ID

23149

Beschrijving

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

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  2. 26-09-17 26-09-17 -
  3. 20-09-21 20-09-21 -
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GlaxoSmithKline

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26 juni 2017

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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)

Engels

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

1 Formulieren  
Introductional information
Beschrijving

Introductional information

Taken note of introductional text
Beschrijving

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.

Datatype

boolean

General Information
Beschrijving

General Information

Date of visit
Beschrijving

Date of visit

Datatype

date

Subject number
Beschrijving

Subject number

Datatype

integer

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

Informed consent

Datatype

date

Demographics
Beschrijving

Demographics

Center number
Beschrijving

Center number

Datatype

integer

Date of birth
Beschrijving

Date of birth

Datatype

date

Gender
Beschrijving

Gender

Datatype

text

Race
Beschrijving

Race

Datatype

text

If other race, please specify
Beschrijving

Specification of other race

Datatype

text

Laboratory tests
Beschrijving

Laboratory tests

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

Blood sample

Datatype

text

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

Date of blood sample (if different from visit date)

Datatype

date

Has the subject received a dose of monovalent or combined Hepatitis A or Hepatitis B vaccine?
Beschrijving

Hepatitis A or Hepatitis B vaccine

Datatype

text

Specification of received Hepatitis A or Hepatitis B vaccine
Beschrijving

Specification of received Hepatitis A or Hepatitis B vaccine

Datatype

text

Has the subject received a dose of Hepatitis A or Hepatitis B immunoglobulins within 6 months prior to bleeding?
Beschrijving

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

Datatype

text

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

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

Datatype

text

Study Conclusion
Beschrijving

Study Conclusion

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

Follow-up studies

Datatype

text

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

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

Datatype

text

Specification of Adverse Events or Serious Adverse Events
Beschrijving

Specification of Adverse Events or Serious Adverse Events

Datatype

text

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

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

Datatype

text

Serious Adverse Event
Beschrijving

Serious Adverse Event

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

Occurence of Serious Adverse Event

Datatype

text

Did the subject become pregnant during the study?
Beschrijving

Pregnancy information

Datatype

text

Investigator´s signature
Beschrijving

Investigator´s signature

Investigator´s signature
Beschrijving

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

Datatype

text

Date
Beschrijving

Date

Datatype

date

Printed investigator´s name
Beschrijving

Printed investigator´s name

Datatype

text

Tracking Document - Reason for non participation
Beschrijving

Tracking Document - Reason for non participation

Previous Subject Number
Beschrijving

Previous Subject Number

Datatype

integer

Date of Birth
Beschrijving

Date of Birth

Datatype

date

Please document reason for non participation
Beschrijving

Reason for non participation

Datatype

integer

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

Eligibility

Datatype

text

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

Specification of adverse event or serious adverse event

Datatype

text

If other reason for non participation, please specify
Beschrijving

Specification of other reason for non participation

Datatype

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 Formulieren
Name
Type
Description | Question | Decode (Coded Value)
Datatype
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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