0 Beoordelingen
ID

24474

Beschrijving

Study ID: 100580 Clinical Study ID: 100580 Study Title: Double-blind, randomized study to evaluate the immunogenicity and reactogenicity of three different lots of GlaxoSmithKline Biologicals' inactivated hepatitis A vaccine containing 1440 EL.U of antigen per mL and injected according to a 0, 6 month schedule in healthy adult subjects Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00289757 https://clinicaltrials.gov/ct2/show/NCT00289757 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: phase 4 Study Recruitment Status: Completed Generic Name: Hepatitis A Vaccine, Inactivated Trade Name: Havrix Study Indication: Hepatitis A Documentation part: Visit 20, Long term Follow-Up, Year 15, Month 180 +/- 2 Months

Link

https://clinicaltrials.gov/ct2/show/NCT00289757

Trefwoorden

Versies (1)
  1. 02-08-17 02-08-17 -
Geüploaded op

2 augustus 2017

DOI

Voor een aanvraag inloggen.

Licentie

Creative Commons BY-NC 3.0
Model Commentaren :

Hier kunt u commentaar leveren op het model. U kunt de tekstballonnen bij de itemgroepen en items gebruiken om er specifiek commentaar op te geven.

Terug naar het model Commentaren
Itemgroep Commentaren voor :

Item Commentaren voor :

  • Nieuwste
  • Oudste
  • Populair
  • Nieuwste
    • Nieuwste
    • Oudste
    • Populair

    Geen commentaren

    U moet ingelogd zijn om formulieren te downloaden. AUB inloggen of schrijf u gratis in.

    Immunogenicity and reactogenicity of GlaxoSmithKline Biologicals' inactivated hepatitis A vaccine Visit 20 100580

    Engels

    Visit 20 Immunogenicity and reactogenicity of GlaxoSmithKline Biologicals' inactivated hepatitis A vaccine 100580

    1 Formulieren  
    Informed Consent
    Beschrijving

    Informed Consent

    Alias
    UMLS CUI-1
    C0021430
    UMLS CUI-2
    C0170300
    Subject Number
    Beschrijving

    Subject Number

    Datatype

    text

    Alias
    UMLS CUI [1]
    C2348585
    Center number
    Beschrijving

    Center number

    Datatype

    text

    Alias
    UMLS CUI [1,1]
    C1301943
    UMLS CUI [1,2]
    C0600091
    Date of Visit
    Beschrijving

    Date of Visit

    Datatype

    date

    Alias
    UMLS CUI [1]
    C1320303
    Informed Consent Date
    Beschrijving

    I certify that Informed Consent has been obtained prior to any study procedure.

    Datatype

    time

    Alias
    UMLS CUI [1,1]
    C0021430
    UMLS CUI [1,2]
    C0011008
    Demographics
    Beschrijving

    Demographics

    Alias
    UMLS CUI-1
    C0011298
    UMLS CUI-2
    C0170300
    Subject Initials
    Beschrijving

    Subject Initials

    Datatype

    text

    Alias
    UMLS CUI [1]
    C2986440
    Date of birth
    Beschrijving

    Date of birth

    Datatype

    date

    Alias
    UMLS CUI [1]
    C0421451
    Gender
    Beschrijving

    Gender

    Datatype

    text

    Alias
    UMLS CUI [1]
    C0079399
    Race
    Beschrijving

    Race

    Datatype

    text

    Alias
    UMLS CUI [1]
    C0034510
    Race, if other please specify
    Beschrijving

    Race

    Datatype

    text

    Alias
    UMLS CUI [1]
    C0034510
    Laboratory Tests
    Beschrijving

    Laboratory Tests

    Alias
    UMLS CUI-1
    C0022885
    UMLS CUI-2
    C0005834
    UMLS CUI-3
    C0170300
    Has a blood sample been taken for serology?
    Beschrijving

    blood sample

    Datatype

    boolean

    Alias
    UMLS CUI [1]
    C0005834
    Has the subject received since the last visit: A dose of Hepatitis A immunoglobulins within 6 months prior to bleeding?
    Beschrijving

    Hepatitis A immunoglobulins

    Datatype

    boolean

    Alias
    UMLS CUI [1]
    C3652495
    Has the subject received a dose of monovalent or combined Hepatitis A vaccine since the last visit? If Yes, please specify
    Beschrijving

    Hepatitis vaccine

    Datatype

    integer

    Alias
    UMLS CUI [1,1]
    C0170300
    UMLS CUI [1,2]
    C3543421
    Did the subject suffer from Hepatitis A since last visit?
    Beschrijving

    Hepatitis A

    Datatype

    boolean

    Alias
    UMLS CUI [1]
    C0019159
    If the subject fulfills criteria for booster administration, does he agree to receive an additional vaccination?
    Beschrijving

    If Yes, the subject will receive Havrix™. Please complete the entire CRF. If No, please complete the SAE section and the study conclusion section only.

    Datatype

    boolean

    Alias
    UMLS CUI [1,1]
    C0042210
    UMLS CUI [1,2]
    C1514756
    Has a blood sample for CMI testing been taken ?
    Beschrijving

    blood sample for CMI testing

    Datatype

    boolean

    Alias
    UMLS CUI [1,1]
    C0013175
    UMLS CUI [1,2]
    C1277698
    Terug naar het begin van de pagina

    Similar models

    Visit 20 Immunogenicity and reactogenicity of GlaxoSmithKline Biologicals' inactivated hepatitis A vaccine 100580

    1 Formulieren
    Name
    Type
    Description | Question | Decode (Coded Value)
    Datatype
    Alias
    Item Group
    Informed Consent
    C0021430 (UMLS CUI-1)
    C0170300 (UMLS CUI-2)
    Subject Number
    Item
    Subject Number
    text
    C2348585 (UMLS CUI [1])
    Center number
    Item
    Center number
    text
    C1301943 (UMLS CUI [1,1])
    C0600091 (UMLS CUI [1,2])
    Date of Visit
    Item
    Date of Visit
    date
    C1320303 (UMLS CUI [1])
    Informed Consent Date
    Item
    Informed Consent Date
    time
    C0021430 (UMLS CUI [1,1])
    C0011008 (UMLS CUI [1,2])
    Item Group
    Demographics
    C0011298 (UMLS CUI-1)
    C0170300 (UMLS CUI-2)
    Subject Initials
    Item
    Subject Initials
    text
    C2986440 (UMLS CUI [1])
    Date of birth
    Item
    Date of birth
    date
    C0421451 (UMLS CUI [1])
    Item
    Gender
    text
    C0079399 (UMLS CUI [1])
    Gender
    Code List
    Gender
    CL Item
    Male (M)
    CL Item
    Female (F)
    Item
    Race
    text
    C0034510 (UMLS CUI [1])
    Race
    Code List
    Race
    CL Item
    White (WH)
    CL Item
    Black (BL)
    CL Item
    Oriental (OR)
    CL Item
    Other (OT)
    Race
    Item
    Race, if other please specify
    text
    C0034510 (UMLS CUI [1])
    Item Group
    Laboratory Tests
    C0022885 (UMLS CUI-1)
    C0005834 (UMLS CUI-2)
    C0170300 (UMLS CUI-3)
    blood sample
    Item
    Has a blood sample been taken for serology?
    boolean
    C0005834 (UMLS CUI [1])
    Hepatitis A immunoglobulins
    Item
    Has the subject received since the last visit: A dose of Hepatitis A immunoglobulins within 6 months prior to bleeding?
    boolean
    C3652495 (UMLS CUI [1])
    Item
    Has the subject received a dose of monovalent or combined Hepatitis A vaccine since the last visit? If Yes, please specify
    integer
    C0170300 (UMLS CUI [1,1])
    C3543421 (UMLS CUI [1,2])
    Hepatitis vaccine
    Code List
    Has the subject received a dose of monovalent or combined Hepatitis A vaccine since the last visit? If Yes, please specify
    CL Item
    Hepatitis A vaccine (1)
    CL Item
    Combined Hepatitis A (or other) vaccine (2)
    Hepatitis A
    Item
    Did the subject suffer from Hepatitis A since last visit?
    boolean
    C0019159 (UMLS CUI [1])
    receive additional vaccination
    Item
    If the subject fulfills criteria for booster administration, does he agree to receive an additional vaccination?
    boolean
    C0042210 (UMLS CUI [1,1])
    C1514756 (UMLS CUI [1,2])
    blood sample for CMI testing
    Item
    Has a blood sample for CMI testing been taken ?
    boolean
    C0013175 (UMLS CUI [1,1])
    C1277698 (UMLS CUI [1,2])
    Terug naar het begin van de pagina 

    Help

    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