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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

Lien

https://clinicaltrials.gov/show/NCT00317122

Mots-clés

  1. 23/09/2016 23/09/2016 -
Téléchargé le

23 septembre 2016

DOI

Pour une demande vous connecter.

Licence

Creative Commons BY-NC 3.0

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    Eligibility Hib Disease NCT00317122

    Eligibility Hib Disease NCT00317122

    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

    Type de données

    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

    Type de données

    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

    Type de données

    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

    Type de données

    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

    Type de données

    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

    Type de données

    boolean

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

    Acute Disease

    Type de données

    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

    Type de données

    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

    Type de données

    boolean

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

    Similar models

    Eligibility Hib Disease NCT00317122

    Name
    Type
    Description | Question | Decode (Coded Value)
    Type de données
    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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