ID

20905

Description

Hepatitis B Vaccine Booster Study (V232-058); ODM derived from: https://clinicaltrials.gov/show/NCT00393523

Link

https://clinicaltrials.gov/show/NCT00393523

Keywords

Versions (1)
  1. 3/26/17 3/26/17 -
Uploaded on

March 26, 2017

DOI

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License

Creative Commons BY 4.0
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Eligibility Hepatitis B NCT00393523

English

Eligibility Hepatitis B NCT00393523

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
healthy children 4 to 8 years of age
Description

Well child | Age

Data type

boolean

Alias
UMLS CUI [1]
C0686744
UMLS CUI [2]
C0001779
complete medical records documenting receiving a previous hepatitis b vaccination during the first year of life (for cohort a and b only)
Description

Medical Records Complete | Hepatitis B vaccination first year of life

Data type

boolean

Alias
UMLS CUI [1,1]
C0025102
UMLS CUI [1,2]
C0205197
UMLS CUI [2,1]
C0474232
UMLS CUI [2,2]
C1857409
complete 3-dose vaccination with either a primary series of recombivax hb or a primary series of engerix-b (for cohort a and b only)
Description

Vaccination Dose Quantity | Recombivax HB Series Primary | Engerix-B Series Primary

Data type

boolean

Alias
UMLS CUI [1,1]
C0042196
UMLS CUI [1,2]
C0178602
UMLS CUI [1,3]
C1265611
UMLS CUI [2,1]
C0140114
UMLS CUI [2,2]
C0205549
UMLS CUI [2,3]
C0205225
UMLS CUI [3,1]
C0116078
UMLS CUI [3,2]
C0205549
UMLS CUI [3,3]
C0205225
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
birth mother known to be a carrier of hepatitis b virus (cohort c only)
Description

Natural mother Carrier Hepatitis B Virus

Data type

boolean

Alias
UMLS CUI [1,1]
C0337486
UMLS CUI [1,2]
C0007294
UMLS CUI [1,3]
C0019169
history of previous hepatitis b vaccine
Description

Hepatitis B Vaccine

Data type

boolean

Alias
UMLS CUI [1]
C2240392
history of vaccination with any hepatitis b vaccine (cohort c only)
Description

Vaccination Hepatitis B Vaccine

Data type

boolean

Alias
UMLS CUI [1,1]
C0042196
UMLS CUI [1,2]
C2240392
known of suspected hypersensitivity to any component of recombivax hb or engerix-b (eg aluminum, yeast) recent administration of hepatitis b immune globulin (hbig), serum immune globulin, or any other blood-derived product
Description

Hypersensitivity Recombivax HB Component | Hypersensitivity Engerix-B Component | Hypersensitivity Yeast | Hypersensitivity Aluminum | hepatitis B immune globulin | immune globulin serum | Blood product

Data type

boolean

Alias
UMLS CUI [1,1]
C0020517
UMLS CUI [1,2]
C0140114
UMLS CUI [1,3]
C1705248
UMLS CUI [2,1]
C0020517
UMLS CUI [2,2]
C0116078
UMLS CUI [2,3]
C1705248
UMLS CUI [3,1]
C0020517
UMLS CUI [3,2]
C0043393
UMLS CUI [4,1]
C0020517
UMLS CUI [4,2]
C0002367
UMLS CUI [5]
C0062525
UMLS CUI [6]
C0301519
UMLS CUI [7]
C0456388
receipt of investigational drugs or vaccines within 3 months prior to study vaccine or planned within study period
Description

Investigational New Drugs | Vaccines Investigational

Data type

boolean

Alias
UMLS CUI [1]
C0013230
UMLS CUI [2,1]
C0042210
UMLS CUI [2,2]
C1517586
impairment of immunologic function or recent use of immunomodulatory medications
Description

Immune System Processes Impaired | Biological Response Modifiers

Data type

boolean

Alias
UMLS CUI [1,1]
C1817756
UMLS CUI [1,2]
C0221099
UMLS CUI [2]
C0005525
a combination of different hepatitis b vaccines used in the primary vaccination series (cohort a and b only)
Description

Hepatitis B Vaccines Different Combined | Vaccination Series Primary

Data type

boolean

Alias
UMLS CUI [1,1]
C2240392
UMLS CUI [1,2]
C1705242
UMLS CUI [1,3]
C0205195
UMLS CUI [2,1]
C0042196
UMLS CUI [2,2]
C0205549
UMLS CUI [2,3]
C0205225
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Similar models

Eligibility Hepatitis B NCT00393523

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Well child | Age
Item
healthy children 4 to 8 years of age
boolean
C0686744 (UMLS CUI [1])
C0001779 (UMLS CUI [2])
Medical Records Complete | Hepatitis B vaccination first year of life
Item
complete medical records documenting receiving a previous hepatitis b vaccination during the first year of life (for cohort a and b only)
boolean
C0025102 (UMLS CUI [1,1])
C0205197 (UMLS CUI [1,2])
C0474232 (UMLS CUI [2,1])
C1857409 (UMLS CUI [2,2])
Vaccination Dose Quantity | Recombivax HB Series Primary | Engerix-B Series Primary
Item
complete 3-dose vaccination with either a primary series of recombivax hb or a primary series of engerix-b (for cohort a and b only)
boolean
C0042196 (UMLS CUI [1,1])
C0178602 (UMLS CUI [1,2])
C1265611 (UMLS CUI [1,3])
C0140114 (UMLS CUI [2,1])
C0205549 (UMLS CUI [2,2])
C0205225 (UMLS CUI [2,3])
C0116078 (UMLS CUI [3,1])
C0205549 (UMLS CUI [3,2])
C0205225 (UMLS CUI [3,3])
Item Group
C0680251 (UMLS CUI)
Natural mother Carrier Hepatitis B Virus
Item
birth mother known to be a carrier of hepatitis b virus (cohort c only)
boolean
C0337486 (UMLS CUI [1,1])
C0007294 (UMLS CUI [1,2])
C0019169 (UMLS CUI [1,3])
Hepatitis B Vaccine
Item
history of previous hepatitis b vaccine
boolean
C2240392 (UMLS CUI [1])
Vaccination Hepatitis B Vaccine
Item
history of vaccination with any hepatitis b vaccine (cohort c only)
boolean
C0042196 (UMLS CUI [1,1])
C2240392 (UMLS CUI [1,2])
Hypersensitivity Recombivax HB Component | Hypersensitivity Engerix-B Component | Hypersensitivity Yeast | Hypersensitivity Aluminum | hepatitis B immune globulin | immune globulin serum | Blood product
Item
known of suspected hypersensitivity to any component of recombivax hb or engerix-b (eg aluminum, yeast) recent administration of hepatitis b immune globulin (hbig), serum immune globulin, or any other blood-derived product
boolean
C0020517 (UMLS CUI [1,1])
C0140114 (UMLS CUI [1,2])
C1705248 (UMLS CUI [1,3])
C0020517 (UMLS CUI [2,1])
C0116078 (UMLS CUI [2,2])
C1705248 (UMLS CUI [2,3])
C0020517 (UMLS CUI [3,1])
C0043393 (UMLS CUI [3,2])
C0020517 (UMLS CUI [4,1])
C0002367 (UMLS CUI [4,2])
C0062525 (UMLS CUI [5])
C0301519 (UMLS CUI [6])
C0456388 (UMLS CUI [7])
Investigational New Drugs | Vaccines Investigational
Item
receipt of investigational drugs or vaccines within 3 months prior to study vaccine or planned within study period
boolean
C0013230 (UMLS CUI [1])
C0042210 (UMLS CUI [2,1])
C1517586 (UMLS CUI [2,2])
Immune System Processes Impaired | Biological Response Modifiers
Item
impairment of immunologic function or recent use of immunomodulatory medications
boolean
C1817756 (UMLS CUI [1,1])
C0221099 (UMLS CUI [1,2])
C0005525 (UMLS CUI [2])
Hepatitis B Vaccines Different Combined | Vaccination Series Primary
Item
a combination of different hepatitis b vaccines used in the primary vaccination series (cohort a and b only)
boolean
C2240392 (UMLS CUI [1,1])
C1705242 (UMLS CUI [1,2])
C0205195 (UMLS CUI [1,3])
C0042196 (UMLS CUI [2,1])
C0205549 (UMLS CUI [2,2])
C0205225 (UMLS CUI [2,3])
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