alias
UMLS CUI-1
C0021430
Subject Number
Description

Subject Number

Type de données

text

Alias
UMLS CUI [1]
C2348585
Date of Visit
Description

Date of Visit

Type de données

date

Alias
UMLS CUI [1]
C1320303
Informed Consent Date
Description

I certify that Informed Consent has been obtained prior to any study procedure.

Type de données

time

Alias
UMLS CUI [1,1]
C0021430
UMLS CUI [1,2]
C0011008
Demographics
Description

Demographics

Alias
UMLS CUI-1
C0011298
Center number
Description

Center number

Type de données

integer

Alias
UMLS CUI [1,1]
C1301943
UMLS CUI [1,2]
C0600091
Date of birth
Description

Date of birth

Type de données

date

Alias
UMLS CUI [1]
C0421451
Gender
Description

Gender

Type de données

text

Alias
UMLS CUI [1]
C0079399
Race
Description

Race

Type de données

integer

Alias
UMLS CUI [1]
C0034510
Race, if other please specify
Description

Race

Type de données

text

Alias
UMLS CUI [1]
C0034510
Laboratory Tests
Description

Laboratory Tests

Alias
UMLS CUI-1
C0022885
UMLS CUI-2
C0005834
Has a blood sample been taken?
Description

blood sample

Type de données

boolean

Alias
UMLS CUI [1]
C0005834
Date sample taken
Description

Please complete only if different from visit date

Type de données

date

Alias
UMLS CUI [1,1]
C0005834
UMLS CUI [1,2]
C0011008
Retour au début de la page

Similar models

Screening Non-inferiority of GSK Biologicals' combined hepatitis A and hepatitis B vaccine to Havrix and Engerix in healthy adults 101377

1 Formulaires
Name
Type
Description | Question | Decode (Coded Value)
Type de données
Alias
Item Group
Informed Consent
C0021430 (UMLS CUI-1)
Subject Number
Item
Subject Number
text
C2348585 (UMLS CUI [1])
Date of Visit
Item
Date of Visit
date
C1320303 (UMLS CUI [1])
Informed Consent Date
Item
Informed Consent Date
time
C0021430 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
Item Group
Demographics
C0011298 (UMLS CUI-1)
Center number
Item
Center number
integer
C1301943 (UMLS CUI [1,1])
C0600091 (UMLS CUI [1,2])
Date of birth
Item
Date of birth
date
C0421451 (UMLS CUI [1])
Item
Gender
text
C0079399 (UMLS CUI [1])
Gender
Code List
Gender
CL Item
Male (M)
CL Item
Female (F)
Item
Race
integer
C0034510 (UMLS CUI [1])
Race
Code List
Race
CL Item
Black (1)
CL Item
Arabic/North African (2)
CL Item
White/Caucasian (3)
CL Item
East & South East Asian (4)
CL Item
South Asian (5)
CL Item
American Hispanic (6)
CL Item
Japanese (7)
CL Item
Other, please specify (8)
Race
Item
Race, if other please specify
text
C0034510 (UMLS CUI [1])
Item Group
Laboratory Tests
C0022885 (UMLS CUI-1)
C0005834 (UMLS CUI-2)
blood sample
Item
Has a blood sample been taken?
boolean
C0005834 (UMLS CUI [1])
Date sample taken
Item
Date sample taken
date
C0005834 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
Retour au début de la page 

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