Information:
Fel:
ID
21146
Beskrivning
Study of Modified Process Hib/Hep B Vaccine in Infants (V121-019)(COMPLETED); ODM derived from: https://clinicaltrials.gov/show/NCT00441012
Länk
https://clinicaltrials.gov/show/NCT00441012
Nyckelord
Versioner (1)
- 2017-04-11 2017-04-11 -
Uppladdad den
11 april 2017
DOI
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Licens
Creative Commons BY 4.0
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Eligibility Haemophilus Influenzae Type B NCT00441012
Eligibility Haemophilus Influenzae Type B NCT00441012
- StudyEvent: Eligibility
Similar models
Eligibility Haemophilus Influenzae Type B NCT00441012
- StudyEvent: Eligibility
Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
Alias
Age and maternal HBs-status
Item
healthy 2-month-old full term infants born to non-hbs ag (hepatitis b virus) carrier mothers
boolean
C0001779 (UMLS CUI [1])
C0019168 (UMLS CUI [2])
C0019168 (UMLS CUI [2])
Hepatits B Carrier
Item
birth mother known to be a carrier of hepatitis b virus (hbsag+) or known carriers ever living in close contact with the subject
boolean
C0262505 (UMLS CUI [1])
History of Hepatitis B infection and/ or vaccination
Item
history of previous hepatitis b infection; history of vaccination with any hepatitis b vaccine
boolean
C0262926 (UMLS CUI [1,1])
C0019163 (UMLS CUI [1,2])
C0262926 (UMLS CUI [2,1])
C0474232 (UMLS CUI [2,2])
C0019163 (UMLS CUI [1,2])
C0262926 (UMLS CUI [2,1])
C0474232 (UMLS CUI [2,2])
Body temperature
Item
recent (<72 hours) history of febrile illness (rectal temperature >=38.1°c/>=100.5°f)
boolean
C0005903 (UMLS CUI [1])
Hypersensitivitiy to recombivaxhb or comvax
Item
known or suspected hypersensitivity to any component of recombivaxhb™ or comvax™
boolean
C0571556 (UMLS CUI [1])
C0020517 (UMLS CUI [2,1])
C0535643 (UMLS CUI [2,2])
C0020517 (UMLS CUI [2,1])
C0535643 (UMLS CUI [2,2])
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-derived product
Item
recent administration (w/i 3 months prior to study start) of hepatitis b immune globulin (hbig), serum immune globulin, or any other blood-derived product
boolean
C0456388 (UMLS CUI [1])
Experimental drug
Item
receipt of investigational drugs or investigational vaccines within 3 months prior to study start or if planned within the study period;
boolean
C0304229 (UMLS CUI [1])
Immunologic function or immunomodulatory medication
Item
known or suspected impairment of immunologic function or recent use (within 3 months prior to study start) of immunomodulatory medications (does not include topical and inhaled steroids);
boolean
C1817756 (UMLS CUI [1])
C1963758 (UMLS CUI [2])
C1963758 (UMLS CUI [2])
Comorbidity
Item
any condition that, in the opinion of the investigator, might interfere with the evaluation of study objectives; or inability to comply with the study schedule and/or inability to attend all required study visits
boolean
C0009488 (UMLS CUI [1])