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ID

33311

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. 05/12/2018 05/12/2018 -
  2. 05/12/2018 05/12/2018 -
Détendeur de droits

GSK group of companies

Téléchargé le

5 décembre 2018

DOI

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Licence

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)

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    Visit 1: Inclusion Criteria

    1 Formulaires  
    Administrative data
    Description

    Administrative data

    Date of Visit
    Description

    Date of Visit

    Type de données

    date

    Subject Number
    Description

    Subject Number

    Type de données

    integer

    Eligibility check
    Description

    Eligibility check

    Did the subject meet all the entry criteria?
    Description

    Did the subject meet all the entry criteria?

    Type de données

    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

    Type de données

    text

    Inclusion Criteria
    Description

    Inclusion Criteria

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

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

    Type de données

    text

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    Visit 1: Inclusion Criteria

    1 Formulaires
    Name
    Type
    Description | Question | Decode (Coded Value)
    Type de données
    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
    Inclusion Criteria
    Item
    For subjects receiving Plain PRP followed by DTPw-HBV Kft:
    text
    For subjects receiving Plain PRP followed by DTPw-HBV Kft:
    Code List
    For subjects receiving Plain PRP followed by DTPw-HBV Kft:
    CL Item
    A male or female infant, 10 to 11 months of age (40-44 weeks), who completed the primary vaccination course in the study DTPw-HBV=Hib Kft-001 (1)
    CL Item
    Subject 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 (2)
    CL Item
    Written informed consent obtained from the parent or guardian of the subject (3)
    CL Item
    Free of obvious health problems as established by medical history and clinical examination before entering into the study (4)
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