ID

43619

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. 6/16/17 6/16/17 -
  2. 9/19/17 9/19/17 -
  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 19 Year 13)

English

Comparative study of the immunogenicity and reactogenicity of three different lots of GlaxoSmithKline Biologicals’ combined hepatitis A - hepatitis B (Visit 19 Year 13)

1 forms  
General Information
Description

General Information

Alias
UMLS CUI-1
C1508263
Centre number
Description

Centre number

Data type

integer

Alias
UMLS CUI [1,1]
C0600091
UMLS CUI [1,2]
C0019994
Subject number
Description

Subject number

Data type

integer

Alias
UMLS CUI [1]
C2348585
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
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
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
Laboratory tests
Description

Laboratory tests

Alias
UMLS CUI-1
C0022885
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
UMLS CUI [2]
C0201478
Date of Blood Sample
Description

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

Hepatitis A or Hepatitis B vaccine

Data type

text

Alias
UMLS CUI [1]
C0170300
UMLS CUI [2]
C2240392
Please specify
Description

Hepatitis A or Hepatitis B vaccine: Specification

Data type

text

Alias
UMLS CUI [1,1]
C0170300
UMLS CUI [1,2]
C2348235
UMLS CUI [2,1]
C2240392
UMLS CUI [2,2]
C2348235
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
Please specify
Description

Hepatitis A or Hepatitis B immunoglobulins: Specification

Data type

text

Alias
UMLS CUI [1,1]
C3652495
UMLS CUI [1,2]
C2348235
UMLS CUI [2,1]
C0062525
UMLS CUI [2,2]
C2348235
Would the subject be willing to participate in a follow-up study?
Description

Follow-up studies

Data type

text

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

Adverse Events, or Serious Adverse Events

Data type

boolean

Alias
UMLS CUI [1]
C0877248
UMLS CUI [2]
C1519255
please specify
Description

Adverse Events, or Serious Adverse Events: 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
Other
Description

Other

Data type

boolean

Alias
UMLS CUI [1]
C0205394
Please specify
Description

Other: Specification

Data type

text

Alias
UMLS CUI [1,1]
C0205394
UMLS CUI [1,2]
C2348235
Study Conclusion
Description

Study Conclusion

Alias
UMLS CUI-1
C1707478
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
Total number of SAE´s
Description

Number of SAE´s

Data type

integer

Alias
UMLS CUI [1,1]
C0449788
UMLS CUI [1,2]
C1519255
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
Text to confirm
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

Alias
UMLS CUI [1]
C0750484
Investigator´s signature
Description

Investigator´s signature

Data type

text

Alias
UMLS CUI [1]
C2346576
Date
Description

Date

Data type

date

Alias
UMLS CUI [1]
C0011008
Printed Investigator´s name 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
1. Subject not eligible?
Description

Eligibility

Data type

boolean

Alias
UMLS CUI [1]
C0013893
Please specify criteria that are not fullfilled
Description

Eligibility: Specification

Data type

text

Alias
UMLS CUI [1,1]
C0013893
UMLS CUI [1,2]
C2348235
Subject lost to follow-up or not reached
Description

Lost to follow-up

Data type

boolean

Alias
UMLS CUI [1]
C1302313
Subject eligible but not willing to participate due to
Description

Willing to participate

Data type

text

Alias
UMLS CUI [1,1]
C0600109
UMLS CUI [1,2]
C2348568
Specification of reason not willing to participate
Description

Willing to participate: Specification

Data type

text

Alias
UMLS CUI [1,1]
C0600109
UMLS CUI [1,2]
C2348568
UMLS CUI [1,3]
C2348235
Subject died on
Description

Date of death

Data type

date

Alias
UMLS CUI [1]
C1148348
Investigator name
Description

Investigator name

Data type

text

Alias
UMLS CUI [1]
C2826892
Signature
Description

Signature

Data type

text

Alias
UMLS CUI [1]
C1519316
Date
Description

Date

Data type

date

Alias
UMLS CUI [1]
C0011008
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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 19 Year 13)

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)
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
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])
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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