0 Ratings
ID

33970

Description

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 the HIV repeat test, that should be performed at visit 6 and is part of amendment 1

Link

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

Keywords

Versions (3)
  1. 10/31/18 10/31/18 -
  2. 11/17/18 11/17/18 -
  3. 1/9/19 1/9/19 -
Copyright Holder

GlaxoSmithKline

Uploaded on

January 9, 2019

DOI

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License

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

    English

    HIV Repeat Test

    1 forms  
    1. StudyEvent: ODM
      1. HIV Repeat Test
    Administrative Data
    Description

    Administrative Data

    Alias
    UMLS CUI-1
    C1320722
    Date of visit
    Description

    Date of visit

    Data type

    date

    Alias
    UMLS CUI [1]
    C1320303
    Subject number
    Description

    Subject number

    Data type

    integer

    Alias
    UMLS CUI [1]
    C2348585
    HIV repeat test
    Description

    HIV repeat test

    Alias
    UMLS CUI-1
    C1321876
    Was a blood sample taken after breast feeding cessation (subject HIV exposed but PCR negative at visit 3) ?
    Description

    This item is only applicable in visit 6 of amendment 1

    Data type

    integer

    Alias
    UMLS CUI [1,1]
    C0332157
    UMLS CUI [1,2]
    C0019682
    UMLS CUI [2,1]
    C0005834
    UMLS CUI [2,2]
    C0687676
    UMLS CUI [2,3]
    C0006147
    UMLS CUI [3,1]
    C0854048
    UMLS CUI [3,2]
    C0032520
    UMLS CUI [3,3]
    C1512346
    Blood sample date
    Description

    Please fill in only if different from visit date

    Data type

    date

    Alias
    UMLS CUI [1,1]
    C0005834
    UMLS CUI [1,2]
    C0011008
    HIV Testing Results (PCR)
    Description

    HIV Testing Results (PCR)

    Data type

    integer

    Alias
    UMLS CUI [1,1]
    C1321876
    UMLS CUI [1,2]
    C0032520
    UMLS CUI [1,3]
    C1274040
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    Similar models

    HIV Repeat Test

    1 forms
    1. StudyEvent: ODM
      1. HIV Repeat Test
    Name
    Type
    Description | Question | Decode (Coded Value)
    Data type
    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 repeat test
    C1321876 (UMLS CUI-1)
    Item
    Was a blood sample taken after breast feeding cessation (subject HIV exposed but PCR negative at visit 3) ?
    integer
    C0332157 (UMLS CUI [1,1])
    C0019682 (UMLS CUI [1,2])
    C0005834 (UMLS CUI [2,1])
    C0687676 (UMLS CUI [2,2])
    C0006147 (UMLS CUI [2,3])
    C0854048 (UMLS CUI [3,1])
    C0032520 (UMLS CUI [3,2])
    C1512346 (UMLS CUI [3,3])
    HIV repeat test
    Code List
    Was a blood sample taken after breast feeding cessation (subject HIV exposed but PCR negative at visit 3) ?
    CL Item
    Yes (1)
    CL Item
    No (2)
    CL Item
    NA (3)
    Blood sample date
    Item
    Blood sample date
    date
    C0005834 (UMLS CUI [1,1])
    C0011008 (UMLS CUI [1,2])
    Item
    HIV Testing Results (PCR)
    integer
    C1321876 (UMLS CUI [1,1])
    C0032520 (UMLS CUI [1,2])
    C1274040 (UMLS CUI [1,3])
    HIV Testing Results (PCR)
    Code List
    HIV Testing Results (PCR)
    CL Item
    Negative (1)
    CL Item
    Positive (2)
    CL Item
    Unknown (3)
    CL Item
    NA (4)
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