ID

22911

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 -
Copyright Holder

GlaxoSmithKline

Uploaded on

June 16, 2017

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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

Centre number
Description

Centre number

Data type

integer

Subject number
Description

Subject number

Data type

integer

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

Informed Consent Date
Description

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

Data type

date

Demographics
Description

Demographics

Center number
Description

Center number

Data type

integer

Date of birth
Description

Date of birth

Data type

date

Gender
Description

Gender

Data type

text

Race
Description

Race

Data type

text

Laboratory tests
Description

Laboratory tests

Has a blood sample been taken for testing anti-HAV and anti-HBs antibodies?
Description

anti-HAV and anti-HBs antibodies

Data type

text

Date of Blood Sample
Description

Please complete only if different from visit date

Data type

date

Has the subject received a dose of monovalent or combined Hepatitis A or Hepatitis B vaccine sind the last visit?
Description

Has the subject received a dose of monovalent or combined Hepatitis A or Hepatitis B vaccine sind the last visit?

Data type

text

Please specify
Description

Specification of monovalent or combined Hepatitis A or Hepatitis B vaccine

Data type

text

A dose of Hepatitis A or Hepatitis B immunoglobulins within 6 months prior to bleeding?
Description

dose of Hepatitis A or Hepatitis B immunoglobulins 6 months prior to bleeding

Data type

text

Please specify
Description

Specification of dose of Hepatitis A or Hepatitis B immunoglobulins within 6 months prior to bleeding

Data type

text

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

Follow-up studies

Data type

text

Adverse Events, or Serious Adverse Events
Description

Adverse Events, or Serious Adverse Events

Data type

boolean

please specify
Description

Specification of Adverse Events, or Serious Adverse Events

Data type

text

Other
Description

Other

Data type

boolean

Please specify
Description

Specification of other

Data type

text

Study Conclusion
Description

Study Conclusion

Did the subject experience any Serious Adverse Event during the study period?
Description

Occurence of Serious Adverse Event

Data type

text

Total number of SAE´s
Description

Total number of SAE´s

Data type

integer

Did the subject become pregnant during the study?
Description

Pregnancy information

Data type

text

Investigator´s signature
Description

Investigator´s signature

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

Investigator´s signature
Description

Investigator´s signature

Data type

text

Date
Description

Date

Data type

date

Printed Investigator´s name name
Description

Printed Investigator´s name

Data type

text

Tracking Document - Reason for non participation
Description

Tracking Document - Reason for non participation

Previous subject number
Description

Previous subject number

Data type

integer

Date of birth
Description

Date of birth

Data type

date

1. Subject not eligible?
Description

Subject not eligible

Data type

boolean

Please specify criteria that are not fullfilled
Description

Specifiation of eiligibility

Data type

text

Subject lost to follow-up or not reached
Description

Subject lost to follow-up or not reached

Data type

boolean

Subject eligible but not willing to participate due to
Description

Subject eligible but not willing to participate due to

Data type

text

Specification of reason not willing to participate
Description

Specification of reason not willing to participate

Data type

text

Subject died on
Description

date of death

Data type

date

Investigator name
Description

Investigator name

Data type

text

Signature
Description

Signature

Data type

text

Date
Description

Date

Data type

date

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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
Centre number
Item
Centre number
integer
Subject number
Item
Subject number
integer
General Instructions
Item
General Instructions
text
Informed Consent
Item
Informed Consent Date
date
Item Group
Demographics
Center number
Item
Center number
integer
Date of birth
Item
Date of birth
date
Item
Gender
text
Gender
Code List
Gender
CL Item
male (1)
CL Item
female (2)
Item
Race
text
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
Item
Has a blood sample been taken for testing anti-HAV and anti-HBs antibodies?
text
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
Item
Has the subject received a dose of monovalent or combined Hepatitis A or Hepatitis B vaccine sind the last visit?
text
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)
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
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)
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
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
Specification of Adverse Events, or Serious Adverse Events
Item
please specify
text
Other
Item
Other
boolean
Specification of other
Item
Please specify
text
Item Group
Study Conclusion
Item
Did the subject experience any Serious Adverse Event during the study period?
text
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)
Total number of SAE´s
Item
Total number of SAE´s
integer
Item
Did the subject become pregnant during the study?
text
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
Text to confirm
Item
Text to confirm
text
Investigator´s signature
Item
Investigator´s signature
text
Date
Item
Date
date
Printed Investigator´s name
Item
Printed Investigator´s name name
text
Item Group
Tracking Document - Reason for non participation
Previous subject number
Item
Previous subject number
integer
Date of birth
Item
Date of birth
date
Subject not eligible
Item
1. Subject not eligible?
boolean
Specifiation of eiligibility
Item
Please specify criteria that are not fullfilled
text
Subject lost to follow-up or not reached
Item
Subject lost to follow-up or not reached
boolean
Item
Subject eligible but not willing to participate due to
text
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)
Specification of reason not willing to participate
Item
Specification of reason not willing to participate
text
date of death
Item
Subject died on
date
Investigator name
Item
Investigator name
text
Signature
Item
Signature
text
Date
Item
Date
date
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