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ID

44006

Description

Visit 2 Vaccine Administration form Study ID: 208127/125 Clinical Study ID: 208127/125 (Ext-HAB-038 Month 90) Study Title: A double-blind, randomized study to evaluate the immunogenicity and reactogenicity of two different lots of GlaxoSmithKline Biologicals' combined hepatitis A / hepatitis B vaccine in healthy children between 6 and 15 years of age. Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: N/A Sponsor:GlaxoSmithKline Collaborators: N/A Phase: Phase 3 Study Recruitment Status: Completed Generic Name: Hepatitis A (Inactivated), Hepatitis B (Recombinant) Vaccine Trade Name: Twinrix Study Indication: Hepatitis A; Hepatitis B

Keywords

Versions (3)
  1. 8/1/17 8/1/17 -
  2. 8/2/17 8/2/17 -
  3. 9/20/21 9/20/21 -
Copyright Holder

GlaxoSmithKline

Uploaded on

September 20, 2021

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License

Creative Commons BY-NC 3.0
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    Visit 2 Vaccine Administration Biologicals HepA/HepB vaccine 208127/125

    English

    Visit 2 Vaccine Administration Biologicals HepA/HepB vaccine 208127/125

    1 forms  
    Header
    Description

    Header

    Alias
    UMLS CUI-1
    C1320722 (Administrative documentation)
    SNOMED
    405624007
    Protocol
    Description

    Protocol

    Data type

    text

    Alias
    UMLS CUI [1]
    C1507394 (Clinical trial protocol document)
    LOINC
    LP33258-2
    Activity
    Description

    Activity

    Data type

    text

    Alias
    UMLS CUI [1]
    C1512346 (Patient Visit)
    Subject number
    Description

    Subject number

    Data type

    text

    Alias
    UMLS CUI [1]
    C2348585 (Clinical Trial Subject Unique Identifier)
    VACCINE ADMINISTRATION
    Description

    VACCINE ADMINISTRATION

    Alias
    UMLS CUI-1
    C2368628 (Administration of vaccine)
    Temperature :
    Description

    As specified in the protocol, the temperature of the subject should be taken by the oral route.

    Data type

    float

    Measurement units
    • °C
    Alias
    UMLS CUI [1]
    C0005903 (Body Temperature)
    SNOMED
    722490005
    LOINC
    LP36617-6
    °C
    Axillary route
    Description

    Axillary temperature

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C1531924 (Axillary temperature)
    SNOMED
    415882003
    Oral route
    Description

    Oral temperature

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C1532216 (Oral temperature)
    SNOMED
    415945006
    Rectal route
    Description

    Rectal temperature

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0489749 (Rectal temperature)
    SNOMED
    307047009
    Has the study vaccine been administered ?
    Description

    If Yes, complete the table below.

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C0042210 (Vaccines)
    SNOMED
    787859002
    LOINC
    LA20283-0
    UMLS CUI [1,2]
    C0008972 (Clinical Research)
    Please specify and go to next page :
    Description

    Study vaccine has not been administered

    Data type

    text

    Alias
    UMLS CUI [1,1]
    C0042210 (Vaccines)
    SNOMED
    787859002
    LOINC
    LA20283-0
    UMLS CUI [1,2]
    C0008972 (Clinical Research)
    HAB
    Description

    Vaccine

    Data type

    text

    Alias
    UMLS CUI [1]
    C5397396 (Hepatitis A and Hepatitis B virus antigens only vaccine product)
    SNOMED
    871803007
    Site/Route of injection: Deltoid I.M.
    Description

    Please specify side :

    Data type

    text

    Alias
    UMLS CUI [1]
    C2700396 (Injection site)
    Date administered (day month year)
    Description

    Date administered

    Data type

    date

    Alias
    UMLS CUI [1]
    C0011008 (Date in time)
    SNOMED
    410671006
    Time (24 hr. clock)
    Description

    Time

    Data type

    time

    Alias
    UMLS CUI [1]
    C0040223 (Time)
    SNOMED
    410670007
    LOINC
    LP73517-2
    Has the study vaccine been administered according to the protocol ?
    Description

    Vaccine protocol

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C2368628 (Administration of vaccine)
    UMLS CUI [2]
    C1507394 (Clinical trial protocol document)
    LOINC
    LP33258-2
    Injection site :
    Description

    study vaccine has not been administered according to the protocol

    Data type

    text

    Alias
    UMLS CUI [1]
    C2700396 (Injection site)
    Route :
    Description

    study vaccine has not been administered according to the protocol

    Data type

    text

    Alias
    UMLS CUI [1]
    C1828121 (Injection Route of Drug Administration)
    POST VACCINATION OBSERVATION
    Description

    POST VACCINATION OBSERVATION

    Alias
    UMLS CUI-1
    C1443955 (Post-vaccination precautions)
    SNOMED
    409634008
    UMLS CUI-2
    C0700325 (Patient observation)
    SNOMED
    103705002
    Has any adverse experience occurred during the immediate 30 minute post vaccination observation period ?
    Description

    If Yes, please fill in the Adverse Experience Section and detail the exact time of onset.

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C0877248 (Adverse event)
    LOINC
    MTHU014542
    UMLS CUI [1,2]
    C0151862 (Post vaccination syndrome)
    Has any prophylactic medication been administered in anticipation of study vaccine reactions ?
    Description

    If Yes, please complete the Medication Section

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C0420172 (Drug prophylaxis)
    SNOMED
    182929008
    UMLS CUI [1,2]
    C0413534 (Vaccine adverse reaction)
    SNOMED
    293104008
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    Similar models

    Visit 2 Vaccine Administration Biologicals HepA/HepB vaccine 208127/125

    1 forms
    Name
    Type
    Description | Question | Decode (Coded Value)
    Data type
    Alias
    Item Group
    Header
    C1320722 (UMLS CUI-1)
    Protocol
    Item
    Protocol
    text
    C1507394 (UMLS CUI [1])
    Activity
    Item
    Activity
    text
    C1512346 (UMLS CUI [1])
    Subject number
    Item
    Subject number
    text
    C2348585 (UMLS CUI [1])
    Item Group
    VACCINE ADMINISTRATION
    C2368628 (UMLS CUI-1)
    Temperature
    Item
    Temperature :
    float
    C0005903 (UMLS CUI [1])
    Axillary temperature
    Item
    Axillary route
    boolean
    C1531924 (UMLS CUI [1])
    Oral temperature
    Item
    Oral route
    boolean
    C1532216 (UMLS CUI [1])
    Rectal temperature
    Item
    Rectal route
    boolean
    C0489749 (UMLS CUI [1])
    Study vaccine administered
    Item
    Has the study vaccine been administered ?
    boolean
    C0042210 (UMLS CUI [1,1])
    C0008972 (UMLS CUI [1,2])
    Study vaccine not administered
    Item
    Please specify and go to next page :
    text
    C0042210 (UMLS CUI [1,1])
    C0008972 (UMLS CUI [1,2])
    Item
    HAB
    text
    C5397396 (UMLS CUI [1])
    Vaccine
    Code List
    HAB
    CL Item
    HAB (HAB)
    Item
    Site/Route of injection: Deltoid I.M.
    text
    C2700396 (UMLS CUI [1])
    Site/Route of injection
    Code List
    Site/Route of injection: Deltoid I.M.
    CL Item
    left (left)
    CL Item
    right (right)
    Date administered
    Item
    Date administered (day month year)
    date
    C0011008 (UMLS CUI [1])
    Time
    Item
    Time (24 hr. clock)
    time
    C0040223 (UMLS CUI [1])
    Vaccine protocol
    Item
    Has the study vaccine been administered according to the protocol ?
    boolean
    C2368628 (UMLS CUI [1])
    C1507394 (UMLS CUI [2])
    Injection site
    Item
    Injection site :
    text
    C2700396 (UMLS CUI [1])
    Route
    Item
    Route :
    text
    C1828121 (UMLS CUI [1])
    Item Group
    POST VACCINATION OBSERVATION
    C1443955 (UMLS CUI-1)
    C0700325 (UMLS CUI-2)
    Adverse experience after vaccination
    Item
    Has any adverse experience occurred during the immediate 30 minute post vaccination observation period ?
    boolean
    C0877248 (UMLS CUI [1,1])
    C0151862 (UMLS CUI [1,2])
    Prophylactic medication
    Item
    Has any prophylactic medication been administered in anticipation of study vaccine reactions ?
    boolean
    C0420172 (UMLS CUI [1,1])
    C0413534 (UMLS CUI [1,2])
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