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43620

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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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Versions (3)
  1. 6/16/17 6/16/17 -
  2. 9/19/17 9/19/17 -
  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 21 Year 15)

    English

    Comparative study of the immunogenicity and reactogenicity of three different lots of GlaxoSmithKline Biologicals’ combined hepatitis A - hepatitis B(Visit 21 Year 15)

    1 forms  
    General Information
    Description

    General Information

    Alias
    UMLS CUI-1
    C1508263 (General information section)
    LOINC
    MTHU015719
    Centre number
    Description

    Centre number

    Data type

    integer

    Alias
    UMLS CUI [1,1]
    C0600091 (Identifier)
    SNOMED
    118522005
    LOINC
    LP31795-5
    UMLS CUI [1,2]
    C0019994 (Hospitals)
    Subject number
    Description

    Subject number

    Data type

    integer

    Alias
    UMLS CUI [1]
    C2348585 (Clinical Trial Subject Unique Identifier)
    General Instructions
    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 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.

    Data type

    text

    Alias
    UMLS CUI [1]
    C1508263 (General information section)
    LOINC
    MTHU015719
    Informed Consent Date
    Description

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

    Data type

    date

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

    Demographics

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

    Centre number

    Data type

    integer

    Alias
    UMLS CUI [1,1]
    C0600091 (Identifier)
    SNOMED
    118522005
    LOINC
    LP31795-5
    UMLS CUI [1,2]
    C0019994 (Hospitals)
    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
    Laboratory tests
    Description

    Laboratory tests

    Alias
    UMLS CUI-1
    C0022885 (Laboratory Procedures)
    SNOMED
    269814003
    Has a blood sample been taken for 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
    Description

    Please complete only if different from visit 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 sind the last visit?
    Description

    Hepatitis A or Hepatitis B vaccine

    Data type

    text

    Alias
    UMLS CUI [1]
    C0170300 (Hepatitis A Vaccines)
    SNOMED
    871751006
    UMLS CUI [2]
    C2240392 (Hepatitis B Vaccines)
    SNOMED
    871822003
    Please specify
    Description

    Hepatitis A or Hepatitis B vaccine: Specification

    Data type

    text

    Alias
    UMLS CUI [1,1]
    C0170300 (Hepatitis A Vaccines)
    SNOMED
    871751006
    UMLS CUI [1,2]
    C2348235 (Specification)
    UMLS CUI [2,1]
    C2240392 (Hepatitis B Vaccines)
    SNOMED
    871822003
    UMLS CUI [2,2]
    C2348235 (Specification)
    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
    Please specify
    Description

    Hepatitis A or Hepatitis B immunoglobulins: Specification

    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)
    Has the subject suffered from hepatitis A or B infection since the last study constact?
    Description

    Hepatitis A or B infection

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0019159 (Hepatitis A)
    SNOMED
    40468003
    UMLS CUI [2]
    C0019163 (Hepatitis B)
    SNOMED
    66071002
    LOINC
    LA18126-5
    Serology conclusion before booster
    Description

    Serology conclusion before booster

    Alias
    UMLS CUI-1
    C0036743 (Serologic tests)
    SNOMED
    68793005
    LOINC
    MTHU008384
    Has the subject lost HBs antibodies at any of the 4 following time points: Y11 or Y12 or Y13 or Y14 (= visit 21 included)?
    Description

    Hepatitis B Surface Antigens

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0019168 (Hepatitis B Surface Antigens)
    SNOMED
    22290004
    LOINC
    LP38331-2
    Has the subject lost HAV antibodies at any of the 4 following time points: Y11 or Y12 or Y13 or Y14 (= visit 21 included)?
    Description

    If YES to any of above, subject will receive either ENGERIX™, HAVRIX™ or TWINRIX™ ADULT as appropriate. Please complete the entire Case Report Form. If NO to both questions, please complete the study conclusion section only.

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0062524 (hepatitis A virus antibodies)
    SNOMED
    32609007
    LOINC
    LP38316-3
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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 21 Year 15)

    1 forms
    Name
    Type
    Description | Question | Decode (Coded Value)
    Data type
    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)
    Hepatitis A or B infection
    Item
    Has the subject suffered from hepatitis A or B infection since the last study constact?
    boolean
    C0019159 (UMLS CUI [1])
    C0019163 (UMLS CUI [2])
    Item Group
    Serology conclusion before booster
    C0036743 (UMLS CUI-1)
    Hepatitis B Surface Antigens
    Item
    Has the subject lost HBs antibodies at any of the 4 following time points: Y11 or Y12 or Y13 or Y14 (= visit 21 included)?
    boolean
    C0019168 (UMLS CUI [1])
    HAV antibodies
    Item
    Has the subject lost HAV antibodies at any of the 4 following time points: Y11 or Y12 or Y13 or Y14 (= visit 21 included)?
    boolean
    C0062524 (UMLS CUI [1])
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