ID

20894

Description

Compare the Immune Response & Safety Elicited by Henogen's Adjuvanted Hepatitis B Vaccine vs Aventis Pasteur MSD's Hepatitis B Vaccine in Pre-Dialysis & Dialysis Patients Who Did Not Respond to Previous Hepatitis B Vaccination; ODM derived from: https://clinicaltrials.gov/show/NCT00291954

Link

https://clinicaltrials.gov/show/NCT00291954

Keywords

Versions (1)
  1. 3/25/17 3/25/17 -
Uploaded on

March 25, 2017

DOI

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License

Creative Commons BY 4.0
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Eligibility Hepatitis B NCT00291954

English

Eligibility Hepatitis B NCT00291954

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
a male or female subject greater than or equal to 15 years of age at the time of study entry
Description

Age

Data type

boolean

Alias
UMLS CUI [1]
C0001779
written informed consent obtained from the subject/ from the parent or guardian of the subject.
Description

Informed Consent | Informed Consent parent | Informed Consent Guardian

Data type

boolean

Alias
UMLS CUI [1]
C0021430
UMLS CUI [2,1]
C0021430
UMLS CUI [2,2]
C0030551
UMLS CUI [3,1]
C0021430
UMLS CUI [3,2]
C1274041
seronegative for anti-hbc antibodies and for hbsag at screening.
Description

Antibody to hepatitis B core antigen Seronegative | Hepatitis B Surface Antigens Seronegative

Data type

boolean

Alias
UMLS CUI [1,1]
C0312631
UMLS CUI [1,2]
C0521144
UMLS CUI [2,1]
C0019168
UMLS CUI [2,2]
C0521144
pre-dialysis patients, peritoneal dialysis patients or haemodialysis patients
Description

Patients Pre-dialysis | Peritoneal Dialysis | Hemodialysis

Data type

boolean

Alias
UMLS CUI [1,1]
C0030705
UMLS CUI [1,2]
C1264634
UMLS CUI [2]
C0031139
UMLS CUI [3]
C0019004
documented evidence of previous hepatitis b vaccination with at least one full primary vaccination course of minimum four injections of licensed vaccine.
Description

Hepatitis B vaccination Evidence of | Vaccine Injection Quantity

Data type

boolean

Alias
UMLS CUI [1,1]
C0474232
UMLS CUI [1,2]
C0332120
UMLS CUI [2,1]
C0042210
UMLS CUI [2,2]
C1533685
UMLS CUI [2,3]
C1265611
the last dose should have been administered at least two months before the planned first dose of study vaccine in this study.
Description

Vaccine Dose Last | Vaccine Clinical Trial Dose First

Data type

boolean

Alias
UMLS CUI [1,1]
C0042210
UMLS CUI [1,2]
C0178602
UMLS CUI [1,3]
C1517741
UMLS CUI [2,1]
C0042210
UMLS CUI [2,2]
C0008976
UMLS CUI [2,3]
C0178602
UMLS CUI [2,4]
C0205435
documented evidence of non-response to previous hepatitis b vaccination after at least one to maximum three months after the last vaccine dose.
Description

Hepatitis B vaccination Absent response to treatment

Data type

boolean

Alias
UMLS CUI [1,1]
C0474232
UMLS CUI [1,2]
C0438286
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
subject included on hn014/hbv-001 study. history of hepatitis b infection use of immunoglobulins within six months preceding the first study vaccination.
Description

Study Subject Participation Status | Hepatitis B | Immunoglobulins Use of

Data type

boolean

Alias
UMLS CUI [1]
C2348568
UMLS CUI [2]
C0019163
UMLS CUI [3,1]
C0021027
UMLS CUI [3,2]
C1524063
any confirmed or suspected human immunodeficiency virus (hiv) infection. pregnant or lactating female
Description

HIV Infection | HIV Infection Suspected | Pregnancy | Breast Feeding

Data type

boolean

Alias
UMLS CUI [1]
C0019693
UMLS CUI [2,1]
C0019693
UMLS CUI [2,2]
C0750491
UMLS CUI [3]
C0032961
UMLS CUI [4]
C0006147
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Similar models

Eligibility Hepatitis B NCT00291954

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Age
Item
a male or female subject greater than or equal to 15 years of age at the time of study entry
boolean
C0001779 (UMLS CUI [1])
Informed Consent | Informed Consent parent | Informed Consent Guardian
Item
written informed consent obtained from the subject/ from the parent or guardian of the subject.
boolean
C0021430 (UMLS CUI [1])
C0021430 (UMLS CUI [2,1])
C0030551 (UMLS CUI [2,2])
C0021430 (UMLS CUI [3,1])
C1274041 (UMLS CUI [3,2])
Antibody to hepatitis B core antigen Seronegative | Hepatitis B Surface Antigens Seronegative
Item
seronegative for anti-hbc antibodies and for hbsag at screening.
boolean
C0312631 (UMLS CUI [1,1])
C0521144 (UMLS CUI [1,2])
C0019168 (UMLS CUI [2,1])
C0521144 (UMLS CUI [2,2])
Patients Pre-dialysis | Peritoneal Dialysis | Hemodialysis
Item
pre-dialysis patients, peritoneal dialysis patients or haemodialysis patients
boolean
C0030705 (UMLS CUI [1,1])
C1264634 (UMLS CUI [1,2])
C0031139 (UMLS CUI [2])
C0019004 (UMLS CUI [3])
Hepatitis B vaccination Evidence of | Vaccine Injection Quantity
Item
documented evidence of previous hepatitis b vaccination with at least one full primary vaccination course of minimum four injections of licensed vaccine.
boolean
C0474232 (UMLS CUI [1,1])
C0332120 (UMLS CUI [1,2])
C0042210 (UMLS CUI [2,1])
C1533685 (UMLS CUI [2,2])
C1265611 (UMLS CUI [2,3])
Vaccine Dose Last | Vaccine Clinical Trial Dose First
Item
the last dose should have been administered at least two months before the planned first dose of study vaccine in this study.
boolean
C0042210 (UMLS CUI [1,1])
C0178602 (UMLS CUI [1,2])
C1517741 (UMLS CUI [1,3])
C0042210 (UMLS CUI [2,1])
C0008976 (UMLS CUI [2,2])
C0178602 (UMLS CUI [2,3])
C0205435 (UMLS CUI [2,4])
Hepatitis B vaccination Absent response to treatment
Item
documented evidence of non-response to previous hepatitis b vaccination after at least one to maximum three months after the last vaccine dose.
boolean
C0474232 (UMLS CUI [1,1])
C0438286 (UMLS CUI [1,2])
Item Group
C0680251 (UMLS CUI)
Study Subject Participation Status | Hepatitis B | Immunoglobulins Use of
Item
subject included on hn014/hbv-001 study. history of hepatitis b infection use of immunoglobulins within six months preceding the first study vaccination.
boolean
C2348568 (UMLS CUI [1])
C0019163 (UMLS CUI [2])
C0021027 (UMLS CUI [3,1])
C1524063 (UMLS CUI [3,2])
HIV Infection | HIV Infection Suspected | Pregnancy | Breast Feeding
Item
any confirmed or suspected human immunodeficiency virus (hiv) infection. pregnant or lactating female
boolean
C0019693 (UMLS CUI [1])
C0019693 (UMLS CUI [2,1])
C0750491 (UMLS CUI [2,2])
C0032961 (UMLS CUI [3])
C0006147 (UMLS CUI [4])
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