ID

43669

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

  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

DOI

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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 21 Year 14)

Comparative study of the immunogenicity and reactogenicity of three different lots of GlaxoSmithKline Biologicals’ combined hepatitis A - hepatitis B (Visit 21 Year 14)

Introductional information
Description

Introductional information

Alias
UMLS CUI-1
C1533716
UMLS CUI-2
C0579004
Taken note of introductional text?
Description

GENERAL INSTRUCTIONS 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]
C0579004
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
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
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 [1,1]
C0170300
UMLS CUI [1,2]
C2240392
Specification of monovalent or combined Hepatitis A or Hepatitis B vaccine
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
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
Please specify
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
Has the subject suffered from hepatitis A or B infection since the last study contact?
Description

Hepatitis A or B infection

Data type

boolean

Alias
UMLS CUI [1]
C0019159
UMLS CUI [2]
C0019163
Serology conclusion before booster
Description

Serology conclusion before booster

Alias
UMLS CUI-1
C0036743
Has the subject lost HBs antibodies at any of the 4 following time points: Y11 or Y12 or Y13 or Y14 (= visit 21 included)?
Description

Please complete this section only after receipt of the serology results related to the assessment done at visit 21.

Data type

boolean

Alias
UMLS CUI [1]
C0201478
Has the subject lost HAV antibodies at any of the 4 following time points: Y11 or Y12 or Y13 or Y14 (= visit 21 included)?
Description

If YES to any of above, subject will receive either ENGERIX™, HAVRIX™ or TWINRIX™ ADULT as appropriate. Please complete the entire Case Report Form. If NO to both questions, please complete the study conclusion section only.

Data type

boolean

Alias
UMLS CUI [1]
C0062524

Similar models

Comparative study of the immunogenicity and reactogenicity of three different lots of GlaxoSmithKline Biologicals’ combined hepatitis A - hepatitis B (Visit 21 Year 14)

Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
Introductional information
C1533716 (UMLS CUI-1)
C0579004 (UMLS CUI-2)
Introduction
Item
Taken note of introductional text?
boolean
C0579004 (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
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])
Code List
Gender
CL Item
Male (1)
CL Item
Female (2)
Item
Race
text
C0034510 (UMLS CUI [1])
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)
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])
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
C0170300 (UMLS CUI [1,1])
C2240392 (UMLS CUI [1,2])
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 monovalent or combined Hepatitis A or Hepatitis B vaccine
text
C0170300 (UMLS CUI [1,1])
C2348235 (UMLS CUI [1,2])
C2240392 (UMLS CUI [2,1])
C2348235 (UMLS CUI [2,2])
Code List
Specification of monovalent or combined 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])
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
Please specify
text
C3652495 (UMLS CUI [1,1])
C2348235 (UMLS CUI [1,2])
C0062525 (UMLS CUI [2,1])
C2348235 (UMLS CUI [2,2])
CL Item
Hepatitis A immunoglobulins (1)
CL Item
Hepatitis B immunoglobulins (2)
Hepatitis A or B infection
Item
Has the subject suffered from hepatitis A or B infection since the last study contact?
boolean
C0019159 (UMLS CUI [1])
C0019163 (UMLS CUI [2])
Item Group
Serology conclusion before booster
C0036743 (UMLS CUI-1)
Anti-HBs antibody
Item
Has the subject lost HBs antibodies at any of the 4 following time points: Y11 or Y12 or Y13 or Y14 (= visit 21 included)?
boolean
C0201478 (UMLS CUI [1])
HAV antibodies
Item
Has the subject lost HAV antibodies at any of the 4 following time points: Y11 or Y12 or Y13 or Y14 (= visit 21 included)?
boolean
C0062524 (UMLS CUI [1])

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