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34703

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Study ID: 103974 (primary study) Clinical Study ID: 103974 Study Title: Demonstrate non-inferiority of Men-C immune response of Hib-MenC with Infanrix™-IPV versus a licensed Men-C vaccine with Pediacel™ when given at 2, 3, 4 months and the immunogenicity of Hib-MenC when given as a booster dose at 12-15 months Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00258700 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 3 Study Recruitment Status: Completed Generic Name: Haemophilus influenzae Type b, Meningococcal C-Tetanus Toxoid Conjugate Vaccine Trade Name: BIO HIB-MENC-TT; Menitorix Study Indication: Haemophilus influenzae type b; Neisseria Meningitidis

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Versioner (1)
  1. 2019-01-23 2019-01-23 -
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GSK group of companies

Uppladdad den

23 januari 2019

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Creative Commons BY-NC 3.0
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    Study of Long-term Antibody Persistence After a Booster Dose of Menitorix Vaccine - 109664

    Engelsk

    Reason for non participation - Tracking Form + Use of Samples Compliance

    1 Formulär  
    Administrative data
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    Administrative data

    Center Number
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    Center Number

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    integer

    Tracking Document
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    Tracking Document

    Previous Subject Number
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    Previous study: 109664 (Hib-MenC-TT-027 EXT: 013 M12)

    Datatyp

    integer

    Date of Birth
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    Date of Birth

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    date

    Reason for non participation
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    Reason for non participation

    Datatyp

    text

    Please specify criteria that are not fulfilled
    Beskrivning

    IfSubjectNotEligible

    Datatyp

    text

    In case of SAE, specify adverse event
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    SAE

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    text

    If Other, please specify
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    Other

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    text

    In case of death, please specify the date
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    DeathDate

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    date

    Date of Contact
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    Date of Contact

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    date

    Investigator Name
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    Print name

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    text

    Signature
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    Signature

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    text

    Date
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    Date

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    date

    Use of Human Samples by GSK
    Beskrivning

    Use of Human Samples by GSK

    In addition to the use of samples for the tests described in the protocol, samples might be used for other resarch by GSK (see protocol). Please tick what is also covered by the subject Informed Consent form of your center.
    Beskrivning

    USE OF HUMAN SAMPLES BY GSK

    Datatyp

    text

    Please tick below box if a 15 years GSK storage period is covered by the subject’s Informed Consent form of your center.
    Beskrivning

    StoragePeriod

    Datatyp

    text

    If Other, please specify
    Beskrivning

    Other

    Datatyp

    text

    ICF Effective date
    Beskrivning

    Complete and submit a new form for each change during the study.

    Datatyp

    date

    Investigator's Signature
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    Investigator's Signature

    Investigator's signature:
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    Investigator's signature:

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    text

    Date:
    Beskrivning

    Date:

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    date

    Printed Investigator's name:
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    Reason for non participation - Tracking Form + Use of Samples Compliance

    1 Formulär
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    Typ
    Description | Question | Decode (Coded Value)
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    Alias
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    Subject eligible but not willing to participate  (3)
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    Subject died (4)
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    In addition to the use of samples for the tests described in the protocol, samples might be used for other resarch by GSK (see protocol). Please tick what is also covered by the subject Informed Consent form of your center.
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    USE OF HUMAN SAMPLES BY GSK
    Code List
    In addition to the use of samples for the tests described in the protocol, samples might be used for other resarch by GSK (see protocol). Please tick what is also covered by the subject Informed Consent form of your center.
    CL Item
    Quality Assurance of tests described in the protocol (This may include the management of the quality of these current tests, the maintenance or (1)
    CL Item
    improvement of these current tests, the development of new test methods for the markers (improvement of these current tests, the development of new test methods for the markers)
    CL Item
    described in the protocol as well as making sure that new tests are comparable to previous (described in the protocol as well as making sure that new tests are comparable to previous)
    CL Item
    methods and work reliably.) (methods and work reliably.))
    CL Item
    Further investigation by GSK Biologicals into the ability of the vaccine to protect people if (2)
    CL Item
    any findings from related studies require it and further research in the disease(s) under (any findings from related studies require it and further research in the disease(s) under)
    CL Item
    study. These investigations excludes genetic and HIV testing. (study. These investigations excludes genetic and HIV testing.)
    CL Item
    Further research by GSK Biologicals that is NOT RELATED to the vaccine(s) or the disease(s) (3)
    CL Item
    under study done on an anonymous basis (meaning that any identification linking the subject (under study done on an anonymous basis (meaning that any identification linking the subject)
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    to the sample is destroyed). This research excludes genetic and HIV testing and does not (to the sample is destroyed). This research excludes genetic and HIV testing and does not)
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    Date:
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    Date:
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    Printed Investigator's name:
    Item
    Printed Investigator's name:
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