0 Ratings
ID

34843

Description

Study ID: 104951 Clinical Study ID: 104951 Study Title: A Phase III, double-blind, randomized, controlled study to evaluate the immunogenicity and safety of GlaxoSmithKline (GSK) Biologicals' HPV-16/18 L1 VLP AS04 vaccine administered intramuscularly according to a 0_ 1_ 6 month schedule in healthy female subjects aged 10 - 14 years. Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00290277 https://clinicaltrials.gov/ct2/show/NCT00290277 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 3 Study Recruitment Status: Completed Generic Name: HPV-16/18 L1/AS04 Vaccine Trade Name: N/A Study Indication: Infections, Papillomavirus This forms contains information about concomitant medication/vaccination. Record any concomitant medication/vaccination, including any medication administered prophylactically in anticipation of reaction to the vaccination (analgesic, antipyretic). This section about concomitant medication/vaccination must be checked for final assessment at the end of the study.

Link

https://clinicaltrials.gov/ct2/show/NCT00290277

Keywords

Versions (2)
  1. 1/31/19 1/31/19 -
  2. 1/31/19 1/31/19 -
Copyright Holder

GlaxoSmithKline

Uploaded on

January 31, 2019

DOI

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License

Creative Commons BY-NC 3.0
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    Evaluation of immunogenicity and safety of GSK Biologicals' HPV-16/18 L1 VLP AS04 vaccine in healthy females NCT00290277

    English

    Pre-vaccination Tests and Vaccination

    1 forms  
    Administrative data
    Description

    Administrative data

    Alias
    UMLS CUI-1
    C1320722
    Subject number
    Description

    Subject number

    Data type

    text

    Alias
    UMLS CUI [1]
    C2348585
    Date of visit
    Description

    Date of visit

    Data type

    date

    Alias
    UMLS CUI [1]
    C1320303
    Visit number
    Description

    The items have to be filled in at visit 1, 2 and 3

    Data type

    text

    Alias
    UMLS CUI [1]
    C1549755
    Pre-vaccination pregnancy test
    Description

    Pre-vaccination pregnancy test

    Alias
    UMLS CUI-1
    C0032976
    UMLS CUI-2
    C0042196
    UMLS CUI-3
    C0332152
    Date of urine sample taking
    Description

    Please complete only if different from visit date.

    Data type

    date

    Alias
    UMLS CUI [1,1]
    C0200354
    UMLS CUI [1,2]
    C0011008
    HCG urine pregnancy test: Has a urine sample been taken?
    Description

    If YES, please complete date of sample taking (if different from visit date) and result. If NO, please postpone vaccination until pregnancy is excluded by HCG.

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C0430056
    UMLS CUI [1,2]
    C0200354
    Result of HCG urine pregnancy test
    Description

    Subjects must have a negative pregnancy test.

    Data type

    text

    Alias
    UMLS CUI [1,1]
    C0427777
    UMLS CUI [1,2]
    C0430056
    Pre-vaccination temperature
    Description

    Pre-vaccination temperature

    Alias
    UMLS CUI-1
    C0005903
    UMLS CUI-2
    C0042196
    UMLS CUI-3
    C0332152
    Date of temperature measurement
    Description

    Fill in only if different from visit date.

    Data type

    date

    Alias
    UMLS CUI [1,1]
    C0005903
    UMLS CUI [1,2]
    C0011008
    Pre-vaccination temperature
    Description

    Oral/axillary temperature ≥ 37.5 °C (99.5 °F) at the time of vaccination is a contraindication to administration of study/ control vaccine at that point in time. The subject may be vaccinated at a later date or withdrawn at the discretion of the investigator. The subject must be followed until resolution of the event.

    Data type

    float

    Measurement units
    • °C
    Alias
    UMLS CUI [1,1]
    C0005903
    UMLS CUI [1,2]
    C0042196
    UMLS CUI [1,3]
    C0332152
    °C
    Route of temperature measurement
    Description

    Rectal measurement ist not recommended.

    Data type

    text

    Alias
    UMLS CUI [1,1]
    C0886414
    UMLS CUI [1,2]
    C0449444
    Vaccine administration
    Description

    Vaccine administration

    Alias
    UMLS CUI-1
    C2368628
    Date of vaccine administration
    Description

    Date of vaccine administration

    Data type

    text

    Alias
    UMLS CUI [1,1]
    C2368628
    UMLS CUI [1,2]
    C0011008
    Vaccine administration
    Description

    Only one box must be ticked by vaccine. If HAV vaccine was administered and correct vial number is existent, tick '2' and note vial number below. If HAV vaccine was administered and wrong vial number is existent, tick '3' and note vial number below. If no vaccine was administered, tick '4' and complete itemgroup 'Why was the vaccine not administered?' below.

    Data type

    text

    Alias
    UMLS CUI [1]
    C2368628
    Has the study vaccine been administered according to the Protocol?
    Description

    If NO, specify Side, Site and Route in itemgroup 'Administration not according to protocol' below

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C2368628
    UMLS CUI [1,2]
    C2348563
    Why was no vaccine administered?
    Description

    Why was no vaccine administered?

    Alias
    UMLS CUI-1
    C2368628
    UMLS CUI-2
    C0566251
    Please tick the major reason for non administration.
    Description

    If you ticked '1', please complete and submit SAE report and note SAE number below. If you ticked '2', please complete Non-Serious Adverese event section and note AE number below. If you ticked '3', please specify below.

    Data type

    text

    Alias
    UMLS CUI [1,1]
    C2368628
    UMLS CUI [1,2]
    C0566251
    UMLS CUI [1,3]
    C0205164
    SAE number
    Description

    Number of Serious adverese event. Fill in, if you ticked 'SAE' as major reason for non administration above.

    Data type

    integer

    Alias
    UMLS CUI [1,1]
    C1519255
    UMLS CUI [1,2]
    C0237753
    AE number
    Description

    Number of Non-Serious adverese event. Fill in, if you ticked 'AEX' as major reason for non administration above.

    Data type

    integer

    Alias
    UMLS CUI [1,1]
    C1518404
    UMLS CUI [1,2]
    C0237753
    Specify 'Other' for non administration.
    Description

    Fill in, if you ticked 'Other' as major reson for non administration above. (e.g.: consent withdrawal, Protocol violation, ..

    Data type

    text

    Alias
    UMLS CUI [1,1]
    C2368628
    UMLS CUI [1,2]
    C0566251
    UMLS CUI [1,3]
    C0205394
    Tick, who made the decision not to administrate the vaccine
    Description

    Who made the decision not administrate the vaccine?

    Data type

    text

    Alias
    UMLS CUI [1,1]
    C2368628
    UMLS CUI [1,2]
    C0679006
    Administration not according to protocol
    Description

    Administration not according to protocol

    Alias
    UMLS CUI-1
    C2368628
    UMLS CUI-2
    C1705236
    Side of vaccination
    Description

    This item has to be filled in only if the vaccine was not administered according to protocol.

    Data type

    text

    Alias
    UMLS CUI [1,1]
    C0042210
    UMLS CUI [1,2]
    C0441987
    Site of vaccination
    Description

    This item has to be filled in only if the vaccine was not administered according to protocol.

    Data type

    text

    Alias
    UMLS CUI [1,1]
    C0042210
    UMLS CUI [1,2]
    C1515974
    Route of vaccination
    Description

    This item has to be filled in only if the vaccine was not administered according to protocol.

    Data type

    text

    Alias
    UMLS CUI [1,1]
    C0042210
    UMLS CUI [1,2]
    C0013153
    Immediate Post-Vaccination Observation
    Description

    Immediate Post-Vaccination Observation

    Alias
    UMLS CUI-1
    C0042196
    UMLS CUI-2
    C0700325
    Did the subject experience any urticaria / rash within 30 minutes after the vaccine administration?
    Description

    Did the subject experience any urticaria / rash within 30 minutes after the vaccine administration?

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C2368628
    UMLS CUI [1,2]
    C0042109
    UMLS CUI [2,1]
    C2368628
    UMLS CUI [2,2]
    C0015230
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    Similar models

    Pre-vaccination Tests and Vaccination

    1 forms
    Name
    Type
    Description | Question | Decode (Coded Value)
    Data type
    Alias
    Item Group
    Administrative data
    C1320722 (UMLS CUI-1)
    Subject number
    Item
    Subject number
    text
    C2348585 (UMLS CUI [1])
    Date of visit
    Item
    Date of visit
    date
    C1320303 (UMLS CUI [1])
    Item
    Visit number
    text
    C1549755 (UMLS CUI [1])
    Visit number
    Code List
    Visit number
    CL Item
    Visit 1 (month 0) (Visit 1)
    CL Item
    Visit 2 (month 1) (Visit 2)
    CL Item
    Visit 3 (month 6) (Visit 3)
    Item Group
    Pre-vaccination pregnancy test
    C0032976 (UMLS CUI-1)
    C0042196 (UMLS CUI-2)
    C0332152 (UMLS CUI-3)
    Date of urine sample taking
    Item
    Date of urine sample taking
    date
    C0200354 (UMLS CUI [1,1])
    C0011008 (UMLS CUI [1,2])
    HCG urine pregnancy test
    Item
    HCG urine pregnancy test: Has a urine sample been taken?
    boolean
    C0430056 (UMLS CUI [1,1])
    C0200354 (UMLS CUI [1,2])
    Item
    Result of HCG urine pregnancy test
    text
    C0427777 (UMLS CUI [1,1])
    C0430056 (UMLS CUI [1,2])
    Result of HCG urine pregnancy test
    Code List
    Result of HCG urine pregnancy test
    CL Item
    Negative (Negative)
    CL Item
    Positive (Positive)
    Item Group
    Pre-vaccination temperature
    C0005903 (UMLS CUI-1)
    C0042196 (UMLS CUI-2)
    C0332152 (UMLS CUI-3)
    Date of temperature measurement
    Item
    Date of temperature measurement
    date
    C0005903 (UMLS CUI [1,1])
    C0011008 (UMLS CUI [1,2])
    Pre-vaccination temperature
    Item
    Pre-vaccination temperature
    float
    C0005903 (UMLS CUI [1,1])
    C0042196 (UMLS CUI [1,2])
    C0332152 (UMLS CUI [1,3])
    Item
    Route of temperature measurement
    text
    C0886414 (UMLS CUI [1,1])
    C0449444 (UMLS CUI [1,2])
    Route of temperature measurement
    Code List
    Route of temperature measurement
    CL Item
    Axillary (Axillary)
    CL Item
    Oral (Oral)
    CL Item
    Rectal (Rectal)
    Item Group
    Vaccine administration
    C2368628 (UMLS CUI-1)
    Date of vaccine administration
    Item
    Date of vaccine administration
    text
    C2368628 (UMLS CUI [1,1])
    C0011008 (UMLS CUI [1,2])
    Item
    Vaccine administration
    text
    C2368628 (UMLS CUI [1])
    Vaccine administration
    Code List
    Vaccine administration
    CL Item
    HPV 16/18 VLP Vaccine (HPV) (1)
    CL Item
    Hepatitis A (HAV) Vaccine  (2)
    CL Item
    Hepatitis A (HAV) Vaccine (Wrong vial number existent) (3)
    CL Item
    Not administered (4)
    Administration of study vaccine according to protocol
    Item
    Has the study vaccine been administered according to the Protocol?
    boolean
    C2368628 (UMLS CUI [1,1])
    C2348563 (UMLS CUI [1,2])
    Item Group
    Why was no vaccine administered?
    C2368628 (UMLS CUI-1)
    C0566251 (UMLS CUI-2)
    Item
    Please tick the major reason for non administration.
    text
    C2368628 (UMLS CUI [1,1])
    C0566251 (UMLS CUI [1,2])
    C0205164 (UMLS CUI [1,3])
    Major reason for non administration
    Code List
    Please tick the major reason for non administration.
    CL Item
    Serious adverse event (SAE) (1)
    CL Item
    Non-Serious adverese event (AEX) (2)
    CL Item
    Other (3)
    SAE number
    Item
    SAE number
    integer
    C1519255 (UMLS CUI [1,1])
    C0237753 (UMLS CUI [1,2])
    AE number
    Item
    AE number
    integer
    C1518404 (UMLS CUI [1,1])
    C0237753 (UMLS CUI [1,2])
    Specify 'Other' reason for non administration
    Item
    Specify 'Other' for non administration.
    text
    C2368628 (UMLS CUI [1,1])
    C0566251 (UMLS CUI [1,2])
    C0205394 (UMLS CUI [1,3])
    Item
    Tick, who made the decision not to administrate the vaccine
    text
    C2368628 (UMLS CUI [1,1])
    C0679006 (UMLS CUI [1,2])
    Who made the decision not administrate the vaccine?
    Code List
    Tick, who made the decision not to administrate the vaccine
    CL Item
    Investigator (1)
    CL Item
    Subject or Parents / Legally Acceptable Representative(s) (2)
    Item Group
    Administration not according to protocol
    C2368628 (UMLS CUI-1)
    C1705236 (UMLS CUI-2)
    Item
    Side of vaccination
    text
    C0042210 (UMLS CUI [1,1])
    C0441987 (UMLS CUI [1,2])
    Side of vaccination
    Code List
    Side of vaccination
    CL Item
    Dominant (D)
    CL Item
    Non-dominant (N)
    Item
    Site of vaccination
    text
    C0042210 (UMLS CUI [1,1])
    C1515974 (UMLS CUI [1,2])
    Site of vaccination
    Code List
    Site of vaccination
    CL Item
    Deltoid (1)
    CL Item
    Thigh (3)
    CL Item
    Buttock (6)
    Item
    Route of vaccination
    text
    C0042210 (UMLS CUI [1,1])
    C0013153 (UMLS CUI [1,2])
    Route of vaccination
    Code List
    Route of vaccination
    CL Item
    I.M. (IM)
    CL Item
    S.C. (SC)
    Item Group
    Immediate Post-Vaccination Observation
    C0042196 (UMLS CUI-1)
    C0700325 (UMLS CUI-2)
    Did the subject experience any urticaria / rash within 30 minutes after the vaccine administration?
    Item
    Did the subject experience any urticaria / rash within 30 minutes after the vaccine administration?
    boolean
    C2368628 (UMLS CUI [1,1])
    C0042109 (UMLS CUI [1,2])
    C2368628 (UMLS CUI [2,1])
    C0015230 (UMLS CUI [2,2])
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