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ID

33319

Description

Study ID: 104065 Clinical Study ID: 104065 Study Title: Immune memory of GSK's DTPw-HBV/Hib vaccine by giving Plain PRP polysaccharide at 10 mths. Immuno & reacto of a booster dose of DTPw-HBV/Hib or DTPw-HBV or DTPw-HBV+Hib at 15-18 mths in infants previously primed with DTPw-HBV/Hib Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00169442  Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 3 Study Recruitment Status: Completet Generic Name: Combined Diphtheria, Tetanus, Whole Cell Pertussis, Hepatitis B, Haemophilus influenzae Type b Vaccine (KFT) Trade Name: Zilbrix/Hib Study Indication: Diphtheria; Haemophilus influenzae type b; Hepatitis B; Tetanus; Whole Cell Pertussis

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Versions (2)
  1. 12/5/18 12/5/18 -
  2. 12/5/18 12/5/18 -
Copyright Holder

GSK group of companies

Uploaded on

December 5, 2018

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Creative Commons BY-NC 3.0
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    Immune memory of Combined Diphtheria, Tetanus, Whole Cell Pertussis, Hepatitis B, Haemophilus influenzae Type b Vaccine at infants (15 to 18 mths) - 104065

    English

    Visit 1: Exclusion Criteria

    1 forms  
    Administrative data
    Description

    Administrative data

    Date of Visit
    Description

    Date of Visit

    Data type

    date

    Subject Number
    Description

    Subject Number

    Data type

    integer

    Eligibility check
    Description

    Eligibility check

    Did the subject meet all the entry criteria?
    Description

    Did the subject meet all the entry criteria?

    Data type

    boolean

    If No, please tick all boxes corresponding to violations of any inclusion/exclusion criteria
    Description

    Do not enter the subject into the study if he/she failed any inclusion or exclusion criteria listed below

    Data type

    text

    Exclusion Criteria
    Description

    Exclusion Criteria

    For subjects receiving Plain PRP followed by DTPw-HBV Kft:
    Description

    tick "Yes" for any of the exclusion criteria that disqualified the subject from entry

    Data type

    text

    Use of investigational or non-registered product other than study vaccine within 30 days preceding administration of the study vaccine, or planned use during the study period.
    Description

    Use of investigational or non-registered product other than study vaccine within 30 days preceding administration of the study vaccine, or planned use during the study period.

    Data type

    boolean

    Chronic administration (more than 14 days) of immunosuppressants or other immune-modifying drugs within six months prior to administration of the study vaccine.
    Description

    For corticosteroids, this will mean prednisone, or equivalent >=0.5 mg/kg/day. Inhaled and topical steroids are allowed

    Data type

    boolean

    Planned administration/administration of vaccine not foreseen by the study protocol during the 30-day period starting before and ending 30 days after administration of the study vaccine with the exception of oral polio vaccine.
    Description

    Planned administration/administration of vaccine not foreseen by the study protocol during the 30-day period starting before and ending 30 days after administration of the study vaccine with the exception of oral polio vaccine.

    Data type

    boolean

    Previous booster vaccination against diphteria, tetanus, pertussis, hepatitis B and/or Hib disease since the conclusion of the study DTPw=Hib Kft-001.
    Description

    Previous booster vaccination against diphteria, tetanus, pertussis, hepatitis B and/or Hib disease since the conclusion of the study DTPw=Hib Kft-001.

    Data type

    boolean

    History of dyphtheria, tetanus, petrussis, hepatits B and/or Kft-001
    Description

    History of dyphtheria, tetanus, petrussis, hepatits B and/or Kft-001

    Data type

    boolean

    Known exposure to diphtheria,tetanus, pertussis, hepatitis B and/or Hib disease
    Description

    Known exposure to diphtheria,tetanus, pertussis, hepatitis B and/or Hib disease

    Data type

    boolean

    Any confirmed or suspected immunosuppressive or immunodeficient condition based on medical history and physical examination (no laboratory testing is required).
    Description

    Any confirmed or suspected immunosuppressive or immunodeficient condition based on medical history and physical examination (no laboratory testing is required).

    Data type

    boolean

    A family history of congenital or hereditary immunodeficiency.
    Description

    A family history of congenital or hereditary immunodeficiency.

    Data type

    boolean

    History of allergic disease or reactions likely to be exacerbated by any component of the vaccine.
    Description

    History of allergic disease or reactions likely to be exacerbated by any component of the vaccine.

    Data type

    boolean

    Major congenital defects or serious chronic illness.
    Description

    Major congenital defects or serious chronic illness.

    Data type

    boolean

    History of any neurologic disorders or seizures.
    Description

    Subject who only had a single, uncomplicated febrile convulsion in the past can be included

    Data type

    boolean

    Acute disease at the time of enrollment.
    Description

    Acute disease - 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 t° <37.5°C/rectal t° <38°C

    Data type

    boolean

    Administration of immunoglobulins and/or any blood products within the three months preceding administration of the study vaccine or planned administration during the study period.
    Description

    Administration of immunoglobulins and/or any blood products within the three months preceding administration of the study vaccine or planned administration during the study period.

    Data type

    boolean

    Other conditions which in the opinion of the investigator may potentially interfere with interpretation of study outcomes.
    Description

    Other conditions which in the opinion of the investigator may potentially interfere with interpretation of study outcomes.

    Data type

    boolean

    Specify other conditions.
    Description

    if necessary

    Data type

    text

    Adverse events
    Description

    one of the following AE that constitute contraindications or precaution to further administration of DTP vaccine, having occurred after previous administration of DTP vaccine

    Data type

    text

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    Similar models

    Visit 1: Exclusion Criteria

    1 forms
    Name
    Type
    Description | Question | Decode (Coded Value)
    Data type
    Alias
    Item Group
    Administrative data
    Date of Visit
    Item
    Date of Visit
    date
    Subject Number
    Item
    Subject Number
    integer
    Item Group
    Eligibility check
    Did the subject meet all the entry criteria?
    Item
    Did the subject meet all the entry criteria?
    boolean
    If No, please tick all boxes corresponding to violations of any inclusion/exclusion criteria
    Item
    If No, please tick all boxes corresponding to violations of any inclusion/exclusion criteria
    text
    Item Group
    Exclusion Criteria
    For subjects receiving Plain PRP followed by DTPw-HBV Kft:
    Item
    For subjects receiving Plain PRP followed by DTPw-HBV Kft:
    text
    Use of investigational or non-registered product other than study vaccine within 30 days preceding administration of the study vaccine, or planned use during the study period.
    Item
    Use of investigational or non-registered product other than study vaccine within 30 days preceding administration of the study vaccine, or planned use during the study period.
    boolean
    Chronic administration (more than 14 days) of immunosuppressants or other immune-modifying drugs within six months prior to administration of the study vaccine.
    Item
    Chronic administration (more than 14 days) of immunosuppressants or other immune-modifying drugs within six months prior to administration of the study vaccine.
    boolean
    Planned administration/administration of vaccine not foreseen by the study protocol during the 30-day period starting before and ending 30 days after administration of the study vaccine with the exception of oral polio vaccine.
    Item
    Planned administration/administration of vaccine not foreseen by the study protocol during the 30-day period starting before and ending 30 days after administration of the study vaccine with the exception of oral polio vaccine.
    boolean
    Previous booster vaccination against diphteria, tetanus, pertussis, hepatitis B and/or Hib disease since the conclusion of the study DTPw=Hib Kft-001.
    Item
    Previous booster vaccination against diphteria, tetanus, pertussis, hepatitis B and/or Hib disease since the conclusion of the study DTPw=Hib Kft-001.
    boolean
    History of dyphtheria, tetanus, petrussis, hepatits B and/or Kft-001
    Item
    History of dyphtheria, tetanus, petrussis, hepatits B and/or Kft-001
    boolean
    Known exposure to diphtheria,tetanus, pertussis, hepatitis B and/or Hib disease
    Item
    Known exposure to diphtheria,tetanus, pertussis, hepatitis B and/or Hib disease
    boolean
    Any confirmed or suspected immunosuppressive or immunodeficient condition based on medical history and physical examination (no laboratory testing is required).
    Item
    Any confirmed or suspected immunosuppressive or immunodeficient condition based on medical history and physical examination (no laboratory testing is required).
    boolean
    A family history of congenital or hereditary immunodeficiency.
    Item
    A family history of congenital or hereditary immunodeficiency.
    boolean
    History of allergic disease or reactions likely to be exacerbated by any component of the vaccine.
    Item
    History of allergic disease or reactions likely to be exacerbated by any component of the vaccine.
    boolean
    Major congenital defects or serious chronic illness.
    Item
    Major congenital defects or serious chronic illness.
    boolean
    History of any neurologic disorders or seizures.
    Item
    History of any neurologic disorders or seizures.
    boolean
    Acute disease at the time of enrollment.
    Item
    Acute disease at the time of enrollment.
    boolean
    Administration of immunoglobulins and/or any blood products within the three months preceding administration of the study vaccine or planned administration during the study period.
    Item
    Administration of immunoglobulins and/or any blood products within the three months preceding administration of the study vaccine or planned administration during the study period.
    boolean
    Other conditions which in the opinion of the investigator may potentially interfere with interpretation of study outcomes.
    Item
    Other conditions which in the opinion of the investigator may potentially interfere with interpretation of study outcomes.
    boolean
    Specify other conditions.
    Item
    Specify other conditions.
    text
    Item
    Adverse events
    text
    Adverse events
    Code List
    Adverse events
    CL Item
    Hypersensitivity to any component of the vaccine, or signs of hypersensitivity after previous administration of diphtheria, tetanus, pertussis, hepatitis B and Hib vaccines (1)
    CL Item
    Encephalopathy (not due to another identifiable cause): acute, severe central nervous system disorder occurring within 7 days following vaccination->major alterations in consciousness, unresponsiveness, generalised or focal seizures that persist more than a few hours, with failure to recover within 24 hours (2)
    CL Item
    Axillary temperature of ≥ 40°C/rectal temperature ≥ 40.5°C within 48 hrs of vaccination (3)
    CL Item
    Collapse or shock-like state (hypotonic-hyporesponsive episode) within 48 hrs of vaccination (4)
    CL Item
    Persistent, inconsolable crying lasting ≥3 hrs, occurring within 48 hrs of vaccination (5)
    CL Item
    Convulsions with or without fever, occuring within 3 days of vaccination (6)
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