ID

21167

Description

Study of Recombinant Modified Process Hepatitis B Vaccine in Older Adults; ODM derived from: https://clinicaltrials.gov/show/NCT00440531

Link

https://clinicaltrials.gov/show/NCT00440531

Keywords

  1. 4/12/17 4/12/17 -
Uploaded on

April 12, 2017

DOI

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License

Creative Commons BY 4.0

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Eligibility Hepatitis B NCT00440531

Eligibility Hepatitis B NCT00440531

Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
healthy male and female older adults greater than or equal to 50 years of age
Description

Gender, health status, age

Data type

boolean

Alias
UMLS CUI [1]
C0079399
UMLS CUI [2]
C0018759
UMLS CUI [3]
C0001779
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
any adult with a history of previous hepatitis b infection
Description

Previous hepatitis B infection

Data type

boolean

Alias
UMLS CUI [1,1]
C0019163
UMLS CUI [1,2]
C0205156
a history of vaccination with any hepatitis b vaccine
Description

Hepatitis B vaccination

Data type

boolean

Alias
UMLS CUI [1]
C0474232
recent (<72 hours) history of febrile illness (oral temperature =37.8ºc/=100.0ºf)
Description

Febrile illness

Data type

boolean

Alias
UMLS CUI [1]
C0743841
known or suspected hypersensitivity to any component of recombivax hb™ or engerix-b™
Description

Hypersensitivity to recombivax or engerix-b

Data type

boolean

Alias
UMLS CUI [1]
C0571556
(e.g., aluminum, yeast)
Description

Hypersensitivity to aluminium, yeast

Data type

boolean

Alias
UMLS CUI [1,1]
C0020517
UMLS CUI [1,2]
C0002367
UMLS CUI [2,1]
C0020517
UMLS CUI [2,2]
C0043393
recent administration (within 3 months prior to first injection with the study vaccine) of hepatitis b immune globulin (hbig), serum immune globulin, or any other blood-derived product
Description

Blood product

Data type

boolean

Alias
UMLS CUI [1]
C0456388
receipt of licensed inactivated vaccines within 14 days prior to first injection with the study vaccine
Description

Licensed inactivated vaccines

Data type

boolean

Alias
UMLS CUI [1]
C0042212
receipt of licensed live virus vaccines within the 30 days prior to injection with the study vaccine
Description

Licensed live virus vaccines

Data type

boolean

Alias
UMLS CUI [1]
C1516086
receipt of investigational drugs or other investigational vaccines within 3 months prior to first injection with the study vaccine
Description

Experimental drugs

Data type

boolean

Alias
UMLS CUI [1]
C0304229
known or suspected impairment of immunologic function or recent use of immunomodulatory medications (e.g., systemic corticosteroids). does not include topical and inhaled steroids
Description

Impairment of immunologic function or Immunomodulation

Data type

boolean

Alias
UMLS CUI [1,1]
C1817756
UMLS CUI [1,2]
C0221099
UMLS CUI [2]
C0005525
pregnant women, nursing mothers, and women planning to become pregnant within the study period
Description

Gynaecological status

Data type

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
UMLS CUI [3]
C3831118
any condition that, in the opinion of the investigator, might interfere with the evaluation of the study objectives
Description

Comorbidity

Data type

boolean

Alias
UMLS CUI [1]
C0009488

Similar models

Eligibility Hepatitis B NCT00440531

Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Gender, health status, age
Item
healthy male and female older adults greater than or equal to 50 years of age
boolean
C0079399 (UMLS CUI [1])
C0018759 (UMLS CUI [2])
C0001779 (UMLS CUI [3])
Item Group
C0680251 (UMLS CUI)
Previous hepatitis B infection
Item
any adult with a history of previous hepatitis b infection
boolean
C0019163 (UMLS CUI [1,1])
C0205156 (UMLS CUI [1,2])
Hepatitis B vaccination
Item
a history of vaccination with any hepatitis b vaccine
boolean
C0474232 (UMLS CUI [1])
Febrile illness
Item
recent (<72 hours) history of febrile illness (oral temperature =37.8ºc/=100.0ºf)
boolean
C0743841 (UMLS CUI [1])
Hypersensitivity to recombivax or engerix-b
Item
known or suspected hypersensitivity to any component of recombivax hb™ or engerix-b™
boolean
C0571556 (UMLS CUI [1])
Hypersensitivity to aluminium, yeast
Item
(e.g., aluminum, yeast)
boolean
C0020517 (UMLS CUI [1,1])
C0002367 (UMLS CUI [1,2])
C0020517 (UMLS CUI [2,1])
C0043393 (UMLS CUI [2,2])
Blood product
Item
recent administration (within 3 months prior to first injection with the study vaccine) of hepatitis b immune globulin (hbig), serum immune globulin, or any other blood-derived product
boolean
C0456388 (UMLS CUI [1])
Licensed inactivated vaccines
Item
receipt of licensed inactivated vaccines within 14 days prior to first injection with the study vaccine
boolean
C0042212 (UMLS CUI [1])
Licensed live virus vaccines
Item
receipt of licensed live virus vaccines within the 30 days prior to injection with the study vaccine
boolean
C1516086 (UMLS CUI [1])
Experimental drugs
Item
receipt of investigational drugs or other investigational vaccines within 3 months prior to first injection with the study vaccine
boolean
C0304229 (UMLS CUI [1])
Impairment of immunologic function or Immunomodulation
Item
known or suspected impairment of immunologic function or recent use of immunomodulatory medications (e.g., systemic corticosteroids). does not include topical and inhaled steroids
boolean
C1817756 (UMLS CUI [1,1])
C0221099 (UMLS CUI [1,2])
C0005525 (UMLS CUI [2])
Gynaecological status
Item
pregnant women, nursing mothers, and women planning to become pregnant within the study period
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
C3831118 (UMLS CUI [3])
Comorbidity
Item
any condition that, in the opinion of the investigator, might interfere with the evaluation of the study objectives
boolean
C0009488 (UMLS CUI [1])

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