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Study ID: 100551 (EXT Y11) Clinical Study ID: 100551 Study Title: A double blind randomised, comparative study of the immunogenicity and reactogenicity of three different lots of GlaxoSmithKline Biologicals’ combined hepatitis A - hepatitis B vaccine when administered in healthy adults Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00289770 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: phase 3 Study Recruitment Status: Completed Generic Name: Hepatitis A (Inactivated), Hepatitis B (Recombinant) Vaccine Trade Name: Twinrix Study Indication: Hepatitis A; Hepatitis B

Nyckelord

Versioner (3)
  1. 2017-06-16 2017-06-16 -
  2. 2017-09-19 2017-09-19 -
  3. 2021-09-20 2021-09-20 -
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20 september 2021

DOI

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Creative Commons BY-NC 3.0
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    Comparative study of the immunogenicity and reactogenicity of three different lots of GlaxoSmithKline Biologicals’ combined hepatitis A - hepatitis B (Visit 20 Year 14)

    Engelsk

    Comparative study of the immunogenicity and reactogenicity of three different lots of GlaxoSmithKline Biologicals’ combined hepatitis A - hepatitis B (Visit 20 Year 14)

    1 Formulär  
    General Information
    Beskrivning

    General Information

    Alias
    UMLS CUI-1
    C1508263
    Centre number
    Beskrivning

    Centre number

    Datatyp

    integer

    Alias
    UMLS CUI [1,1]
    C0600091
    UMLS CUI [1,2]
    C0019994
    Subject number
    Beskrivning

    Subject number

    Datatyp

    integer

    Alias
    UMLS CUI [1]
    C2348585
    General Instructions
    Beskrivning

    Print clearly in CAPITAL LETTERS using a black fountain or ball-point pen and press firmly so that all copies are legible. Insert the writing board beneath all copies of the form being completed. Fill in the Subject Number on every page and answer all questions except where otherwise indicated. Do not write in shaded areas which are qualified “For GSK”. Information written in these areas are not the responsibility of the investigator. ABBREVIATIONS: Abbreviations for medical conditions, clinical events or drug names should not be used. Units and route of administration of medication may be abbreviated. NA: not applicable. ERRORS/CORRECTIONS: Errors should be crossed out with a single line and the alteration made as near to the original as possible. All alterations must be printed, initialled and dated by the investigator or authorised staff. DATES Use the following three-letter abbreviations for each month: January = JAN February = FEB March = MAR April = APR May = MAY June = JUN July = JUL August = AUG September = SEP October = OCT November = NOV December = DEC Example: |__|__| |__|__|__| |__|__|__|__|= 1st January 2002 day month year The Serious Adverse Event (SAE) form must be checked for final assessment at the end of the study. For all subjects enrolled, please complete the Study Conclusion form. ADVERSE EVENT DEFINITIONS INTENSITY 1: Mild: An adverse event which is easily tolerated by the subject, causing minimal discomfort and not interfering with everyday activities. 2: Moderate: An adverse event which is sufficiently discomforting to interfere with normal everyday activities. 3: Severe: An adverse event which prevents normal, everyday activities (In adults/ adolescents, such an adverse event would, for example, prevent attendance at work/school and would necessitate the administration of corrective therapy). CAUSALITY / RELATIONSHIP TO INVESTIGATIONAL PRODUCTS Is there a reasonable possibility that the AE may have been caused by the investigational product? NO: The adverse event is not causally related to administration of the study vaccine(s). There are other, more likely causes and administration of the study vaccine(s) is not suspected to have contributed to the adverse event. YES: There is a reasonable possibility that the vaccine contributed to the adverse event. OUTCOME 1: Recovered / Resolved 2: Recovering / Resolving: If the subject is recovering at the time the subject completes the study or at the time the subject dropped out 3: Not recovered / Not resolved: This means an AE ongoing at the time the subject completes the study or becomes lost to follow-up; if AE/SAE was ongoing at the time of death, but was not the cause of death. 4: Recovered with sequelae / Resolved with sequelae SERIOUS ADVERSE EVENT A serious adverse event is any untoward medical occurrence that: • results in death • is life threatening • results in persistent or significant disability / incapacity • requires in-patient hospitalization • prolongation of existing hospitalization • is a congenital anomaly / birth defect in the offspring of a study subject • In addition, important medical events that may jeopardize the subject or may require intervention to prevent one of the other outcomes listed above should be considered serious. (Examples of such events are invasive or malignant cancers, intensive treatment in an emergency room or at home for allergic bronchospasm; blood dyscrasias or convulsions that do not result in hospitalization.) For each serious adverse event, please fill in the Serious Adverse Event (SAE) form and contact GlaxoSmithKline within 24 hours. Informed Consent has to be obtained prior to any study procedure.

    Datatyp

    text

    Alias
    UMLS CUI [1]
    C1508263
    Informed Consent Date
    Beskrivning

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

    Datatyp

    date

    Alias
    UMLS CUI [1]
    C0021430
    Demographics
    Beskrivning

    Demographics

    Alias
    UMLS CUI-1
    C1704791
    Center number
    Beskrivning

    Centre number

    Datatyp

    integer

    Alias
    UMLS CUI [1,1]
    C0600091
    UMLS CUI [1,2]
    C0019994
    Date of birth
    Beskrivning

    Date of birth

    Datatyp

    date

    Alias
    UMLS CUI [1]
    C0421451
    Gender
    Beskrivning

    Gender

    Datatyp

    text

    Alias
    UMLS CUI [1]
    C0079399
    Race
    Beskrivning

    Race

    Datatyp

    text

    Alias
    UMLS CUI [1]
    C0034510
    Laboratory tests
    Beskrivning

    Laboratory tests

    Alias
    UMLS CUI-1
    C0022885
    Has a blood sample been taken for testing anti-HAV and anti-HBs antibodies?
    Beskrivning

    anti-HAV and anti-HBs antibodies

    Datatyp

    text

    Alias
    UMLS CUI [1]
    C0201473
    UMLS CUI [2]
    C0201478
    Date of Blood Sample
    Beskrivning

    Please complete only if different from visit date

    Datatyp

    date

    Alias
    UMLS CUI [1]
    C1317250
    Has the subject received a dose of monovalent or combined Hepatitis A or Hepatitis B vaccine sind the last visit?
    Beskrivning

    Hepatitis A or Hepatitis B vaccine

    Datatyp

    text

    Alias
    UMLS CUI [1]
    C0170300
    UMLS CUI [2]
    C2240392
    Please specify
    Beskrivning

    Hepatitis A or Hepatitis B vaccine: Specification

    Datatyp

    text

    Alias
    UMLS CUI [1,1]
    C0170300
    UMLS CUI [1,2]
    C2348235
    UMLS CUI [2,1]
    C2240392
    UMLS CUI [2,2]
    C2348235
    A dose of Hepatitis A or Hepatitis B immunoglobulins within 6 months prior to bleeding?
    Beskrivning

    Hepatitis A or Hepatitis B immunoglobulins

    Datatyp

    text

    Alias
    UMLS CUI [1]
    C3652495
    UMLS CUI [2]
    C0062525
    Please specify
    Beskrivning

    Hepatitis A or Hepatitis B immunoglobulins: Specification

    Datatyp

    text

    Alias
    UMLS CUI [1,1]
    C3652495
    UMLS CUI [1,2]
    C2348235
    UMLS CUI [2,1]
    C0062525
    UMLS CUI [2,2]
    C2348235
    Would the subject be willing to participate in a follow-up study?
    Beskrivning

    Follow-up studies

    Datatyp

    text

    Alias
    UMLS CUI [1]
    C0016441
    Adverse Events, or Serious Adverse Events
    Beskrivning

    Adverse Events, or Serious Adverse Events

    Datatyp

    boolean

    Alias
    UMLS CUI [1]
    C0877248
    UMLS CUI [2]
    C1519255
    please specify
    Beskrivning

    Adverse Events, or Serious Adverse Events: Specification

    Datatyp

    text

    Alias
    UMLS CUI [1,1]
    C0877248
    UMLS CUI [1,2]
    C2348235
    UMLS CUI [2,1]
    C1519255
    UMLS CUI [2,2]
    C2348235
    Other
    Beskrivning

    Other

    Datatyp

    boolean

    Alias
    UMLS CUI [1]
    C0205394
    Please specify
    Beskrivning

    Other: Specification

    Datatyp

    text

    Alias
    UMLS CUI [1,1]
    C0205394
    UMLS CUI [1,2]
    C2348235
    Study Conclusion
    Beskrivning

    Study Conclusion

    Alias
    UMLS CUI-1
    C1707478
    Did the subject experience any Serious Adverse Event during the study period?
    Beskrivning

    Occurence of Serious Adverse Event

    Datatyp

    text

    Alias
    UMLS CUI [1,1]
    C1519255
    UMLS CUI [1,2]
    C2745955
    Total number of SAE´s
    Beskrivning

    Number of SAE´s

    Datatyp

    integer

    Alias
    UMLS CUI [1,1]
    C0449788
    UMLS CUI [1,2]
    C1519255
    Did the subject become pregnant during the study?
    Beskrivning

    Pregnancy

    Datatyp

    text

    Alias
    UMLS CUI [1]
    C0032961
    Investigator´s signature
    Beskrivning

    Investigator´s signature

    Alias
    UMLS CUI-1
    C2346576
    Text to confirm
    Beskrivning

    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.

    Datatyp

    text

    Alias
    UMLS CUI [1]
    C0750484
    Investigator´s signature
    Beskrivning

    Investigator´s signature

    Datatyp

    text

    Alias
    UMLS CUI [1]
    C2346576
    Date
    Beskrivning

    Date

    Datatyp

    date

    Alias
    UMLS CUI [1]
    C0011008
    Printed Investigator´s name name
    Beskrivning

    Investigator´s name

    Datatyp

    text

    Alias
    UMLS CUI [1]
    C2826892
    Tracking Document - Reason for non participation
    Beskrivning

    Tracking Document - Reason for non participation

    Alias
    UMLS CUI-1
    C3889409
    Previous subject number
    Beskrivning

    Previous subject number

    Datatyp

    integer

    Alias
    UMLS CUI [1,1]
    C2348585
    UMLS CUI [1,2]
    C0205156
    Date of birth
    Beskrivning

    Date of birth

    Datatyp

    date

    Alias
    UMLS CUI [1]
    C0421451
    1. Subject not eligible?
    Beskrivning

    Eligibility

    Datatyp

    boolean

    Alias
    UMLS CUI [1]
    C0013893
    Please specify criteria that are not fullfilled
    Beskrivning

    Eligibility: Specification

    Datatyp

    text

    Alias
    UMLS CUI [1,1]
    C0013893
    UMLS CUI [1,2]
    C2348235
    Subject lost to follow-up or not reached
    Beskrivning

    Lost to follow-up

    Datatyp

    boolean

    Alias
    UMLS CUI [1]
    C1302313
    Subject eligible but not willing to participate due to
    Beskrivning

    Willing to participate

    Datatyp

    text

    Alias
    UMLS CUI [1,1]
    C0600109
    UMLS CUI [1,2]
    C2348568
    Specification of reason not willing to participate
    Beskrivning

    Willing to participate: Specification

    Datatyp

    text

    Alias
    UMLS CUI [1,1]
    C0600109
    UMLS CUI [1,2]
    C2348568
    UMLS CUI [1,3]
    C2348235
    Subject died on
    Beskrivning

    Date of death

    Datatyp

    date

    Alias
    UMLS CUI [1]
    C1148348
    Investigator name
    Beskrivning

    Investigator name

    Datatyp

    text

    Alias
    UMLS CUI [1]
    C2826892
    Signature
    Beskrivning

    Signature

    Datatyp

    text

    Alias
    UMLS CUI [1]
    C1519316
    Date
    Beskrivning

    Date

    Datatyp

    date

    Alias
    UMLS CUI [1]
    C0011008
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    Similar models

    Comparative study of the immunogenicity and reactogenicity of three different lots of GlaxoSmithKline Biologicals’ combined hepatitis A - hepatitis B (Visit 20 Year 14)

    1 Formulär
    Name
    Typ
    Description | Question | Decode (Coded Value)
    Datatyp
    Alias
    Item Group
    General Information
    C1508263 (UMLS CUI-1)
    Centre number
    Item
    Centre number
    integer
    C0600091 (UMLS CUI [1,1])
    C0019994 (UMLS CUI [1,2])
    Subject number
    Item
    Subject number
    integer
    C2348585 (UMLS CUI [1])
    General Instructions
    Item
    General Instructions
    text
    C1508263 (UMLS CUI [1])
    Informed Consent
    Item
    Informed Consent Date
    date
    C0021430 (UMLS CUI [1])
    Item Group
    Demographics
    C1704791 (UMLS CUI-1)
    Centre number
    Item
    Center number
    integer
    C0600091 (UMLS CUI [1,1])
    C0019994 (UMLS CUI [1,2])
    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 (1)
    CL Item
    female (2)
    Item
    Race
    text
    C0034510 (UMLS CUI [1])
    Race
    Code List
    Race
    CL Item
    Black (1)
    CL Item
    Arabic/North African (2)
    CL Item
    White/Caucasian (3)
    CL Item
    East & South East Asian (4)
    CL Item
    South Asian (5)
    CL Item
    American Hispanic (6)
    CL Item
    Japanese (7)
    CL Item
    Other, please specify (8)
    Item Group
    Laboratory tests
    C0022885 (UMLS CUI-1)
    Item
    Has a blood sample been taken for testing anti-HAV and anti-HBs antibodies?
    text
    C0201473 (UMLS CUI [1])
    C0201478 (UMLS CUI [2])
    anti-HAV and anti-HBs antibodies
    Code List
    Has a blood sample been taken for testing anti-HAV and anti-HBs antibodies?
    CL Item
    Yes (Please complete the following question) (1)
    CL Item
    No (2)
    Date of blood sample
    Item
    Date of Blood Sample
    date
    C1317250 (UMLS CUI [1])
    Item
    Has the subject received a dose of monovalent or combined Hepatitis A or Hepatitis B vaccine sind the last visit?
    text
    C0170300 (UMLS CUI [1])
    C2240392 (UMLS CUI [2])
    Has the subject received a dose of monovalent or combined Hepatitis A or Hepatitis B vaccine sind the last visit?
    Code List
    Has the subject received a dose of monovalent or combined Hepatitis A or Hepatitis B vaccine sind the last visit?
    CL Item
    Yes (please answer the next item) (1)
    CL Item
    No (2)
    Item
    Please specify
    text
    C0170300 (UMLS CUI [1,1])
    C2348235 (UMLS CUI [1,2])
    C2240392 (UMLS CUI [2,1])
    C2348235 (UMLS CUI [2,2])
    Specification of monovalent or combined Hepatitis A or Hepatitis B vaccine
    Code List
    Please specify
    CL Item
    Hepatitis A vaccine (1)
    CL Item
    Hepatitis B vaccine (2)
    CL Item
    Combined Hepatitis A and B vaccine (3)
    Item
    A dose of Hepatitis A or Hepatitis B immunoglobulins within 6 months prior to bleeding?
    text
    C3652495 (UMLS CUI [1])
    C0062525 (UMLS CUI [2])
    dose of Hepatitis A or Hepatitis B immunoglobulins within 6 months prior to bleeding
    Code List
    A dose of Hepatitis A or Hepatitis B immunoglobulins within 6 months prior to bleeding?
    CL Item
    Yes (please specify) (1)
    CL Item
    No (2)
    Item
    Please specify
    text
    C3652495 (UMLS CUI [1,1])
    C2348235 (UMLS CUI [1,2])
    C0062525 (UMLS CUI [2,1])
    C2348235 (UMLS CUI [2,2])
    Specification of dose of Hepatitis A or Hepatitis B immunoglobulins within 6 months prior to bleeding
    Code List
    Please specify
    CL Item
    Hepatitis A immunoglobulins (1)
    CL Item
    Hepatitis B immunoglobulins (2)
    Item
    Would the subject be willing to participate in a follow-up study?
    text
    C0016441 (UMLS CUI [1])
    Follow-up studies
    Code List
    Would the subject be willing to participate in a follow-up study?
    CL Item
    Yes (1)
    CL Item
    No, please specify the most appropriate reason below (2)
    Adverse Events, or Serious Adverse Events
    Item
    Adverse Events, or Serious Adverse Events
    boolean
    C0877248 (UMLS CUI [1])
    C1519255 (UMLS CUI [2])
    Adverse Events, or Serious Adverse Events: Specification
    Item
    please specify
    text
    C0877248 (UMLS CUI [1,1])
    C2348235 (UMLS CUI [1,2])
    C1519255 (UMLS CUI [2,1])
    C2348235 (UMLS CUI [2,2])
    Other
    Item
    Other
    boolean
    C0205394 (UMLS CUI [1])
    Other: Specification
    Item
    Please specify
    text
    C0205394 (UMLS CUI [1,1])
    C2348235 (UMLS CUI [1,2])
    Item Group
    Study Conclusion
    C1707478 (UMLS CUI-1)
    Item
    Did the subject experience any Serious Adverse Event during the study period?
    text
    C1519255 (UMLS CUI [1,1])
    C2745955 (UMLS CUI [1,2])
    Occurence of Serious Adverse Event
    Code List
    Did the subject experience any Serious Adverse Event during the study period?
    CL Item
    No (1)
    CL Item
    Yes (Specify total number of SAE´s below) (2)
    Number of SAE´s
    Item
    Total number of SAE´s
    integer
    C0449788 (UMLS CUI [1,1])
    C1519255 (UMLS CUI [1,2])
    Item
    Did the subject become pregnant during the study?
    text
    C0032961 (UMLS CUI [1])
    Pregnancy information
    Code List
    Did the subject become pregnant during the study?
    CL Item
    No (1)
    CL Item
    Yes (Complete the Pregnancy Notification form) (2)
    CL Item
    Not Applicable (not of childbearing potential or male) (3)
    Item Group
    Investigator´s signature
    C2346576 (UMLS CUI-1)
    Confirmation
    Item
    Text to confirm
    text
    C0750484 (UMLS CUI [1])
    Investigator´s signature
    Item
    Investigator´s signature
    text
    C2346576 (UMLS CUI [1])
    Date
    Item
    Date
    date
    C0011008 (UMLS CUI [1])
    Investigator´s name
    Item
    Printed Investigator´s name name
    text
    C2826892 (UMLS CUI [1])
    Item Group
    Tracking Document - Reason for non participation
    C3889409 (UMLS CUI-1)
    Previous subject number
    Item
    Previous subject number
    integer
    C2348585 (UMLS CUI [1,1])
    C0205156 (UMLS CUI [1,2])
    Date of birth
    Item
    Date of birth
    date
    C0421451 (UMLS CUI [1])
    Eligibility
    Item
    1. Subject not eligible?
    boolean
    C0013893 (UMLS CUI [1])
    Eligibility: Specification
    Item
    Please specify criteria that are not fullfilled
    text
    C0013893 (UMLS CUI [1,1])
    C2348235 (UMLS CUI [1,2])
    Lost to follow-up
    Item
    Subject lost to follow-up or not reached
    boolean
    C1302313 (UMLS CUI [1])
    Item
    Subject eligible but not willing to participate due to
    text
    C0600109 (UMLS CUI [1,1])
    C2348568 (UMLS CUI [1,2])
    Subject eligible but not willing to participate due to
    Code List
    Subject eligible but not willing to participate due to
    CL Item
    adverse events, or serious adverse event (please specifiy) (1)
    CL Item
    other (please specify) (2)
    Willing to participate: Specification
    Item
    Specification of reason not willing to participate
    text
    C0600109 (UMLS CUI [1,1])
    C2348568 (UMLS CUI [1,2])
    C2348235 (UMLS CUI [1,3])
    Date of death
    Item
    Subject died on
    date
    C1148348 (UMLS CUI [1])
    Investigator name
    Item
    Investigator name
    text
    C2826892 (UMLS CUI [1])
    Signature
    Item
    Signature
    text
    C1519316 (UMLS CUI [1])
    Date
    Item
    Date
    date
    C0011008 (UMLS CUI [1])
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