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ID

33995

Descrição

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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Versões (1)
  1. 10/01/2019 10/01/2019 -
Titular dos direitos

GSK group of companies

Transferido a

10 de janeiro de 2019

DOI

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Licença

Creative Commons BY-NC 3.0
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    Primary & Booster Immunogenicity of Hib-MenC vs a Licensed Men-C Vaccine - 104056

    Inglês

    Diary Card - Booster Dose (day 0-day 42)

    1 Formulários  
    Administrative data
    Descrição

    Administrative data

    Previous Study Number
    Descrição

    Previous Study Number

    Tipo de dados

    text

    Subject Number
    Descrição

    Subject Number

    Tipo de dados

    integer

    Temperature
    Descrição

    Temperature

    Record the type of temperature measurement
    Descrição

    preferably rectal measurement; please record temperature daily from day 0 to day 14 after vaccination at bedtime; if temperature has been taken more than once a day, please report the highest value for the day; if multiple measures a day, please report the highest value for the day. Fever definition: Rectal (≥ 38°C), Axillary (≥ 37.5°C)

    Tipo de dados

    text

    Temperature Log
    Descrição

    Temperature Log

    Day number
    Descrição

    Please record the information every day within 42-day period

    Tipo de dados

    integer

    Temperature
    Descrição

    Temperature

    Tipo de dados

    float

    Unidades de medida
    • °C
    °C
    Medically attended visit?
    Descrição

    Medically attended visit?

    Tipo de dados

    boolean

    Rash / Exanthem
    Descrição

    Rash / Exanthem

    Has any rash / exanthem event occurred?
    Descrição

    In case rash/exanthem is (are) observed, the parents/guardians are instructed to bring the child for a visit to investigator for complete clinical examination, further assessments and/or appropriate treatment

    Tipo de dados

    boolean

    Rash Event Log
    Descrição

    Rash Event Log

    Rash Episode Number
    Descrição

    Rash Episode Number

    Tipo de dados

    integer

    Description
    Descrição

    Description

    Tipo de dados

    text

    Administration Site
    Descrição

    Administration Site

    Tipo de dados

    integer

    Date started
    Descrição

    Date started

    Tipo de dados

    date

    Date stopped
    Descrição

    Date stopped

    Tipo de dados

    date

    Did the subject seek medical advice?
    Descrição

    medical advice

    Tipo de dados

    boolean

    Record the intensity
    Descrição

    Rash intensity

    Tipo de dados

    integer

    Was the visit medically attended?
    Descrição

    medically attended visit?

    Tipo de dados

    boolean

    Temperature
    Descrição

    Temperature

    Tipo de dados

    float

    Unidades de medida
    • °C
    °C
    Parotid / Salivary Gland Swelling
    Descrição

    Parotid / Salivary Gland Swelling

    Has any parotid/salivary gland swelling occurred?
    Descrição

    In case rash/exanthem is (are) observed, the parents/guardians are instructed to bring the child for a visit to investigator for complete clinical examination, further assessments and/or appropriate treatment

    Tipo de dados

    boolean

    Parotid/Salivary Gland Swelling Events
    Descrição

    Parotid/Salivary Gland Swelling Events

    Episode Number
    Descrição

    Episode Number

    Tipo de dados

    integer

    Description
    Descrição

    Description

    Tipo de dados

    text

    Date started
    Descrição

    Date started

    Tipo de dados

    date

    Date stopped
    Descrição

    Date stopped

    Tipo de dados

    date

    Intensity
    Descrição

    Intensity

    Tipo de dados

    integer

    Was the visit medically attended?
    Descrição

    medically attended visit

    Tipo de dados

    boolean

    Temperature
    Descrição

    Temperature

    Tipo de dados

    float

    Unidades de medida
    • °C
    °C
    Febrile Convulsions - Suspected Signs of Meningism
    Descrição

    Febrile Convulsions - Suspected Signs of Meningism

    Has any case of febrile convulsions occurred?
    Descrição

    In case rash/exanthem is (are) observed, the parents/guardians are instructed to bring the child for a visit to investigator for complete clinical examination, further assessments and/or appropriate treatment

    Tipo de dados

    boolean

    Febrile Convulsions Log
    Descrição

    Febrile Convulsions Log

    Episode Number
    Descrição

    Episode Number

    Tipo de dados

    integer

    Descriptions
    Descrição

    Descriptions

    Tipo de dados

    text

    Date started
    Descrição

    Date started

    Tipo de dados

    date

    Date stopped
    Descrição

    Date stopped

    Tipo de dados

    date

    Was the visit medically attended?
    Descrição

    medically attended visit?

    Tipo de dados

    boolean

    Temperature
    Descrição

    Temperature

    Tipo de dados

    float

    Unidades de medida
    • °C
    °C
    Reminder
    Descrição

    Reminder

    Please do not forget to bring back the diary card on
    Descrição

    Record the date below

    Tipo de dados

    date

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    Similar models

    Diary Card - Booster Dose (day 0-day 42)

    1 Formulários
    Name
    Tipo
    Description | Question | Decode (Coded Value)
    Tipo de dados
    Alias
    Item Group
    Administrative data
    Item
    Previous Study Number
    text
    Previous Study Number
    Code List
    Previous Study Number
    CL Item
    103974 (1)
    Subject Number
    Item
    Subject Number
    integer
    Item Group
    Temperature
    Item
    Record the type of temperature measurement
    text
    Fever
    Code List
    Record the type of temperature measurement
    CL Item
    Rectal  (1)
    CL Item
    Axillary  (2)
    Item Group
    Temperature Log
    Day number
    Item
    Day number
    integer
    Temperature
    Item
    Temperature
    float
    Medically attended visit?
    Item
    Medically attended visit?
    boolean
    Item Group
    Rash / Exanthem
    Rash
    Item
    Has any rash / exanthem event occurred?
    boolean
    Item Group
    Rash Event Log
    Rash Episode Number
    Item
    Rash Episode Number
    integer
    Description
    Item
    Description
    text
    Item
    Administration Site
    integer
    Administration Site
    Code List
    Administration Site
    CL Item
    Right deltoid (1)
    CL Item
    Non-administration site (2)
    Date started
    Item
    Date started
    date
    Date stopped
    Item
    Date stopped
    date
    medical advice
    Item
    Did the subject seek medical advice?
    boolean
    Item
    Record the intensity
    integer
    Rash intensity
    Code List
    Record the intensity
    CL Item
    1-50 lesions (1)
    CL Item
    51 - 150 lesions (2)
    CL Item
    > 150 lesions (3)
    medically attended visit?
    Item
    Was the visit medically attended?
    boolean
    Temperature
    Item
    Temperature
    float
    Item Group
    Parotid / Salivary Gland Swelling
    parotid / salivary gland swelling
    Item
    Has any parotid/salivary gland swelling occurred?
    boolean
    Item Group
    Parotid/Salivary Gland Swelling Events
    Episode Number
    Item
    Episode Number
    integer
    Description
    Item
    Description
    text
    Date started
    Item
    Date started
    date
    Date stopped
    Item
    Date stopped
    date
    Item
    Intensity
    integer
    Intensity
    Code List
    Intensity
    CL Item
    Swelling without difficulties to move the jaw (1)
    CL Item
    Swelling with difficulties to move the jaw (2)
    CL Item
    Swelling and additional general symptoms (3)
    medically attended visit
    Item
    Was the visit medically attended?
    boolean
    Temperature
    Item
    Temperature
    float
    Item Group
    Febrile Convulsions - Suspected Signs of Meningism
    Febrile Convulsions
    Item
    Has any case of febrile convulsions occurred?
    boolean
    Item Group
    Febrile Convulsions Log
    Episode Number
    Item
    Episode Number
    integer
    Descriptions
    Item
    Descriptions
    text
    Date started
    Item
    Date started
    date
    Date stopped
    Item
    Date stopped
    date
    medically attended visit?
    Item
    Was the visit medically attended?
    boolean
    Temperature
    Item
    Temperature
    float
    Item Group
    Reminder
    Please do not forget to bring back the diary card on
    Item
    Please do not forget to bring back the diary card on
    date
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