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36169

Description

Study ID: 109616 (Y7) Clinical Study ID: 109616 (Y7) Study Title: A blinded long-term follow-up study of the efficacy of candidate HPV-16/18 L1 VLP AS04 vaccine in young adult women in Brazil vaccinated in the phase IIb, double-blind, multi- center primary study HPV-001 and having participated in the follow-up study HPV-007 Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00518336 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 2 Study Recruitment Status: Completed Generic Name: HPV Vaccine Trade Name: Cervarix Study Indication: Infections, Papillomavirus

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Versions (1)
  1. 4/22/19 4/22/19 -
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GlaxoSmithKline

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April 22, 2019

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Creative Commons BY-NC 3.0
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    Candidate HPV-16/18 L1 VLP A04 Vaccine in Young Adult Women Vaccinated in Phase IIb, NCT00518336

    English

    Study Conclusion

    1 forms  
    1. StudyEvent: ODM
      1. Study Conclusion
    Administrative Data
    Description

    Administrative Data

    Alias
    UMLS CUI-1
    C1320722
    Subject Number
    Description

    Clinical Trial Subject Unique Identifier

    Data type

    integer

    Alias
    UMLS CUI [1]
    C2348585
    Occurrence of Serious Adverse Event
    Description

    Occurrence of Serious Adverse Event

    Alias
    UMLS CUI-1
    C1519255
    Did the subject experience any Serious Adverse Event since the last visit of HPV-007?
    Description

    Serious Adverse Event

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C1519255
    Specify total number of SAE's
    Description

    Serious Adverse Event, Numbers

    Data type

    integer

    Alias
    UMLS CUI [1,1]
    C1519255
    UMLS CUI [1,2]
    C0237753
    Pregnancy Information
    Description

    Pregnancy Information

    Alias
    UMLS CUI-1
    C0032961
    UMLS CUI-2
    C1533716
    Did the subject become pregnant since the last visit of HPV-007?
    Description

    Pregnancy, Clinical Trials

    Data type

    text

    Alias
    UMLS CUI [1,1]
    C0032961
    UMLS CUI [1,2]
    C0008976
    Status of Treatment Blind
    Description

    Status of Treatment Blind

    Alias
    UMLS CUI-1
    C2347038
    UMLS CUI-2
    C0449438
    Was the treatment blind broken during the study?
    Description

    Subject Unblinding Event Record

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C3897431
    If Yes, complete Date
    Description

    Subject Unblinding Event Record, Date in time

    Data type

    date

    Alias
    UMLS CUI [1,1]
    C3897431
    UMLS CUI [1,2]
    C0011008
    If Yes, tick one reason below
    Description

    Subject Unblinding Event Record, Reason

    Data type

    text

    Alias
    UMLS CUI [1,1]
    C3897431
    UMLS CUI [1,2]
    C0566251
    Elimination Criteria
    Description

    Elimination Criteria

    Alias
    UMLS CUI-1
    C0680251
    Did any elimination criteria become applicable during the study?
    Description

    Exclusion Criteria

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0680251
    Specify
    Description

    Exclusion Criteria

    Data type

    text

    Alias
    UMLS CUI [1]
    C0680251
    Withdrawal
    Description

    Withdrawal

    Alias
    UMLS CUI-1
    C2349954
    Was the subject withdrawn from the study?
    Description

    Withdraw

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C2349954
    Major reason for withdrawal (tick one box only)
    Description

    Withdraw, Reason

    Data type

    text

    Alias
    UMLS CUI [1,1]
    C2349954
    UMLS CUI [1,2]
    C0566251
    Who made the decision?
    Description

    Withdraw, Decision

    Data type

    text

    Alias
    UMLS CUI [1,1]
    C2349954
    UMLS CUI [1,2]
    C0679006
    Date of last contact
    Description

    Withdraw Date last contact

    Data type

    date

    Alias
    UMLS CUI [1,1]
    C2349954
    UMLS CUI [1,2]
    C0805839
    Was the subject in good condition at date of last contact?
    Description

    Withdraw, Date last contact, General physical condition

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C2349954
    UMLS CUI [1,2]
    C0805839
    UMLS CUI [1,3]
    C1142435
    Investigator's Signature
    Description

    Investigator's Signature

    Alias
    UMLS CUI-1
    C2346576
    Investigator's signature
    Description

    I confirm that I have reviewed the data in this Case Report Form for this subject. All information entered by myself or my colleagues is, to the best of my knowledge, complete and accurate, as of the date below.

    Data type

    text

    Alias
    UMLS CUI [1]
    C2346576
    Date
    Description

    Investigator Signature, Date in time

    Data type

    date

    Alias
    UMLS CUI [1,1]
    C2346576
    UMLS CUI [1,2]
    C0011008
    Printed Investigator's name
    Description

    Investigator Name

    Data type

    text

    Alias
    UMLS CUI [1]
    C2826892
    Cervical Colposcopy Diagram
    Description

    Cervical Colposcopy Diagram

    Alias
    UMLS CUI-1
    C0009417
    UMLS CUI-2
    C0681494
    Please indicate in the diagram the precise type(s) and location(s) of lesion(s) according to the abbreviated list below.
    Description

    L Leukoplakia W White Epithelium P Punctation M Mosaic V Atypical Vessels C Condyloma Po Polyp E Erosion/ Ulceration X Biopsy Sites I Invasive Carcinoma

    Data type

    text

    Alias
    UMLS CUI [1,1]
    C0009417
    UMLS CUI [1,2]
    C0221198
    UMLS CUI [1,3]
    C0450429
    UMLS CUI [1,4]
    C0332307
    Use of Human Samples by GSK
    Description

    Use of Human Samples by GSK

    Alias
    UMLS CUI-1
    C0022885
    UMLS CUI-2
    C0457083
    In addition to the use of samples for the tests described in the protocol, samples might be used for other resarch by GSK (see protocol). Please tick what is also covered by the subject Informed Consent form of your center.
    Description

    Laboratory Procedures, Usage

    Data type

    text

    Alias
    UMLS CUI [1,1]
    C0022885
    UMLS CUI [1,2]
    C0457083
    Please tick below box if a 15 years GSK storage period is covered by the subject’s Informed Consent form of your center.
    Description

    Laboratory Procedures, Storage, Duration

    Data type

    text

    Alias
    UMLS CUI [1,1]
    C0022885
    UMLS CUI [1,2]
    C1698986
    UMLS CUI [1,3]
    C0449238
    ICF Effective date
    Description

    Date in time, Consent Forms

    Data type

    date

    Alias
    UMLS CUI [1,1]
    C0011008
    UMLS CUI [1,2]
    C0009797
    Investigator's Signature
    Description

    Investigator's Signature

    Alias
    UMLS CUI-1
    C2346576
    Investigator's signature
    Description

    Investigator Signature

    Data type

    text

    Alias
    UMLS CUI [1]
    C2346576
    Date
    Description

    Investigator Signature, Date in time

    Data type

    date

    Alias
    UMLS CUI [1,1]
    C2346576
    UMLS CUI [1,2]
    C0011008
    Printed Investigator's name
    Description

    Investigator Name

    Data type

    text

    Alias
    UMLS CUI [1]
    C2826892
    Reason for Non-Participation
    Description

    Reason for Non-Participation

    Alias
    UMLS CUI-1
    C0558080
    UMLS CUI-2
    C0679823
    UMLS CUI-3
    C0392360
    Previous Subject Number
    Description

    Clinical Trial Subject Unique Identifier, Previous

    Data type

    integer

    Alias
    UMLS CUI [1,1]
    C2348585
    UMLS CUI [1,2]
    C0205156
    Date of Birth
    Description

    Patient date of birth

    Data type

    date

    Alias
    UMLS CUI [1]
    C0421451
    Reason for non participation
    Description

    Unwilling, participation, Indication

    Data type

    text

    Alias
    UMLS CUI [1,1]
    C0558080
    UMLS CUI [1,2]
    C0679823
    UMLS CUI [1,3]
    C0392360
    Reason for non participation - Specifications
    Description

    Unwilling, participation, Indication

    Data type

    text

    Alias
    UMLS CUI [1,1]
    C0558080
    UMLS CUI [1,2]
    C0679823
    UMLS CUI [1,3]
    C0392360
    Date of Contact
    Description

    Date last contact

    Data type

    date

    Alias
    UMLS CUI [1]
    C0805839
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    Similar models

    Study Conclusion

    1 forms
    1. StudyEvent: ODM
      1. Study Conclusion
    Name
    Type
    Description | Question | Decode (Coded Value)
    Data type
    Alias
    Item Group
    Administrative Data
    C1320722 (UMLS CUI-1)
    Clinical Trial Subject Unique Identifier
    Item
    Subject Number
    integer
    C2348585 (UMLS CUI [1])
    Item Group
    Occurrence of Serious Adverse Event
    C1519255 (UMLS CUI-1)
    Serious Adverse Event
    Item
    Did the subject experience any Serious Adverse Event since the last visit of HPV-007?
    boolean
    C1519255 (UMLS CUI [1])
    Serious Adverse Event, Numbers
    Item
    Specify total number of SAE's
    integer
    C1519255 (UMLS CUI [1,1])
    C0237753 (UMLS CUI [1,2])
    Item Group
    Pregnancy Information
    C0032961 (UMLS CUI-1)
    C1533716 (UMLS CUI-2)
    Item
    Did the subject become pregnant since the last visit of HPV-007?
    text
    C0032961 (UMLS CUI [1,1])
    C0008976 (UMLS CUI [1,2])
    Pregnancy, Clinical Trials
    Code List
    Did the subject become pregnant since the last visit of HPV-007?
    CL Item
    No (1)
    CL Item
    Yes (2)
    CL Item
    Not Applicable (3)
    Item Group
    Status of Treatment Blind
    C2347038 (UMLS CUI-1)
    C0449438 (UMLS CUI-2)
    Subject Unblinding Event Record
    Item
    Was the treatment blind broken during the study?
    boolean
    C3897431 (UMLS CUI [1])
    Subject Unblinding Event Record, Date in time
    Item
    If Yes, complete Date
    date
    C3897431 (UMLS CUI [1,1])
    C0011008 (UMLS CUI [1,2])
    Item
    If Yes, tick one reason below
    text
    C3897431 (UMLS CUI [1,1])
    C0566251 (UMLS CUI [1,2])
    Subject Unblinding Event Record, Reason
    Code List
    If Yes, tick one reason below
    CL Item
    Medical emergency requiring identification of investigational product for further treatments (1)
    CL Item
    Other (2)
    Item Group
    Elimination Criteria
    C0680251 (UMLS CUI-1)
    Exclusion Criteria
    Item
    Did any elimination criteria become applicable during the study?
    boolean
    C0680251 (UMLS CUI [1])
    Exclusion Criteria
    Item
    Specify
    text
    C0680251 (UMLS CUI [1])
    Item Group
    Withdrawal
    C2349954 (UMLS CUI-1)
    Withdraw
    Item
    Was the subject withdrawn from the study?
    boolean
    C2349954 (UMLS CUI [1])
    Item
    Major reason for withdrawal (tick one box only)
    text
    C2349954 (UMLS CUI [1,1])
    C0566251 (UMLS CUI [1,2])
    Withdraw, Reason
    Code List
    Major reason for withdrawal (tick one box only)
    CL Item
    Serious adverse event (Please complete and submit SAE report, Please specify SAE No.) (1)
    CL Item
    Non-Serious adverse event (Please complete Non-serious Adverse Event section, Please specify AE No.) (2)
    CL Item
    Protocol violation (please specify) (3)
    CL Item
    Consent withdrawal, not due to an adverse event (4)
    CL Item
    Administration of any HPV vaccine other than that used in study HPV-001 (5)
    CL Item
    Unblinding to allow the subject to decide if she will consider immunization with a licensed HPV vaccine. (6)
    CL Item
    Migrated / moved from the study area (7)
    CL Item
    Lost to follow-up. (8)
    CL Item
    Other, please specify (9)
    Item
    Who made the decision?
    text
    C2349954 (UMLS CUI [1,1])
    C0679006 (UMLS CUI [1,2])
    Withdraw, Decision
    Code List
    Who made the decision?
    CL Item
    Investigator  (1)
    CL Item
    Subject (2)
    Withdraw Date last contact
    Item
    Date of last contact
    date
    C2349954 (UMLS CUI [1,1])
    C0805839 (UMLS CUI [1,2])
    Withdraw, Date last contact, General physical condition
    Item
    Was the subject in good condition at date of last contact?
    boolean
    C2349954 (UMLS CUI [1,1])
    C0805839 (UMLS CUI [1,2])
    C1142435 (UMLS CUI [1,3])
    Item Group
    Investigator's Signature
    C2346576 (UMLS CUI-1)
    Investigator Signature
    Item
    Investigator's signature
    text
    C2346576 (UMLS CUI [1])
    Investigator Signature, Date in time
    Item
    Date
    date
    C2346576 (UMLS CUI [1,1])
    C0011008 (UMLS CUI [1,2])
    Investigator Name
    Item
    Printed Investigator's name
    text
    C2826892 (UMLS CUI [1])
    Item Group
    Cervical Colposcopy Diagram
    C0009417 (UMLS CUI-1)
    C0681494 (UMLS CUI-2)
    Colposcopy, Diagram, Lesion, Location, Type
    Item
    Please indicate in the diagram the precise type(s) and location(s) of lesion(s) according to the abbreviated list below.
    text
    C0009417 (UMLS CUI [1,1])
    C0221198 (UMLS CUI [1,2])
    C0450429 (UMLS CUI [1,3])
    C0332307 (UMLS CUI [1,4])
    Item Group
    Use of Human Samples by GSK
    C0022885 (UMLS CUI-1)
    C0457083 (UMLS CUI-2)
    Item
    In addition to the use of samples for the tests described in the protocol, samples might be used for other resarch by GSK (see protocol). Please tick what is also covered by the subject Informed Consent form of your center.
    text
    C0022885 (UMLS CUI [1,1])
    C0457083 (UMLS CUI [1,2])
    Laboratory Procedures, Usage
    Code List
    In addition to the use of samples for the tests described in the protocol, samples might be used for other resarch by GSK (see protocol). Please tick what is also covered by the subject Informed Consent form of your center.
    CL Item
    Quality Assurance of tests described in the protocol. This may include the management of t equality of these current tests, the maintenance or improvement of these current tests, the development of new test methods for the markers described in the protocol as well as making sure that new tests are comparable to previous methods and work reliably. (1)
    CL Item
    Further investigation by GSK Biologicals into the ability of HPV- vaccine to protect people if any findings from related studies require it and further research in cervical cancer. These investigations excludes genetics and HIV testing. (2)
    CL Item
    Further investigation by GSK Biologicals into the ability of HPV- vaccine to protect people if any findings from related studies require it and further research in cervical cancer. These investigations excludes genetic and HIV testing. Investigator will always ask in advance the permission of the independent Ethics Committee/Institutional Review Board linked to the institution where this research is performed. (3)
    Item
    Please tick below box if a 15 years GSK storage period is covered by the subject’s Informed Consent form of your center.
    text
    C0022885 (UMLS CUI [1,1])
    C1698986 (UMLS CUI [1,2])
    C0449238 (UMLS CUI [1,3])
    Laboratory Procedures, Storage, Duration
    Code List
    Please tick below box if a 15 years GSK storage period is covered by the subject’s Informed Consent form of your center.
    CL Item
    At least 15 years storage period by GSK Biologicals  (1)
    CL Item
    Other,specify (2)
    Date in time, Consent Forms
    Item
    ICF Effective date
    date
    C0011008 (UMLS CUI [1,1])
    C0009797 (UMLS CUI [1,2])
    Item Group
    Investigator's Signature
    C2346576 (UMLS CUI-1)
    Investigator Signature
    Item
    Investigator's signature
    text
    C2346576 (UMLS CUI [1])
    Investigator Signature, Date in time
    Item
    Date
    date
    C2346576 (UMLS CUI [1,1])
    C0011008 (UMLS CUI [1,2])
    Investigator Name
    Item
    Printed Investigator's name
    text
    C2826892 (UMLS CUI [1])
    Item Group
    Reason for Non-Participation
    C0558080 (UMLS CUI-1)
    C0679823 (UMLS CUI-2)
    C0392360 (UMLS CUI-3)
    Clinical Trial Subject Unique Identifier, Previous
    Item
    Previous Subject Number
    integer
    C2348585 (UMLS CUI [1,1])
    C0205156 (UMLS CUI [1,2])
    Patient date of birth
    Item
    Date of Birth
    date
    C0421451 (UMLS CUI [1])
    Item
    Reason for non participation
    text
    C0558080 (UMLS CUI [1,1])
    C0679823 (UMLS CUI [1,2])
    C0392360 (UMLS CUI [1,3])
    Unwilling, participation, Indication
    Code List
    Reason for non participation
    CL Item
    Subject not eligible (Please specify criteria that are not fulfilled) (1)
    CL Item
    Subject lost to follow-up or not reached (2)
    CL Item
    Subject eligible but not willing to participate due to Adverse event(s), or serious adverse event (Please specify), Other (Please specify) (3)
    CL Item
    Subject died on (4)
    Item
    Reason for non participation - Specifications
    text
    C0558080 (UMLS CUI [1,1])
    C0679823 (UMLS CUI [1,2])
    C0392360 (UMLS CUI [1,3])
    Unwilling, participation, Indication
    Code List
    Reason for non participation - Specifications
    Date last contact
    Item
    Date of Contact
    date
    C0805839 (UMLS CUI [1])
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