ID

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 -
Uploaded on

September 20, 2021

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License

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
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
General Information
Description

General Information

Alias
UMLS CUI-1
C1508263
Date of visit
Description

Date of visit

Data type

date

Alias
UMLS CUI [1]
C1320303
Subject number
Description

Subject number

Data type

integer

Alias
UMLS CUI [1]
C2348585
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
Demographics
Description

Demographics

Alias
UMLS CUI-1
C1704791
Center number
Description

Center number

Data type

integer

Alias
UMLS CUI [1,1]
C1301943
UMLS CUI [1,2]
C0600091
Date of birth
Description

Date of birth

Data type

date

Alias
UMLS CUI [1]
C0421451
Gender
Description

Gender

Data type

text

Alias
UMLS CUI [1]
C0079399
Race
Description

Race

Data type

text

Alias
UMLS CUI [1]
C0034510
If other race, please specify
Description

Race: Specification

Data type

text

Alias
UMLS CUI [1,1]
C0034510
UMLS CUI [1,2]
C2348235
Laboratory tests
Description

Laboratory tests

Alias
UMLS CUI-1
C0022885
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
UMLS CUI [2]
C0201478
Date of blood sample (if different from visit date)
Description

Collection Date

Data type

date

Alias
UMLS CUI [1]
C1317250
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
UMLS CUI [2]
C0474232
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
UMLS CUI [1,2]
C2348235
UMLS CUI [2,1]
C0474232
UMLS CUI [2,2]
C2348235
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
UMLS CUI [2]
C0062525
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
UMLS CUI [1,2]
C2348235
UMLS CUI [2,1]
C0062525
UMLS CUI [2,2]
C2348235
Study Conclusion
Description

Study Conclusion

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

Follow-up studies

Data type

text

Alias
UMLS CUI [1]
C0016441
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
Specification of Adverse Events or Serious Adverse Events
Description

Adverse Events or Serious Adverse Events

Data type

text

Alias
UMLS CUI [1]
C0877248
UMLS CUI [2]
C1519255
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
UMLS CUI [1,2]
C2348235
Serious Adverse Event
Description

Serious Adverse Event

Alias
UMLS CUI-1
C1519255
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
UMLS CUI [1,2]
C2745955
Did the subject become pregnant during the study?
Description

Pregnancy

Data type

text

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

Investigator´s signature

Alias
UMLS CUI-1
C2346576
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
Printed investigator´s name
Description

Investigator´s name

Data type

text

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

Tracking Document - Reason for non participation

Alias
UMLS CUI-1
C3889409
Previous Subject Number
Description

Previous Subject Number

Data type

integer

Alias
UMLS CUI [1,1]
C2348585
UMLS CUI [1,2]
C0205156
Date of Birth
Description

Date of Birth

Data type

date

Alias
UMLS CUI [1]
C0421451
Please document reason for non participation
Description

Reason for non participation

Data type

integer

Alias
UMLS CUI [1]
C3166257
Subject not eligible? Please specify criteria that are not fulfilled
Description

Eligibility

Data type

text

Alias
UMLS CUI [1]
C0013893
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
UMLS CUI [1,2]
C2348235
UMLS CUI [2,1]
C1519255
UMLS CUI [2,2]
C2348235
If other reason for non participation, please specify
Description

Study Participation Status

Data type

text

Alias
UMLS CUI [1]
C2348568
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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])
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