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ID

24169

Description

Study ID: 100577 Clinical Study ID: 100577 Study Title: Double-blind, randomized study to evaluate the immunogenicity and reactogenicity of three different lots of GlaxoSmithKline Biologicals' inactivated hepatitis A vaccine containing 1440 EL.U of antigen per mL and injected according to a 0, 6 month schedule in healthy adult subjects Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00289757 https://clinicaltrials.gov/ct2/show/NCT00289757 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: phase 4 Study Recruitment Status: Completed Generic Name: Hepatitis A Vaccine, Inactivated Trade Name: Havrix Study Indication: Hepatitis A Documentation part: Tracking Document, Long Term Follow-up

Link

https://clinicaltrials.gov/ct2/show/NCT00289757

Keywords

Versions (1)
  1. 7/27/17 7/27/17 -
Uploaded on

July 27, 2017

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Creative Commons BY-NC 3.0
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    Immunogenicity and reactogenicity of GlaxoSmithKline Biologicals' inactivated hepatitis A vaccine Serious Long Term Follow-up 100577

    English

    Long Term Follow-up Immunogenicity and reactogenicity of GlaxoSmithKline Biologicals' inactivated hepatitis A vaccine 100577

    1 forms  
    Long Term Follow-up
    Description

    Long Term Follow-up

    Alias
    UMLS CUI-1
    C1517942 (Long-term Follow-up)
    UMLS CUI-2
    C0170300 (Hepatitis A Vaccines)
    SNOMED
    871751006
    Subject number of previous study
    Description

    Subject number of previous study

    Data type

    text

    Alias
    UMLS CUI [1,1]
    C2348585 (Clinical Trial Subject Unique Identifier)
    UMLS CUI [1,2]
    C2242969 (clinical trial participant (history))
    Subject initials
    Description

    Subject initials

    Data type

    text

    Alias
    UMLS CUI [1,1]
    C2986440 (Person Initials)
    UMLS CUI [1,2]
    C0681850 (Study Subject)
    Date of birth
    Description

    Date of birth

    Data type

    date

    Alias
    UMLS CUI [1]
    C0421451 (Patient date of birth)
    SNOMED
    184099003
    LOINC
    LP57552-9
    Please contact the following subjects for inclusion in the long-term follow-up study and document whether or not he/she agrees to participate.
    Description

    long-term follow-up study participation

    Data type

    integer

    Alias
    UMLS CUI [1,1]
    C2348568 (Study Subject Participation Status)
    UMLS CUI [1,2]
    C1517942 (Long-term Follow-up)
    UMLS CUI [1,3]
    C0170300 (Hepatitis A Vaccines)
    SNOMED
    871751006
    Subject eligible but not willing to participate due to:
    Description

    long-term follow-up study participation

    Data type

    integer

    Alias
    UMLS CUI [1,1]
    C2348568 (Study Subject Participation Status)
    UMLS CUI [1,2]
    C1517942 (Long-term Follow-up)
    UMLS CUI [1,3]
    C0170300 (Hepatitis A Vaccines)
    SNOMED
    871751006
    If adverse events, or serious adverse event, please specify
    Description

    Subject eligible but not willing to participate due to

    Data type

    text

    Alias
    UMLS CUI [1]
    C0877248 (Adverse event)
    LOINC
    MTHU014542
    UMLS CUI [2,1]
    C2348568 (Study Subject Participation Status)
    UMLS CUI [2,2]
    C1517942 (Long-term Follow-up)
    UMLS CUI [2,3]
    C0170300 (Hepatitis A Vaccines)
    SNOMED
    871751006
    If Other, please specify
    Description

    Subject eligible but not willing to participate due to

    Data type

    text

    Alias
    UMLS CUI [1,1]
    C2348568 (Study Subject Participation Status)
    UMLS CUI [1,2]
    C1517942 (Long-term Follow-up)
    UMLS CUI [1,3]
    C0170300 (Hepatitis A Vaccines)
    SNOMED
    871751006
    Investigator signature
    Description

    Investigator signature

    Data type

    text

    Alias
    UMLS CUI [1]
    C2346576 (Investigator Signature)
    Investigator signature date
    Description

    Investigator signature date

    Data type

    date

    Alias
    UMLS CUI [1,1]
    C2346576 (Investigator Signature)
    UMLS CUI [1,2]
    C0011008 (Date in time)
    SNOMED
    410671006
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    Similar models

    Long Term Follow-up Immunogenicity and reactogenicity of GlaxoSmithKline Biologicals' inactivated hepatitis A vaccine 100577

    1 forms
    Name
    Type
    Description | Question | Decode (Coded Value)
    Data type
    Alias
    Item Group
    Long Term Follow-up
    C1517942 (UMLS CUI-1)
    C0170300 (UMLS CUI-2)
    Subject number of previous study
    Item
    Subject number of previous study
    text
    C2348585 (UMLS CUI [1,1])
    C2242969 (UMLS CUI [1,2])
    Subject initials
    Item
    Subject initials
    text
    C2986440 (UMLS CUI [1,1])
    C0681850 (UMLS CUI [1,2])
    Date of birth
    Item
    Date of birth
    date
    C0421451 (UMLS CUI [1])
    Item
    Please contact the following subjects for inclusion in the long-term follow-up study and document whether or not he/she agrees to participate.
    integer
    C2348568 (UMLS CUI [1,1])
    C1517942 (UMLS CUI [1,2])
    C0170300 (UMLS CUI [1,3])
    long-term follow-up study participation
    Code List
    Please contact the following subjects for inclusion in the long-term follow-up study and document whether or not he/she agrees to participate.
    CL Item
    Subject not eligible (1)
    CL Item
    Subject lost to follow-up or not reached  (2)
    CL Item
    Subject eligible but not willing to participate due to: (3)
    CL Item
    Subject eligible and agreed to participate in the long-term follow-up study (4)
    Item
    Subject eligible but not willing to participate due to:
    integer
    C2348568 (UMLS CUI [1,1])
    C1517942 (UMLS CUI [1,2])
    C0170300 (UMLS CUI [1,3])
    undefined item
    Code List
    Subject eligible but not willing to participate due to:
    CL Item
    adverse events, or serious adverse event (1)
    CL Item
    Other (2)
    long-term follow-up study participation
    Item
    If adverse events, or serious adverse event, please specify
    text
    C0877248 (UMLS CUI [1])
    C2348568 (UMLS CUI [2,1])
    C1517942 (UMLS CUI [2,2])
    C0170300 (UMLS CUI [2,3])
    long-term follow-up study participation
    Item
    If Other, please specify
    text
    C2348568 (UMLS CUI [1,1])
    C1517942 (UMLS CUI [1,2])
    C0170300 (UMLS CUI [1,3])
    Investigator signature
    Item
    Investigator signature
    text
    C2346576 (UMLS CUI [1])
    Investigator signature date
    Item
    Investigator signature date
    date
    C2346576 (UMLS CUI [1,1])
    C0011008 (UMLS CUI [1,2])
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