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33316

Beschreibung

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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Versionen (2)
  1. 05.12.18 05.12.18 -
  2. 05.12.18 05.12.18 -
Rechteinhaber

GSK group of companies

Hochgeladen am

5. Dezember 2018

DOI

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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) - 104065

    Englisch

    Visit 1: Inclusion Criteria

    1 Formulare  
    Administrative data
    Beschreibung

    Administrative data

    Date of Visit
    Beschreibung

    Date of Visit

    Datentyp

    date

    Subject Number
    Beschreibung

    Subject Number

    Datentyp

    integer

    Eligibility check
    Beschreibung

    Eligibility check

    Did the subject meet all the entry criteria?
    Beschreibung

    Did the subject meet all the entry criteria?

    Datentyp

    boolean

    If No, please tick all boxes corresponding to violations of any inclusion/exclusion criteria
    Beschreibung

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

    Datentyp

    text

    Inclusion Criteria
    Beschreibung

    Inclusion Criteria

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

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

    Datentyp

    text

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    Visit 1: Inclusion Criteria

    1 Formulare
    Name
    Typ
    Description | Question | Decode (Coded Value)
    Datentyp
    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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