0 Evaluaciones
ID

34703

Descripción

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

Palabras clave

Versiones (1)
  1. 23/1/19 23/1/19 -
Titular de derechos de autor

GSK group of companies

Subido en

23 de enero de 2019

DOI

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Licencia

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

    Inglés

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

    1 formularios  
    Administrative data
    Descripción

    Administrative data

    Center Number
    Descripción

    Center Number

    Tipo de datos

    integer

    Tracking Document
    Descripción

    Tracking Document

    Previous Subject Number
    Descripción

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

    Tipo de datos

    integer

    Date of Birth
    Descripción

    Date of Birth

    Tipo de datos

    date

    Reason for non participation
    Descripción

    Reason for non participation

    Tipo de datos

    text

    Please specify criteria that are not fulfilled
    Descripción

    IfSubjectNotEligible

    Tipo de datos

    text

    In case of SAE, specify adverse event
    Descripción

    SAE

    Tipo de datos

    text

    If Other, please specify
    Descripción

    Other

    Tipo de datos

    text

    In case of death, please specify the date
    Descripción

    DeathDate

    Tipo de datos

    date

    Date of Contact
    Descripción

    Date of Contact

    Tipo de datos

    date

    Investigator Name
    Descripción

    Print name

    Tipo de datos

    text

    Signature
    Descripción

    Signature

    Tipo de datos

    text

    Date
    Descripción

    Date

    Tipo de datos

    date

    Use of Human Samples by GSK
    Descripción

    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.
    Descripción

    USE OF HUMAN SAMPLES BY GSK

    Tipo de datos

    text

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

    StoragePeriod

    Tipo de datos

    text

    If Other, please specify
    Descripción

    Other

    Tipo de datos

    text

    ICF Effective date
    Descripción

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

    Tipo de datos

    date

    Investigator's Signature
    Descripción

    Investigator's Signature

    Investigator's signature:
    Descripción

    Investigator's signature:

    Tipo de datos

    text

    Date:
    Descripción

    Date:

    Tipo de datos

    date

    Printed Investigator's name:
    Descripción

    Printed Investigator's name:

    Tipo de datos

    text

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

    1 formularios
    Name
    Tipo
    Description | Question | Decode (Coded Value)
    Tipo de datos
    Alias
    Item Group
    Administrative data
    Center Number
    Item
    Center Number
    integer
    Item Group
    Tracking Document
    Previous Subject Number
    Item
    Previous Subject Number
    integer
    Date of Birth
    Item
    Date of Birth
    date
    Item
    Reason for non participation
    text
    Reason for non participation
    Code List
    Reason for non participation
    CL Item
    Subject not eligible (1)
    CL Item
    Subject lost to follow-up or not reached (2)
    CL Item
    Subject eligible but not willing to participate  (3)
    CL Item
    Subject died (4)
    IfSubjectNotEligible
    Item
    Please specify criteria that are not fulfilled
    text
    SAE
    Item
    In case of SAE, specify adverse event
    text
    Other
    Item
    If Other, please specify
    text
    DeathDate
    Item
    In case of death, please specify the date
    date
    Date of Contact
    Item
    Date of Contact
    date
    Investigator Name
    Item
    Investigator Name
    text
    Signature
    Item
    Signature
    text
    Date
    Item
    Date
    date
    Item Group
    Use of Human Samples by GSK
    Item
    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.
    text
    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)
    CL Item
    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)
    CL Item
    affect subject participation in the study. (affect subject participation in the study.)
    Item
    Please tick below box if a 15 years GSK storage period is covered by the subject’s Informed Consent form of your center.
    text
    StoragePeriod
    Code List
    Please tick below box if a 15 years GSK storage period is covered by the subject’s Informed Consent form of your center.
    CL Item
    At least 15 years storage period by GSK Biologicals (1)
    CL Item
    Other (2)
    Other
    Item
    If Other, please specify
    text
    ICF Effective date
    Item
    ICF Effective date
    date
    Item Group
    Investigator's Signature
    Investigator's signature:
    Item
    Investigator's signature:
    text
    Date:
    Item
    Date:
    date
    Printed Investigator's name:
    Item
    Printed Investigator's name:
    text
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