ID
22907
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)
- 6/16/17 6/16/17 -
- 9/19/17 9/19/17 -
- 9/20/21 9/20/21 -
Copyright Holder
GlaxoSmithKline
Uploaded on
June 16, 2017
DOI
To request one please log in.
License
Creative Commons BY-NC 3.0
Model comments :
You can comment on the data model here. Via the speech bubbles at the itemgroups and items you can add comments to those specificially.
Itemgroup comments for :
Item comments for :
In order to download data models you must be logged in. Please log in or register for free.
Comparative study of the immunogenicity and reactogenicity of three different lots of GlaxoSmithKline Biologicals’ combined hepatitis A - hepatitis B (Visit 17 Year 11)
Comparative study of the immunogenicity and reactogenicity of three different lots of GlaxoSmithKline Biologicals’ combined hepatitis A - hepatitis B (Visit 17 Year 11)
Description
Demographics
Description
Center number
Data type
integer
Description
Date of birth
Data type
date
Description
Gender
Data type
text
Description
Race
Data type
text
Description
Laboratory tests
Description
anti-HAV and anti-HBs antibodies
Data type
text
Description
Please complete only if different from visit date
Data type
date
Description
Has the subject received a dose of monovalent or combined Hepatitis A or Hepatitis B vaccine sind the last visit?
Data type
text
Description
Specification of monovalent or combined Hepatitis A or Hepatitis B vaccine
Data type
text
Description
dose of Hepatitis A or Hepatitis B immunoglobulins 6 months prior to bleeding
Data type
text
Description
Specification of dose of Hepatitis A or Hepatitis B immunoglobulins within 6 months prior to bleeding
Data type
text
Description
Follow-up studies
Data type
text
Description
Adverse Events, or Serious Adverse Events
Data type
boolean
Description
Specification of Adverse Events, or Serious Adverse Events
Data type
text
Description
Other
Data type
boolean
Description
Specification of other
Data type
text
Description
Study Conclusion
Description
Occurence of Serious Adverse Event
Data type
text
Description
Total number of SAE´s
Data type
integer
Description
Pregnancy information
Data type
text
Description
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
Description
Investigator´s signature
Data type
text
Description
Date
Data type
date
Description
Printed Investigator´s name
Data type
text
Description
Tracking Document - Reason for non participation
Description
Previous subject number
Data type
integer
Description
Date of birth
Data type
date
Description
Subject not eligible
Data type
boolean
Description
Specifiation of eiligibility
Data type
text
Description
Subject lost to follow-up or not reached
Data type
boolean
Description
Subject eligible but not willing to participate due to
Data type
text
Description
Specification of reason not willing to participate
Data type
text
Description
date of death
Data type
date
Description
Investigator name
Data type
text
Description
Signature
Data type
text
Description
Date
Data type
date
No comments