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37843

Description

Study ID: 111634 Clinical Study ID: 111634 Study Title: A phase III, open, controlled study in South Africa to assess the immunogenicity, safety and reactogenicity of GSK Biologicals’ 10-valent pneumococcal conjugate vaccine administered as a 3-dose (6, 10, 14 weeks) primary immunization course in HIV infected infants, HIV exposed uninfected infants and HIV unexposed uninfected infants followed by a booster vaccination at 9-10 months of age. Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00829010 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 3 Study Recruitment Status: Completed Generic Name: Pneumococcal vaccine GSK1024850A Trade Name: Tritanrix-HepB/Hib, Rotarix Study Indication: Infections, Streptococcal This phase III trial studies the immunogenicity, safety and reactogenicity of a 10-valent pneumococcal conjugate vaccine in three groups of infants that differ by HIV status: HIV-positive infants, HIV-negative infants who are exposed to the virus (by their HIV-positive mother), and HIV-negative infants who are not exposed. The study consists of Screening at 4-8 weeks of age (only for HIV-positive and HIV-exposed infants without HIV-DNA test) and 10 subsequent Visits over a period of 23 months. There are five study cohorts: HIV-positive and HIV-exposed participants receive the vaccine at Visits 1, 2, 3 (i.e. 6, 10 and 14 weeks of life; primary course) and 5 (9-10 months of age; booster), whereas HIV-negative, unexposed infants are randomly assigned to one of three vaccination schedules: the aforementioned schedule consisting of the primary course and the booster, or the 3-dose primary course only without the booster vaccination, or a different primary course consisting of only two vaccinations at Visits 1 and 3 (6 and 14 weeks of age) followed by a booster at Visit 5 (9-10 months). Visit 1 is scheduled at 6-10 weeks of life. The interval between Visits 1 and 2, 2 and 3, as well as 3 and 4 has to be 28-42 days each. Visit 5 then takes place at 9-10 months of age. The interval between Visit 5 and 6 again has to be 28-42 days. Visit 7 is scheduled at 12-13 months of age, Visit 8 at 15-18 months, Visit 9 at 16-19 months, and the final Visit 10 is performed when the subjects are 24-27 months old. This form contains the study's Inclusion/Exclusion Criteria and is to be filled in at Visit 1.

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  1. 8/27/19 8/27/19 -
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GlaxoSmithKline

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August 27, 2019

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    10-valent pneumococcal vaccine in HIV-positive, HIV-exposed and HIV-negative infants - NCT00829010

    English

    Eligibility Criteria

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

    Administrative data

    Alias
    UMLS CUI-1
    C1320722
    Subject Identifier
    Description

    Clinical Trial Subject Unique Identifier

    Data type

    integer

    Alias
    UMLS CUI [1]
    C2348585
    Cohort
    Description

    Cohort

    Data type

    integer

    Alias
    UMLS CUI [1]
    C0599755
    Date of Visit
    Description

    Date of Visit

    Data type

    date

    Alias
    UMLS CUI [1]
    C1320303
    Eligibility check
    Description

    Eligibility check

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

    If No, fill in all items below 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

    boolean

    Alias
    UMLS CUI [1,1]
    C1516637
    UMLS CUI [1,2]
    C1550543
    Inclusion Criteria
    Description

    Inclusion Criteria

    Alias
    UMLS CUI-1
    C1512693
    Male or female subjects between, and including 6-10 weeks (42-76 days) of age at the time of the first vaccination.
    Description

    Gender and age at first vaccination

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0079399
    UMLS CUI [2,1]
    C0001779
    UMLS CUI [2,2]
    C0205435
    UMLS CUI [2,3]
    C0042196
    Subjects for whom the investigator believes that their parent(s)/guardian(s) can and will comply with the requirements of the protocol (e.g. return for vaccination and follow-up visits).
    Description

    Parents/guardians protocol compliance

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C0525058
    UMLS CUI [1,2]
    C0030551
    UMLS CUI [2,1]
    C0525058
    UMLS CUI [2,2]
    C1274041
    Written informed consent obtained from the parent(s)/guardian(s) of the child
    Description

    informed consent obtained from the parent(s)/guardian(s)

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C0021430
    UMLS CUI [1,2]
    C0030551
    UMLS CUI [2,1]
    C0021430
    UMLS CUI [2,2]
    C1274041
    Free of any known or suspected health problems (as established by medical history and clinical examination before entering into the study), that would contraindicate the initiation of routine immunizations outside a clinical trial context.
    Description

    No known/suspected health problems contraindicating immunizations, by medical history and examination

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C0332296
    UMLS CUI [1,2]
    C0750491
    UMLS CUI [1,3]
    C1446390
    UMLS CUI [1,4]
    C1301624
    UMLS CUI [1,5]
    C0020971
    UMLS CUI [2,1]
    C0332296
    UMLS CUI [2,2]
    C0205309
    UMLS CUI [2,3]
    C1446390
    UMLS CUI [2,4]
    C1301624
    UMLS CUI [2,5]
    C0020971
    UMLS CUI [3]
    C0262926
    UMLS CUI [4]
    C0031809
    Exclusion Criteria
    Description

    Exclusion Criteria

    Alias
    UMLS CUI-1
    C0680251
    Use of any investigational or non-registered product (drug or vaccine) other than the study vaccines within 30 days preceding the first dose of the study vaccines, or planned use during the study period.
    Description

    Recent or planned use of any other investigational or non-registered product

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C1524063
    UMLS CUI [1,2]
    C0013230
    UMLS CUI [1,3]
    C0347984
    UMLS CUI [1,4]
    C2347804
    UMLS CUI [2,1]
    C1524063
    UMLS CUI [2,2]
    C0013230
    UMLS CUI [2,3]
    C0332185
    A family history of hereditary immunodeficiency other than HIV infection
    Description

    family history of hereditary immunodeficiency other than HIV infection

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C0241889
    UMLS CUI [1,2]
    C0439660
    UMLS CUI [1,3]
    C0021051
    UMLS CUI [1,4]
    C1705847
    UMLS CUI [1,5]
    C0019693
    Major congenital defects or serious chronic illness other than HIV infection
    Description

    Applicable only for subjects who have been enrolled using the initial ICF

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C0000768
    UMLS CUI [1,2]
    C0205164
    UMLS CUI [2,1]
    C0008679
    UMLS CUI [2,2]
    C0205404
    UMLS CUI [2,3]
    C1705847
    UMLS CUI [2,4]
    C0019693
    Moderately and severely symptomatic: stages III and IV according to latest version of the WHO classification
    Description

    For HIV infected infants

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C1976611
    Administration of immunoglobulins and/or any blood products since birth or planned administration during the study period
    Description

    Administration of immunoglobulins and/or blood products, since birth or planned during study

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C1533734
    UMLS CUI [1,2]
    C0021027
    UMLS CUI [1,3]
    C0262926
    UMLS CUI [2,1]
    C1533734
    UMLS CUI [2,2]
    C0021027
    UMLS CUI [2,3]
    C1301732
    UMLS CUI [2,4]
    C0347984
    UMLS CUI [2,5]
    C2347804
    UMLS CUI [3,1]
    C0371802
    UMLS CUI [3,2]
    C0262926
    UMLS CUI [4,1]
    C0371802
    UMLS CUI [4,2]
    C1301732
    UMLS CUI [4,3]
    C0347984
    UMLS CUI [4,4]
    C2347804
    Previous vaccination against diphtheria, tetanus, pertussis, Haemophilus influenzae type b, rotavirus and/or Streptococcus pneumoniae
    Description

    The exclusion criteria concerning the previous vaccination against rotavirus is applicable only for subjects who have been enrolled during the Amendment 1/ Amendment 2 ICF

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C0205156
    UMLS CUI [1,2]
    C0042196
    UMLS CUI [1,3]
    C0012546
    UMLS CUI [2,1]
    C0205156
    UMLS CUI [2,2]
    C0042196
    UMLS CUI [2,3]
    C0039614
    UMLS CUI [3,1]
    C0205156
    UMLS CUI [3,2]
    C0042196
    UMLS CUI [3,3]
    C0043167
    UMLS CUI [4,1]
    C0205156
    UMLS CUI [4,2]
    C0042196
    UMLS CUI [4,3]
    C0121772
    UMLS CUI [5,1]
    C0205156
    UMLS CUI [5,2]
    C0042196
    UMLS CUI [5,3]
    C0038410
    UMLS CUI [6,1]
    C0205156
    UMLS CUI [6,2]
    C0042196
    UMLS CUI [6,3]
    C0597418
    History of, or intercurrent, diphtheria, tetanus, pertussis, and Haemophilus influenzae type b disease
    Description

    History of, or intercurrent, diphtheria, tetanus, pertussis, and Haemophilus influenzae type b disease

    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]
    C0121772
    UMLS CUI [8,1]
    C0277557
    UMLS CUI [8,2]
    C0121772
    History of allergic disease or reactions likely to be exacerbated by any component of the vaccines
    Description

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

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C2106654
    UMLS CUI [1,2]
    C0750492
    UMLS CUI [1,3]
    C4086268
    UMLS CUI [1,4]
    C1705248
    UMLS CUI [1,5]
    C0042210
    History of any neurological disorders or seizures
    Description

    Applicable only for subjects who have been enrolled using the initial ICF

    Data type

    boolean

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

    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 or mild upper respiratory infection, provided the body temperature is <38°C (rectal measurement) or <37.5°C (for oral/axi llary/tympanic measurements). Study entry should be delayed until the illness has improved.

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C0001314
    UMLS CUI [1,2]
    C0521116
    Babies for which weight for age is < 3rd percentile at Visit 1, using standard growth charts
    Description

    From approval of protocol amendment II, the exclusion criterion will be modified as follow: Babies whose weight for age is < 3rd percentile at Visit 1, using standard growth charts, with the exception of HIV infected infants for which the decision of enrolment is left to the investigator’s discretion. (Amended 29 June 2009)

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0517416
    Gastroenteritis within 7 days preceding the study vaccine administration
    Description

    warrants deferral of the vaccination Applicable only for subjects who have been enrolled using the Amendment 1 / Amendment2 ICF

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C0017160
    UMLS CUI [1,2]
    C0332185
    Any clinically significant history of chronic gastrointestinal disease including any uncorrected congenital malformation of the gastrointestinal (GI) tract, intussusception (IS) or other medical condition determined to be serious by the investigator
    Description

    Applicable only for subjects who have been enrolled using the Amendment 1 / Amendment2 ICF

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C0750502
    UMLS CUI [1,2]
    C0262926
    UMLS CUI [1,3]
    C0017178
    UMLS CUI [1,4]
    C0008679
    UMLS CUI [2,1]
    C0017189
    UMLS CUI [2,2]
    C0000768
    UMLS CUI [2,3]
    C4072785
    UMLS CUI [3]
    C0021933
    UMLS CUI [4,1]
    C0205394
    UMLS CUI [4,2]
    C0009488
    UMLS CUI [4,3]
    C0205082
    UMLS CUI [4,4]
    C0008961
    UMLS CUI [4,5]
    C0022423
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    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)
    Clinical Trial Subject Unique Identifier
    Item
    Subject Identifier
    integer
    C2348585 (UMLS CUI [1])
    Item
    Cohort
    integer
    C0599755 (UMLS CUI [1])
    Cohort
    Code List
    Cohort
    CL Item
    HIV-pos. (1)
    CL Item
    HIV-neg. exposed (2)
    CL Item
    HIV-neg. unexposed, 3+1 schedule (3)
    CL Item
    HIV-neg. unexposed, 3+0 schedule (4)
    CL Item
    HIV-neg. unexposed, 2+1 schedule (5)
    Date of Visit
    Item
    Date of Visit
    date
    C1320303 (UMLS CUI [1])
    Item Group
    Eligibility check
    C1516637 (UMLS CUI-1)
    Entry criteria fulfilled?
    Item
    Did the subject meet all the entry criteria?
    boolean
    C1516637 (UMLS CUI [1,1])
    C1550543 (UMLS CUI [1,2])
    Item Group
    Inclusion Criteria
    C1512693 (UMLS CUI-1)
    Gender and age at first vaccination
    Item
    Male or female subjects between, and including 6-10 weeks (42-76 days) of age at the time of the first vaccination.
    boolean
    C0079399 (UMLS CUI [1])
    C0001779 (UMLS CUI [2,1])
    C0205435 (UMLS CUI [2,2])
    C0042196 (UMLS CUI [2,3])
    Parents/guardians protocol compliance
    Item
    Subjects for whom the investigator believes that their parent(s)/guardian(s) can and will comply with the requirements of the protocol (e.g. return for vaccination and follow-up visits).
    boolean
    C0525058 (UMLS CUI [1,1])
    C0030551 (UMLS CUI [1,2])
    C0525058 (UMLS CUI [2,1])
    C1274041 (UMLS CUI [2,2])
    informed consent obtained from the parent(s)/guardian(s)
    Item
    Written informed consent obtained from the parent(s)/guardian(s) of the child
    boolean
    C0021430 (UMLS CUI [1,1])
    C0030551 (UMLS CUI [1,2])
    C0021430 (UMLS CUI [2,1])
    C1274041 (UMLS CUI [2,2])
    No known/suspected health problems contraindicating immunizations, by medical history and examination
    Item
    Free of any known or suspected health problems (as established by medical history and clinical examination before entering into the study), that would contraindicate the initiation of routine immunizations outside a clinical trial context.
    boolean
    C0332296 (UMLS CUI [1,1])
    C0750491 (UMLS CUI [1,2])
    C1446390 (UMLS CUI [1,3])
    C1301624 (UMLS CUI [1,4])
    C0020971 (UMLS CUI [1,5])
    C0332296 (UMLS CUI [2,1])
    C0205309 (UMLS CUI [2,2])
    C1446390 (UMLS CUI [2,3])
    C1301624 (UMLS CUI [2,4])
    C0020971 (UMLS CUI [2,5])
    C0262926 (UMLS CUI [3])
    C0031809 (UMLS CUI [4])
    Item Group
    Exclusion Criteria
    C0680251 (UMLS CUI-1)
    Recent or planned use of any other investigational or non-registered product
    Item
    Use of any investigational or non-registered product (drug or vaccine) other than the study vaccines within 30 days preceding the first dose of the study vaccines, or planned use during the study period.
    boolean
    C1524063 (UMLS CUI [1,1])
    C0013230 (UMLS CUI [1,2])
    C0347984 (UMLS CUI [1,3])
    C2347804 (UMLS CUI [1,4])
    C1524063 (UMLS CUI [2,1])
    C0013230 (UMLS CUI [2,2])
    C0332185 (UMLS CUI [2,3])
    family history of hereditary immunodeficiency other than HIV infection
    Item
    A family history of hereditary immunodeficiency other than HIV infection
    boolean
    C0241889 (UMLS CUI [1,1])
    C0439660 (UMLS CUI [1,2])
    C0021051 (UMLS CUI [1,3])
    C1705847 (UMLS CUI [1,4])
    C0019693 (UMLS CUI [1,5])
    Major congenital defects or serious chronic illness other than HIV infection
    Item
    Major congenital defects or serious chronic illness other than HIV infection
    boolean
    C0000768 (UMLS CUI [1,1])
    C0205164 (UMLS CUI [1,2])
    C0008679 (UMLS CUI [2,1])
    C0205404 (UMLS CUI [2,2])
    C1705847 (UMLS CUI [2,3])
    C0019693 (UMLS CUI [2,4])
    WHO HIV staging
    Item
    Moderately and severely symptomatic: stages III and IV according to latest version of the WHO classification
    boolean
    C1976611 (UMLS CUI [1])
    Administration of immunoglobulins and/or blood products, since birth or planned during study
    Item
    Administration of immunoglobulins and/or any blood products since birth or planned administration during the study period
    boolean
    C1533734 (UMLS CUI [1,1])
    C0021027 (UMLS CUI [1,2])
    C0262926 (UMLS CUI [1,3])
    C1533734 (UMLS CUI [2,1])
    C0021027 (UMLS CUI [2,2])
    C1301732 (UMLS CUI [2,3])
    C0347984 (UMLS CUI [2,4])
    C2347804 (UMLS CUI [2,5])
    C0371802 (UMLS CUI [3,1])
    C0262926 (UMLS CUI [3,2])
    C0371802 (UMLS CUI [4,1])
    C1301732 (UMLS CUI [4,2])
    C0347984 (UMLS CUI [4,3])
    C2347804 (UMLS CUI [4,4])
    Previous vaccination against diphtheria, tetanus, pertussis, Haemophilus influenzae type b, rotavirus and/or Streptococcus pneumoniae
    Item
    Previous vaccination against diphtheria, tetanus, pertussis, Haemophilus influenzae type b, rotavirus and/or Streptococcus pneumoniae
    boolean
    C0205156 (UMLS CUI [1,1])
    C0042196 (UMLS CUI [1,2])
    C0012546 (UMLS CUI [1,3])
    C0205156 (UMLS CUI [2,1])
    C0042196 (UMLS CUI [2,2])
    C0039614 (UMLS CUI [2,3])
    C0205156 (UMLS CUI [3,1])
    C0042196 (UMLS CUI [3,2])
    C0043167 (UMLS CUI [3,3])
    C0205156 (UMLS CUI [4,1])
    C0042196 (UMLS CUI [4,2])
    C0121772 (UMLS CUI [4,3])
    C0205156 (UMLS CUI [5,1])
    C0042196 (UMLS CUI [5,2])
    C0038410 (UMLS CUI [5,3])
    C0205156 (UMLS CUI [6,1])
    C0042196 (UMLS CUI [6,2])
    C0597418 (UMLS CUI [6,3])
    History of, or intercurrent, diphtheria, tetanus, pertussis, and Haemophilus influenzae type b disease
    Item
    History of, or intercurrent, diphtheria, tetanus, pertussis, and Haemophilus influenzae type b disease
    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])
    C0121772 (UMLS CUI [7,2])
    C0277557 (UMLS CUI [8,1])
    C0121772 (UMLS CUI [8,2])
    allergic disease or reactions likely to be exacerbated by any component of the vaccines
    Item
    History of allergic disease or reactions likely to be exacerbated by any component of the vaccines
    boolean
    C2106654 (UMLS CUI [1,1])
    C0750492 (UMLS CUI [1,2])
    C4086268 (UMLS CUI [1,3])
    C1705248 (UMLS CUI [1,4])
    C0042210 (UMLS CUI [1,5])
    History of any neurological disorders or seizures
    Item
    History of any neurological disorders or seizures
    boolean
    C0262926 (UMLS CUI [1,1])
    C0027765 (UMLS CUI [1,2])
    C0262926 (UMLS CUI [2,1])
    C0036572 (UMLS CUI [2,2])
    Acute disease at the time of enrolment
    Item
    Acute disease at the time of enrolment
    boolean
    C0001314 (UMLS CUI [1,1])
    C0521116 (UMLS CUI [1,2])
    Weight for age by percentile
    Item
    Babies for which weight for age is < 3rd percentile at Visit 1, using standard growth charts
    boolean
    C0517416 (UMLS CUI [1])
    Recent gastroenteritis
    Item
    Gastroenteritis within 7 days preceding the study vaccine administration
    boolean
    C0017160 (UMLS CUI [1,1])
    C0332185 (UMLS CUI [1,2])
    significant history of chronic gastrointestinal disease including any uncorrected congenital malformation of the gastrointestinal (GI) tract, intussusception (IS) or other medical condition determined to be serious by the investigator
    Item
    Any clinically significant history of chronic gastrointestinal disease including any uncorrected congenital malformation of the gastrointestinal (GI) tract, intussusception (IS) or other medical condition determined to be serious by the investigator
    boolean
    C0750502 (UMLS CUI [1,1])
    C0262926 (UMLS CUI [1,2])
    C0017178 (UMLS CUI [1,3])
    C0008679 (UMLS CUI [1,4])
    C0017189 (UMLS CUI [2,1])
    C0000768 (UMLS CUI [2,2])
    C4072785 (UMLS CUI [2,3])
    C0021933 (UMLS CUI [3])
    C0205394 (UMLS CUI [4,1])
    C0009488 (UMLS CUI [4,2])
    C0205082 (UMLS CUI [4,3])
    C0008961 (UMLS CUI [4,4])
    C0022423 (UMLS CUI [4,5])
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