0 Evaluaciones
ID

35777

Descripción

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

Palabras clave

Versiones (1)
  1. 22/3/19 22/3/19 -
Titular de derechos de autor

GlaxoSmithKline

Subido en

22 de marzo de 2019

DOI

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Licencia

Creative Commons BY-NC 3.0
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    Safety and Immune Response of Two-Doses of Candidate Influenza Vaccine in Adults, NCT00510874

    Inglés

    Laboratory test, Influenza serology sample, Urine pregnancy test

    1 formularios  
    Administrative data
    Descripción

    Administrative data

    Alias
    UMLS CUI-1
    C1320722 (Administrative documentation)
    SNOMED
    405624007
    Subject Number
    Descripción

    Subject Number

    Tipo de datos

    text

    Alias
    UMLS CUI [1]
    C2348585 (Clinical Trial Subject Unique Identifier)
    Visit type
    Descripción

    Visit type

    Tipo de datos

    integer

    Alias
    UMLS CUI [1,1]
    C0545082 (Visit)
    UMLS CUI [1,2]
    C0332307 (Type - attribute)
    SNOMED
    261664005
    Visit date
    Descripción

    day month year

    Tipo de datos

    date

    Alias
    UMLS CUI [1]
    C1320303 (Date of visit)
    SNOMED
    406543005
    Laboratory tests
    Descripción

    Laboratory tests

    Alias
    UMLS CUI-1
    C0022885 (Laboratory Procedures)
    SNOMED
    269814003
    Has a blood sample been taken for Safety Analysis?
    Descripción

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

    Tipo de datos

    text

    Alias
    UMLS CUI [1]
    C0005834 (Collection of blood specimen for laboratory procedure)
    SNOMED
    82078001
    LOINC
    LP125037-4
    If a blood sample was taken, please note the date if different from visit date
    Descripción

    day month year

    Tipo de datos

    date

    Alias
    UMLS CUI [1,1]
    C0005834 (Collection of blood specimen for laboratory procedure)
    SNOMED
    82078001
    LOINC
    LP125037-4
    UMLS CUI [1,2]
    C0011008 (Date in time)
    SNOMED
    410671006
    Influenza serology sample
    Descripción

    Influenza serology sample

    Alias
    UMLS CUI-1
    C4316910 (Influenza virus)
    SNOMED
    725894000
    LOINC
    LP17147-7
    UMLS CUI-2
    C0036743 (Serologic tests)
    SNOMED
    68793005
    LOINC
    MTHU008384
    Has a blood sample been taken for influenza serology (14 mL)?
    Descripción

    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)

    Tipo de datos

    text

    Alias
    UMLS CUI [1,1]
    C0005834 (Collection of blood specimen for laboratory procedure)
    SNOMED
    82078001
    LOINC
    LP125037-4
    UMLS CUI [1,2]
    C4316910 (Influenza virus)
    SNOMED
    725894000
    LOINC
    LP17147-7
    UMLS CUI [1,3]
    C0036743 (Serologic tests)
    SNOMED
    68793005
    LOINC
    MTHU008384
    If a blood sample was taken, please note the date if different from visit date
    Descripción

    day month year

    Tipo de datos

    date

    Alias
    UMLS CUI [1,1]
    C0005834 (Collection of blood specimen for laboratory procedure)
    SNOMED
    82078001
    LOINC
    LP125037-4
    UMLS CUI [1,2]
    C4316910 (Influenza virus)
    SNOMED
    725894000
    LOINC
    LP17147-7
    UMLS CUI [1,3]
    C0036743 (Serologic tests)
    SNOMED
    68793005
    LOINC
    MTHU008384
    UMLS CUI [1,4]
    C0011008 (Date in time)
    SNOMED
    410671006
    HCG urine pregnancy test
    Descripción

    HCG urine pregnancy test

    Alias
    UMLS CUI-1
    C0430056 (Urine pregnancy test)
    SNOMED
    167252002
    Has a urine sample been taken?
    Descripción

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

    Tipo de datos

    text

    Alias
    UMLS CUI [1]
    C0200354 (Urine Specimen Collection)
    SNOMED
    57617002
    Result of urine sample
    Descripción

    Result of urine sample

    Tipo de datos

    text

    Alias
    UMLS CUI [1,1]
    C0200354 (Urine Specimen Collection)
    SNOMED
    57617002
    UMLS CUI [1,2]
    C0456984 (Test Result)
    SNOMED
    277775005
    If a urine sample was taken, please note the date if different from visit date
    Descripción

    day month year

    Tipo de datos

    date

    Alias
    UMLS CUI [1,1]
    C0011008 (Date in time)
    SNOMED
    410671006
    UMLS CUI [1,2]
    C0200354 (Urine Specimen Collection)
    SNOMED
    57617002
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    Similar models

    Laboratory test, Influenza serology sample, Urine pregnancy test

    1 formularios
    Name
    Tipo
    Description | Question | Decode (Coded Value)
    Tipo de datos
    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])
    Visit type
    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])
    Blood sample
    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])
    Blood sample for influenza serology
    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])
    Urine sample
    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])
    Result of urine sample
    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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