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36105

Description

Study ID: 107007 Clinical Study ID: 107007 Study Title: A phase IIIb randomized, double-blind, controlled study to assess the safety, reactogenicity and immunogenicity of GlaxoSmithKline (GSK) Biologicals’ 10-valent pneumococcal conjugate vaccine compared to Prevenar™, when co-administered with DTPw-HBV/Hib and OPV or IPV vaccines as a 3-dose primary immunization course during the first 6 months of age. Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00344318 https://clinicaltrials.gov/ct2/show/NCT00344318 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 3 Study Recruitment Status: Completed Generic Name: Pneumococcal conjugate vaccine GSK1024850A Trade Name: Prevenar, Tritanrix-HepB, Hiberix, Polio Sabin., Poliorix Study Indication: Infections, Streptococcal This study consists of 2 groups of probands (Children of 6-10-14 weeks or 2-4-6 months of age are included): One group receive a 3-dose primary vaccination with the GSK Biologicals' (10-valent) pneumococcal conjugate vaccine. The other group r eceive a 3-dose primary vaccination with Prevenar™. All probands receive DTPw-HBV/Hib and OPV or IPV vaccines. Ths study consists of 3 workbooks (WB): WB 1: The WB 1 consists 4 visits (all in active phase): Visit 1, Timing: Month 0; Age for 6-12 weeks scheduled Visit 2, Timing: Month 1; Age for 10 weeks scheduled Visit 3, Timing: Month 2; Age for 14 weeks scheduled Visit 4, Timing: Month 3; Age for +/- 4 months scheduled Intervals between the visits: Visit 1 to Visit 2: 28-42 days, Visit 2 to Visit 3: 28-42 days, Visit 3 to Visit 4: 30-42 days WB 2: The WB 2 consists 4 visits (all in active phase): Visit 1, Timing: Month 0; Age for 6-12 weeks scheduled Visit 2, Timing: Month 2; Age for +/- 4 months scheduled Visit 3, Timing: Month 4; Age for +/- 6 months scheduled Visit 4, Timing: Month 5; Age for +/- 7 months scheduled Intervals between the visits: Visit 1 to Visit 2: 49-83 days, Visit 2 to Visit 3: 49-83 days, Visit 3 to Visit 4: 30-42 days WB 3: The WB 3 consists the phone contact (6 months safety follow-up), Timing: Month 8 or 10. This document contains the Eligibility criteria form. It has to be filled in for Visit 1.

Link

https://clinicaltrials.gov/ct2/show/NCT00344318

Keywords

Versions (2)
  1. 4/9/19 4/9/19 -
  2. 4/15/19 4/15/19 - Sarah Riepenhausen
Copyright Holder

GlaxoSmithKline

Uploaded on

April 15, 2019

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Creative Commons BY-NC 3.0
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    Safety, reactogenicity and immunogenicity 10-valent pneumococcal conjugate vaccine compared to Prevenar™, co-administration of DTPw-HBV/Hib and OPV or IPV vaccines in infants, NCT00344318

    English

    Eligibility criteria

    1 forms  
    1. StudyEvent: ODM
      1. Eligibility criteria
    Administrative data
    Description

    Administrative data

    Alias
    UMLS CUI-1
    C1320722
    Subject Number
    Description

    Subject Number

    Data type

    text

    Alias
    UMLS CUI [1]
    C2348585
    Workbook Number
    Description

    Workbook Number

    Data type

    integer

    Alias
    UMLS CUI [1]
    C2986015
    Visit Date
    Description

    day month year

    Data type

    date

    Alias
    UMLS CUI [1]
    C1320303
    Eligibility check
    Description

    Eligibility check

    Alias
    UMLS CUI-1
    C0013893
    Did the subject meet all the entry criteria?
    Description

    If you tick No, tick all boxes corresponding to violations of any inclusion/exclusion criteria. Do not enter the subject into the study if he/she failed any inclusion or exclusion criteria below.

    Data type

    text

    Alias
    UMLS CUI [1]
    C1516637
    Inclusion criteria
    Description

    Inclusion criteria

    Alias
    UMLS CUI-1
    C1512693
    Male or female between, and including, 6-12 weeks (42 to 90 days) of age at the time of the first vaccination.
    Description

    Gender, Age

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0079399
    UMLS CUI [2]
    C0001779
    Subjects for whom 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).
    Description

    Compliance to requirements of the protocol

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C0525058
    UMLS CUI [1,2]
    C0030551
    UMLS CUI [2,1]
    C0525058
    UMLS CUI [2,2]
    C0023226
    Written informed consent obtained from the parent or guardian of the subject.
    Description

    Informed consent

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C0021430
    UMLS CUI [1,2]
    C0030551
    UMLS CUI [2,1]
    C0021430
    UMLS CUI [2,2]
    C0023226
    Free of obvious health problems as established by medical history and clinical examination before entering into the study.
    Description

    No Disease (medical history and clinical examination)

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C3898900
    UMLS CUI [1,2]
    C0262926
    UMLS CUI [2,1]
    C3898900
    UMLS CUI [2,2]
    C1456356
    Born after a gestation period (between 36 and 42 weeks).
    Description

    Born after a gestation period

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C3814420
    Exclusion Criterion
    Description

    Exclusion Criterion

    Alias
    UMLS CUI-1
    C0680251
    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 (active phase and 6 months safety follow-up).
    Description

    Other investigational drug/vaccine

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C0205394
    UMLS CUI [1,2]
    C0013230
    UMLS CUI [2,1]
    C0205394
    UMLS CUI [2,2]
    C1517586
    UMLS CUI [2,3]
    C0042210
    Chronic administration of immunosuppressants or other immune-modifying drugs within six months prior to the first vaccine dose. (For corticosteroids, this will mean prednisone, or equivalent, >= 0.5 mg/kg/day. Inhaled and topical steroids are allowed.)
    Description

    Chron administration is defined as more than 14 days.

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C0205191
    UMLS CUI [1,2]
    C0021081
    UMLS CUI [2,1]
    C0683607
    UMLS CUI [2,2]
    C2065041
    UMLS CUI [3,1]
    C0683607
    UMLS CUI [3,2]
    C3897353
    Planned administration/ administration of a vaccine not foreseen by the study protocol during the period starting one month before each dose of vaccine(s) and ending 7 days after dose 1 and dose 2 or 1 month after dose 3.
    Description

    Administration of other vaccine

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C2368628
    UMLS CUI [1,2]
    C1518384
    UMLS CUI [1,3]
    C0750503
    UMLS CUI [1,4]
    C0042196
    Previous vaccination against diphtheria, tetanus, pertussis, polio, hepatitis B, Haemophilus influenzae type b, Bacillus Calmette-Guérin (BCG), and/or S. pneumoniae with the exception of vaccines where the first dose can be given within the first two weeks of life according to the national recommendations (for example hepatitis B vaccination)
    Description

    Previous vaccination against diphtheria, tetanus, pertussis, polio, hepatitis B, Haemophilus influenzae type b, Bacillus Calmette-Guérin (BCG), and/or S. pneumoniae (excepted hepatitis B vaccination)

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C0205156
    UMLS CUI [1,2]
    C0012559
    UMLS CUI [2,1]
    C0205156
    UMLS CUI [2,2]
    C0199809
    UMLS CUI [3,1]
    C0205156
    UMLS CUI [3,2]
    C0199818
    UMLS CUI [4,1]
    C0205156
    UMLS CUI [4,2]
    C0004886
    UMLS CUI [5,1]
    C0205156
    UMLS CUI [5,2]
    C0042196
    UMLS CUI [5,3]
    C0038410
    UMLS CUI [6,1]
    C0332300
    UMLS CUI [6,2]
    C0474232
    History of or intercurrent diphtheria, tetanus, pertussis, hepatitis B, polio, and Haemophilus influenzae type b diseases.
    Description

    History of/intercurrent diphtheria, tetanus, pertussis, hepatitis B, polio, Haemophilus influenzae type b

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C0262926
    UMLS CUI [1,2]
    C0012546
    UMLS CUI [2,1]
    C0277557
    UMLS CUI [2,2]
    C0012546
    UMLS CUI [3,1]
    C0262926
    UMLS CUI [3,2]
    C0039614
    UMLS CUI [4,1]
    C0277557
    UMLS CUI [4,2]
    C0039614
    UMLS CUI [5,1]
    C0262926
    UMLS CUI [5,2]
    C0043167
    UMLS CUI [6,1]
    C0277557
    UMLS CUI [6,2]
    C0043167
    UMLS CUI [7,1]
    C0262926
    UMLS CUI [7,2]
    C0019163
    UMLS CUI [8,1]
    C0277557
    UMLS CUI [8,2]
    C0019163
    UMLS CUI [9,1]
    C0262926
    UMLS CUI [9,2]
    C0032371
    UMLS CUI [10,1]
    C0277557
    UMLS CUI [10,2]
    C0032371
    UMLS CUI [11,1]
    C0262926
    UMLS CUI [11,2]
    C0121772
    UMLS CUI [12,1]
    C0277557
    UMLS CUI [12,2]
    C0121772
    History of allergic disease or reactions likely to be exacerbated by any component of the vaccines, including diphtheria toxoid.
    Description

    Allergic disease/reactions to vaccine component (including diphtheria toxoid)

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C1527304
    UMLS CUI [1,2]
    C0042210
    UMLS CUI [1,3]
    C1705248
    UMLS CUI [2,1]
    C0020517
    UMLS CUI [2,2]
    C0042210
    UMLS CUI [2,3]
    C1705248
    UMLS CUI [3,1]
    C0332257
    UMLS CUI [3,2]
    C0012551
    History of seizures or neurological disease.
    Description

    History of seizures/neurological disease

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C0262926
    UMLS CUI [1,2]
    C0036572
    UMLS CUI [2,1]
    C0262926
    UMLS CUI [2,2]
    C0027765
    Acute disease at the time of enrolment.
    Description

    Definition: 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 diarrhea or mild upper respiratory infections with or without lowgrade febrile illness, i.e. oral/axillary/tympanic temperature <37.5°C / rectal temperature <38.0°C.

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0001314
    Any confirmed or suspected immunosuppressive or immunodeficient condition based on medical history and physical examination (no laboratory testing required).
    Description

    Immunosuppression (based on medical hisytory and physical examination)

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C4048329
    UMLS CUI [1,2]
    C0262926
    UMLS CUI [2,1]
    C4048329
    UMLS CUI [2,2]
    C0031809
    UMLS CUI [3,1]
    C0021051
    UMLS CUI [3,2]
    C0262926
    UMLS CUI [4,1]
    C0021051
    UMLS CUI [4,2]
    C0031809
    A family history of congenital or hereditary immunodeficiency.
    Description

    Family history of congenital or hereditary immunodeficiency

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C0241889
    UMLS CUI [1,2]
    C0853602
    UMLS CUI [2,1]
    C0241889
    UMLS CUI [2,2]
    C0439660
    UMLS CUI [2,3]
    C0021051
    Major congenital defects or serious chronic illness.
    Description

    Major congenital defects/serious chronic illness

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C0000768
    UMLS CUI [1,2]
    C0205164
    UMLS CUI [2,1]
    C0008679
    UMLS CUI [2,2]
    C0205404
    Administration of immunoglobulins and/or any blood products since birth or planned administration during the active phase of the study.
    Description

    Immunoglobulins, blood products

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0021027
    UMLS CUI [2]
    C0456388
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    Similar models

    Eligibility criteria

    1 forms
    1. StudyEvent: ODM
      1. Eligibility criteria
    Name
    Type
    Description | Question | Decode (Coded Value)
    Data type
    Alias
    Item Group
    Administrative data
    C1320722 (UMLS CUI-1)
    Subject Number
    Item
    Subject Number
    text
    C2348585 (UMLS CUI [1])
    Item
    Workbook Number
    integer
    C2986015 (UMLS CUI [1])
    Workbook Number
    Code List
    Workbook Number
    CL Item
    WB 1 (1)
    CL Item
    WB 2 (2)
    Visit Date
    Item
    Visit Date
    date
    C1320303 (UMLS CUI [1])
    Item Group
    Eligibility check
    C0013893 (UMLS CUI-1)
    Item
    Did the subject meet all the entry criteria?
    text
    C1516637 (UMLS CUI [1])
    Entry criteria
    Code List
    Did the subject meet all the entry criteria?
    CL Item
    Yes (Y)
    CL Item
    No (N)
    Item Group
    Inclusion criteria
    C1512693 (UMLS CUI-1)
    Gender, Age
    Item
    Male or female between, and including, 6-12 weeks (42 to 90 days) of age at the time of the first vaccination.
    boolean
    C0079399 (UMLS CUI [1])
    C0001779 (UMLS CUI [2])
    Compliance to requirements of the protocol
    Item
    Subjects for whom 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).
    boolean
    C0525058 (UMLS CUI [1,1])
    C0030551 (UMLS CUI [1,2])
    C0525058 (UMLS CUI [2,1])
    C0023226 (UMLS CUI [2,2])
    Informed consent
    Item
    Written informed consent obtained from the parent or guardian of the subject.
    boolean
    C0021430 (UMLS CUI [1,1])
    C0030551 (UMLS CUI [1,2])
    C0021430 (UMLS CUI [2,1])
    C0023226 (UMLS CUI [2,2])
    No Disease (medical history and clinical examination)
    Item
    Free of obvious health problems as established by medical history and clinical examination before entering into the study.
    boolean
    C3898900 (UMLS CUI [1,1])
    C0262926 (UMLS CUI [1,2])
    C3898900 (UMLS CUI [2,1])
    C1456356 (UMLS CUI [2,2])
    Born after a gestation period
    Item
    Born after a gestation period (between 36 and 42 weeks).
    boolean
    C3814420 (UMLS CUI [1])
    Item Group
    Exclusion Criterion
    C0680251 (UMLS CUI-1)
    Other investigational drug/vaccine
    Item
    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 (active phase and 6 months safety follow-up).
    boolean
    C0205394 (UMLS CUI [1,1])
    C0013230 (UMLS CUI [1,2])
    C0205394 (UMLS CUI [2,1])
    C1517586 (UMLS CUI [2,2])
    C0042210 (UMLS CUI [2,3])
    Chronic use of Immunosuppressants/ immunemodifying drugs (excluding inhaled/topical steroids)
    Item
    Chronic administration of immunosuppressants or other immune-modifying drugs within six months prior to the first vaccine dose. (For corticosteroids, this will mean prednisone, or equivalent, >= 0.5 mg/kg/day. Inhaled and topical steroids are allowed.)
    boolean
    C0205191 (UMLS CUI [1,1])
    C0021081 (UMLS CUI [1,2])
    C0683607 (UMLS CUI [2,1])
    C2065041 (UMLS CUI [2,2])
    C0683607 (UMLS CUI [3,1])
    C3897353 (UMLS CUI [3,2])
    Administration of other vaccine
    Item
    Planned administration/ administration of a vaccine not foreseen by the study protocol during the period starting one month before each dose of vaccine(s) and ending 7 days after dose 1 and dose 2 or 1 month after dose 3.
    boolean
    C2368628 (UMLS CUI [1,1])
    C1518384 (UMLS CUI [1,2])
    C0750503 (UMLS CUI [1,3])
    C0042196 (UMLS CUI [1,4])
    Previous vaccination against diphtheria, tetanus, pertussis, polio, hepatitis B, Haemophilus influenzae type b, Bacillus Calmette-Guérin (BCG), and/or S. pneumoniae (excepted hepatitis B vaccination)
    Item
    Previous vaccination against diphtheria, tetanus, pertussis, polio, hepatitis B, Haemophilus influenzae type b, Bacillus Calmette-Guérin (BCG), and/or S. pneumoniae with the exception of vaccines where the first dose can be given within the first two weeks of life according to the national recommendations (for example hepatitis B vaccination)
    boolean
    C0205156 (UMLS CUI [1,1])
    C0012559 (UMLS CUI [1,2])
    C0205156 (UMLS CUI [2,1])
    C0199809 (UMLS CUI [2,2])
    C0205156 (UMLS CUI [3,1])
    C0199818 (UMLS CUI [3,2])
    C0205156 (UMLS CUI [4,1])
    C0004886 (UMLS CUI [4,2])
    C0205156 (UMLS CUI [5,1])
    C0042196 (UMLS CUI [5,2])
    C0038410 (UMLS CUI [5,3])
    C0332300 (UMLS CUI [6,1])
    C0474232 (UMLS CUI [6,2])
    History of/intercurrent diphtheria, tetanus, pertussis, hepatitis B, polio, Haemophilus influenzae type b
    Item
    History of or intercurrent diphtheria, tetanus, pertussis, hepatitis B, polio, and Haemophilus influenzae type b diseases.
    boolean
    C0262926 (UMLS CUI [1,1])
    C0012546 (UMLS CUI [1,2])
    C0277557 (UMLS CUI [2,1])
    C0012546 (UMLS CUI [2,2])
    C0262926 (UMLS CUI [3,1])
    C0039614 (UMLS CUI [3,2])
    C0277557 (UMLS CUI [4,1])
    C0039614 (UMLS CUI [4,2])
    C0262926 (UMLS CUI [5,1])
    C0043167 (UMLS CUI [5,2])
    C0277557 (UMLS CUI [6,1])
    C0043167 (UMLS CUI [6,2])
    C0262926 (UMLS CUI [7,1])
    C0019163 (UMLS CUI [7,2])
    C0277557 (UMLS CUI [8,1])
    C0019163 (UMLS CUI [8,2])
    C0262926 (UMLS CUI [9,1])
    C0032371 (UMLS CUI [9,2])
    C0277557 (UMLS CUI [10,1])
    C0032371 (UMLS CUI [10,2])
    C0262926 (UMLS CUI [11,1])
    C0121772 (UMLS CUI [11,2])
    C0277557 (UMLS CUI [12,1])
    C0121772 (UMLS CUI [12,2])
    Allergic disease/reactions to vaccine component (including diphtheria toxoid)
    Item
    History of allergic disease or reactions likely to be exacerbated by any component of the vaccines, including diphtheria toxoid.
    boolean
    C1527304 (UMLS CUI [1,1])
    C0042210 (UMLS CUI [1,2])
    C1705248 (UMLS CUI [1,3])
    C0020517 (UMLS CUI [2,1])
    C0042210 (UMLS CUI [2,2])
    C1705248 (UMLS CUI [2,3])
    C0332257 (UMLS CUI [3,1])
    C0012551 (UMLS CUI [3,2])
    History of seizures/neurological disease
    Item
    History of seizures or neurological disease.
    boolean
    C0262926 (UMLS CUI [1,1])
    C0036572 (UMLS CUI [1,2])
    C0262926 (UMLS CUI [2,1])
    C0027765 (UMLS CUI [2,2])
    Acute disease
    Item
    Acute disease at the time of enrolment.
    boolean
    C0001314 (UMLS CUI [1])
    Immunosuppression (based on medical hisytory and physical examination)
    Item
    Any confirmed or suspected immunosuppressive or immunodeficient condition based on medical history and physical examination (no laboratory testing required).
    boolean
    C4048329 (UMLS CUI [1,1])
    C0262926 (UMLS CUI [1,2])
    C4048329 (UMLS CUI [2,1])
    C0031809 (UMLS CUI [2,2])
    C0021051 (UMLS CUI [3,1])
    C0262926 (UMLS CUI [3,2])
    C0021051 (UMLS CUI [4,1])
    C0031809 (UMLS CUI [4,2])
    Family history of congenital or hereditary immunodeficiency
    Item
    A family history of congenital or hereditary immunodeficiency.
    boolean
    C0241889 (UMLS CUI [1,1])
    C0853602 (UMLS CUI [1,2])
    C0241889 (UMLS CUI [2,1])
    C0439660 (UMLS CUI [2,2])
    C0021051 (UMLS CUI [2,3])
    Major congenital defects/serious chronic illness
    Item
    Major congenital defects or serious chronic illness.
    boolean
    C0000768 (UMLS CUI [1,1])
    C0205164 (UMLS CUI [1,2])
    C0008679 (UMLS CUI [2,1])
    C0205404 (UMLS CUI [2,2])
    Immunoglobulins, blood products
    Item
    Administration of immunoglobulins and/or any blood products since birth or planned administration during the active phase of the study.
    boolean
    C0021027 (UMLS CUI [1])
    C0456388 (UMLS CUI [2])
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