ID

21167

Beschrijving

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

Trefwoorden

  1. 12-04-17 12-04-17 -
Geüploaded op

12 april 2017

DOI

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Licentie

Creative Commons BY 4.0

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Eligibility Hepatitis B NCT00440531

Eligibility Hepatitis B NCT00440531

Inclusion Criteria
Beschrijving

Inclusion Criteria

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

Gender, health status, age

Datatype

boolean

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

Exclusion Criteria

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

Previous hepatitis B infection

Datatype

boolean

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

Hepatitis B vaccination

Datatype

boolean

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

Febrile illness

Datatype

boolean

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

Hypersensitivity to recombivax or engerix-b

Datatype

boolean

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

Hypersensitivity to aluminium, yeast

Datatype

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
Beschrijving

Blood product

Datatype

boolean

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

Licensed inactivated vaccines

Datatype

boolean

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

Licensed live virus vaccines

Datatype

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
Beschrijving

Experimental drugs

Datatype

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
Beschrijving

Impairment of immunologic function or Immunomodulation

Datatype

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
Beschrijving

Gynaecological status

Datatype

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
Beschrijving

Comorbidity

Datatype

boolean

Alias
UMLS CUI [1]
C0009488

Similar models

Eligibility Hepatitis B NCT00440531

Name
Type
Description | Question | Decode (Coded Value)
Datatype
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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