0 Ratings

ID

36166

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

Keywords

  1. 22/04/2019 22/04/2019 -
Copyright Holder

GlaxoSmithKline

Uploaded on

22 avril 2019

DOI

To request one please log in.

License

Creative Commons BY-NC 3.0

Model comments :

You can comment on the data model here. Via the speech bubbles at the itemgroups and items you can add comments to those specificially.

Itemgroup comments for :

Item comments for :


    No comments

    In order to download data models you must be logged in. Please log in or register for free.

    Candidate HPV-16/18 L1 VLP A04 Vaccine in Young Adult Women Vaccinated in Phase IIb, NCT00518336

    Concomitant Vaccination

    Administrative Data
    Description

    Administrative Data

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

    Clinical Trial Subject Unique Identifier

    Data type

    integer

    Alias
    UMLS CUI [1]
    C2348585 (Clinical Trial Subject Unique Identifier)
    Concomitant Vaccination
    Description

    Concomitant Vaccination

    Alias
    UMLS CUI-1
    C0042196 (Vaccination)
    SNOMED
    33879002
    LOINC
    LP29692-8
    UMLS CUI-2
    C2347852 (Concomitant Agent)
    Have any HPV vaccine other than that used in the study HPV-001 or any investigational vaccine been administered at any time during the study?
    Description

    Human Papilloma Virus Vaccine, Other

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C1512511 (Human Papilloma Virus Vaccine)
    UMLS CUI [1,2]
    C0205394 (Other)
    SNOMED
    74964007
    LOINC
    LP21049-9
    Trade / (Generic) Name
    Description

    Vaccination, Concomitant Agent, Medication Name

    Data type

    text

    Alias
    UMLS CUI [1,1]
    C0042196 (Vaccination)
    SNOMED
    33879002
    LOINC
    LP29692-8
    UMLS CUI [1,2]
    C2347852 (Concomitant Agent)
    UMLS CUI [1,3]
    C2360065 (Medication name)
    LOINC
    MTHU027854
    Route
    Description

    Vaccination, Concomitant Agent, Drug Administration Routes

    Data type

    text

    Alias
    UMLS CUI [1,1]
    C0042196 (Vaccination)
    SNOMED
    33879002
    LOINC
    LP29692-8
    UMLS CUI [1,2]
    C2347852 (Concomitant Agent)
    UMLS CUI [1,3]
    C0013153 (Drug Administration Routes)
    SNOMED
    410675002
    LOINC
    LP40261-7
    Administration date
    Description

    Vaccination, Concomitant Agent, Date in time

    Data type

    date

    Alias
    UMLS CUI [1,1]
    C0042196 (Vaccination)
    SNOMED
    33879002
    LOINC
    LP29692-8
    UMLS CUI [1,2]
    C2347852 (Concomitant Agent)
    UMLS CUI [1,3]
    C0011008 (Date in time)
    SNOMED
    410671006

    Similar models

    Concomitant Vaccination

    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
    Concomitant Vaccination
    C0042196 (UMLS CUI-1)
    C2347852 (UMLS CUI-2)
    Human Papilloma Virus Vaccine, Other
    Item
    Have any HPV vaccine other than that used in the study HPV-001 or any investigational vaccine been administered at any time during the study?
    boolean
    C1512511 (UMLS CUI [1,1])
    C0205394 (UMLS CUI [1,2])
    Vaccination, Concomitant Agent, Medication Name
    Item
    Trade / (Generic) Name
    text
    C0042196 (UMLS CUI [1,1])
    C2347852 (UMLS CUI [1,2])
    C2360065 (UMLS CUI [1,3])
    Vaccination, Concomitant Agent, Drug Administration Routes
    Item
    Route
    text
    C0042196 (UMLS CUI [1,1])
    C2347852 (UMLS CUI [1,2])
    C0013153 (UMLS CUI [1,3])
    Vaccination, Concomitant Agent, Date in time
    Item
    Administration date
    date
    C0042196 (UMLS CUI [1,1])
    C2347852 (UMLS CUI [1,2])
    C0011008 (UMLS CUI [1,3])

    Do you need help on how to use the search function? Please watch the corresponding tutorial video for more details and learn how to use the search function most efficiently.

    Watch Tutorial