ID

33110

Description

Study ID: 104021 Clinical Study ID: 104021 Study Title: A phase III, partially blind, randomized study to evaluate the immunogenicity, safety and reactogenicity of GlaxoSmithKline (GSK) Biologicals’ Tritanrix™-HepB and GSK Biologicals Kft’s DTPw-HBV vaccines as compared to concomitant administration of Commonwealth Serum Laboratory’s (CSL’s) DTPw (Triple Antigen™) and GSK Biologicals’ HBV (Engerix™-B), when co-administered with GSK Biologicals’ oral live attenuated human rotavirus (HRV) vaccine, to healthy infants at 3, 4½ and 6 months of age, after a birth dose of hepatitis B vaccine. Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00158756 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 3 Study Recruitment Status: Completed Generic Name: Hepatitis B Vaccine, Recombinant Trade Name: Engerix B Study Indication: Hepatitis B

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Versions (1)
  1. 11/28/18 11/28/18 -
Copyright Holder

GSK group of companies

Uploaded on

November 28, 2018

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Creative Commons BY-NC 3.0
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    Immunogenicity of co-administration of Tritanrix™-HepB and DTPw-HBV vaccines or Triple Antigen™ and Engerix™-B with HRV vaccine to infants (3, 4½ and 6 month) - 104021

    English

    Visit 1: Eligibility Form

    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

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

    Data type

    integer

    Inclusion Criteria
    Description

    Inclusion Criteria

    Tick "No" for any inclusion criteria subject failed
    Description

    Tick "No" for any inclusion criteria subject failed

    Data type

    text

    1.Subjects who the investigator believes that their parent/guardian 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.
    Description

    1.Subjects who the investigator believes that their parent/guardian 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.

    Data type

    boolean

    2.Administration of one dose of hepatitis B vaccine at birth (within 72 hours after birth)
    Description

    2.Administration of one dose of hepatitis B vaccine at birth (within 72 hours after birth)

    Data type

    boolean

    3.A male or female between, and including, 11 and 17 weeks of age at the time of the first DTPw vaccination.
    Description

    3.A male or female between, and including, 11 and 17 weeks of age at the time of the first DTPw vaccination.

    Data type

    boolean

    4.Written informed consent obtained from parent or guardian of the subject.
    Description

    4.Written informed consent obtained from parent or guardian of the subject.

    Data type

    boolean

    5.Free of obvious health problems as established by medical history and clinical examination before entering into the study.
    Description

    5.Free of obvious health problems as established by medical history and clinical examination before entering into the study.

    Data type

    boolean

    6.Born after a normal gestation period (36 to 42 weeks).
    Description

    6.Born after a normal gestation period (36 to 42 weeks).

    Data type

    boolean

    Exclusion Criteria
    Description

    Exclusion Criteria

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

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

    Data type

    text

    7.Use of any investigational or non-registered product (drug or vaccine) other than the study vaccine(s) within 30 days preceding the first dose of study vaccine, or planned use during the study period.
    Description

    7.Use of any investigational or non-registered product (drug or vaccine) other than the study vaccine(s) within 30 days preceding the first dose of study vaccine, or planned use during the study period.

    Data type

    boolean

    8.Chronic administration (>14 days) of immunosuppressants or other immune-modifying drugs since birth.
    Description

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

    Data type

    boolean

    9.Planned administration/Administration of vaccine not foreseen by the study protocol within 30 days before the first vaccine dose or planned administration during the study period with the exeption of oral polio vaccine (OPV).
    Description

    9.Planned administration/Administration of vaccine not foreseen by the study protocol within 30 days before the first vaccine dose or planned administration during the study period with the exeption of oral polio vaccine (OPV).

    Data type

    boolean

    10.Bacille-Calmette-Guérin (BCG) vaccine received after the first 6 weeks of life.
    Description

    10.Bacille-Calmette-Guérin (BCG) vaccine received after the first 6 weeks of life.

    Data type

    boolean

    11. Previous vaccination against diphtheria, tetanus, and/or pertussis.
    Description

    11. Previous vaccination against diphtheria, tetanus, and/or pertussis.

    Data type

    boolean

    12.History of diphtheris, tetanus, pertussis and/or hepatitis B disease.
    Description

    12.History of diphtheris, tetanus, pertussis and/or hepatitis B disease.

    Data type

    boolean

    13.Known exposure to diphtheria, tetanus, pertussis and/or hepatitis B disease since birth.
    Description

    13.Known exposure to diphtheria, tetanus, pertussis and/or hepatitis B disease since birth.

    Data type

    boolean

    14.Gastroenteritis within 7 days preceeding the first study vaccine administration.
    Description

    warrants deferral of the vacination

    Data type

    boolean

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

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

    Data type

    boolean

    16.A family history of congenital or hereditary immunodeficiency.
    Description

    16.A family history of congenital or hereditary immunodeficiency.

    Data type

    boolean

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

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

    Data type

    boolean

    18.Major congenital defects or serious chronic illness.
    Description

    18.Major congenital defects or serious chronic illness.

    Data type

    boolean

    19.History of any neurologic disorders or seizures
    Description

    19.History of any neurologic disorders or seizures

    Data type

    boolean

    20.Acute disease at the time of enrollment.
    Description

    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.r. axillary temperature <37.5°C/rectal temperature <38°C

    Data type

    boolean

    21.Administration of immunoglobulins and/or any blood products since birth or planned administration during the study period.
    Description

    21.Administration of immunoglobulins and/or any blood products since birth or planned administration during the study period.

    Data type

    boolean

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

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

    Data type

    boolean

    Randomisation/Treatment allocation
    Description

    Randomisation/Treatment allocation

    Record treatment number
    Description

    Record treatment number

    Data type

    integer

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    Similar models

    Visit 1: Eligibility Form

    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
    Item
    Did the subject meet all the entry criteria?
    integer
    Did the subject meet all the entry criteria?
    Code List
    Did the subject meet all the entry criteria?
    CL Item
    Yes (1)
    CL Item
    No (tick all boxes corresponding to violations of any inclusion/exclusion criteria below) (2)
    Item Group
    Inclusion Criteria
    Tick "No" for any inclusion criteria subject failed
    Item
    Tick "No" for any inclusion criteria subject failed
    text
    1.Subjects who the investigator believes that their parent/guardian 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.
    Item
    1.Subjects who the investigator believes that their parent/guardian 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.
    boolean
    2.Administration of one dose of hepatitis B vaccine at birth (within 72 hours after birth)
    Item
    2.Administration of one dose of hepatitis B vaccine at birth (within 72 hours after birth)
    boolean
    3.A male or female between, and including, 11 and 17 weeks of age at the time of the first DTPw vaccination.
    Item
    3.A male or female between, and including, 11 and 17 weeks of age at the time of the first DTPw vaccination.
    boolean
    4.Written informed consent obtained from parent or guardian of the subject.
    Item
    4.Written informed consent obtained from parent or guardian of the subject.
    boolean
    5.Free of obvious health problems as established by medical history and clinical examination before entering into the study.
    Item
    5.Free of obvious health problems as established by medical history and clinical examination before entering into the study.
    boolean
    6.Born after a normal gestation period (36 to 42 weeks).
    Item
    6.Born after a normal gestation period (36 to 42 weeks).
    boolean
    Item Group
    Exclusion Criteria
    Tick "Yes" for any of the exclusion criteria that disqualified the subject from entry
    Item
    Tick "Yes" for any of the exclusion criteria that disqualified the subject from entry
    text
    7.Use of any investigational or non-registered product (drug or vaccine) other than the study vaccine(s) within 30 days preceding the first dose of study vaccine, or planned use during the study period.
    Item
    7.Use of any investigational or non-registered product (drug or vaccine) other than the study vaccine(s) within 30 days preceding the first dose of study vaccine, or planned use during the study period.
    boolean
    8.Chronic administration (>14 days) of immunosuppressants or other immune-modifying drugs since birth.
    Item
    8.Chronic administration (>14 days) of immunosuppressants or other immune-modifying drugs since birth.
    boolean
    9.Planned administration/Administration of vaccine not foreseen by the study protocol within 30 days before the first vaccine dose or planned administration during the study period with the exeption of oral polio vaccine (OPV).
    Item
    9.Planned administration/Administration of vaccine not foreseen by the study protocol within 30 days before the first vaccine dose or planned administration during the study period with the exeption of oral polio vaccine (OPV).
    boolean
    10.Bacille-Calmette-Guérin (BCG) vaccine received after the first 6 weeks of life.
    Item
    10.Bacille-Calmette-Guérin (BCG) vaccine received after the first 6 weeks of life.
    boolean
    11. Previous vaccination against diphtheria, tetanus, and/or pertussis.
    Item
    11. Previous vaccination against diphtheria, tetanus, and/or pertussis.
    boolean
    12.History of diphtheris, tetanus, pertussis and/or hepatitis B disease.
    Item
    12.History of diphtheris, tetanus, pertussis and/or hepatitis B disease.
    boolean
    13.Known exposure to diphtheria, tetanus, pertussis and/or hepatitis B disease since birth.
    Item
    13.Known exposure to diphtheria, tetanus, pertussis and/or hepatitis B disease since birth.
    boolean
    14.Gastroenteritis within 7 days preceeding the first study vaccine administration.
    Item
    14.Gastroenteritis within 7 days preceeding the first study vaccine administration.
    boolean
    15.Any confirmed or suspected immunosuppresive or immunodeficient condition based on medical history and physical examination (no laboratory testing is required).
    Item
    15.Any confirmed or suspected immunosuppresive or immunodeficient condition based on medical history and physical examination (no laboratory testing is required).
    boolean
    16.A family history of congenital or hereditary immunodeficiency.
    Item
    16.A family history of congenital or hereditary immunodeficiency.
    boolean
    17.History of allergic disease or reactions likely to be exacerbated by any component of the vaccines.
    Item
    17.History of allergic disease or reactions likely to be exacerbated by any component of the vaccines.
    boolean
    18.Major congenital defects or serious chronic illness.
    Item
    18.Major congenital defects or serious chronic illness.
    boolean
    19.History of any neurologic disorders or seizures
    Item
    19.History of any neurologic disorders or seizures
    boolean
    20.Acute disease at the time of enrollment.
    Item
    20.Acute disease at the time of enrollment.
    boolean
    21.Administration of immunoglobulins and/or any blood products since birth or planned administration during the study period.
    Item
    21.Administration of immunoglobulins and/or any blood products since birth or planned administration during the study period.
    boolean
    22.Other conditions which in the opinion of the investigator may potentially interfere with interpretation of study outcomes.
    Item
    22.Other conditions which in the opinion of the investigator may potentially interfere with interpretation of study outcomes.
    boolean
    Item Group
    Randomisation/Treatment allocation
    Record treatment number
    Item
    Record treatment number
    integer
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