Information:
Fel:
ID
21167
Beskrivning
Study of Recombinant Modified Process Hepatitis B Vaccine in Older Adults; ODM derived from: https://clinicaltrials.gov/show/NCT00440531
Länk
https://clinicaltrials.gov/show/NCT00440531
Nyckelord
Versioner (1)
- 2017-04-12 2017-04-12 -
Uppladdad den
12 april 2017
DOI
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Licens
Creative Commons BY 4.0
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Eligibility Hepatitis B NCT00440531
Eligibility Hepatitis B NCT00440531
- StudyEvent: Eligibility
Similar models
Eligibility Hepatitis B NCT00440531
- StudyEvent: Eligibility
Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
Alias
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])
C0018759 (UMLS CUI [2])
C0001779 (UMLS CUI [3])
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])
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])
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])
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])
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])