0 Evaluaciones
ID

32436

Descripción

Study ID: 102248 Clinical Study ID: 102248 Study Title: Multi-Center Study to Assess the Efficacy, Safety and Immunogenicity of 2 or 3 Doses of GSK Biologicals' Oral Live Attenuated Human Rotavirus (HRV) Vaccine Given Concomitantly With Routine EPI Vaccinations in Healthy Infants Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00241644 Study Link: https://clinicaltrials.gov/ct2/show/NCT00241644 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 3 Study Recruitment Status: Completed Generic Name: Rotavirus Vaccine Trade Name: Rotarix Study Indication: Infections, Rotavirus The visits are defined as follows: Visit 1: (Study/Participation) Day 0, Age: 5-10 weeks, Dose 1 Visit 2: (Study/Participation) Month 1, 30-48 days after Visit 1, Dose 2 Visit 3: (Study/Participation) Month 2, 30-48 days after Visit 2, Dose 3 Visit 4: (Study/Participation) Month 3, 30-48 days after Visit 3, Visit 5: (Study/Participation) 1 year of age, 343-391 days of age For amendment 5: Visit 5: (Study/Participation) 21-48 days after Visit 4 Visit 6: (Study/Participation) 1 year of age, 343-391 days of age This form contains information about testing the subject for HIV. It should be checked at Visit 3 and is part of study amendment 1.

Link

https://clinicaltrials.gov/ct2/show/NCT00241644

Palabras clave

Versiones (1)
  1. 1/11/18 1/11/18 -
Titular de derechos de autor

GlaxoSmithKline

Subido en

1 de noviembre de 2018

DOI

Para solicitar uno, por favor iniciar sesión.

Licencia

Creative Commons BY-NC 3.0
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    Efficacy, Safety and Immunogenicity of Oral HRV Vaccine NCT00241644

    Inglés

    HIV Testing

    1 formularios  
    1. StudyEvent: ODM
      1. HIV Testing
    Administrative Data
    Descripción

    Administrative Data

    Alias
    UMLS CUI-1
    C1320722 (Administrative documentation)
    SNOMED
    405624007
    Date of visit
    Descripción

    Date of visit

    Tipo de datos

    date

    Alias
    UMLS CUI [1]
    C1320303 (Date of visit)
    SNOMED
    406543005
    Subject number
    Descripción

    Subject number

    Tipo de datos

    integer

    Alias
    UMLS CUI [1]
    C2348585 (Clinical Trial Subject Unique Identifier)
    HIV Testing
    Descripción

    HIV Testing

    Alias
    UMLS CUI-1
    C1321876 (Human immunodeficiency virus test)
    SNOMED
    165813002
    Has the subject been exposed to HIV?
    Descripción

    Medical History for HIV exposure

    Tipo de datos

    text

    Alias
    UMLS CUI [1,1]
    C0262926 (Medical History)
    SNOMED
    392521001
    LOINC
    LP6817-3
    UMLS CUI [1,2]
    C0019682 (HIV)
    SNOMED
    19030005
    LOINC
    LP17126-1
    UMLS CUI [1,3]
    C0332157 (Exposure to)
    SNOMED
    24932003
    Has the Informed Consent Addendum for HIV testing been signed at visit 3 or previously due to hospitalization or symptoms indicative of AIDS ?
    Descripción

    Informed Consent Addendum for HIV Testing

    Tipo de datos

    boolean

    Alias
    UMLS CUI [1,1]
    C0021430 (Informed Consent)
    UMLS CUI [1,2]
    C0459958 (HIV screen)
    SNOMED
    171121004
    Informed Consent Date
    Descripción

    If the subject has previously signed informed consent

    Tipo de datos

    date

    Alias
    UMLS CUI [1]
    C2985782 (Informed Consent Date)
    Was a blood sample taken for the HIV testing at visit 3 or previously due to hospitalization or symptoms indicative of AIDS ?
    Descripción

    If bloodsample had been taken

    Tipo de datos

    boolean

    Alias
    UMLS CUI [1]
    C0005834 (Collection of blood specimen for laboratory procedure)
    SNOMED
    82078001
    LOINC
    LP125037-4
    Blood sample date
    Descripción

    If bloodsample had been taken

    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
    Elisa testing result
    Descripción

    If bloodsample had been taken

    Tipo de datos

    text

    Alias
    UMLS CUI [1]
    C0014441 (Enzyme-Linked Immunosorbent Assay)
    SNOMED
    76978006
    PCR testing result
    Descripción

    Subjects testet positive need a confirmatory test at visit 4, if HIV asymptomatic up to visit 4.

    Tipo de datos

    text

    Alias
    UMLS CUI [1,1]
    C0032520 (Polymerase Chain Reaction)
    SNOMED
    258066000
    LOINC
    LA26418-6
    UMLS CUI [1,2]
    C1274040 (Result)
    SNOMED
    394617004
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    Similar models

    HIV Testing

    1 formularios
    1. StudyEvent: ODM
      1. HIV Testing
    Name
    Tipo
    Description | Question | Decode (Coded Value)
    Tipo de datos
    Alias
    Item Group
    C1320722 (UMLS CUI-1)
    Date of visit
    Item
    Date of visit
    date
    C1320303 (UMLS CUI [1])
    Subject number
    Item
    Subject number
    integer
    C2348585 (UMLS CUI [1])
    Item Group
    HIV Testing
    C1321876 (UMLS CUI-1)
    Item
    Has the subject been exposed to HIV?
    text
    C0262926 (UMLS CUI [1,1])
    C0019682 (UMLS CUI [1,2])
    C0332157 (UMLS CUI [1,3])
    Medical History for HIV
    Code List
    Has the subject been exposed to HIV?
    CL Item
    Yes (Yes)
    CL Item
    No (No)
    CL Item
    Unknown (Unknown)
    Informed Consent Addendum for HIV Testing
    Item
    Has the Informed Consent Addendum for HIV testing been signed at visit 3 or previously due to hospitalization or symptoms indicative of AIDS ?
    boolean
    C0021430 (UMLS CUI [1,1])
    C0459958 (UMLS CUI [1,2])
    Informed Consent Date
    Item
    Informed Consent Date
    date
    C2985782 (UMLS CUI [1])
    Blood Sample for HIV Testing
    Item
    Was a blood sample taken for the HIV testing at visit 3 or previously due to hospitalization or symptoms indicative of AIDS ?
    boolean
    C0005834 (UMLS CUI [1])
    Blood sample date
    Item
    Blood sample date
    date
    C0005834 (UMLS CUI [1,1])
    C0011008 (UMLS CUI [1,2])
    Item
    Elisa testing result
    text
    C0014441 (UMLS CUI [1])
    Elisa testing result
    Code List
    Elisa testing result
    CL Item
    Negative (Negative)
    CL Item
    Positive (Positive)
    CL Item
    Unknown (Unknown)
    CL Item
    Not applicable (subjects exposed to HIV) (Not applicable (subjects exposed to HIV))
    Item
    PCR testing result
    text
    C0032520 (UMLS CUI [1,1])
    C1274040 (UMLS CUI [1,2])
    PCR testing result
    Code List
    PCR testing result
    CL Item
    Negative (Negative)
    CL Item
    Positive (Positive)
    CL Item
    Unknown (Unknown)
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