ID

23414

Beskrivning

Clinical Study ID: 100450 Study Title: Comparative study of the immunogenicity and protective efficacy of GlaxoSmithKline Biologicals’ rec-DNA hepatitis B vaccine with or without hepatitis B immunoglobulins (HBIg) in newborns of HBeAg+ mothers. Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00240526 https://clinicaltrials.gov/ct2/show/NCT00240526 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: phase 4 Study Recruitment Status: Completed Generic Name: Hepatitis B Vaccine, Recombinant Trade Name: Engerix-B Study Indication: Hepatitis B Documentation part: Visit 21, Year 15, Long Term Follow-Up, 15 Years +/- 6 Months

Länk

https://clinicaltrials.gov/ct2/show/NCT00240526

Nyckelord

Versioner (1)
  1. 2017-07-04 2017-07-04 -
Uppladdad den

4 juli 2017

DOI

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Licens

Creative Commons BY-NC 3.0
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Rec-DNA hepatitis B vaccine with or without hepatitis B immunoglobulins Visit 21 NCT00240526

Engelsk

Visit 21 Rec-DNA hepatitis B vaccine with or without hepatitis B immunoglobulins NCT00240526

1 Formulär  
Informed Consent
Beskrivning

Informed Consent

Alias
UMLS CUI-1
C0021430
UMLS CUI-2
C0474232
Center
Beskrivning

Center

Datatyp

text

Alias
UMLS CUI [1,1]
C1301943
UMLS CUI [1,2]
C0600091
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
UMLS CUI-2
C0474232
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
Beskrivning

If Other, please specify

Datatyp

integer

Alias
UMLS CUI [1]
C0034510
Height
Beskrivning

Height

Datatyp

integer

Måttenheter
  • cm
Alias
UMLS CUI [1]
C0005890
cm
Weight
Beskrivning

Weight

Datatyp

float

Måttenheter
  • kg
Alias
UMLS CUI [1]
C0005910
kg
Laboratory Tests
Beskrivning

Laboratory Tests

Alias
UMLS CUI-1
C0022885
UMLS CUI-2
C0005834
UMLS CUI-3
C0474232
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
Did the subject receive a dose of Hepatitis B vaccine since the last visit
Beskrivning

Hepatitis B vaccine

Datatyp

boolean

Alias
UMLS CUI [1]
C2240392
Did the subject develop clinical signs possibly related to hepatitis B since last visit or suffered from hepatitis B?
Beskrivning

hepatitis B

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0019163
UMLS CUI [1,2]
C1457887
UMLS CUI [2]
C0267797
If Yes, please specify
Beskrivning

Did the subject develop clinical signs possibly related to hepatitis B since last visit or suffered from hepatitis B?

Datatyp

text

Alias
UMLS CUI [1,1]
C0019163
UMLS CUI [1,2]
C1457887
UMLS CUI [2]
C0267797
Tillbaka till toppen

Similar models

Visit 21 Rec-DNA hepatitis B vaccine with or without hepatitis B immunoglobulins NCT00240526

1 Formulär
Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
Alias
Item Group
Informed Consent
C0021430 (UMLS CUI-1)
C0474232 (UMLS CUI-2)
Center
Item
Center
text
C1301943 (UMLS CUI [1,1])
C0600091 (UMLS CUI [1,2])
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)
C0474232 (UMLS CUI-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
Other (6)
Race
Item
Race
integer
C0034510 (UMLS CUI [1])
Height
Item
Height
integer
C0005890 (UMLS CUI [1])
Weight
Item
Weight
float
C0005910 (UMLS CUI [1])
Item Group
Laboratory Tests
C0022885 (UMLS CUI-1)
C0005834 (UMLS CUI-2)
C0474232 (UMLS CUI-3)
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])
Hepatitis B vaccine
Item
Did the subject receive a dose of Hepatitis B vaccine since the last visit
boolean
C2240392 (UMLS CUI [1])
hepatitis B
Item
Did the subject develop clinical signs possibly related to hepatitis B since last visit or suffered from hepatitis B?
boolean
C0019163 (UMLS CUI [1,1])
C1457887 (UMLS CUI [1,2])
C0267797 (UMLS CUI [2])
hepatitis B
Item
If Yes, please specify
text
C0019163 (UMLS CUI [1,1])
C1457887 (UMLS CUI [1,2])
C0267797 (UMLS CUI [2])
Tillbaka till toppen 

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