ID

31762

Description

Hepatitis B Vaccination in Infants; ODM derived from: https://clinicaltrials.gov/show/NCT01896596

Link

https://clinicaltrials.gov/show/NCT01896596

Keywords

Versions (1)
  1. 9/26/18 9/26/18 -
Copyright Holder

Dr. Shamez Ladhani, Public Health England

Uploaded on

September 26, 2018

DOI

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License

Creative Commons BY-NC 3.0
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Eligibility Hepatitis B Vaccination in Infants NCT01896596

English

Eligibility Hepatitis B Vaccination in Infants NCT01896596

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
male or female infants born at term (at least 37 weeks gestation) who are aged <12 weeks and have not yet received their primary immunisations
Description

Infants acquired full gestation not yet vaccined

Data type

boolean

Alias
UMLS CUI [1]
C0021270
UMLS CUI [2]
C2114495
UMLS CUI [3]
C0001779
UMLS CUI [4,1]
C0042196
UMLS CUI [4,2]
C0205225
UMLS CUI [4,3]
C1298908
with written informed consent obtained from the parent or legal guardian of the infant to participate in the study
Description

Informed Consent from a custody

Data type

boolean

Alias
UMLS CUI [1,1]
C0021430
UMLS CUI [1,2]
C0030551
UMLS CUI [2,1]
C0021430
UMLS CUI [2,2]
C1274041
do not fulfil any of the exclusion criteria.
Description

Fulfil of exclusion criteria

Data type

boolean

Alias
UMLS CUI [1,1]
C1298908
UMLS CUI [1,2]
C0680251
Participant may not be included in the study if any of the following apply:
Description

Participant may not be included in the study if any of the following apply:

Alias
UMLS CUI-1
C0680251
history of infection with haemophilus influenzae serotype b (hib), pneumococcal or meningococcal disease, pertussis, polio, diphtheria, tetanus or hepatitis b
Description

Infection with HIB, pneumococcal/ meningococcal disease, pertussis, polio, diphtheria, tetanus or hepatitis b

Data type

boolean

Alias
UMLS CUI [1]
C2028293
UMLS CUI [2]
C0032269
UMLS CUI [3]
C0025303
UMLS CUI [4]
C0043167
UMLS CUI [5]
C0032371
UMLS CUI [6]
C0012546
UMLS CUI [7]
C0039614
UMLS CUI [8]
C0019163
history of maternal acute or chronic hepatitis b infection
Description

Acute or chronic hepatitis b infection of mother

Data type

boolean

Alias
UMLS CUI [1,1]
C0262926
UMLS CUI [1,2]
C0026591
UMLS CUI [1,3]
C0019163
UMLS CUI [2,1]
C0262926
UMLS CUI [2,2]
C0026591
UMLS CUI [2,3]
C0524909
confirmed or suspected immunosuppressive or immunodeficient condition (including hiv)
Description

Immunosuppressive or immunodeficient condition, including HIV

Data type

boolean

Alias
UMLS CUI [1,1]
C0750484
UMLS CUI [1,2]
C4048329
UMLS CUI [2,1]
C0750484
UMLS CUI [2,2]
C0021051
UMLS CUI [3,1]
C0019682
UMLS CUI [3,2]
C0332257
bleeding disorders and/or prolonged bleeding time
Description

Bleeding disorder

Data type

boolean

Alias
UMLS CUI [1]
C0005779
UMLS CUI [2]
C0151529
major congenital defects or chronic disease
Description

Major congenital defects, chronic disease

Data type

boolean

Alias
UMLS CUI [1,1]
C0220810
UMLS CUI [1,2]
C0205164
UMLS CUI [2]
C0008679
premature birth (<37 weeks gestation at birth).
Description

Premature birth

Data type

boolean

Alias
UMLS CUI [1]
C0151526
previously received any vaccine (particularly hepatitis b)
Description

Previous vaccine, particularly hepatitis b

Data type

boolean

Alias
UMLS CUI [1,1]
C0042210
UMLS CUI [1,2]
C0205156
UMLS CUI [2,1]
C0042210
UMLS CUI [2,2]
C0205156
UMLS CUI [2,3]
C0019163
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Similar models

Eligibility Hepatitis B Vaccination in Infants NCT01896596

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Infants acquired full gestation not yet vaccined
Item
male or female infants born at term (at least 37 weeks gestation) who are aged <12 weeks and have not yet received their primary immunisations
boolean
C0021270 (UMLS CUI [1])
C2114495 (UMLS CUI [2])
C0001779 (UMLS CUI [3])
C0042196 (UMLS CUI [4,1])
C0205225 (UMLS CUI [4,2])
C1298908 (UMLS CUI [4,3])
Informed Consent from a custody
Item
with written informed consent obtained from the parent or legal guardian of the infant to participate in the study
boolean
C0021430 (UMLS CUI [1,1])
C0030551 (UMLS CUI [1,2])
C0021430 (UMLS CUI [2,1])
C1274041 (UMLS CUI [2,2])
Fulfil of exclusion criteria
Item
do not fulfil any of the exclusion criteria.
boolean
C1298908 (UMLS CUI [1,1])
C0680251 (UMLS CUI [1,2])
Item Group
Participant may not be included in the study if any of the following apply:
C0680251 (UMLS CUI-1)
Infection with HIB, pneumococcal/ meningococcal disease, pertussis, polio, diphtheria, tetanus or hepatitis b
Item
history of infection with haemophilus influenzae serotype b (hib), pneumococcal or meningococcal disease, pertussis, polio, diphtheria, tetanus or hepatitis b
boolean
C2028293 (UMLS CUI [1])
C0032269 (UMLS CUI [2])
C0025303 (UMLS CUI [3])
C0043167 (UMLS CUI [4])
C0032371 (UMLS CUI [5])
C0012546 (UMLS CUI [6])
C0039614 (UMLS CUI [7])
C0019163 (UMLS CUI [8])
Acute or chronic hepatitis b infection of mother
Item
history of maternal acute or chronic hepatitis b infection
boolean
C0262926 (UMLS CUI [1,1])
C0026591 (UMLS CUI [1,2])
C0019163 (UMLS CUI [1,3])
C0262926 (UMLS CUI [2,1])
C0026591 (UMLS CUI [2,2])
C0524909 (UMLS CUI [2,3])
Immunosuppressive or immunodeficient condition, including HIV
Item
confirmed or suspected immunosuppressive or immunodeficient condition (including hiv)
boolean
C0750484 (UMLS CUI [1,1])
C4048329 (UMLS CUI [1,2])
C0750484 (UMLS CUI [2,1])
C0021051 (UMLS CUI [2,2])
C0019682 (UMLS CUI [3,1])
C0332257 (UMLS CUI [3,2])
Bleeding disorder
Item
bleeding disorders and/or prolonged bleeding time
boolean
C0005779 (UMLS CUI [1])
C0151529 (UMLS CUI [2])
Major congenital defects, chronic disease
Item
major congenital defects or chronic disease
boolean
C0220810 (UMLS CUI [1,1])
C0205164 (UMLS CUI [1,2])
C0008679 (UMLS CUI [2])
Premature birth
Item
premature birth (<37 weeks gestation at birth).
boolean
C0151526 (UMLS CUI [1])
Previous vaccine, particularly hepatitis b
Item
previously received any vaccine (particularly hepatitis b)
boolean
C0042210 (UMLS CUI [1,1])
C0205156 (UMLS CUI [1,2])
C0042210 (UMLS CUI [2,1])
C0205156 (UMLS CUI [2,2])
C0019163 (UMLS CUI [2,3])
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