ID

17558

Description

Assess the Immune Response Following Primary Vaccination With GSK Biologicals' Tritanrix™-HepB/Hib-MenAC vs Tritanrix™-HepB/Hiberix™ Given at 6,10 & 14 Wks of Age to Infants Who Received Hepatitis B Vaccine at Birth; ODM derived from: https://clinicaltrials.gov/show/NCT00317122

Link

https://clinicaltrials.gov/show/NCT00317122

Keywords

Versions (1)
  1. 9/23/16 9/23/16 -
Uploaded on

September 23, 2016

DOI

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License

Creative Commons BY-NC 3.0
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Eligibility Hib Disease NCT00317122

English

Eligibility Hib Disease NCT00317122

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
healthy infants aged 7 days +/- 3 days old born to mothers who are tested as seronegative for hiv & hbsag, written informed consent obtained from the parents, born after a gestation period of 36 to 42 weeks.
Description

infant healthy | Age | Mother HIV test negative | Mother Hepatitis B surface antigen negative | Informed Consent parent | Duration of gestation

Data type

boolean

Alias
UMLS CUI [1]
C2049683
UMLS CUI [2]
C0001779
UMLS CUI [3,1]
C0026591
UMLS CUI [3,2]
C0854048
UMLS CUI [4,1]
C0026591
UMLS CUI [4,2]
C0919711
UMLS CUI [5,1]
C0021430
UMLS CUI [5,2]
C0030551
UMLS CUI [6]
C0460089
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
known exposure to diphtheria, tetanus, pertussis, hepatitis b, haemophilus influenzae type b and/or meningococcal disease since birth.
Description

Exposure to Diphtheria | Exposure to Tetanus | Exposure to Pertussis | Exposure to Hepatitis B | Exposure to Haemophilus influenzae type b | Exposure to Meningococcal Infections

Data type

boolean

Alias
UMLS CUI [1,1]
C0332157
UMLS CUI [1,2]
C0012546
UMLS CUI [2,1]
C0332157
UMLS CUI [2,2]
C0039614
UMLS CUI [3,1]
C0332157
UMLS CUI [3,2]
C0043167
UMLS CUI [4,1]
C0332157
UMLS CUI [4,2]
C0019163
UMLS CUI [5,1]
C0332157
UMLS CUI [5,2]
C0121772
UMLS CUI [6,1]
C0332157
UMLS CUI [6,2]
C0025303
any confirmed or suspected immunosuppressive or immunodeficient condition, based on physical examination.
Description

Immunosuppression | Immunologic Deficiency Syndromes | Physical Examination

Data type

boolean

Alias
UMLS CUI [1]
C4048329
UMLS CUI [2]
C0021051
UMLS CUI [3]
C0031809
a family history of congenital or hereditary immunodeficiency.
Description

Immunodeficiency congenital Family history | Immunologic Deficiency Syndromes Hereditary Family history

Data type

boolean

Alias
UMLS CUI [1,1]
C0853602
UMLS CUI [1,2]
C0241889
UMLS CUI [2,1]
C0021051
UMLS CUI [2,2]
C0439660
UMLS CUI [2,3]
C0241889
major congenital defects or serious illness.
Description

Congenital defects Major | Illness Serious

Data type

boolean

Alias
UMLS CUI [1,1]
C0220810
UMLS CUI [1,2]
C0205164
UMLS CUI [2,1]
C0221423
UMLS CUI [2,2]
C0205404
any neurologic disorders or seizures.
Description

nervous system disorder | Seizures

Data type

boolean

Alias
UMLS CUI [1]
C0027765
UMLS CUI [2]
C0036572
acute disease at the time of enrolment.
Description

Acute Disease

Data type

boolean

Alias
UMLS CUI [1]
C0001314
administration of immunoglobulins and/or any blood products since birth or planned administration during the study period.
Description

Immunoglobulins | Blood product

Data type

boolean

Alias
UMLS CUI [1]
C0021027
UMLS CUI [2]
C0456388
a birth dose of hepatitis b vaccine given outside the frame of this study.
Description

Hepatitis B Vaccine Dose Birth time

Data type

boolean

Alias
UMLS CUI [1,1]
C2240392
UMLS CUI [1,2]
C0178602
UMLS CUI [1,3]
C2736116
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Similar models

Eligibility Hib Disease NCT00317122

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
infant healthy | Age | Mother HIV test negative | Mother Hepatitis B surface antigen negative | Informed Consent parent | Duration of gestation
Item
healthy infants aged 7 days +/- 3 days old born to mothers who are tested as seronegative for hiv & hbsag, written informed consent obtained from the parents, born after a gestation period of 36 to 42 weeks.
boolean
C2049683 (UMLS CUI [1])
C0001779 (UMLS CUI [2])
C0026591 (UMLS CUI [3,1])
C0854048 (UMLS CUI [3,2])
C0026591 (UMLS CUI [4,1])
C0919711 (UMLS CUI [4,2])
C0021430 (UMLS CUI [5,1])
C0030551 (UMLS CUI [5,2])
C0460089 (UMLS CUI [6])
Item Group
C0680251 (UMLS CUI)
Exposure to Diphtheria | Exposure to Tetanus | Exposure to Pertussis | Exposure to Hepatitis B | Exposure to Haemophilus influenzae type b | Exposure to Meningococcal Infections
Item
known exposure to diphtheria, tetanus, pertussis, hepatitis b, haemophilus influenzae type b and/or meningococcal disease since birth.
boolean
C0332157 (UMLS CUI [1,1])
C0012546 (UMLS CUI [1,2])
C0332157 (UMLS CUI [2,1])
C0039614 (UMLS CUI [2,2])
C0332157 (UMLS CUI [3,1])
C0043167 (UMLS CUI [3,2])
C0332157 (UMLS CUI [4,1])
C0019163 (UMLS CUI [4,2])
C0332157 (UMLS CUI [5,1])
C0121772 (UMLS CUI [5,2])
C0332157 (UMLS CUI [6,1])
C0025303 (UMLS CUI [6,2])
Immunosuppression | Immunologic Deficiency Syndromes | Physical Examination
Item
any confirmed or suspected immunosuppressive or immunodeficient condition, based on physical examination.
boolean
C4048329 (UMLS CUI [1])
C0021051 (UMLS CUI [2])
C0031809 (UMLS CUI [3])
Immunodeficiency congenital Family history | Immunologic Deficiency Syndromes Hereditary Family history
Item
a family history of congenital or hereditary immunodeficiency.
boolean
C0853602 (UMLS CUI [1,1])
C0241889 (UMLS CUI [1,2])
C0021051 (UMLS CUI [2,1])
C0439660 (UMLS CUI [2,2])
C0241889 (UMLS CUI [2,3])
Congenital defects Major | Illness Serious
Item
major congenital defects or serious illness.
boolean
C0220810 (UMLS CUI [1,1])
C0205164 (UMLS CUI [1,2])
C0221423 (UMLS CUI [2,1])
C0205404 (UMLS CUI [2,2])
nervous system disorder | Seizures
Item
any neurologic disorders or seizures.
boolean
C0027765 (UMLS CUI [1])
C0036572 (UMLS CUI [2])
Acute Disease
Item
acute disease at the time of enrolment.
boolean
C0001314 (UMLS CUI [1])
Immunoglobulins | Blood product
Item
administration of immunoglobulins and/or any blood products since birth or planned administration during the study period.
boolean
C0021027 (UMLS CUI [1])
C0456388 (UMLS CUI [2])
Hepatitis B Vaccine Dose Birth time
Item
a birth dose of hepatitis b vaccine given outside the frame of this study.
boolean
C2240392 (UMLS CUI [1,1])
C0178602 (UMLS CUI [1,2])
C2736116 (UMLS CUI [1,3])
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