0 Ratings
ID

30011

Description

Study ID: 100480, 759346/004 & 100791 Clinical Study ID: 100480, 759346/004 & 100791 Study Title: A phase III, partially double blind, randomized, controlled primary vaccination study to assess the reactogenicity and safety of GlaxoSmithKline (GSK) Biologicals’ Tritanrix-HepB/Hib-MenAC vaccine as compared to Tritanrix-HepB/Hib2.5 + Meningitec™ when administered to healthy infants at 6, 10, 14 weeks of age, who have received a birth dose of hepatitis B vaccine. Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: Sponsor: GlaxoSmithKline Collaborators: N/A Phase: phase 3 Study Recruitment Status: Completed Generic Name: Combined Diphtheria, Tetanus, Whole Cell Pertussis, Hepatitis B, Haemophilus influenzae Type b Vaccine Trade Name: Tritanrix HepB/Hiberix Study Indication: Diphtheria; Haemophilus influenzae type b; Hepatitis B; Tetanus; Whole Cell Pertussis Documentation part: Visit 1, Day 0, HBV Birth Dose

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Versions (2)
  1. 7/10/17 7/10/17 -
  2. 5/4/18 5/4/18 - Sarah Riepenhausen
Copyright Holder

GlaxoSmithKline

Uploaded on

May 4, 2018

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License

Creative Commons BY-NC 3.0
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    Tritanrix-HepB/Hib-MenAC vaccine compared to Tritanrix-HepB/Hiberix and Meningitec Visit 1 759346/004

    English

    Visit 1 Tritanrix-HepB/Hib-MenAC vaccine compared to Tritanrix-HepB/Hiberix and Meningitec 759346/004

    1 forms  
    Informed Consent
    Description

    Informed Consent

    Alias
    UMLS CUI-1
    C0021430
    UMLS CUI-2
    C0042210
    Subject Number
    Description

    Subject Number

    Data type

    text

    Alias
    UMLS CUI [1]
    C2348585
    Date of Visit
    Description

    Date of Visit

    Data type

    date

    Alias
    UMLS CUI [1]
    C1320303
    Informed Consent Date
    Description

    I certify that Informed Consent has been obtained prior to any study procedure.

    Data type

    time

    Alias
    UMLS CUI [1,1]
    C0021430
    UMLS CUI [1,2]
    C0011008
    Demographics
    Description

    Demographics

    Alias
    UMLS CUI-1
    C0011298
    UMLS CUI-2
    C0042210
    Center number
    Description

    Center number

    Data type

    text

    Alias
    UMLS CUI [1,1]
    C1301943
    UMLS CUI [1,2]
    C0600091
    Date of birth
    Description

    Date of birth

    Data type

    date

    Alias
    UMLS CUI [1]
    C0421451
    Gender
    Description

    Gender

    Data type

    text

    Alias
    UMLS CUI [1]
    C0079399
    Race
    Description

    Race

    Data type

    integer

    Alias
    UMLS CUI [1]
    C0034510
    Race, if other please specify
    Description

    Race

    Data type

    text

    Alias
    UMLS CUI [1]
    C0034510
    Eligibility Question
    Description

    Eligibility Question

    Alias
    UMLS CUI-1
    C1516637
    UMLS CUI-2
    C0042210
    Did the subject meet all the entry criteria?
    Description

    If No, please complete below.

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C1516637
    Inclusion Criteria
    Description

    Tick the boxes corresponding to any of the inclusion criteria the subject failed

    Data type

    integer

    Alias
    UMLS CUI [1]
    C1512693
    Exclusion Criteria
    Description

    Tick the box corresponding to any of the exclusion criteria that disqualified the subject from entry.

    Data type

    integer

    Alias
    UMLS CUI [1]
    C0680251
    Hepatitis B Vaccine
    Description

    Hepatitis B Vaccine

    Alias
    UMLS CUI-1
    C2240392
    Has the Hepatitis B vaccine been administered ?
    Description

    Hepatitis B vaccine

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C2240392
    UMLS CUI [1,2]
    C2368628
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    Similar models

    Visit 1 Tritanrix-HepB/Hib-MenAC vaccine compared to Tritanrix-HepB/Hiberix and Meningitec 759346/004

    1 forms
    Name
    Type
    Description | Question | Decode (Coded Value)
    Data type
    Alias
    Item Group
    Informed Consent
    C0021430 (UMLS CUI-1)
    C0042210 (UMLS CUI-2)
    Subject Number
    Item
    Subject Number
    text
    C2348585 (UMLS CUI [1])
    Date of Visit
    Item
    Date of Visit
    date
    C1320303 (UMLS CUI [1])
    Informed Consent Date
    Item
    Informed Consent Date
    time
    C0021430 (UMLS CUI [1,1])
    C0011008 (UMLS CUI [1,2])
    Item Group
    Demographics
    C0011298 (UMLS CUI-1)
    C0042210 (UMLS CUI-2)
    Center number
    Item
    Center number
    text
    C1301943 (UMLS CUI [1,1])
    C0600091 (UMLS CUI [1,2])
    Date of birth
    Item
    Date of birth
    date
    C0421451 (UMLS CUI [1])
    Item
    Gender
    text
    C0079399 (UMLS CUI [1])
    Gender
    Code List
    Gender
    Item
    Race
    integer
    C0034510 (UMLS CUI [1])
    Race
    Code List
    Race
    CL Item
    Black (1)
    CL Item
    Arabic/North African (2)
    CL Item
    White/Caucasian (3)
    CL Item
    East & South East Asian (4)
    CL Item
    South Asian (5)
    CL Item
    Other, please specify (6)
    Race
    Item
    Race, if other please specify
    text
    C0034510 (UMLS CUI [1])
    Item Group
    Eligibility Question
    C1516637 (UMLS CUI-1)
    C0042210 (UMLS CUI-2)
    Did the subject meet all the entry criteria?
    Item
    Did the subject meet all the entry criteria?
    boolean
    C1516637 (UMLS CUI [1])
    Item
    Inclusion Criteria
    integer
    C1512693 (UMLS CUI [1])
    Inclusion Criteria
    Code List
    Inclusion Criteria
    CL Item
    Subjects who the investigator believes that their parents/guardians can and will comply with the requirements of the protocol (e.g., completion of the diary cards, return for follow-up visits) should be enrolled in the study. (1)
    CL Item
    Written informed consent obtained from the parent or guardian of the subject (2)
    CL Item
    Free of obvious health problems as established by medical history and clinical examination before entering into the study. (3)
    CL Item
    Born after a gestation period of 36 to 42 weeks (4)
    CL Item
    A male or female less than or equal to 3 days (72 hours) of age at the time of the birth dose of hepatitis B vaccine. (5)
    Item
    Exclusion Criteria
    integer
    C0680251 (UMLS CUI [1])
    Exclusion Criteria
    Code List
    Exclusion Criteria
    CL Item
    Any confirmed or suspected immunosuppressive or immunodeficient condition, including human immunodeficiency virus (HIV) infection. (1)
    CL Item
    A family history of congenital or hereditary immunodeficiency. (2)
    CL Item
    Major congenital defects or serious chronic illness. (3)
    CL Item
    History of any neurologic disorders or seizures. (4)
    CL Item
    Administration of immunoglobulins and/or any blood products since birth or planned administration during the study period. (5)
    CL Item
    Acute disease at the time of enrolment (Acute disease is defined as the presence of a moderate or severe illness with or without fever). All vaccines can be administered to persons with a minor illness such as diarrhoea, mild upper respiratory infection with or without low-grade febrile illness, i.e., axillary temperature <37.5°C or rectal temperature <38.0°C). (6)
    CL Item
    Other conditions which in the opinion of the investigator may potentially interfere with interpretation of study outcomes. (7)
    Item Group
    Hepatitis B Vaccine
    C2240392 (UMLS CUI-1)
    Hepatitis B vaccine
    Item
    Has the Hepatitis B vaccine been administered ?
    boolean
    C2240392 (UMLS CUI [1,1])
    C2368628 (UMLS CUI [1,2])
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