ID

33805

Description

Hepatitis B Challenge Dose in Adults; ODM derived from: https://clinicaltrials.gov/show/NCT01251276

Link

https://clinicaltrials.gov/show/NCT01251276

Keywords

Versions (1)
  1. 12/28/18 12/28/18 -
Copyright Holder

See clinicaltrials.gov

Uploaded on

December 28, 2018

DOI

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License

Creative Commons BY 4.0
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Eligibility Hepatitis B NCT01251276

English

Eligibility Hepatitis B NCT01251276

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
in general good health based on a medical history.
Description

General health good Medical History

Data type

boolean

Alias
UMLS CUI [1,1]
C1277245
UMLS CUI [1,2]
C0262926
received 3 doses of an hepatitis b vaccine at least 2 years prior to enrollment in this study.
Description

Hepatitis B Vaccine Dose Quantity

Data type

boolean

Alias
UMLS CUI [1,1]
C2240392
UMLS CUI [1,2]
C0178602
UMLS CUI [1,3]
C1265611
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
known history of previous hepatitis b infection.
Description

Hepatitis B Previous

Data type

boolean

Alias
UMLS CUI [1,1]
C0019163
UMLS CUI [1,2]
C0205156
history of vaccination with any hepatitis b vaccine within the last 2 years.
Description

History of hepatitis B vaccination

Data type

boolean

Alias
UMLS CUI [1]
C1960633
history of febrile illness.
Description

Febrile illness

Data type

boolean

Alias
UMLS CUI [1]
C0743841
known or suspected hypersensitivity to any component of hbvaxpro.
Description

Hypersensitivity Component Hepatitis B virus recombinant vaccine | Hypersensitivity Suspected Component Hepatitis B virus recombinant vaccine

Data type

boolean

Alias
UMLS CUI [1,1]
C0020517
UMLS CUI [1,2]
C1705248
UMLS CUI [1,3]
C1445761
UMLS CUI [2,1]
C0020517
UMLS CUI [2,2]
C0750491
UMLS CUI [2,3]
C1705248
UMLS CUI [2,4]
C1445761
receipt of medication / vaccine that may interfere with study assessments.
Description

Pharmaceutical Preparation Interferes with Trial Assessment | Vaccine Interferes with Trial Assessment

Data type

boolean

Alias
UMLS CUI [1,1]
C0013227
UMLS CUI [1,2]
C0521102
UMLS CUI [1,3]
C0008976
UMLS CUI [1,4]
C1516048
UMLS CUI [2,1]
C0042210
UMLS CUI [2,2]
C0521102
UMLS CUI [2,3]
C0008976
UMLS CUI [2,4]
C1516048
known or suspected immune impairment.
Description

Immune system Impairment | Immune system Impairment Suspected

Data type

boolean

Alias
UMLS CUI [1,1]
C0020962
UMLS CUI [1,2]
C0221099
UMLS CUI [2,1]
C0020962
UMLS CUI [2,2]
C0221099
UMLS CUI [2,3]
C0750491
pregnant women and nursing mothers.
Description

Pregnancy | Breast Feeding

Data type

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
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Similar models

Eligibility Hepatitis B NCT01251276

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
General health good Medical History
Item
in general good health based on a medical history.
boolean
C1277245 (UMLS CUI [1,1])
C0262926 (UMLS CUI [1,2])
Hepatitis B Vaccine Dose Quantity
Item
received 3 doses of an hepatitis b vaccine at least 2 years prior to enrollment in this study.
boolean
C2240392 (UMLS CUI [1,1])
C0178602 (UMLS CUI [1,2])
C1265611 (UMLS CUI [1,3])
Item Group
C0680251 (UMLS CUI)
Hepatitis B Previous
Item
known history of previous hepatitis b infection.
boolean
C0019163 (UMLS CUI [1,1])
C0205156 (UMLS CUI [1,2])
History of hepatitis B vaccination
Item
history of vaccination with any hepatitis b vaccine within the last 2 years.
boolean
C1960633 (UMLS CUI [1])
Febrile illness
Item
history of febrile illness.
boolean
C0743841 (UMLS CUI [1])
Hypersensitivity Component Hepatitis B virus recombinant vaccine | Hypersensitivity Suspected Component Hepatitis B virus recombinant vaccine
Item
known or suspected hypersensitivity to any component of hbvaxpro.
boolean
C0020517 (UMLS CUI [1,1])
C1705248 (UMLS CUI [1,2])
C1445761 (UMLS CUI [1,3])
C0020517 (UMLS CUI [2,1])
C0750491 (UMLS CUI [2,2])
C1705248 (UMLS CUI [2,3])
C1445761 (UMLS CUI [2,4])
Pharmaceutical Preparation Interferes with Trial Assessment | Vaccine Interferes with Trial Assessment
Item
receipt of medication / vaccine that may interfere with study assessments.
boolean
C0013227 (UMLS CUI [1,1])
C0521102 (UMLS CUI [1,2])
C0008976 (UMLS CUI [1,3])
C1516048 (UMLS CUI [1,4])
C0042210 (UMLS CUI [2,1])
C0521102 (UMLS CUI [2,2])
C0008976 (UMLS CUI [2,3])
C1516048 (UMLS CUI [2,4])
Immune system Impairment | Immune system Impairment Suspected
Item
known or suspected immune impairment.
boolean
C0020962 (UMLS CUI [1,1])
C0221099 (UMLS CUI [1,2])
C0020962 (UMLS CUI [2,1])
C0221099 (UMLS CUI [2,2])
C0750491 (UMLS CUI [2,3])
Pregnancy | Breast Feeding
Item
pregnant women and nursing mothers.
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
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