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43666

Description

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

Keywords

Versions (3)
  1. 6/26/17 6/26/17 -
  2. 9/26/17 9/26/17 -
  3. 9/20/21 9/20/21 -
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September 20, 2021

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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 17 Year 11)

    English

    Comparative study of the immunogenicity and reactogenicity of three different lots of GlaxoSmithKline Biologicals’ combined hepatitis A - hepatitis B (Visit 17 Year 11)

    1 forms  
    Introductional information
    Description

    Introductional information

    Alias
    UMLS CUI-1
    C1533716 (Information)
    Taken note of introductional text
    Description

    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 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.

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C1533716 (Information)
    General Information
    Description

    General Information

    Alias
    UMLS CUI-1
    C1508263 (General information section)
    LOINC
    MTHU015719
    Date of visit
    Description

    Date of visit

    Data type

    date

    Alias
    UMLS CUI [1]
    C1320303 (Date of visit)
    SNOMED
    406543005
    Subject number
    Description

    Subject number

    Data type

    integer

    Alias
    UMLS CUI [1]
    C2348585 (Clinical Trial Subject Unique Identifier)
    I certify that Informed Consent has been obtained prior to any study procedure. Informed Consent Date
    Description

    Informed consent

    Data type

    date

    Alias
    UMLS CUI [1]
    C0021430 (Informed Consent)
    Demographics
    Description

    Demographics

    Alias
    UMLS CUI-1
    C1704791 (Demographics Domain)
    Center number
    Description

    Center number

    Data type

    integer

    Alias
    UMLS CUI [1,1]
    C1301943 (Institution name)
    SNOMED
    398321007
    UMLS CUI [1,2]
    C0600091 (Identifier)
    SNOMED
    118522005
    LOINC
    LP31795-5
    Date of birth
    Description

    Date of birth

    Data type

    date

    Alias
    UMLS CUI [1]
    C0421451 (Patient date of birth)
    SNOMED
    184099003
    LOINC
    LP57552-9
    Gender
    Description

    Gender

    Data type

    text

    Alias
    UMLS CUI [1]
    C0079399 (Gender)
    SNOMED
    263495000
    LOINC
    LP61312-2
    Race
    Description

    Race

    Data type

    text

    Alias
    UMLS CUI [1]
    C0034510 (Racial group)
    SNOMED
    415229000
    LOINC
    LP7528-5
    If other race, please specify
    Description

    Race: Specification

    Data type

    text

    Alias
    UMLS CUI [1,1]
    C0034510 (Racial group)
    SNOMED
    415229000
    LOINC
    LP7528-5
    UMLS CUI [1,2]
    C2348235 (Specification)
    Laboratory tests
    Description

    Laboratory tests

    Alias
    UMLS CUI-1
    C0022885 (Laboratory Procedures)
    SNOMED
    269814003
    Has a blood sample been taken fot testing anti-HAV and anti-HBs antibodies?
    Description

    Anti-HAV and anti-HBs antibodies

    Data type

    text

    Alias
    UMLS CUI [1]
    C0201473 (Hepatitis A virus antibody measurement)
    SNOMED
    697001
    UMLS CUI [2]
    C0201478 (Hepatitis B surface antibody measurement)
    SNOMED
    65911000
    Date of blood sample (if different from visit date)
    Description

    Collection Date

    Data type

    date

    Alias
    UMLS CUI [1]
    C1317250 (Collection Date)
    Has the subject received a dose of monovalent or combined Hepatitis A or Hepatitis B vaccine?
    Description

    Hepatitis A or Hepatitis B vaccine

    Data type

    text

    Alias
    UMLS CUI [1]
    C0419735 (Hepatitis A immunization)
    SNOMED
    243789007
    UMLS CUI [2]
    C0474232 (Administration of hepatitis B vaccine)
    SNOMED
    16584000
    Specification of received Hepatitis A or Hepatitis B vaccine
    Description

    Specification of received Hepatitis A or Hepatitis B vaccine

    Data type

    text

    Alias
    UMLS CUI [1,1]
    C0419735 (Hepatitis A immunization)
    SNOMED
    243789007
    UMLS CUI [1,2]
    C2348235 (Specification)
    UMLS CUI [2,1]
    C0474232 (Administration of hepatitis B vaccine)
    SNOMED
    16584000
    UMLS CUI [2,2]
    C2348235 (Specification)
    Has the subject received a dose of Hepatitis A or Hepatitis B immunoglobulins within 6 months prior to bleeding?
    Description

    Hepatitis A or Hepatitis B immunoglobulins

    Data type

    text

    Alias
    UMLS CUI [1]
    C3652495 (hepatitis A immunoglobulin)
    UMLS CUI [2]
    C0062525 (hepatitis B immune globulin)
    SNOMED
    9542007
    Specification of Hepatitis A or Hepatitis B immunoglobulins within 6 months prior to bleeding
    Description

    Specification of Hepatitis A or Hepatitis B immunoglobulins

    Data type

    text

    Alias
    UMLS CUI [1,1]
    C3652495 (hepatitis A immunoglobulin)
    UMLS CUI [1,2]
    C2348235 (Specification)
    UMLS CUI [2,1]
    C0062525 (hepatitis B immune globulin)
    SNOMED
    9542007
    UMLS CUI [2,2]
    C2348235 (Specification)
    Study Conclusion
    Description

    Study Conclusion

    Alias
    UMLS CUI-1
    C1707478 (Conclusion)
    Would the subject be willing to participate in a follow-up study?
    Description

    Follow-up studies

    Data type

    text

    Alias
    UMLS CUI [1]
    C0016441 (Follow-Up Studies)
    Specification of the most appropriate reason the subject is not willing to participate in a follow-up study
    Description

    Compliance

    Data type

    text

    Alias
    UMLS CUI [1]
    C1321605 (Compliance behavior)
    SNOMED
    405078008
    Specification of Adverse Events or Serious Adverse Events
    Description

    Adverse Events or Serious Adverse Events

    Data type

    text

    Alias
    UMLS CUI [1]
    C0877248 (Adverse event)
    LOINC
    MTHU014542
    UMLS CUI [2]
    C1519255 (Serious Adverse Event)
    Specification of other reason for not willing to participate in a follow-up study
    Description

    Compliance: Specification

    Data type

    text

    Alias
    UMLS CUI [1,1]
    C1321605 (Compliance behavior)
    SNOMED
    405078008
    UMLS CUI [1,2]
    C2348235 (Specification)
    Serious Adverse Event
    Description

    Serious Adverse Event

    Alias
    UMLS CUI-1
    C1519255 (Serious Adverse Event)
    Did the subject experience any Serious Adverse Event during the study period?
    Description

    Occurence of Serious Adverse Event

    Data type

    text

    Alias
    UMLS CUI [1,1]
    C1519255 (Serious Adverse Event)
    UMLS CUI [1,2]
    C2745955 (Occurrence)
    SNOMED
    246454002
    Did the subject become pregnant during the study?
    Description

    Pregnancy

    Data type

    text

    Alias
    UMLS CUI [1]
    C0032961 (Pregnancy)
    SNOMED
    289908002
    LOINC
    LP75920-6
    Investigator´s signature
    Description

    Investigator´s signature

    Alias
    UMLS CUI-1
    C2346576 (Investigator Signature)
    Investigator´s signature
    Description

    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

    Data type

    text

    Date
    Description

    Date

    Data type

    date

    Alias
    UMLS CUI [1]
    C0011008 (Date in time)
    SNOMED
    410671006
    Printed investigator´s name
    Description

    Investigator´s name

    Data type

    text

    Alias
    UMLS CUI [1]
    C2826892 (Investigator Name)
    Tracking Document - Reason for non participation
    Description

    Tracking Document - Reason for non participation

    Alias
    UMLS CUI-1
    C3889409 (Clinical Trial Regulatory Tracking Document)
    Previous Subject Number
    Description

    Previous Subject Number

    Data type

    integer

    Alias
    UMLS CUI [1,1]
    C2348585 (Clinical Trial Subject Unique Identifier)
    UMLS CUI [1,2]
    C0205156 (Previous)
    SNOMED
    9130008
    LOINC
    LP21061-4
    Date of Birth
    Description

    Date of Birth

    Data type

    date

    Alias
    UMLS CUI [1]
    C0421451 (Patient date of birth)
    SNOMED
    184099003
    LOINC
    LP57552-9
    Please document reason for non participation
    Description

    Reason for non participation

    Data type

    integer

    Alias
    UMLS CUI [1]
    C3166257 (Reason stopped)
    LOINC
    LP117875-7
    Subject not eligible? Please specify criteria that are not fulfilled
    Description

    Eligibility

    Data type

    text

    Alias
    UMLS CUI [1]
    C0013893 (Eligibility Determination)
    If reason is adverse event or serious adverse event, please specify
    Description

    Adverse event or serious adverse event: Specification

    Data type

    text

    Alias
    UMLS CUI [1,1]
    C0877248 (Adverse event)
    LOINC
    MTHU014542
    UMLS CUI [1,2]
    C2348235 (Specification)
    UMLS CUI [2,1]
    C1519255 (Serious Adverse Event)
    UMLS CUI [2,2]
    C2348235 (Specification)
    If other reason for non participation, please specify
    Description

    Study Participation Status

    Data type

    text

    Alias
    UMLS CUI [1]
    C2348568 (Study Subject Participation Status)
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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 17 Year 11)

    1 forms
    Name
    Type
    Description | Question | Decode (Coded Value)
    Data type
    Alias
    Item Group
    Introductional information
    C1533716 (UMLS CUI-1)
    Introductional information
    Item
    Taken note of introductional text
    boolean
    C1533716 (UMLS CUI [1])
    Item Group
    General Information
    C1508263 (UMLS CUI-1)
    Date of visit
    Item
    Date of visit
    date
    C1320303 (UMLS CUI [1])
    Subject number
    Item
    Subject number
    integer
    C2348585 (UMLS CUI [1])
    Informed consent
    Item
    I certify that Informed Consent has been obtained prior to any study procedure. Informed Consent Date
    date
    C0021430 (UMLS CUI [1])
    Item Group
    Demographics
    C1704791 (UMLS CUI-1)
    Center number
    Item
    Center number
    integer
    C1301943 (UMLS CUI [1,1])
    C0600091 (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 (8)
    Race: Specification
    Item
    If other race, please specify
    text
    C0034510 (UMLS CUI [1,1])
    C2348235 (UMLS CUI [1,2])
    Item Group
    Laboratory tests
    C0022885 (UMLS CUI-1)
    Item
    Has a blood sample been taken fot testing anti-HAV and anti-HBs antibodies?
    text
    C0201473 (UMLS CUI [1])
    C0201478 (UMLS CUI [2])
    Blood sample
    Code List
    Has a blood sample been taken fot testing anti-HAV and anti-HBs antibodies?
    CL Item
    Yes (please fill in date below, in case different from visit date) (1)
    CL Item
    No (2)
    Collection Date
    Item
    Date of blood sample (if different from visit date)
    date
    C1317250 (UMLS CUI [1])
    Item
    Has the subject received a dose of monovalent or combined Hepatitis A or Hepatitis B vaccine?
    text
    C0419735 (UMLS CUI [1])
    C0474232 (UMLS CUI [2])
    Hepatitis A or Hepatitis B vaccine
    Code List
    Has the subject received a dose of monovalent or combined Hepatitis A or Hepatitis B vaccine?
    CL Item
    Yes, please specify below (1)
    CL Item
    No (2)
    Item
    Specification of received Hepatitis A or Hepatitis B vaccine
    text
    C0419735 (UMLS CUI [1,1])
    C2348235 (UMLS CUI [1,2])
    C0474232 (UMLS CUI [2,1])
    C2348235 (UMLS CUI [2,2])
    Specification of received Hepatitis A or Hepatitis B vaccine
    Code List
    Specification of received Hepatitis A or Hepatitis B vaccine
    CL Item
    Hepatitis A vaccine (1)
    CL Item
    Hepatitis B vaccine (2)
    CL Item
    Combined Hepatitis A and B vaccine (3)
    Item
    Has the subject received a dose of Hepatitis A or Hepatitis B immunoglobulins within 6 months prior to bleeding?
    text
    C3652495 (UMLS CUI [1])
    C0062525 (UMLS CUI [2])
    Hepatitis A or Hepatitis B immunoglobulins within 6 months prior to bleeding
    Code List
    Has the subject received a dose of Hepatitis A or Hepatitis B immunoglobulins within 6 months prior to bleeding?
    CL Item
    Yes (please specify below) (1)
    CL Item
    No (2)
    Item
    Specification of Hepatitis A or Hepatitis B immunoglobulins within 6 months prior to bleeding
    text
    C3652495 (UMLS CUI [1,1])
    C2348235 (UMLS CUI [1,2])
    C0062525 (UMLS CUI [2,1])
    C2348235 (UMLS CUI [2,2])
    Specification of Hepatitis A or Hepatitis B immunoglobulins within 6 months prior to bleeding
    Code List
    Specification of Hepatitis A or Hepatitis B immunoglobulins within 6 months prior to bleeding
    CL Item
    Hepatitis A immunoglobulins (1)
    CL Item
    Hepatitis B immunoglobulins (2)
    Item Group
    Study Conclusion
    C1707478 (UMLS CUI-1)
    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)
    Item
    Specification of the most appropriate reason the subject is not willing to participate in a follow-up study
    text
    C1321605 (UMLS CUI [1])
    Specification of reason the subject is not willing to participate in a follow-up study
    Code List
    Specification of the most appropriate reason the subject is not willing to participate in a follow-up study
    CL Item
    Adverse Events or Serious Adverse Events (please specify below) (1)
    CL Item
    Other (please specify below) (2)
    Adverse Events or Serious Adverse Events
    Item
    Specification of Adverse Events or Serious Adverse Events
    text
    C0877248 (UMLS CUI [1])
    C1519255 (UMLS CUI [2])
    Compliance: Specification
    Item
    Specification of other reason for not willing to participate in a follow-up study
    text
    C1321605 (UMLS CUI [1,1])
    C2348235 (UMLS CUI [1,2])
    Item Group
    Serious Adverse Event
    C1519255 (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)
    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)
    Investigator´s signature
    Item
    Investigator´s signature
    text
    Date
    Item
    Date
    date
    C0011008 (UMLS CUI [1])
    Investigator´s name
    Item
    Printed investigator´s 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])
    Item
    Please document reason for non participation
    integer
    C3166257 (UMLS CUI [1])
    Reason for non participation
    Code List
    Please document reason for non participation
    CL Item
    Subject not eligible (1)
    CL Item
    Subject lost to follow-up or not reached (2)
    CL Item
    Subject eligible but not willing to participate (3)
    CL Item
    Adverse events, or serious adverse event (4)
    CL Item
    Other (5)
    CL Item
    Subject died (6)
    Eligibility
    Item
    Subject not eligible? Please specify criteria that are not fulfilled
    text
    C0013893 (UMLS CUI [1])
    Adverse event or serious adverse event: Specification
    Item
    If reason is adverse event or serious adverse event, please specify
    text
    C0877248 (UMLS CUI [1,1])
    C2348235 (UMLS CUI [1,2])
    C1519255 (UMLS CUI [2,1])
    C2348235 (UMLS CUI [2,2])
    Study Participation Status
    Item
    If other reason for non participation, please specify
    text
    C2348568 (UMLS CUI [1])
    Back to the top of the page 

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