ID

23160

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

Mots-clés

  1. 26/06/2017 26/06/2017 -
  2. 26/09/2017 26/09/2017 -
  3. 20/09/2021 20/09/2021 -
Détendeur de droits

GlaxoSmithKline

Téléchargé le

26 juin 2017

DOI

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Licence

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

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.

Type de données

boolean

General Information
Description

General Information

Date of visit
Description

Date of visit

Type de données

date

Subject Number
Description

Subject Number

Type de données

integer

Informed Consent Date
Description

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

Type de données

date

Demographics
Description

Demographics

Center number
Description

Center number

Type de données

integer

Date of birth
Description

Date of birth

Type de données

date

Gender
Description

Gender

Type de données

text

Race
Description

Race

Type de données

text

If other race, please specify
Description

Specification of other race

Type de données

text

Laboratory tests
Description

Laboratory tests

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

Blood sample

Type de données

text

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

Date of blood sample (if different from visit date)

Type de données

date

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

Monovalent or combined Hepatitis A or Hepatitis B vaccine

Type de données

text

Specification of monovalent or combined Hepatitis A or Hepatitis B vaccine
Description

Specification of monovalent or combined Hepatitis A or Hepatitis B vaccine

Type de données

text

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

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

Type de données

text

Please specify
Description

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

Type de données

text

Has the subject suffered from hepatitis A or B infection since the last study contact?
Description

Hepatitis A or B infection since the last study contact

Type de données

boolean

Serology conclusion before booster
Description

Serology conclusion before booster

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.

Type de données

boolean

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.

Type de données

boolean

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)
Type de données
Alias
Item Group
Introductional information
Introductional text
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
Informed Consent Date
date
Item Group
Demographics
Center number
Item
Center number
integer
Date of birth
Item
Date of birth
date
Item
Gender
text
Code List
Gender
CL Item
Male (1)
CL Item
Female (2)
Item
Race
text
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)
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
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
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
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
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)
CL Item
Hepatitis A immunoglobulins (1)
CL Item
Hepatitis B immunoglobulins (2)
Hepatitis A or B infection since the last study contact
Item
Has the subject suffered from hepatitis A or B infection since the last study contact?
boolean
Item Group
Serology conclusion before booster
Loss of HBs antibodies
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
Loss of 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

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