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35971

Description

Study ID: 107007 Clinical Study ID: 107007 Study Title: A phase IIIb randomized, double-blind, controlled study to assess the safety, reactogenicity and immunogenicity of GlaxoSmithKline (GSK) Biologicals’ 10-valent pneumococcal conjugate vaccine compared to Prevenar™, when co-administered with DTPw-HBV/Hib and OPV or IPV vaccines as a 3-dose primary immunization course during the first 6 months of age. Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00344318 https://clinicaltrials.gov/ct2/show/NCT00344318 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 3 Study Recruitment Status: Completed Generic Name: Pneumococcal conjugate vaccine GSK1024850A Trade Name: Prevenar, Tritanrix-HepB, Hiberix, Polio Sabin., Poliorix Study Indication: Infections, Streptococcal This study consists of 2 groups of probands (Children of 6-10-14 weeks or 2-4-6 months of age are included): One group receive a 3-dose primary vaccination with the GSK Biologicals' (10-valent) pneumococcal conjugate vaccine. The other group r eceive a 3-dose primary vaccination with Prevenar™. All probands receive DTPw-HBV/Hib and OPV or IPV vaccines. Ths study consists of 3 workbooks (WB): WB 1: The WB 1 consists 4 visits (all in active phase): Visit 1, Timing: Month 0; Age for 6-12 weeks scheduled Visit 2, Timing: Month 1; Age for 10 weeks scheduled Visit 3, Timing: Month 2; Age for 14 weeks scheduled Visit 4, Timing: Month 3; Age for +/- 4 months scheduled Intervals between the visits: Visit 1 to Visit 2: 28-42 days, Visit 2 to Visit 3: 28-42 days, Visit 3 to Visit 4: 30-42 days WB 2: The WB 2 consists 4 visits (all in active phase): Visit 1, Timing: Month 0; Age for 6-12 weeks scheduled Visit 2, Timing: Month 2; Age for +/- 4 months scheduled Visit 3, Timing: Month 4; Age for +/- 6 months scheduled Visit 4, Timing: Month 5; Age for +/- 7 months scheduled Intervals between the visits: Visit 1 to Visit 2: 49-83 days, Visit 2 to Visit 3: 49-83 days, Visit 3 to Visit 4: 30-42 days WB 3: The WB 3 consists the phone contact (6 months safety follow-up), Timing: Month 8 or 10. This document contains Laboratory tests form. It has to be filled in for WB1 and WB2 for Visit 1 and Visit 4.

Link

https://clinicaltrials.gov/ct2/show/NCT00344318

Keywords

  1. 4/8/19 4/8/19 -
Copyright Holder

GlaxoSmithKline

Uploaded on

April 8, 2019

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License

Creative Commons BY-NC 3.0

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    Safety, reactogenicity and immunogenicity 10-valent pneumococcal conjugate vaccine compared to Prevenar™, co-administration of DTPw-HBV/Hib and OPV or IPV vaccines in infants, NCT00344318

    Laboratory tests

    1. StudyEvent: ODM
      1. Laboratory tests
    Administrative data
    Description

    Administrative data

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

    Subject Number

    Data type

    text

    Alias
    UMLS CUI [1]
    C2348585 (Clinical Trial Subject Unique Identifier)
    Workbook Number
    Description

    Workbook Number

    Data type

    integer

    Alias
    UMLS CUI [1]
    C2986015 (Document Version Number Text)
    Visit type
    Description

    Visit type

    Data type

    integer

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

    day month year.

    Data type

    date

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

    Laboratory tests (blood sample)

    Alias
    UMLS CUI-1
    C0022885 (Laboratory Procedures)
    SNOMED
    269814003
    UMLS CUI-2
    C0005834 (Collection of blood specimen for laboratory procedure)
    SNOMED
    82078001
    LOINC
    LP125037-4
    Has a blood sample been taken ?
    Description

    Blood sample taken

    Data type

    text

    Alias
    UMLS CUI [1]
    C1277698 (Blood sample taken)
    SNOMED
    313334002
    If blood sample has been taken, please date if different from visit date
    Description

    day month year

    Data type

    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

    Similar models

    Laboratory tests

    1. StudyEvent: ODM
      1. Laboratory tests
    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
    Workbook Number
    integer
    C2986015 (UMLS CUI [1])
    Code List
    Workbook Number
    CL Item
    WB 1 (1)
    CL Item
    WB 2 (2)
    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 4 (2)
    Visit Date
    Item
    Visit Date
    date
    C1320303 (UMLS CUI [1])
    Item Group
    Laboratory tests (blood sample)
    C0022885 (UMLS CUI-1)
    C0005834 (UMLS CUI-2)
    Item
    Has a blood sample been taken ?
    text
    C1277698 (UMLS CUI [1])
    Code List
    Has a blood sample been taken ?
    CL Item
    Yes (Y)
    CL Item
    No (N)
    Date of blood sample
    Item
    If blood sample has been taken, please date if different from visit date
    date
    C0005834 (UMLS CUI [1,1])
    C0011008 (UMLS CUI [1,2])

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