ID

14146

Descrição

Comparison of Adjuvanted Hepatitis B Vaccine to Double Dose of Engerix™-B in Pre- /Haemodialysis Patients Aged ≥15 Years; ODM derived from: https://clinicaltrials.gov/show/NCT00383383

Link

https://clinicaltrials.gov/show/NCT00383383

Palavras-chave

  1. 31/03/2016 31/03/2016 -
Transferido a

31 de março de 2016

DOI

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Licença

Creative Commons BY 4.0

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Eligibility Hepatitis B NCT00383383

Eligibility Hepatitis B NCT00383383

Inclusion Criteria
Descrição

Inclusion Criteria

Alias
UMLS CUI
C1512693
a male or female > = 15 years of age at the time of the first vaccination.
Descrição

Gender and age at the first vaccination

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0079399
UMLS CUI [2,1]
C0001779
UMLS CUI [2,2]
C0419726
written informed consent obtained from the subject/ from the parents or guardians of the subject.
Descrição

Written informed consent

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0021430
seronegative for anti-hbs antibodies, anti-hbc antibodies & hepatitis b surface antigen (hbsag).
Descrição

Anti-hbs antibodies, anti-hbc antibodies & hepatitis b surface antigen

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0201478
UMLS CUI [2]
C0201480
UMLS CUI [3]
C0201477
if the subject was a female, she was of non-childbearing potential or, if of childbearing potential, she had to be abstinent or use adequate contraceptive precautions for one month prior to enrollment and up to two months after the last vaccination.
Descrição

Gynaecological status

Tipo de dados

boolean

Alias
UMLS CUI [1]
C3831118
UMLS CUI [2]
C0700589
pre-haemodialysis patient* or a patient on haemodialysis.
Descrição

Pre-haemodialysis or haemodialysis

Tipo de dados

boolean

Alias
UMLS CUI [1]
C1264634
UMLS CUI [2]
C0019004
Exclusion Criteria
Descrição

Exclusion Criteria

Alias
UMLS CUI
C0680251
use of any investigational or non-registered drug or vaccine other than the study vaccine during the study period or within 30 days preceding the first dose of study vaccine.
Descrição

Experimental drug

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0304229
previous vaccination against hepatitis b.
Descrição

Hepatitis b vaccination

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0474232
history of hepatitis b infection.
Descrição

Hepatitis b infection

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0019163
known exposure to hepatitis b virus within 6 weeks. pregnant or lactating female
Descrição

HBV exposure

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0019169
UMLS CUI [1,2]
C0332157
clinically abnormal alt/ast values (> 3 times normal values)
Descrição

Alt/ast values

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0201836
UMLS CUI [2]
C0201899

Similar models

Eligibility Hepatitis B NCT00383383

Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de dados
Alias
Item Group
C1512693 (UMLS CUI)
Gender and age at the first vaccination
Item
a male or female > = 15 years of age at the time of the first vaccination.
boolean
C0079399 (UMLS CUI [1])
C0001779 (UMLS CUI [2,1])
C0419726 (UMLS CUI [2,2])
Written informed consent
Item
written informed consent obtained from the subject/ from the parents or guardians of the subject.
boolean
C0021430 (UMLS CUI [1])
Anti-hbs antibodies, anti-hbc antibodies & hepatitis b surface antigen
Item
seronegative for anti-hbs antibodies, anti-hbc antibodies & hepatitis b surface antigen (hbsag).
boolean
C0201478 (UMLS CUI [1])
C0201480 (UMLS CUI [2])
C0201477 (UMLS CUI [3])
Gynaecological status
Item
if the subject was a female, she was of non-childbearing potential or, if of childbearing potential, she had to be abstinent or use adequate contraceptive precautions for one month prior to enrollment and up to two months after the last vaccination.
boolean
C3831118 (UMLS CUI [1])
C0700589 (UMLS CUI [2])
Pre-haemodialysis or haemodialysis
Item
pre-haemodialysis patient* or a patient on haemodialysis.
boolean
C1264634 (UMLS CUI [1])
C0019004 (UMLS CUI [2])
Item Group
C0680251 (UMLS CUI)
Experimental drug
Item
use of any investigational or non-registered drug or vaccine other than the study vaccine during the study period or within 30 days preceding the first dose of study vaccine.
boolean
C0304229 (UMLS CUI [1])
Hepatitis b vaccination
Item
previous vaccination against hepatitis b.
boolean
C0474232 (UMLS CUI [1])
Hepatitis b infection
Item
history of hepatitis b infection.
boolean
C0019163 (UMLS CUI [1])
HBV exposure
Item
known exposure to hepatitis b virus within 6 weeks. pregnant or lactating female
boolean
C0019169 (UMLS CUI [1,1])
C0332157 (UMLS CUI [1,2])
Alt/ast values
Item
clinically abnormal alt/ast values (> 3 times normal values)
boolean
C0201836 (UMLS CUI [1])
C0201899 (UMLS CUI [2])

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