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22912

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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

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  1. 16-06-17 16-06-17 -
  2. 19-09-17 19-09-17 -
  3. 20-09-21 20-09-21 -
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GlaxoSmithKline

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16 juni 2017

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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)

    Engels

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

    1 Formulieren  
    General Information
    Beschrijving

    General Information

    Centre number
    Beschrijving

    Centre number

    Datatype

    integer

    Subject number
    Beschrijving

    Subject number

    Datatype

    integer

    General Instructions
    Beschrijving

    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.

    Datatype

    text

    Informed Consent Date
    Beschrijving

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

    Datatype

    date

    Demographics
    Beschrijving

    Demographics

    Center number
    Beschrijving

    Center number

    Datatype

    integer

    Date of birth
    Beschrijving

    Date of birth

    Datatype

    date

    Gender
    Beschrijving

    Gender

    Datatype

    text

    Race
    Beschrijving

    Race

    Datatype

    text

    Laboratory tests
    Beschrijving

    Laboratory tests

    Has a blood sample been taken for testing anti-HAV and anti-HBs antibodies?
    Beschrijving

    anti-HAV and anti-HBs antibodies

    Datatype

    text

    Date of Blood Sample
    Beschrijving

    Please complete only if different from visit date

    Datatype

    date

    Has the subject received a dose of monovalent or combined Hepatitis A or Hepatitis B vaccine sind the last visit?
    Beschrijving

    Has the subject received a dose of monovalent or combined Hepatitis A or Hepatitis B vaccine sind the last visit?

    Datatype

    text

    Please specify
    Beschrijving

    Specification of monovalent or combined Hepatitis A or Hepatitis B vaccine

    Datatype

    text

    A dose of Hepatitis A or Hepatitis B immunoglobulins within 6 months prior to bleeding?
    Beschrijving

    dose of Hepatitis A or Hepatitis B immunoglobulins 6 months prior to bleeding

    Datatype

    text

    Please specify
    Beschrijving

    Specification of dose of Hepatitis A or Hepatitis B immunoglobulins within 6 months prior to bleeding

    Datatype

    text

    Would the subject be willing to participate in a follow-up study?
    Beschrijving

    Follow-up studies

    Datatype

    text

    Adverse Events, or Serious Adverse Events
    Beschrijving

    Adverse Events, or Serious Adverse Events

    Datatype

    boolean

    please specify
    Beschrijving

    Specification of Adverse Events, or Serious Adverse Events

    Datatype

    text

    Other
    Beschrijving

    Other

    Datatype

    boolean

    Please specify
    Beschrijving

    Specification of other

    Datatype

    text

    Study Conclusion
    Beschrijving

    Study Conclusion

    Did the subject experience any Serious Adverse Event during the study period?
    Beschrijving

    Occurence of Serious Adverse Event

    Datatype

    text

    Total number of SAE´s
    Beschrijving

    Total number of SAE´s

    Datatype

    integer

    Did the subject become pregnant during the study?
    Beschrijving

    Pregnancy information

    Datatype

    text

    Investigator´s signature
    Beschrijving

    Investigator´s signature

    Text to confirm
    Beschrijving

    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.

    Datatype

    text

    Investigator´s signature
    Beschrijving

    Investigator´s signature

    Datatype

    text

    Date
    Beschrijving

    Date

    Datatype

    date

    Printed Investigator´s name name
    Beschrijving

    Printed Investigator´s name

    Datatype

    text

    Tracking Document - Reason for non participation
    Beschrijving

    Tracking Document - Reason for non participation

    Previous subject number
    Beschrijving

    Previous subject number

    Datatype

    integer

    Date of birth
    Beschrijving

    Date of birth

    Datatype

    date

    1. Subject not eligible?
    Beschrijving

    Subject not eligible

    Datatype

    boolean

    Please specify criteria that are not fullfilled
    Beschrijving

    Specifiation of eiligibility

    Datatype

    text

    Subject lost to follow-up or not reached
    Beschrijving

    Subject lost to follow-up or not reached

    Datatype

    boolean

    Subject eligible but not willing to participate due to
    Beschrijving

    Subject eligible but not willing to participate due to

    Datatype

    text

    Specification of reason not willing to participate
    Beschrijving

    Specification of reason not willing to participate

    Datatype

    text

    Subject died on
    Beschrijving

    date of death

    Datatype

    date

    Investigator name
    Beschrijving

    Investigator name

    Datatype

    text

    Signature
    Beschrijving

    Signature

    Datatype

    text

    Date
    Beschrijving

    Date

    Datatype

    date

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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 Formulieren
    Name
    Type
    Description | Question | Decode (Coded Value)
    Datatype
    Alias
    Item Group
    General Information
    Centre number
    Item
    Centre number
    integer
    Subject number
    Item
    Subject number
    integer
    General Instructions
    Item
    General Instructions
    text
    Informed Consent
    Item
    Informed Consent Date
    date
    Item Group
    Demographics
    Center number
    Item
    Center number
    integer
    Date of birth
    Item
    Date of birth
    date
    Item
    Gender
    text
    Gender
    Code List
    Gender
    CL Item
    male (1)
    CL Item
    female (2)
    Item
    Race
    text
    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
    Item
    Has a blood sample been taken for testing anti-HAV and anti-HBs antibodies?
    text
    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
    Item
    Has the subject received a dose of monovalent or combined Hepatitis A or Hepatitis B vaccine sind the last visit?
    text
    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)
    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
    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)
    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
    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
    Specification of Adverse Events, or Serious Adverse Events
    Item
    please specify
    text
    Other
    Item
    Other
    boolean
    Specification of other
    Item
    Please specify
    text
    Item Group
    Study Conclusion
    Item
    Did the subject experience any Serious Adverse Event during the study period?
    text
    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)
    Total number of SAE´s
    Item
    Total number of SAE´s
    integer
    Item
    Did the subject become pregnant during the study?
    text
    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
    Text to confirm
    Item
    Text to confirm
    text
    Investigator´s signature
    Item
    Investigator´s signature
    text
    Date
    Item
    Date
    date
    Printed Investigator´s name
    Item
    Printed Investigator´s name name
    text
    Item Group
    Tracking Document - Reason for non participation
    Previous subject number
    Item
    Previous subject number
    integer
    Date of birth
    Item
    Date of birth
    date
    Subject not eligible
    Item
    1. Subject not eligible?
    boolean
    Specifiation of eiligibility
    Item
    Please specify criteria that are not fullfilled
    text
    Subject lost to follow-up or not reached
    Item
    Subject lost to follow-up or not reached
    boolean
    Item
    Subject eligible but not willing to participate due to
    text
    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)
    Specification of reason not willing to participate
    Item
    Specification of reason not willing to participate
    text
    date of death
    Item
    Subject died on
    date
    Investigator name
    Item
    Investigator name
    text
    Signature
    Item
    Signature
    text
    Date
    Item
    Date
    date
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