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43616

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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

Palavras-chave

Versões (3)
  1. 16/06/2017 16/06/2017 -
  2. 19/09/2017 19/09/2017 -
  3. 20/09/2021 20/09/2021 -
Transferido a

20 de setembro de 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 17 Year 11)

    Inglês

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

    1 Formulários  
    General Information
    Descrição

    General Information

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

    Centre number

    Tipo de dados

    integer

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

    Subject number

    Tipo de dados

    integer

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

    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.

    Tipo de dados

    text

    Informed Consent Date
    Descrição

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

    Tipo de dados

    date

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

    Demographics

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

    Center number

    Tipo de dados

    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
    Descrição

    Date of birth

    Tipo de dados

    date

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

    Gender

    Tipo de dados

    text

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

    Race

    Tipo de dados

    text

    Alias
    UMLS CUI [1]
    C0034510 (Racial group)
    SNOMED
    415229000
    LOINC
    LP7528-5
    Laboratory tests
    Descrição

    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?
    Descrição

    anti-HAV and anti-HBs antibodies

    Tipo de dados

    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
    Descrição

    Please complete only if different from visit date

    Tipo de dados

    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?
    Descrição

    Hepatitis A or Hepatitis B vaccine

    Tipo de dados

    text

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

    Hepatitis A or Hepatitis B vaccine: Specification

    Tipo de dados

    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?
    Descrição

    Hepatitis A or Hepatitis B immunoglobulins

    Tipo de dados

    text

    Alias
    UMLS CUI [1]
    C3652495 (hepatitis A immunoglobulin)
    UMLS CUI [2]
    C0062525 (hepatitis B immune globulin)
    SNOMED
    9542007
    Please specify
    Descrição

    Hepatitis A or Hepatitis B immunoglobulins: Specification

    Tipo de dados

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

    Follow-up studies

    Tipo de dados

    text

    Alias
    UMLS CUI [1]
    C0016441 (Follow-Up Studies)
    Adverse Events, or Serious Adverse Events
    Descrição

    Adverse Events, or Serious Adverse Events

    Tipo de dados

    boolean

    Alias
    UMLS CUI [1]
    C0877248 (Adverse event)
    LOINC
    MTHU014542
    UMLS CUI [2]
    C1519255 (Serious Adverse Event)
    please specify
    Descrição

    Adverse Events, or Serious Adverse Events: Specification

    Tipo de dados

    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)
    Other
    Descrição

    Other

    Tipo de dados

    boolean

    Alias
    UMLS CUI [1]
    C0205394 (Other)
    SNOMED
    74964007
    LOINC
    LP21049-9
    Please specify
    Descrição

    Other: Specification

    Tipo de dados

    text

    Alias
    UMLS CUI [1,1]
    C0205394 (Other)
    SNOMED
    74964007
    LOINC
    LP21049-9
    UMLS CUI [1,2]
    C2348235 (Specification)
    Study Conclusion
    Descrição

    Study Conclusion

    Alias
    UMLS CUI-1
    C1707478 (Conclusion)
    Did the subject experience any Serious Adverse Event during the study period?
    Descrição

    Occurence of Serious Adverse Event

    Tipo de dados

    text

    Alias
    UMLS CUI [1,1]
    C1519255 (Serious Adverse Event)
    UMLS CUI [1,2]
    C2745955 (Occurrence)
    SNOMED
    246454002
    Total number of SAE´s
    Descrição

    Number of SAE´s

    Tipo de dados

    integer

    Alias
    UMLS CUI [1,1]
    C0449788 (Count of entities)
    SNOMED
    410681005
    UMLS CUI [1,2]
    C1519255 (Serious Adverse Event)
    Did the subject become pregnant during the study?
    Descrição

    Pregnancy

    Tipo de dados

    text

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

    Investigator´s signature

    Alias
    UMLS CUI-1
    C2346576 (Investigator Signature)
    Text to confirm
    Descrição

    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.

    Tipo de dados

    text

    Alias
    UMLS CUI [1]
    C0750484 (Confirmation)
    LOINC
    LA15290-2
    Investigator´s signature
    Descrição

    Investigator´s signature

    Tipo de dados

    text

    Alias
    UMLS CUI [1]
    C2346576 (Investigator Signature)
    Date
    Descrição

    Date

    Tipo de dados

    date

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

    Investigator´s name

    Tipo de dados

    text

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

    Tracking Document - Reason for non participation

    Alias
    UMLS CUI-1
    C2348568 (Study Subject Participation Status)
    UMLS CUI-2
    C0392360 (Indication of (contextual qualifier))
    SNOMED
    230165009
    LOINC
    MTHU008319
    Previous subject number
    Descrição

    Previous subject number

    Tipo de dados

    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
    Descrição

    Date of birth

    Tipo de dados

    date

    Alias
    UMLS CUI [1]
    C0421451 (Patient date of birth)
    SNOMED
    184099003
    LOINC
    LP57552-9
    1. Subject not eligible?
    Descrição

    Eligibility

    Tipo de dados

    boolean

    Alias
    UMLS CUI [1]
    C0013893 (Eligibility Determination)
    Please specify criteria that are not fullfilled
    Descrição

    Eligibility: Specification

    Tipo de dados

    text

    Alias
    UMLS CUI [1,1]
    C0013893 (Eligibility Determination)
    UMLS CUI [1,2]
    C2348235 (Specification)
    Subject lost to follow-up or not reached
    Descrição

    Lost to follow-up

    Tipo de dados

    boolean

    Alias
    UMLS CUI [1]
    C1302313 (Lost to Follow-Up)
    SNOMED
    399307001
    Subject eligible but not willing to participate due to
    Descrição

    Willing to participate

    Tipo de dados

    text

    Alias
    UMLS CUI [1,1]
    C0600109 (Willing)
    SNOMED
    225466006
    UMLS CUI [1,2]
    C2348568 (Study Subject Participation Status)
    Specification of reason not willing to participate
    Descrição

    Willing to participate: Specification

    Tipo de dados

    text

    Alias
    UMLS CUI [1,1]
    C0600109 (Willing)
    SNOMED
    225466006
    UMLS CUI [1,2]
    C2348568 (Study Subject Participation Status)
    UMLS CUI [1,3]
    C2348235 (Specification)
    Subject died on
    Descrição

    Date of death

    Tipo de dados

    date

    Alias
    UMLS CUI [1]
    C1148348 (Date of death)
    SNOMED
    399753006
    LOINC
    MTHU014693
    Investigator name
    Descrição

    Investigator name

    Tipo de dados

    text

    Alias
    UMLS CUI [1]
    C2826892 (Investigator Name)
    Signature
    Descrição

    Signature

    Tipo de dados

    text

    Alias
    UMLS CUI [1]
    C1519316 (Signature)
    LOINC
    LP248948-4
    Date
    Descrição

    Date

    Tipo de dados

    date

    Alias
    UMLS CUI [1]
    C0011008 (Date in time)
    SNOMED
    410671006
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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 Formulários
    Name
    Tipo
    Description | Question | Decode (Coded Value)
    Tipo de dados
    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
    Informed Consent
    Item
    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, 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
    C2348568 (UMLS CUI-1)
    C0392360 (UMLS CUI-2)
    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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