ID

21146

Description

Study of Modified Process Hib/Hep B Vaccine in Infants (V121-019)(COMPLETED); ODM derived from: https://clinicaltrials.gov/show/NCT00441012

Link

https://clinicaltrials.gov/show/NCT00441012

Keywords

Versions (1)
  1. 4/11/17 4/11/17 -
Uploaded on

April 11, 2017

DOI

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License

Creative Commons BY 4.0
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Eligibility Haemophilus Influenzae Type B NCT00441012

English

Eligibility Haemophilus Influenzae Type B NCT00441012

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
healthy 2-month-old full term infants born to non-hbs ag (hepatitis b virus) carrier mothers
Description

Age and maternal HBs-status

Data type

boolean

Alias
UMLS CUI [1]
C0001779
UMLS CUI [2]
C0019168
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
birth mother known to be a carrier of hepatitis b virus (hbsag+) or known carriers ever living in close contact with the subject
Description

Hepatits B Carrier

Data type

boolean

Alias
UMLS CUI [1]
C0262505
history of previous hepatitis b infection; history of vaccination with any hepatitis b vaccine
Description

History of Hepatitis B infection and/ or vaccination

Data type

boolean

Alias
UMLS CUI [1,1]
C0262926
UMLS CUI [1,2]
C0019163
UMLS CUI [2,1]
C0262926
UMLS CUI [2,2]
C0474232
recent (<72 hours) history of febrile illness (rectal temperature >=38.1°c/>=100.5°f)
Description

Body temperature

Data type

boolean

Alias
UMLS CUI [1]
C0005903
known or suspected hypersensitivity to any component of recombivaxhb™ or comvax™
Description

Hypersensitivitiy to recombivaxhb or comvax

Data type

boolean

Alias
UMLS CUI [1]
C0571556
UMLS CUI [2,1]
C0020517
UMLS CUI [2,2]
C0535643
(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 (w/i 3 months prior to study start) of hepatitis b immune globulin (hbig), serum immune globulin, or any other blood-derived product
Description

Blood-derived product

Data type

boolean

Alias
UMLS CUI [1]
C0456388
receipt of investigational drugs or investigational vaccines within 3 months prior to study start or if planned within the study period;
Description

Experimental drug

Data type

boolean

Alias
UMLS CUI [1]
C0304229
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);
Description

Immunologic function or immunomodulatory medication

Data type

boolean

Alias
UMLS CUI [1]
C1817756
UMLS CUI [2]
C1963758
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
Description

Comorbidity

Data type

boolean

Alias
UMLS CUI [1]
C0009488
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Similar models

Eligibility Haemophilus Influenzae Type B NCT00441012

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
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])
Item Group
C0680251 (UMLS CUI)
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])
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])
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-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])
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])
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