0 Ratings
ID

33993

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

Keywords

Versions (2)
  1. 1/10/19 1/10/19 -
  2. 1/10/19 1/10/19 -
Copyright Holder

GSK group of companies

Uploaded on

January 10, 2019

DOI

To request one please log in.

License

Creative Commons BY-NC 3.0
Model comments :

You can comment on the data model here. Via the speech bubbles at the itemgroups and items you can add comments to those specificially.

Back to model comments
Itemgroup comments for :

Item comments for :

  • Newest
  • Oldest
  • Popular
  • Newest
    • Newest
    • Oldest
    • Popular

    No comments

    In order to download data models you must be logged in. Please log in or register for free.

    Primary & Booster Immunogenicity of Hib-MenC vs a Licensed Men-C Vaccine - 103974

    English

    Diary Cards for Booster Dose (Local and General Symptoms)

    1 forms  
    Administrative data
    Description

    Administrative data

    Subject Number
    Description

    Subject Number

    Data type

    integer

    Booster Dose - Local Symptoms - Vaccine 1
    Description

    Booster Dose - Local Symptoms - Vaccine 1

    Please fill in the section below and assess the occurrence of any signs or symptoms at injection site
    Description

    for Hib-MenC vaccine

    Data type

    text

    Side of injection
    Description

    for investigator only

    Data type

    text

    Site of injection
    Description

    for investigator only

    Data type

    text

    Redness (Local Symptoms)
    Description

    Redness (Local Symptoms)

    Day
    Description

    Day

    Data type

    integer

    Size
    Description

    please measure the greatest diameter

    Data type

    float

    Measurement units
    • mm
    mm
    Is the symptom ongoing after day 3?
    Description

    Ongoing after day 3?

    Data type

    boolean

    If Yes, please record the last day of symptoms
    Description

    last day of symptoms

    Data type

    date

    Was the visit medically attended?
    Description

    medically attended visit

    Data type

    boolean

    Swelling (Local Symptoms)
    Description

    Swelling (Local Symptoms)

    Day
    Description

    Day

    Data type

    text

    Size
    Description

    please measure the greatest diameter

    Data type

    float

    Measurement units
    • mm
    mm
    Is the symptom ongoing after day 3?
    Description

    Ongoing after day 3?

    Data type

    boolean

    If Yes, please record the last day of symptoms
    Description

    last day of symptoms

    Data type

    date

    Was the visit medically attended?
    Description

    medically attended visit?

    Data type

    boolean

    Pain (Local Symptoms)
    Description

    Pain (Local Symptoms)

    Day
    Description

    Day

    Data type

    integer

    Intensity
    Description

    Intensity

    Data type

    integer

    Is the symptom ongoing after day 3?
    Description

    Ongoing after day 3?

    Data type

    boolean

    If Yes, please record the last day of symptom
    Description

    last day of symptom

    Data type

    date

    Was the visit medically attended?
    Description

    medically attended visit?

    Data type

    boolean

    Booster Dose - Local Symptoms - Vaccine 2
    Description

    Booster Dose - Local Symptoms - Vaccine 2

    Please fill in the section below and assess the occurrence of any signs or symptoms at injection site
    Description

    PriorixTM vaccine

    Data type

    text

    Injection Side
    Description

    for investigator only

    Data type

    text

    Injection Site
    Description

    for investigator only

    Data type

    text

    Redness (Local Symptoms)
    Description

    Redness (Local Symptoms)

    Day
    Description

    Day

    Data type

    integer

    Size
    Description

    please measure the greatest diameter

    Data type

    float

    Measurement units
    • mm
    mm
    Is the symptom ongoing after day 3?
    Description

    Ongoing after day 3?

    Data type

    boolean

    If Yes, please record the last day of symptom
    Description

    the last day of symptom

    Data type

    date

    Was the visit medically attended?
    Description

    medically attended visit

    Data type

    boolean

    Swelling (Local Symptoms)
    Description

    Swelling (Local Symptoms)

    Day
    Description

    Day

    Data type

    integer

    Size
    Description

    please measure the greatest diameter

    Data type

    float

    Measurement units
    • mm
    mm
    Is the symptom ongoing after day 3?
    Description

    Ongoing after day 3?

    Data type

    boolean

    If Yes, please record the last day of symptom
    Description

    last day of symptom

    Data type

    date

    Was the visit medically attended?
    Description

    medically attended visit?

    Data type

    boolean

    Pain (Local Symptoms)
    Description

    Pain (Local Symptoms)

    Day
    Description

    Day

    Data type

    integer

    Intensity
    Description

    Intensity

    Data type

    integer

    Is the symptom ongoing after day 3?
    Description

    Ongoing after day 3?

    Data type

    boolean

    If Yes, please record the last day of symptom
    Description

    last day of symptom

    Data type

    date

    Was the visit medically attended?
    Description

    medically attended visit

    Data type

    boolean

    Booster Dose - Other Local Symptoms
    Description

    Booster Dose - Other Local Symptoms

    Describe the side(s), site(s), and other details
    Description

    Description

    Data type

    text

    Please record the intensity of a symptom
    Description

    Mild (an adverse event which is easily tolerated by the subject, causing minimal discomfort and not interfering with everyday activities). Moderate (an adverse event which is sufficiently discomforting to interfere with normal everyday activities). Severe (an adverse event which prevents normal, everyday activities; in a young child, such an adverse event would, for example, prevent attendance at school/kindergarten/a day-care center and would cause the parents/guardians to seek medical advice).

    Data type

    integer

    Start date
    Description

    Start date

    Data type

    date

    End date
    Description

    End date

    Data type

    date

    Is the symptom/event ongoing after day 3?
    Description

    Ongoing?

    Data type

    boolean

    Was the visit medically attended?
    Description

    Medically attended visit?

    Data type

    boolean

    Booster Dose - General Symptoms
    Description

    Booster Dose - General Symptoms

    Please fill in the section below and assess the occurrence of any signs or symptoms at injection site
    Description

    signs or symptoms at injection site

    Data type

    text

    Temperature (General Symptoms)
    Description

    Temperature (General Symptoms)

    Day
    Description

    Day

    Data type

    integer

    Please record temperature
    Description

    Body Temperature

    Data type

    float

    Measurement units
    • °C
    °C
    Type of temperature taking
    Description

    Type of temperature taking

    Data type

    text

    Is the symptom ongoing after day 3?
    Description

    Ongoing after day 3?

    Data type

    boolean

    If Yes, please record the last day of symptoms
    Description

    last day of symptoms

    Data type

    date

    Was the visit medically attended?
    Description

    Medically attended visit?

    Data type

    boolean

    Irritability / Fussiness (General Symptoms)
    Description

    Irritability / Fussiness (General Symptoms)

    Day
    Description

    Day

    Data type

    integer

    Intensity
    Description

    Intensity

    Data type

    integer

    Is the symptom ongoing after day 3?
    Description

    Ongoing after day 3?

    Data type

    boolean

    If Yes, please record the last day of symptoms
    Description

    last day of symptoms

    Data type

    date

    Was the visit medically attended?
    Description

    medically attended visit?

    Data type

    boolean

    Drowsiness (General Symptoms)
    Description

    Drowsiness (General Symptoms)

    Day
    Description

    Day

    Data type

    integer

    Intensity
    Description

    Intensity

    Data type

    integer

    Is the symptom ongoing after day 3?
    Description

    Ongoing after day 3?

    Data type

    boolean

    If Yes, please record the last day of symptoms
    Description

    last day of symptoms

    Data type

    date

    Was the visit medically attended?
    Description

    medically attended visit?

    Data type

    boolean

    Loss of Appetite (General Symptoms)
    Description

    Loss of Appetite (General Symptoms)

    Day
    Description

    Day

    Data type

    text

    Intensity
    Description

    Intensity

    Data type

    integer

    Is the symptom ongoing after day 3?
    Description

    ongoing after day 3?

    Data type

    boolean

    If Yes, please record the last day of symptoms
    Description

    last day of symptoms

    Data type

    date

    Was the visit medically attended?
    Description

    Medically attended visit?

    Data type

    boolean

    Booster Dose - Other General Symptoms
    Description

    Booster Dose - Other General Symptoms

    Describe the side(s), site(s), and other details below
    Description

    Symptom description

    Data type

    text

    Intensity
    Description

    Mild (an adverse event which is easily tolerated by the subject, causing minimal discomfort and not interfering with everyday activities). Moderate (an adverse event which is sufficiently discomforting to interfere with normal everyday activities). Severe (an adverse event which prevents normal, everyday activities; in a young child, such an adverse event would, for example, prevent attendance at school/kindergarten/a day-care center and would cause the parents/guardians to seek medical advice).

    Data type

    text

    Start date
    Description

    Start date

    Data type

    date

    End date
    Description

    End date

    Data type

    boolean

    Is the symptom / event ongoing?
    Description

    ongoing

    Data type

    boolean

    Was the visit medically attended?
    Description

    medically attended visit

    Data type

    boolean

    Booster Dose - Medication
    Description

    Booster Dose - Medication

    Trade / Generic Name
    Description

    Please fill in if any medication has been taken since the vaccination

    Data type

    text

    Reason
    Description

    Reason

    Data type

    text

    Total Daily Dose
    Description

    Total Daily Dose

    Data type

    text

    Start Date
    Description

    Start Date

    Data type

    date

    End Date
    Description

    End Date

    Data type

    date

    Is the medication treatment ongoing?
    Description

    Ongoing?

    Data type

    boolean

    Reminder
    Description

    Reminder

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

    record date below

    Data type

    date

    Back to the top of the page

    Similar models

    Diary Cards for Booster Dose (Local and General Symptoms)

    1 forms
    Name
    Type
    Description | Question | Decode (Coded Value)
    Data type
    Alias
    Item Group
    Administrative data
    Subject Number
    Item
    Subject Number
    integer
    Item Group
    Booster Dose - Local Symptoms - Vaccine 1
    signs or symptoms at injection site
    Item
    Please fill in the section below and assess the occurrence of any signs or symptoms at injection site
    text
    Item
    Side of injection
    text
    Injection side
    Code List
    Side of injection
    CL Item
    Left (1)
    CL Item
    Right (2)
    Item
    Site of injection
    text
    Injection site
    Code List
    Site of injection
    CL Item
    Arm (1)
    CL Item
    Thigh (2)
    CL Item
    Buttock (3)
    Item Group
    Redness (Local Symptoms)
    Item
    Day
    integer
    Day
    Code List
    Day
    CL Item
    Day 0 (1)
    CL Item
    Day 1 (2)
    CL Item
    Day 2 (3)
    CL Item
    Day 3 (4)
    Size
    Item
    Size
    float
    Ongoing after day 3?
    Item
    Is the symptom ongoing after day 3?
    boolean
    last day of symptoms
    Item
    If Yes, please record the last day of symptoms
    date
    medically attended visit
    Item
    Was the visit medically attended?
    boolean
    Item Group
    Swelling (Local Symptoms)
    Item
    Day
    text
    Day
    Code List
    Day
    CL Item
    Day 0 (1)
    CL Item
    Day 1 (2)
    CL Item
    Day 2 (3)
    CL Item
    Day 3 (4)
    Size
    Item
    Size
    float
    Ongoing after day 3?
    Item
    Is the symptom ongoing after day 3?
    boolean
    last day of symptoms
    Item
    If Yes, please record the last day of symptoms
    date
    medically attended visit?
    Item
    Was the visit medically attended?
    boolean
    Item Group
    Pain (Local Symptoms)
    Item
    Day
    integer
    Day
    Code List
    Day
    CL Item
    Day 0 (1)
    CL Item
    Day 1 (2)
    CL Item
    Day 2 (3)
    CL Item
    Day 3 (4)
    Item
    Intensity
    integer
    Intensity
    Code List
    Intensity
    CL Item
    absent (1)
    CL Item
    minor reaction to touch (2)
    CL Item
    cries /protests on touch (3)
    CL Item
    cries when limb is moved / spontaneously painful (4)
    Ongoing after day 3?
    Item
    Is the symptom ongoing after day 3?
    boolean
    last day of symptom
    Item
    If Yes, please record the last day of symptom
    date
    medically attended visit?
    Item
    Was the visit medically attended?
    boolean
    Item Group
    Booster Dose - Local Symptoms - Vaccine 2
    signs or symptoms at injection site
    Item
    Please fill in the section below and assess the occurrence of any signs or symptoms at injection site
    text
    Item
    Injection Side
    text
    Injection Side
    Code List
    Injection Side
    CL Item
    Left (1)
    CL Item
    Right (2)
    Item
    Injection Site
    text
    Injection Site
    Code List
    Injection Site
    CL Item
    Arm (1)
    CL Item
    Thigh (2)
    CL Item
    Buttock (3)
    Item Group
    Redness (Local Symptoms)
    Item
    Day
    integer
    Day
    Code List
    Day
    CL Item
    Day 0 (1)
    CL Item
    Day 1 (2)
    CL Item
    Day 2 (3)
    CL Item
    Day 3 (4)
    Size
    Item
    Size
    float
    Ongoing after day 3?
    Item
    Is the symptom ongoing after day 3?
    boolean
    the last day of symptom
    Item
    If Yes, please record the last day of symptom
    date
    medically attended visit
    Item
    Was the visit medically attended?
    boolean
    Item Group
    Swelling (Local Symptoms)
    Item
    Day
    integer
    Day
    Code List
    Day
    CL Item
    Day 0 (1)
    CL Item
    Day 1 (2)
    CL Item
    Day 2 (3)
    CL Item
    Day 3 (4)
    Size
    Item
    Size
    float
    Ongoing after day 3?
    Item
    Is the symptom ongoing after day 3?
    boolean
    last day of symptom
    Item
    If Yes, please record the last day of symptom
    date
    medically attended visit?
    Item
    Was the visit medically attended?
    boolean
    Item Group
    Pain (Local Symptoms)
    Item
    Day
    integer
    Day
    Code List
    Day
    CL Item
    Day 0 (1)
    CL Item
    Day 1 (2)
    CL Item
    Day 2 (3)
    CL Item
    Day 3 (4)
    Item
    Intensity
    integer
    Intensity
    Code List
    Intensity
    CL Item
    absent (1)
    CL Item
    minor reaction to touch (2)
    CL Item
    cries /protests on touch (3)
    CL Item
    cries when limb is moved / spontaneously painful (4)
    Ongoing after day 3?
    Item
    Is the symptom ongoing after day 3?
    boolean
    last day of symptom
    Item
    If Yes, please record the last day of symptom
    date
    medically attended visit
    Item
    Was the visit medically attended?
    boolean
    Item Group
    Booster Dose - Other Local Symptoms
    Description
    Item
    Describe the side(s), site(s), and other details
    text
    Item
    Please record the intensity of a symptom
    integer
    Intensity
    Code List
    Please record the intensity of a symptom
    CL Item
    mild  (1)
    CL Item
    moderate  (2)
    CL Item
    severe (3)
    Start date
    Item
    Start date
    date
    End date
    Item
    End date
    date
    Ongoing?
    Item
    Is the symptom/event ongoing after day 3?
    boolean
    Medically attended visit?
    Item
    Was the visit medically attended?
    boolean
    Item Group
    Booster Dose - General Symptoms
    signs or symptoms at injection site
    Item
    Please fill in the section below and assess the occurrence of any signs or symptoms at injection site
    text
    Item Group
    Temperature (General Symptoms)
    Item
    Day
    integer
    Day
    Code List
    Day
    CL Item
    Day 0 (1)
    CL Item
    Day 1 (2)
    CL Item
    Day 2 (3)
    CL Item
    Day 3 (4)
    Body Temperature
    Item
    Please record temperature
    float
    Item
    Type of temperature taking
    text
    Type of temperature taking
    Code List
    Type of temperature taking
    CL Item
    Axillary (1)
    CL Item
    Rectal (2)
    Ongoing after day 3?
    Item
    Is the symptom ongoing after day 3?
    boolean
    last day of symptoms
    Item
    If Yes, please record the last day of symptoms
    date
    Medically attended visit?
    Item
    Was the visit medically attended?
    boolean
    Item Group
    Irritability / Fussiness (General Symptoms)
    Item
    Day
    integer
    Day
    Code List
    Day
    CL Item
    Day 0 (1)
    CL Item
    Day 1 (2)
    CL Item
    Day 2 (3)
    CL Item
    Day 3 (4)
    Item
    Intensity
    integer
    Intensity
    Code List
    Intensity
    CL Item
    Behavior as usual (1)
    CL Item
    Crying more than usual / no effect on normal activity (2)
    CL Item
    Crying more than usual / interferes with normal activity (3)
    CL Item
    Crying that cannot be comforted / prevents normal activity (4)
    Ongoing after day 3?
    Item
    Is the symptom ongoing after day 3?
    boolean
    last day of symptoms
    Item
    If Yes, please record the last day of symptoms
    date
    medically attended visit?
    Item
    Was the visit medically attended?
    boolean
    Item Group
    Drowsiness (General Symptoms)
    Item
    Day
    integer
    Day
    Code List
    Day
    CL Item
    Day 0 (1)
    CL Item
    Day 1 (2)
    CL Item
    Day 2 (3)
    CL Item
    Day 3 (4)
    Item
    Intensity
    integer
    Intensity
    Code List
    Intensity
    CL Item
    Behavior as usual (1)
    CL Item
    Drowsiness easily tolerated (2)
    CL Item
    Drowsiness that interferes with normal activity (3)
    CL Item
    Drowsiness that prevents normal activity (4)
    Ongoing after day 3?
    Item
    Is the symptom ongoing after day 3?
    boolean
    last day of symptoms
    Item
    If Yes, please record the last day of symptoms
    date
    medically attended visit?
    Item
    Was the visit medically attended?
    boolean
    Item Group
    Loss of Appetite (General Symptoms)
    Item
    Day
    text
    Day
    Code List
    Day
    CL Item
    Day 0 (1)
    CL Item
    Day 1 (2)
    CL Item
    Day 2 (3)
    CL Item
    Day 3 (4)
    Item
    Intensity
    integer
    Intensity
    Code List
    Intensity
    CL Item
    Appetite as usual (1)
    CL Item
    Eating less than usual / no effect on normal activity (2)
    CL Item
    Eating less than usual / interferes with normal activity (3)
    CL Item
    Not eating at all (4)
    ongoing after day 3?
    Item
    Is the symptom ongoing after day 3?
    boolean
    last day of symptoms
    Item
    If Yes, please record the last day of symptoms
    date
    Medically attended visit?
    Item
    Was the visit medically attended?
    boolean
    Item Group
    Booster Dose - Other General Symptoms
    Symptom description
    Item
    Describe the side(s), site(s), and other details below
    text
    Item
    Intensity
    text
    Intensity
    Code List
    Intensity
    CL Item
    mild (1)
    CL Item
    moderate (2)
    CL Item
    severe (3)
    Start date
    Item
    Start date
    date
    End date
    Item
    End date
    boolean
    ongoing
    Item
    Is the symptom / event ongoing?
    boolean
    medically attended visit
    Item
    Was the visit medically attended?
    boolean
    Item Group
    Booster Dose - Medication
    Trade / Generic Name
    Item
    Trade / Generic Name
    text
    Reason
    Item
    Reason
    text
    Total Daily Dose
    Item
    Total Daily Dose
    text
    Start Date
    Item
    Start Date
    date
    End Date
    Item
    End Date
    date
    Ongoing?
    Item
    Is the medication treatment ongoing?
    boolean
    Item Group
    Reminder
    diary card date reminder
    Item
    Please do not forget to bring back the diary card on
    date
    Back to the top of the page 

    Help

    Do you need help on how to use the search function? Please watch the corresponding tutorial video for more details and learn how to use the search function most efficiently.

    Watch Tutorial