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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

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Versions (1)
  1. 4/22/19 4/22/19 -
Copyright Holder

GlaxoSmithKline

Uploaded on

April 22, 2019

DOI

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License

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

    Concomitant Vaccination

    1 forms  
    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
    Concomitant Vaccination
    Description

    Concomitant Vaccination

    Alias
    UMLS CUI-1
    C0042196
    UMLS CUI-2
    C2347852
    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
    UMLS CUI [1,2]
    C0205394
    Trade / (Generic) Name
    Description

    Vaccination, Concomitant Agent, Medication Name

    Data type

    text

    Alias
    UMLS CUI [1,1]
    C0042196
    UMLS CUI [1,2]
    C2347852
    UMLS CUI [1,3]
    C2360065
    Route
    Description

    Vaccination, Concomitant Agent, Drug Administration Routes

    Data type

    text

    Alias
    UMLS CUI [1,1]
    C0042196
    UMLS CUI [1,2]
    C2347852
    UMLS CUI [1,3]
    C0013153
    Administration date
    Description

    Vaccination, Concomitant Agent, Date in time

    Data type

    date

    Alias
    UMLS CUI [1,1]
    C0042196
    UMLS CUI [1,2]
    C2347852
    UMLS CUI [1,3]
    C0011008
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    Similar models

    Concomitant Vaccination

    1 forms
    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])
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