ID

34016

Description

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

Mots-clés

Versions (1)
  1. 11/01/2019 11/01/2019 -
Détendeur de droits

GSK group of companies

Téléchargé le

11 janvier 2019

DOI

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Licence

Creative Commons BY-NC 3.0
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    Primary & Booster Immunogenicity of Hib-MenC vs a Licensed Men-C Vaccine - 103974

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    Visit 6: Eligibility Check, Laboratory Test

    1 Formulaires  
    Administrative data
    Description

    Administrative data

    Visit Number
    Description

    Visit Number

    Type de données

    integer

    Day
    Description

    Day

    Type de données

    text

    Subject Number
    Description

    Subject Number

    Type de données

    integer

    Date of Visit
    Description

    Date of Visit

    Type de données

    date

    Check for Study Continuation
    Description

    Check for Study Continuation

    Did the subject return for Visit 6?
    Description

    Did the subject return for Visit 6?

    Type de données

    boolean

    If No, please tick ONE most appropriate reason
    Description

    If No, please tick ONE most appropriate reason

    Type de données

    text

    If Other, please specify
    Description

    If Other, please specify

    Type de données

    text

    If SAE, record the SAE number
    Description

    If SAE, record the SAE number

    Type de données

    integer

    If non-SAE, please record the AE number
    Description

    If non-SAE, please record the AE number

    Type de données

    integer

    Please tick who took the decision
    Description

    Please tick who took the decision

    Type de données

    text

    Elimination Criteria During The Study
    Description

    Elimination Criteria During The Study

    The following criteria should be checked at each visit subsequent to the first visit.
    Description

    If any of the criteria become applicable during the study, it will not require withdrawal of the subject from the study but may determine a subject's evaluability in the according-to-protocol (ATP) analysis.

    Type de données

    text

    1. Use of any investigational or non-registered product (drug or vaccine) other than the study vaccine(s) during the study period
    Description

    1. Use of any investigational or non-registered product (drug or vaccine) other than the study vaccine(s) during the study period

    Type de données

    text

    2. Chronic administration (defined as more than 14 days) or immunodepressants or other imminodefying drugs during the study period.
    Description

    2. Chronic administration (defined as more than 14 days) or immunodepressants or other imminodefying drugs during the study period.

    Type de données

    text

    3. Administration of a vaccine not foreseen by the study protocol during the period starting from 30 days before each dose of vaccine(s) and ending 30 days after
    Description

    3. Administration of a vaccine not foreseen by the study protocol during the period starting from 30 days before each dose of vaccine(s) and ending 30 days after

    Type de données

    text

    4. Administration of immunoglobulins and/or any blood products during the study period
    Description

    4. Administration of immunoglobulins and/or any blood products during the study period

    Type de données

    text

    Laboratory Tests - Blood
    Description

    Laboratory Tests - Blood

    Has a blood sample been taken?
    Description

    Has a blood sample been taken?

    Type de données

    boolean

    Date blood sample taken
    Description

    please fill in only if different from visit date

    Type de données

    date

    Retour au début de la page

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    Visit 6: Eligibility Check, Laboratory Test

    1 Formulaires
    Name
    Type
    Description | Question | Decode (Coded Value)
    Type de données
    Alias
    Item Group
    Administrative data
    Item
    Visit Number
    integer
    Visit Number
    Code List
    Visit Number
    CL Item
    Visit 6 (1)
    Item
    Day
    text
    Day
    Code List
    Day
    CL Item
    42-56 days after Visit 5 (1)
    Subject Number
    Item
    Subject Number
    integer
    Date of Visit
    Item
    Date of Visit
    date
    Item Group
    Check for Study Continuation
    Did the subject return for Visit 6?
    Item
    Did the subject return for Visit 6?
    boolean
    Item
    If No, please tick ONE most appropriate reason
    text
    If No, please tick ONE most appropriate reason
    Code List
    If No, please tick ONE most appropriate reason
    CL Item
    Serious Adverse Event (SAE) (1)
    CL Item
    Non-Serious Adverse Event (Non-SAE) (2)
    CL Item
    Other (e.g.withdrawal,protocol violation) (3)
    If Other, please specify
    Item
    If Other, please specify
    text
    If SAE, record the SAE number
    Item
    If SAE, record the SAE number
    integer
    If non-SAE, please record the AE number
    Item
    If non-SAE, please record the AE number
    integer
    Item
    Please tick who took the decision
    text
    Please tick who took the decision
    Code List
    Please tick who took the decision
    CL Item
    Investigator (1)
    CL Item
    Parents / Guardians (2)
    Item Group
    Elimination Criteria During The Study
    Item
    The following criteria should be checked at each visit subsequent to the first visit.
    text
    The following criteria should be checked at each visit subsequent to the first visit.
    Code List
    The following criteria should be checked at each visit subsequent to the first visit.
    CL Item
    Use of any investigational or non-registered product (drug or vaccine) other than the study vaccine(s) during the study period (1)
    CL Item
    Chronic administration (defined as more than 14 days) or immunodepressants or other imminodefying drugs during the study period. (For corticosteroids, this will mean prednisone, or equivalent, ≥0.5 mg/kg/day. Inhaled and topical steroids are allowed.) (2)
    Item
    1. Use of any investigational or non-registered product (drug or vaccine) other than the study vaccine(s) during the study period
    text
    1. Use of any investigational or non-registered product (drug or vaccine) other than the study vaccine(s) during the study period
    Code List
    1. Use of any investigational or non-registered product (drug or vaccine) other than the study vaccine(s) during the study period
    CL Item
    Applicable (1)
    CL Item
    Not applicable (2)
    Item
    2. Chronic administration (defined as more than 14 days) or immunodepressants or other imminodefying drugs during the study period.
    text
    2. Chronic administration (defined as more than 14 days) or immunodepressants or other imminodefying drugs during the study period.
    Code List
    2. Chronic administration (defined as more than 14 days) or immunodepressants or other imminodefying drugs during the study period.
    CL Item
    Applicable (1)
    CL Item
    Not applicable (2)
    Item
    3. Administration of a vaccine not foreseen by the study protocol during the period starting from 30 days before each dose of vaccine(s) and ending 30 days after
    text
    3. Administration of a vaccine not foreseen by the study protocol during the period starting from 30 days before each dose of vaccine(s) and ending 30 days after
    Code List
    3. Administration of a vaccine not foreseen by the study protocol during the period starting from 30 days before each dose of vaccine(s) and ending 30 days after
    CL Item
    Applicable (1)
    CL Item
    Not applicable (2)
    Item
    4. Administration of immunoglobulins and/or any blood products during the study period
    text
    4. Administration of immunoglobulins and/or any blood products during the study period
    Code List
    4. Administration of immunoglobulins and/or any blood products during the study period
    CL Item
    Applicable (1)
    CL Item
    Not applicable (2)
    Item Group
    Laboratory Tests - Blood
    Has a blood sample been taken?
    Item
    Has a blood sample been taken?
    boolean
    Date blood sample taken
    Item
    Date blood sample taken
    date
    Retour au début de la page 

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