ID

17559

Beschreibung

Safety Study of a Vaccine Against Meningitis in Infants (2,4 & 6 Months Age) After a Birth Dose of Hepatitis B.; ODM derived from: https://clinicaltrials.gov/show/NCT00317187

Link

https://clinicaltrials.gov/show/NCT00317187

Stichworte

  1. 23.09.16 23.09.16 -
Hochgeladen am

23. September 2016

DOI

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Lizenz

Creative Commons BY 4.0

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    Eligibility Hib Disease NCT00317187

    Eligibility Hib Disease NCT00317187

    Inclusion Criteria
    Beschreibung

    Inclusion Criteria

    Alias
    UMLS CUI
    C1512693
    • healthy infants 56-83 days of age at the time of the first vaccine dose, written informed consent obtained from the parents, born after a gestation period of 36 to 42 weeks & has received a birth dose of hepatitis b vaccine within the first 3 days of life.
    Beschreibung

    infant appeared healthy at birth | Age | Informed Consent parent | Duration of gestation | Hepatitis B Vaccine Dose Birth time

    Datentyp

    boolean

    Alias
    UMLS CUI [1]
    C2049683
    UMLS CUI [2]
    C0001779
    UMLS CUI [3,1]
    C0021430
    UMLS CUI [3,2]
    C0030551
    UMLS CUI [4]
    C0460089
    UMLS CUI [5,1]
    C2240392
    UMLS CUI [5,2]
    C0178602
    UMLS CUI [5,3]
    C2736116
    Exclusion Criteria
    Beschreibung

    Exclusion Criteria

    Alias
    UMLS CUI
    C0680251
    any confirmed immunodeficient condition, based on medical history and physical examination.
    Beschreibung

    Immunologic Deficiency Syndromes | Medical History | Physical Examination

    Datentyp

    boolean

    Alias
    UMLS CUI [1]
    C0021051
    UMLS CUI [2]
    C0262926
    UMLS CUI [3]
    C0031809
    planned administration/administration of a vaccine not foreseen by the study protocol within 30 days before the first dose of study vaccine, or planned administration during the study period with the exception of oral polio vaccine (opv).
    Beschreibung

    Vaccine Planned | Oral Poliovirus Vaccine

    Datentyp

    boolean

    Alias
    UMLS CUI [1,1]
    C0042210
    UMLS CUI [1,2]
    C1301732
    UMLS CUI [2]
    C0032375
    use of any investigational or non-registered drug or vaccine other than the study vaccine(s) within 30 days preceding the first dose of study vaccine, or planned use during the study period.
    Beschreibung

    Investigational New Drugs | Drugs, Non-Prescription | Vaccine Investigational

    Datentyp

    boolean

    Alias
    UMLS CUI [1]
    C0013230
    UMLS CUI [2]
    C0013231
    UMLS CUI [3,1]
    C0042210
    UMLS CUI [3,2]
    C1517586
    chronic administration (defined as more than 14 days) of immunosuppressants or other immune-modifying drugs since birth.
    Beschreibung

    Immunosuppressive Agents chronic | Biological Response Modifiers chronic

    Datentyp

    boolean

    Alias
    UMLS CUI [1,1]
    C0021081
    UMLS CUI [1,2]
    C0205191
    UMLS CUI [2,1]
    C0005525
    UMLS CUI [2,2]
    C0205191
    bacille calmette-guérin (bcg) vaccine received after the first 2 weeks of life.
    Beschreibung

    BCG Vaccine

    Datentyp

    boolean

    Alias
    UMLS CUI [1]
    C0004886
    previous vaccination against diphtheria, tetanus, pertussis, haemophilus influenzae type b, and/or meningococcal disease.
    Beschreibung

    Vaccination Against Diphtheria | Vaccination Against Tetanus | Vaccination Against Pertussis | Vaccination Against Haemophilus influenzae type b | Vaccination Against Meningococcal Infections

    Datentyp

    boolean

    Alias
    UMLS CUI [1,1]
    C0042196
    UMLS CUI [1,2]
    C0521124
    UMLS CUI [1,3]
    C0012546
    UMLS CUI [2,1]
    C0042196
    UMLS CUI [2,2]
    C0521124
    UMLS CUI [2,3]
    C0039614
    UMLS CUI [3,1]
    C0042196
    UMLS CUI [3,2]
    C0521124
    UMLS CUI [3,3]
    C0043167
    UMLS CUI [4,1]
    C0042196
    UMLS CUI [4,2]
    C0521124
    UMLS CUI [4,3]
    C0121772
    UMLS CUI [5,1]
    C0042196
    UMLS CUI [5,2]
    C0521124
    UMLS CUI [5,3]
    C0025303
    history of diphtheria, tetanus, pertussis, hepatitis b, haemophilus influenzae type b and/or meningococcal disease or known exposure to these diseases since birth.
    Beschreibung

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

    Datentyp

    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
    administration of immunoglobulins and/or any blood products since birth or planned administration during the study period.
    Beschreibung

    Immunoglobulins | Blood product

    Datentyp

    boolean

    Alias
    UMLS CUI [1]
    C0021027
    UMLS CUI [2]
    C0456388

    Ähnliche Modelle

    Eligibility Hib Disease NCT00317187

    Name
    Typ
    Description | Question | Decode (Coded Value)
    Datentyp
    Alias
    Item Group
    C1512693 (UMLS CUI)
    infant appeared healthy at birth | Age | Informed Consent parent | Duration of gestation | Hepatitis B Vaccine Dose Birth time
    Item
    • healthy infants 56-83 days of age at the time of the first vaccine dose, written informed consent obtained from the parents, born after a gestation period of 36 to 42 weeks & has received a birth dose of hepatitis b vaccine within the first 3 days of life.
    boolean
    C2049683 (UMLS CUI [1])
    C0001779 (UMLS CUI [2])
    C0021430 (UMLS CUI [3,1])
    C0030551 (UMLS CUI [3,2])
    C0460089 (UMLS CUI [4])
    C2240392 (UMLS CUI [5,1])
    C0178602 (UMLS CUI [5,2])
    C2736116 (UMLS CUI [5,3])
    Item Group
    C0680251 (UMLS CUI)
    Immunologic Deficiency Syndromes | Medical History | Physical Examination
    Item
    any confirmed immunodeficient condition, based on medical history and physical examination.
    boolean
    C0021051 (UMLS CUI [1])
    C0262926 (UMLS CUI [2])
    C0031809 (UMLS CUI [3])
    Vaccine Planned | Oral Poliovirus Vaccine
    Item
    planned administration/administration of a vaccine not foreseen by the study protocol within 30 days before the first dose of study vaccine, or planned administration during the study period with the exception of oral polio vaccine (opv).
    boolean
    C0042210 (UMLS CUI [1,1])
    C1301732 (UMLS CUI [1,2])
    C0032375 (UMLS CUI [2])
    Investigational New Drugs | Drugs, Non-Prescription | Vaccine Investigational
    Item
    use of any investigational or non-registered drug or vaccine other than the study vaccine(s) within 30 days preceding the first dose of study vaccine, or planned use during the study period.
    boolean
    C0013230 (UMLS CUI [1])
    C0013231 (UMLS CUI [2])
    C0042210 (UMLS CUI [3,1])
    C1517586 (UMLS CUI [3,2])
    Immunosuppressive Agents chronic | Biological Response Modifiers chronic
    Item
    chronic administration (defined as more than 14 days) of immunosuppressants or other immune-modifying drugs since birth.
    boolean
    C0021081 (UMLS CUI [1,1])
    C0205191 (UMLS CUI [1,2])
    C0005525 (UMLS CUI [2,1])
    C0205191 (UMLS CUI [2,2])
    BCG Vaccine
    Item
    bacille calmette-guérin (bcg) vaccine received after the first 2 weeks of life.
    boolean
    C0004886 (UMLS CUI [1])
    Vaccination Against Diphtheria | Vaccination Against Tetanus | Vaccination Against Pertussis | Vaccination Against Haemophilus influenzae type b | Vaccination Against Meningococcal Infections
    Item
    previous vaccination against diphtheria, tetanus, pertussis, haemophilus influenzae type b, and/or meningococcal disease.
    boolean
    C0042196 (UMLS CUI [1,1])
    C0521124 (UMLS CUI [1,2])
    C0012546 (UMLS CUI [1,3])
    C0042196 (UMLS CUI [2,1])
    C0521124 (UMLS CUI [2,2])
    C0039614 (UMLS CUI [2,3])
    C0042196 (UMLS CUI [3,1])
    C0521124 (UMLS CUI [3,2])
    C0043167 (UMLS CUI [3,3])
    C0042196 (UMLS CUI [4,1])
    C0521124 (UMLS CUI [4,2])
    C0121772 (UMLS CUI [4,3])
    C0042196 (UMLS CUI [5,1])
    C0521124 (UMLS CUI [5,2])
    C0025303 (UMLS CUI [5,3])
    Exposure to Diphtheria | Exposure to Tetanus | Exposure to Pertussis | Exposure to Hepatitis B | Exposure to Haemophilus influenzae type b | Exposure to Meningococcal Infections
    Item
    history of diphtheria, tetanus, pertussis, hepatitis b, haemophilus influenzae type b and/or meningococcal disease or known exposure to these diseases 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])
    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])

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