ID

23149

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 -
Copyright Holder

GlaxoSmithKline

Uploaded on

June 26, 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 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

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

General Information
Description

General Information

Date of visit
Description

Date of visit

Data type

date

Subject number
Description

Subject number

Data type

integer

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

Informed consent

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

If other race, please specify
Description

Specification of other race

Data type

text

Laboratory tests
Description

Laboratory tests

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

Blood sample

Data type

text

Date of blood sample (if different from visit date)
Description

Date of blood sample (if different from visit date)

Data type

date

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

Specification of received Hepatitis A or Hepatitis B vaccine
Description

Specification of received Hepatitis A or Hepatitis B vaccine

Data type

text

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 within 6 months prior to bleeding

Data type

text

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

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

Data type

text

Study Conclusion
Description

Study Conclusion

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

Follow-up studies

Data type

text

Specification of the most appropriate reason the subject is not willing to participate in a follow-up study
Description

Specification of the most appropriate reason the subject is not willing to participate in a follow-up study

Data type

text

Specification of Adverse Events or Serious Adverse Events
Description

Specification of Adverse Events or Serious Adverse Events

Data type

text

Specification of other reason for not willing to participate in a follow-up study
Description

Specification of other reason for not willing to participate in a follow-up study

Data type

text

Serious Adverse Event
Description

Serious Adverse Event

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

Occurence of Serious Adverse Event

Data type

text

Did the subject become pregnant during the study?
Description

Pregnancy information

Data type

text

Investigator´s signature
Description

Investigator´s signature

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

Printed investigator´s 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

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

If reason is adverse event or serious adverse event, please specify
Description

Specification of adverse event or serious adverse event

Data type

text

If other reason for non participation, please specify
Description

Specification of other reason for non participation

Data type

text

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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
Introductional information
Item
Taken note of introductional text
boolean
Item Group
General Information
Date of visit
Item
Date of visit
date
Subject number
Item
Subject number
integer
Informed consent
Item
I certify that Informed Consent has been obtained prior to any study procedure. 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 (8)
Specification of other race
Item
If other race, please specify
text
Item Group
Laboratory tests
Item
Has a blood sample been taken fot testing anti-HAV and anti-HBs antibodies?
text
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)
Date of blood sample (if different from visit date)
Item
Date of blood sample (if different from visit date)
date
Item
Has the subject received a dose of monovalent or combined Hepatitis A or Hepatitis B vaccine?
text
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
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
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
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
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)
Item
Specification of the most appropriate reason the subject is not willing to participate in a follow-up study
text
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)
Specification of Adverse Events or Serious Adverse Events
Item
Specification of Adverse Events or Serious Adverse Events
text
Specification of other reason for not willing to participate in a follow-up study
Item
Specification of other reason for not willing to participate in a follow-up study
text
Item Group
Serious Adverse Event
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)
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
Investigator´s signature
Item
Investigator´s signature
text
Date
Item
Date
date
Printed investigator´s name
Item
Printed investigator´s 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
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
Specification of adverse event or serious adverse event
Item
If reason is adverse event or serious adverse event, please specify
text
Specification of other reason for non participation
Item
If other reason for non participation, please specify
text
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