0 Ratings
ID

23891

Description

Study part: Adverse Events- Post- Vaccination Observation Booster Dose. A phase 2 study to assess safety, reactogenicity and immunogenicity of a booster dose of an investigational vaccination regimen and GSK Biologicals Hib-MenC vaccine (co-administered with Infanrix penta) compared to a booster dose of Menjugate (co-administered with Infanrix hexa).Patient Level Data: Study Listed on ClinicalStudyDataRequest.com. Study ID: 100381, Clinical Study ID: 100381

Keywords

Versions (1)
  1. 7/16/17 7/16/17 -
Copyright Holder

GlaxoSmithKline

Uploaded on

July 16, 2017

DOI

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License

Creative Commons BY-NC 3.0
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    Adverse Events- Post- Vaccination Observation Booster Dose Hib-MenCY-TT-004 BST 003 Neisseria Meningitidis-Haemophilus influenzae type b Vaccine 100381

    English

    Adverse Events- Post- Vaccination Observation Booster Dose

    1 forms  
    ADVERSE EVENTS – POST–VACCINATION OBSERVATION
    Description

    ADVERSE EVENTS – POST–VACCINATION OBSERVATION

    Alias
    UMLS CUI-1
    C0877248
    Subject number
    Description

    Subject number

    Data type

    integer

    Alias
    UMLS CUI [1]
    C2348585
    Has the subject experienced any serious or non-serious unsolicited adverse events within one month (minimum 30 days) post-vaccination?
    Description

    Adverse Events

    Data type

    text

    Alias
    UMLS CUI [1]
    C0877248
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    Similar models

    Adverse Events- Post- Vaccination Observation Booster Dose

    1 forms
    Name
    Type
    Description | Question | Decode (Coded Value)
    Data type
    Alias
    Item Group
    ADVERSE EVENTS – POST–VACCINATION OBSERVATION
    C0877248 (UMLS CUI-1)
    Subject number
    Item
    Subject number
    integer
    C2348585 (UMLS CUI [1])
    Item
    Has the subject experienced any serious or non-serious unsolicited adverse events within one month (minimum 30 days) post-vaccination?
    text
    C0877248 (UMLS CUI [1])
    Adverse Events
    Code List
    Has the subject experienced any serious or non-serious unsolicited adverse events within one month (minimum 30 days) post-vaccination?
    CL Item
    Information not retrievable [U (Information not retrievable [U)
    CL Item
    No Vaccine administered [NA (No Vaccine administered [NA)
    CL Item
    No [N (No [N)
    CL Item
    Yes, fill in the Non-Serious Adverse Event pages or Serious Adverse Event form [Y (Yes, fill in the Non-Serious Adverse Event pages or Serious Adverse Event form [Y)
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