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35777

Description

Study ID: 110028 Clinical Study ID: 110028 Study Title: Study to Evaluate the Safety and Immune Response of Two-Doses of Candidate Influenza Vaccine GSK 1557484A in Adults Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00510874 https://clinicaltrials.gov/ct2/show/NCT00510874 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 1 Study Recruitment Status: Completed Generic Name: Candidate Influenza Vaccine Trade Name: Pumarix, Pandemrix Study Indication: Influenza This study consists of 6 Visits and one Telephone Contact: -Visit 1: Visit „Day 0“ -Visit 2: Visit „Day 7“, Contact Window: Day 6-8, Minimum Number of Days between Successive Visits: 6 -Visit 3: Visit „Day 21“: Contact Window: Day 19-23, Minimum Number of Days between Successive Visits: 12 -Visit 4: Visit „Day 28“: Contact Window: Day 26-30, Minimum Number of Days between Successive Visits: 6 -Visit 5: Visit „Day 42“: Contact Window: Day 38-46, Minimum Number of Days between Successive Visits: 12 -Telephone Contact „Day 84“: Contact Window: Day 80-88 -Visit 6: Visit „Day 182“: Contact Window: Day 167-197 The screening can take place up to 21 days prior to Visit 1. This document contains the Laboratory test, Influenza serology sample and Urine pregnancy test. The Laboratory test has to be filled in for: Visit 1, Visit 2 and Visit 5. The Influenza serology sample has to be filled in for: Visit 1, Visit 3, Visit 5 and Visit 6. The Urine pregnancy test has to be filled in for: Visit 1 and Visit 3.

Link

https://clinicaltrials.gov/ct2/show/NCT00510874

Keywords

  1. 3/22/19 3/22/19 -
Copyright Holder

GlaxoSmithKline

Uploaded on

March 22, 2019

DOI

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License

Creative Commons BY-NC 3.0

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    Safety and Immune Response of Two-Doses of Candidate Influenza Vaccine in Adults, NCT00510874

    Laboratory test, Influenza serology sample, Urine pregnancy test

    Administrative data
    Description

    Administrative data

    Alias
    UMLS CUI-1
    C1320722
    Subject Number
    Description

    Subject Number

    Data type

    text

    Alias
    UMLS CUI [1]
    C2348585
    Visit type
    Description

    Visit type

    Data type

    integer

    Alias
    UMLS CUI [1,1]
    C0545082
    UMLS CUI [1,2]
    C0332307
    Visit date
    Description

    day month year

    Data type

    date

    Alias
    UMLS CUI [1]
    C1320303
    Laboratory tests
    Description

    Laboratory tests

    Alias
    UMLS CUI-1
    C0022885
    Has a blood sample been taken for Safety Analysis?
    Description

    This blood sample has to be taken for: Visit 1, Visit 2 and Visit 5.

    Data type

    text

    Alias
    UMLS CUI [1]
    C0005834
    If a blood sample was taken, please note the date if different from visit date
    Description

    day month year

    Data type

    date

    Alias
    UMLS CUI [1,1]
    C0005834
    UMLS CUI [1,2]
    C0011008
    Influenza serology sample
    Description

    Influenza serology sample

    Alias
    UMLS CUI-1
    C4316910
    UMLS CUI-2
    C0036743
    Has a blood sample been taken for influenza serology (14 mL)?
    Description

    This sample has to be taken for: Visit 1, Visit 3, Visit 5 and Visit 6. (including vaccine-homologous virus hemaglutination-inhibiting antibody reciprocal titers; drift variant H5N1 virus hemagglutination-inhibiting antibody reciprocal titers; and microneutralization titers against homologous and drift viruses)

    Data type

    text

    Alias
    UMLS CUI [1,1]
    C0005834
    UMLS CUI [1,2]
    C4316910
    UMLS CUI [1,3]
    C0036743
    If a blood sample was taken, please note the date if different from visit date
    Description

    day month year

    Data type

    date

    Alias
    UMLS CUI [1,1]
    C0005834
    UMLS CUI [1,2]
    C4316910
    UMLS CUI [1,3]
    C0036743
    UMLS CUI [1,4]
    C0011008
    HCG urine pregnancy test
    Description

    HCG urine pregnancy test

    Alias
    UMLS CUI-1
    C0430056
    Has a urine sample been taken?
    Description

    The Urine pregnancy test has to be taken for: Visit 1 and Visit 3. NA only for male.

    Data type

    text

    Alias
    UMLS CUI [1]
    C0200354
    Result of urine sample
    Description

    Result of urine sample

    Data type

    text

    Alias
    UMLS CUI [1,1]
    C0200354
    UMLS CUI [1,2]
    C0456984
    If a urine sample was taken, please note the date if different from visit date
    Description

    day month year

    Data type

    date

    Alias
    UMLS CUI [1,1]
    C0011008
    UMLS CUI [1,2]
    C0200354

    Similar models

    Laboratory test, Influenza serology sample, Urine pregnancy test

    Name
    Type
    Description | Question | Decode (Coded Value)
    Data type
    Alias
    Item Group
    Administrative data
    C1320722 (UMLS CUI-1)
    Subject Number
    Item
    Subject Number
    text
    C2348585 (UMLS CUI [1])
    Item
    Visit type
    integer
    C0545082 (UMLS CUI [1,1])
    C0332307 (UMLS CUI [1,2])
    Code List
    Visit type
    CL Item
    Visit 1 (1)
    CL Item
    Visit 2 (2)
    CL Item
    Visit 3 (3)
    CL Item
    Visit 4 (4)
    CL Item
    Visit 5 (5)
    CL Item
    Visit 6  (6)
    Visit date
    Item
    Visit date
    date
    C1320303 (UMLS CUI [1])
    Item Group
    Laboratory tests
    C0022885 (UMLS CUI-1)
    Item
    Has a blood sample been taken for Safety Analysis?
    text
    C0005834 (UMLS CUI [1])
    Code List
    Has a blood sample been taken for Safety Analysis?
    CL Item
    Yes (Y)
    CL Item
    No (N)
    Date of blood sample
    Item
    If a blood sample was taken, please note the date if different from visit date
    date
    C0005834 (UMLS CUI [1,1])
    C0011008 (UMLS CUI [1,2])
    Item Group
    Influenza serology sample
    C4316910 (UMLS CUI-1)
    C0036743 (UMLS CUI-2)
    Item
    Has a blood sample been taken for influenza serology (14 mL)?
    text
    C0005834 (UMLS CUI [1,1])
    C4316910 (UMLS CUI [1,2])
    C0036743 (UMLS CUI [1,3])
    Code List
    Has a blood sample been taken for influenza serology (14 mL)?
    CL Item
    Yes (Y)
    CL Item
    No (N)
    Date of blood sample
    Item
    If a blood sample was taken, please note the date if different from visit date
    date
    C0005834 (UMLS CUI [1,1])
    C4316910 (UMLS CUI [1,2])
    C0036743 (UMLS CUI [1,3])
    C0011008 (UMLS CUI [1,4])
    Item Group
    HCG urine pregnancy test
    C0430056 (UMLS CUI-1)
    Item
    Has a urine sample been taken?
    text
    C0200354 (UMLS CUI [1])
    Code List
    Has a urine sample been taken?
    CL Item
    Yes (Y)
    CL Item
    No (N)
    CL Item
    NA (NA)
    Item
    Result of urine sample
    text
    C0200354 (UMLS CUI [1,1])
    C0456984 (UMLS CUI [1,2])
    Code List
    Result of urine sample
    CL Item
    Positive (P)
    CL Item
    Negative (N)
    Date of urine sample
    Item
    If a urine sample was taken, please note the date if different from visit date
    date
    C0011008 (UMLS CUI [1,1])
    C0200354 (UMLS CUI [1,2])

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