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ID

15000

Description

This study will evaluate the safety, reactogenicity and immunogenicity of a booster dose of GSK Biologicals' pneumococcal conjugate vaccine compared to Prevenar™ given at 12-18 mo of age to children primed with either pneumococcal vaccine or Prevenar™ in study 105553. Antibody persistence will be evaluated at 8-14 mo after completion of the 3-dose immunization course in study 105553. The immune response to a booster dose of GSK Biologicals' pneumococcal conjugate vaccine will also be evaluated when given at 12-18 mo to subjects not primed with GSK Biologicals' vaccine but with Prevenar™. The study has 3 groups. 1 group of children primed with GSK Biologicals' pneumococcal conjugate vaccine will receive a booster dose of the same vaccine. 2nd group of children primed with Prevenar™ will receive a booster dose of Prevenar™ (control group). 3rd group of children primed with Prevenar™ will receive a booster dose of GSK Biologicals' pneumococcal conjugate vaccine. All children will receive concomitantly a booster dose of DTPa-HBV-IPV/Hib vaccine. NCT00370396 Part: Concomitant Vaccination

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Versions (2)
  1. 5/9/16 5/9/16 -
  2. 5/11/16 5/11/16 -
Uploaded on

May 11, 2016

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License

Creative Commons BY-NC 3.0
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    Concomitant Vaccination Safety and Immunogenicity Study of a Booster Dose of GSK Biologicals 10-valent Pneumococcal Conjugate Vaccine NCT00370396

    English

    Concomitant Vaccination "Safety and Immunogenicity Study of a Booster Dose of GSK Biologicals' 10-valent Pneumococcal Conjugate Vaccine" NCT00370396

    1 forms  
    Identification
    Description

    Identification

    Alias
    UMLS CUI-1
    C1300638
    Center number
    Description

    Center number

    Data type

    text

    Alias
    UMLS CUI [1,1]
    C1301943
    UMLS CUI [1,2]
    C0805701
    Subject ID
    Description

    Subject ID

    Data type

    text

    Alias
    UMLS CUI [1]
    C2348585
    Treatment Number
    Description

    Treatment Number

    Data type

    text

    Alias
    UMLS CUI [1]
    C1522541
    Visit Number
    Description

    Visit Number

    Data type

    integer

    Alias
    UMLS CUI [1]
    C0545082
    Concomitant Vaccination
    Description

    Concomitant Vaccination

    Alias
    UMLS CUI-1
    C0042196
    UMLS CUI-2
    C2347852
    Has any vaccine other than the study vaccine(s) been administered during the timeframe as specified in the Protocol?
    Description

    If yes, please record concomitant vaccination with trade name and I or generic name, route and vaccine administration date.

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C0042196
    UMLS CUI [1,2]
    C2347852
    Concomitant Vaccination List
    Description

    Concomitant Vaccination List

    Alias
    UMLS CUI-1
    C0042196
    UMLS CUI-2
    C2347852
    Trade / (Generic) Name
    Description

    Trade / (Generic) Name

    Data type

    text

    Alias
    UMLS CUI [1]
    C0027365
    Route
    Description

    Route

    Data type

    text

    Alias
    UMLS CUI [1]
    C0013153
    Administration date
    Description

    Administration date

    Data type

    date

    Alias
    UMLS CUI [1]
    C0011008
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    Similar models

    Concomitant Vaccination "Safety and Immunogenicity Study of a Booster Dose of GSK Biologicals' 10-valent Pneumococcal Conjugate Vaccine" NCT00370396

    1 forms
    Name
    Type
    Description | Question | Decode (Coded Value)
    Data type
    Alias
    Item Group
    Identification
    C1300638 (UMLS CUI-1)
    Center number
    Item
    Center number
    text
    C1301943 (UMLS CUI [1,1])
    C0805701 (UMLS CUI [1,2])
    Subject ID
    Item
    Subject ID
    text
    C2348585 (UMLS CUI [1])
    Treatment Number
    Item
    Treatment Number
    text
    C1522541 (UMLS CUI [1])
    Item
    Visit Number
    integer
    C0545082 (UMLS CUI [1])
    Visit Number
    Code List
    Visit Number
    CL Item
    1 (1)
    CL Item
    2 (2)
    Item Group
    Concomitant Vaccination
    C0042196 (UMLS CUI-1)
    C2347852 (UMLS CUI-2)
    Other Vaccinations
    Item
    Has any vaccine other than the study vaccine(s) been administered during the timeframe as specified in the Protocol?
    boolean
    C0042196 (UMLS CUI [1,1])
    C2347852 (UMLS CUI [1,2])
    Item Group
    Concomitant Vaccination List
    C0042196 (UMLS CUI-1)
    C2347852 (UMLS CUI-2)
    Trade / (Generic) Name
    Item
    Trade / (Generic) Name
    text
    C0027365 (UMLS CUI [1])
    Item
    Route
    text
    C0013153 (UMLS CUI [1])
    Route
    Code List
    Route
    CL Item
    lntradermal (ID)
    CL Item
    Inhalation (IH)
    CL Item
    Intramuscular (IM)
    CL Item
    Intravenous (IV)
    CL Item
    Intranasal (NA)
    CL Item
    Other (OTH)
    CL Item
    Parenteral (PE)
    CL Item
    Oral (PO)
    CL Item
    Subcutaneous (SC)
    CL Item
    Sublingual (SL)
    CL Item
    Transdermal (TD)
    CL Item
    Unknown (UNK)
    Administration date
    Item
    Administration date
    date
    C0011008 (UMLS CUI [1])
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