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ID
25891
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)
- 6/23/17 6/23/17 -
- 6/23/17 6/23/17 -
- 9/25/17 9/25/17 -
Uploaded on
September 25, 2017
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 23 Year 15)
Comparative study of the immunogenicity and reactogenicity of three different lots of GlaxoSmithKline Biologicals’ combined hepatitis A - hepatitis B (Visit 23 Year 15)
Similar models
Comparative study of the immunogenicity and reactogenicity of three different lots of GlaxoSmithKline Biologicals’ combined hepatitis A - hepatitis B (Visit 23 Year 15)
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Subject number
Item
Subject number
integer
C2348585 (UMLS CUI [1])
Item
Did the subject return for follow-up concerning the additional vaccination visit?
text
C0805733 (UMLS CUI [1])
Code List
Did the subject return for follow-up concerning the additional vaccination visit?
CL Item
yes -> Please complete the next pages (1)
CL Item
No -> Please complete below. (2)
Item
Please tick the ONE most appropriate reason and skip the following pages of this visit.
text
C1522577 (UMLS CUI [1])
Code List
Please tick the ONE most appropriate reason and skip the following pages of this visit.
CL Item
Serious adverse event (complete the Serious Adverse Event form) (1)
CL Item
Non-Serious adverse event (complete the Non-serious Adverse Event section) (2)
CL Item
Other, please specify. (3)
Follow-Up: Specification
Item
If Other reason, please specify
text
C1522577 (UMLS CUI [1,1])
C2348235 (UMLS CUI [1,2])
C2348235 (UMLS CUI [1,2])
CL Item
Investigator (1)
CL Item
Subject (2)
Date of visit
Item
Date of visit
date
C1320303 (UMLS CUI [1])
Laboratory Test: Subject number
Item
Subject number
integer
C0022885 (UMLS CUI [1,1])
C2348585 (UMLS CUI [1,2])
C2348585 (UMLS CUI [1,2])
CL Item
Yes -> Please complete next item if different from visit date. (1)
CL Item
No. (2)
Collection Date
Item
Date blood sample was taken
date
C1317250 (UMLS CUI [1])
Item
Has any vaccine other than the study vaccine(s) been administered one starting 30 days prior to the vaccone dose and ending one month (minimum 30 days) after the vaccine dose?
text
Code List
Has any vaccine other than the study vaccine(s) been administered one starting 30 days prior to the vaccone dose and ending one month (minimum 30 days) after the vaccine dose?
CL Item
No (1)
CL Item
Yes, please record concomitant vaccination with trade name and/or generic name, route and vaccine administration date (fill in items below). (2)
Item Group
Specification of concomitant Vaccination
C0042196 (UMLS CUI-1)
C2347852 (UMLS CUI-2)
C2347852 (UMLS CUI-2)
Trade Name
Item
Trade / (Generic) Name
text
C2360065 (UMLS CUI [1])
Route
Item
Route
text
Administration date
Item
Administration date
date
C1533734 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,2])
Item Group
Additional Vaccination / Medication
C0042196 (UMLS CUI-1)
C0940824 (UMLS CUI-2)
C0940824 (UMLS CUI-2)
Additional Vaccination: Subject Number
Item
Subject Number
integer
C0042196 (UMLS CUI [1,1])
C0940824 (UMLS CUI [1,2])
C2348585 (UMLS CUI [1,3])
C0940824 (UMLS CUI [1,2])
C2348585 (UMLS CUI [1,3])
Item
Have any medications/treatments been administered starting 30 days prior to the vaccine dose and ending one month (minimum 30 days) after the vaccine dose?
text
C0013227 (UMLS CUI [1])
Code List
Have any medications/treatments been administered starting 30 days prior to the vaccine dose and ending one month (minimum 30 days) after the vaccine dose?
CL Item
No (1)
CL Item
Yes, please complete the following table. (2)
Item Group
Specification of additional Vaccination / Medication
C2348235 (UMLS CUI-1)
C0042196 (UMLS CUI-2)
C0940824 (UMLS CUI-3)
C0042196 (UMLS CUI-2)
C0940824 (UMLS CUI-3)
Additional Vaccination: Specification Trade name
Item
Trade / Generic name
text
C2360065 (UMLS CUI [1,1])
C0042196 (UMLS CUI [1,2])
C0940824 (UMLS CUI [1,3])
C0042196 (UMLS CUI [1,2])
C0940824 (UMLS CUI [1,3])
Medical Indication
Item
Medical Indication
text
C2315323 (UMLS CUI [1])
Prophylactic
Item
Prophylactic
boolean
C0199176 (UMLS CUI [1])
Total daily dose
Item
Total daily dose
float
C2348070 (UMLS CUI [1])
Administration Route
Item
Route
text
C0013153 (UMLS CUI [1])
Start date
Item
Start date
date
C0808070 (UMLS CUI [1])
End date
Item
End date
date
C0806020 (UMLS CUI [1])
Continuing Therapy
Item
Continuing at the end of study?
boolean
C1553904 (UMLS CUI [1])
Item Group
Additional Vaccination / Non-Serious Adverse Events
C1518404 (UMLS CUI-1)
Subject Number
Item
Subject Number
integer
Item
Has any non-serious adverse event occured within the one month (minimum 30 days) post-vaccination, excluding those recorded on the Solicited Adverse Events Pages?
text
Code List
Has any non-serious adverse event occured within the one month (minimum 30 days) post-vaccination, excluding those recorded on the Solicited Adverse Events Pages?
CL Item
No. (1)
CL Item
Yes, please complete the following items. (2)
Adverse Event Number
Item
AE No.
integer
C0877248 (UMLS CUI [1,1])
C0449788 (UMLS CUI [1,2])
C0449788 (UMLS CUI [1,2])
Description
Item
Description
text
C0678257 (UMLS CUI [1])
CL Item
Administration site (1)
CL Item
Non-administration site (2)
Date started
Item
Date started
date
Start Time: post-vaccination period
Item
Started during immediate post-vaccination period (30 minutes)
boolean
C0042196 (UMLS CUI [1,1])
C0687676 (UMLS CUI [1,2])
C1301880 (UMLS CUI [1,3])
C0687676 (UMLS CUI [1,2])
C1301880 (UMLS CUI [1,3])
End Date
Item
Date stopped
date
C0806020 (UMLS CUI [1])
CL Item
Mild (1)
CL Item
Moderate (2)
CL Item
Severe (3)
Relationship to investigational products
Item
Is there a reasonable possibility that the AE may have been caused by the investigational product?
boolean
C0085978 (UMLS CUI [1,1])
C0877248 (UMLS CUI [1,2])
C0877248 (UMLS CUI [1,2])
CL Item
Recovered / Resolved (1)
CL Item
Recovering / resolving (2)
CL Item
Not recovered / not resolved (3)
CL Item
Recovered with sequelae / Resolved with sequelae (4)
Item
If a follow-up study is offered in the future, would the subject be willing to be contacted and learn more about it?
text
C0016441 (UMLS CUI [1])
Code List
If a follow-up study is offered in the future, would the subject be willing to be contacted and learn more about it?
CL Item
Yes (1)
CL Item
No, please specify the most appropriate reason. (2)
Code List
Reason not willing to be contacted in the future
CL Item
Adverse Events, or Serious Adverse Events (1)
CL Item
Other (2)
Adverse Events: Specification
Item
If Adverse Events, or Serious Adverse Events, please specify
text
C0877248 (UMLS CUI [1,1])
C2348235 (UMLS CUI [1,2])
C2348235 (UMLS CUI [1,2])
Other Reason
Item
If other reason not willing to be contacted in the future, please specify
text
C3840932 (UMLS CUI [1])
Item
Did the subject experience any Serious Adverse Event during the study period as specified in the protocol?
text
C1519255 (UMLS CUI [1,1])
C2745955 (UMLS CUI [1,2])
C2745955 (UMLS CUI [1,2])
Code List
Did the subject experience any Serious Adverse Event during the study period as specified in the protocol?
CL Item
No (1)
CL Item
Yes, Specify number of AE´s below. (2)
Number of SAE´s
Item
Please specify total number of AE´s
integer
C0449788 (UMLS CUI [1,1])
C1519255 (UMLS CUI [1,2])
C1519255 (UMLS CUI [1,2])
Item
Did the subject become pregnant during the study period?
text
C0032961 (UMLS CUI [1])
CL Item
No (1)
CL Item
Yes (complete the Pregnancy Notification form) (2)
CL Item
Not Applicable (not of child bearing potential or male) (3)
CL Item
No (1)
CL Item
Yes, please fill in following items (2)
Item
Major reason for withdrawal (tick one box)
text
C2349954 (UMLS CUI [1,1])
C2348235 (UMLS CUI [1,2])
C2348235 (UMLS CUI [1,2])
CL Item
SAE Serious Adverse event (Please complete and submit SAE report and specify SAE No.) (1)
CL Item
Non-Serious Adverse event (Please complete Non-Serious Adverse Event section and specify AE No. or Soliticed AE Code (2)
CL Item
Protocol violation, please specify below. (3)
CL Item
Consent withdrawal, not due to an adverse event (4)
CL Item
Migrated / moved from the study area (5)
CL Item
Lost to follow-up (6)
CL Item
Other, please specify (7)
Protocol violation
Item
If protocol violation, please specify
text
C1709750 (UMLS CUI [1])
Withdrawal: Other reason
Item
If Other reason for withdrawal, please specify
text
C2349954 (UMLS CUI [1,1])
C3840932 (UMLS CUI [1,2])
C3840932 (UMLS CUI [1,2])
Item
Who made the decision?
text
C0679006 (UMLS CUI [1,1])
C0679006 (UMLS CUI [1,2])
C0679006 (UMLS CUI [1,2])
CL Item
Investigator (1)
CL Item
Subject (2)
Date of last contact
Item
Date of last contact
date
C0805839 (UMLS CUI [1])
Item
Was the subject in good condition at date of last contact?
text
C0012634 (UMLS CUI [1])
CL Item
No -> Please give details in Adverse Events section. (1)
CL Item
Yes. (2)
Investigator´s signature
Item
Investigator´s signature
text
C2346576 (UMLS CUI [1])
Date
Item
Date
date
C0011008 (UMLS CUI [1])
Investigator´s name
Item
Printed Investigator´s name
text
C2826892 (UMLS CUI [1])
Previous subject number
Item
Previous subject number
integer
C2348585 (UMLS CUI [1,1])
C0205156 (UMLS CUI [1,2])
C0205156 (UMLS CUI [1,2])
Date of birth
Item
Date of birth
date
C0421451 (UMLS CUI [1])
CL Item
Subject not eligible - please specify criteria that are not fulfilled below (1)
CL Item
Subject lost to follow-up or not reached (2)
CL Item
Subject eligible but not willing due to adverse events, or serious adverse events (please specify below) (3)
CL Item
Subject eligible but not willing due to other (please specify below) (4)
CL Item
Subject died (specify date of death below) (5)
Eligibility criteria
Item
If subject not eligible, please specify criteria that are not fullfilled.
text
C0013893 (UMLS CUI [1])
Adverse Event: Specification
Item
If subject eligible but not willing to participate due to adverse event or serious adverse event, please specify
text
C0877248 (UMLS CUI [1,1])
C2348235 (UMLS CUI [1,2])
C2348235 (UMLS CUI [1,2])
Compliance: Specification
Item
If subject is eligible but not willing to participate due to other, please specify other
text
C1321605 (UMLS CUI [1,1])
C2348235 (UMLS CUI [1,2])
C2348235 (UMLS CUI [1,2])
Death
Item
If subject died, please specificate date of death
date
C0011065 (UMLS CUI [1])
Investigator name
Item
Investigator name
text
C2826892 (UMLS CUI [1])
Signature
Item
Signature
text
C1519316 (UMLS CUI [1])
Date
Item
Date
date
C0011008 (UMLS CUI [1])