ID

24005

Beskrivning

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)

Nyckelord

  1. 2017-07-21 2017-07-21 -
Uppladdad den

21 juli 2017

DOI

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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

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

Informed Consent
Beskrivning

Informed Consent

Alias
UMLS CUI-1
C0021430
Subject Number
Beskrivning

Subject Number

Datatyp

text

Alias
UMLS CUI [1]
C2348585
Date of Visit
Beskrivning

Date of Visit

Datatyp

date

Alias
UMLS CUI [1]
C1320303
Informed Consent Date
Beskrivning

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

Datatyp

time

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

Demographics

Alias
UMLS CUI-1
C0011298
Center number
Beskrivning

Center number

Datatyp

integer

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

Date of birth

Datatyp

date

Alias
UMLS CUI [1]
C0421451
Gender
Beskrivning

Gender

Datatyp

text

Alias
UMLS CUI [1]
C0079399
Race
Beskrivning

Race

Datatyp

integer

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

Race

Datatyp

text

Alias
UMLS CUI [1]
C0034510
Laboratory Tests
Beskrivning

Laboratory Tests

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

blood sample

Datatyp

boolean

Alias
UMLS CUI [1]
C0005834
Date sample taken
Beskrivning

Please complete only if different from visit date

Datatyp

date

Alias
UMLS CUI [1,1]
C0005834
UMLS CUI [1,2]
C0011008

Similar models

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

Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
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])
Code List
Gender
CL Item
Male (M)
CL Item
Female (F)
Item
Race
integer
C0034510 (UMLS CUI [1])
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])

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