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ID

20894

Descrição

Compare the Immune Response & Safety Elicited by Henogen's Adjuvanted Hepatitis B Vaccine vs Aventis Pasteur MSD's Hepatitis B Vaccine in Pre-Dialysis & Dialysis Patients Who Did Not Respond to Previous Hepatitis B Vaccination; ODM derived from: https://clinicaltrials.gov/show/NCT00291954

Link

https://clinicaltrials.gov/show/NCT00291954

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Versões (1)
  1. 25/03/2017 25/03/2017 -
Transferido a

25 de março de 2017

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Creative Commons BY 4.0
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    Eligibility Hepatitis B NCT00291954

    Inglês

    Eligibility Hepatitis B NCT00291954

    1 Formulários  
    Inclusion Criteria
    Descrição

    Inclusion Criteria

    Alias
    UMLS CUI
    C1512693
    a male or female subject greater than or equal to 15 years of age at the time of study entry
    Descrição

    Age

    Tipo de dados

    boolean

    Alias
    UMLS CUI [1]
    C0001779
    written informed consent obtained from the subject/ from the parent or guardian of the subject.
    Descrição

    Informed Consent | Informed Consent parent | Informed Consent Guardian

    Tipo de dados

    boolean

    Alias
    UMLS CUI [1]
    C0021430
    UMLS CUI [2,1]
    C0021430
    UMLS CUI [2,2]
    C0030551
    UMLS CUI [3,1]
    C0021430
    UMLS CUI [3,2]
    C1274041
    seronegative for anti-hbc antibodies and for hbsag at screening.
    Descrição

    Antibody to hepatitis B core antigen Seronegative | Hepatitis B Surface Antigens Seronegative

    Tipo de dados

    boolean

    Alias
    UMLS CUI [1,1]
    C0312631
    UMLS CUI [1,2]
    C0521144
    UMLS CUI [2,1]
    C0019168
    UMLS CUI [2,2]
    C0521144
    pre-dialysis patients, peritoneal dialysis patients or haemodialysis patients
    Descrição

    Patients Pre-dialysis | Peritoneal Dialysis | Hemodialysis

    Tipo de dados

    boolean

    Alias
    UMLS CUI [1,1]
    C0030705
    UMLS CUI [1,2]
    C1264634
    UMLS CUI [2]
    C0031139
    UMLS CUI [3]
    C0019004
    documented evidence of previous hepatitis b vaccination with at least one full primary vaccination course of minimum four injections of licensed vaccine.
    Descrição

    Hepatitis B vaccination Evidence of | Vaccine Injection Quantity

    Tipo de dados

    boolean

    Alias
    UMLS CUI [1,1]
    C0474232
    UMLS CUI [1,2]
    C0332120
    UMLS CUI [2,1]
    C0042210
    UMLS CUI [2,2]
    C1533685
    UMLS CUI [2,3]
    C1265611
    the last dose should have been administered at least two months before the planned first dose of study vaccine in this study.
    Descrição

    Vaccine Dose Last | Vaccine Clinical Trial Dose First

    Tipo de dados

    boolean

    Alias
    UMLS CUI [1,1]
    C0042210
    UMLS CUI [1,2]
    C0178602
    UMLS CUI [1,3]
    C1517741
    UMLS CUI [2,1]
    C0042210
    UMLS CUI [2,2]
    C0008976
    UMLS CUI [2,3]
    C0178602
    UMLS CUI [2,4]
    C0205435
    documented evidence of non-response to previous hepatitis b vaccination after at least one to maximum three months after the last vaccine dose.
    Descrição

    Hepatitis B vaccination Absent response to treatment

    Tipo de dados

    boolean

    Alias
    UMLS CUI [1,1]
    C0474232
    UMLS CUI [1,2]
    C0438286
    Exclusion Criteria
    Descrição

    Exclusion Criteria

    Alias
    UMLS CUI
    C0680251
    subject included on hn014/hbv-001 study. history of hepatitis b infection use of immunoglobulins within six months preceding the first study vaccination.
    Descrição

    Study Subject Participation Status | Hepatitis B | Immunoglobulins Use of

    Tipo de dados

    boolean

    Alias
    UMLS CUI [1]
    C2348568
    UMLS CUI [2]
    C0019163
    UMLS CUI [3,1]
    C0021027
    UMLS CUI [3,2]
    C1524063
    any confirmed or suspected human immunodeficiency virus (hiv) infection. pregnant or lactating female
    Descrição

    HIV Infection | HIV Infection Suspected | Pregnancy | Breast Feeding

    Tipo de dados

    boolean

    Alias
    UMLS CUI [1]
    C0019693
    UMLS CUI [2,1]
    C0019693
    UMLS CUI [2,2]
    C0750491
    UMLS CUI [3]
    C0032961
    UMLS CUI [4]
    C0006147
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    Similar models

    Eligibility Hepatitis B NCT00291954

    1 Formulários
    Name
    Tipo
    Description | Question | Decode (Coded Value)
    Tipo de dados
    Alias
    Item Group
    C1512693 (UMLS CUI)
    Age
    Item
    a male or female subject greater than or equal to 15 years of age at the time of study entry
    boolean
    C0001779 (UMLS CUI [1])
    Informed Consent | Informed Consent parent | Informed Consent Guardian
    Item
    written informed consent obtained from the subject/ from the parent or guardian of the subject.
    boolean
    C0021430 (UMLS CUI [1])
    C0021430 (UMLS CUI [2,1])
    C0030551 (UMLS CUI [2,2])
    C0021430 (UMLS CUI [3,1])
    C1274041 (UMLS CUI [3,2])
    Antibody to hepatitis B core antigen Seronegative | Hepatitis B Surface Antigens Seronegative
    Item
    seronegative for anti-hbc antibodies and for hbsag at screening.
    boolean
    C0312631 (UMLS CUI [1,1])
    C0521144 (UMLS CUI [1,2])
    C0019168 (UMLS CUI [2,1])
    C0521144 (UMLS CUI [2,2])
    Patients Pre-dialysis | Peritoneal Dialysis | Hemodialysis
    Item
    pre-dialysis patients, peritoneal dialysis patients or haemodialysis patients
    boolean
    C0030705 (UMLS CUI [1,1])
    C1264634 (UMLS CUI [1,2])
    C0031139 (UMLS CUI [2])
    C0019004 (UMLS CUI [3])
    Hepatitis B vaccination Evidence of | Vaccine Injection Quantity
    Item
    documented evidence of previous hepatitis b vaccination with at least one full primary vaccination course of minimum four injections of licensed vaccine.
    boolean
    C0474232 (UMLS CUI [1,1])
    C0332120 (UMLS CUI [1,2])
    C0042210 (UMLS CUI [2,1])
    C1533685 (UMLS CUI [2,2])
    C1265611 (UMLS CUI [2,3])
    Vaccine Dose Last | Vaccine Clinical Trial Dose First
    Item
    the last dose should have been administered at least two months before the planned first dose of study vaccine in this study.
    boolean
    C0042210 (UMLS CUI [1,1])
    C0178602 (UMLS CUI [1,2])
    C1517741 (UMLS CUI [1,3])
    C0042210 (UMLS CUI [2,1])
    C0008976 (UMLS CUI [2,2])
    C0178602 (UMLS CUI [2,3])
    C0205435 (UMLS CUI [2,4])
    Hepatitis B vaccination Absent response to treatment
    Item
    documented evidence of non-response to previous hepatitis b vaccination after at least one to maximum three months after the last vaccine dose.
    boolean
    C0474232 (UMLS CUI [1,1])
    C0438286 (UMLS CUI [1,2])
    Item Group
    C0680251 (UMLS CUI)
    Study Subject Participation Status | Hepatitis B | Immunoglobulins Use of
    Item
    subject included on hn014/hbv-001 study. history of hepatitis b infection use of immunoglobulins within six months preceding the first study vaccination.
    boolean
    C2348568 (UMLS CUI [1])
    C0019163 (UMLS CUI [2])
    C0021027 (UMLS CUI [3,1])
    C1524063 (UMLS CUI [3,2])
    HIV Infection | HIV Infection Suspected | Pregnancy | Breast Feeding
    Item
    any confirmed or suspected human immunodeficiency virus (hiv) infection. pregnant or lactating female
    boolean
    C0019693 (UMLS CUI [1])
    C0019693 (UMLS CUI [2,1])
    C0750491 (UMLS CUI [2,2])
    C0032961 (UMLS CUI [3])
    C0006147 (UMLS CUI [4])
    Voltar ao início da página 

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