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Information:
Fel:
ID
23096
Beskrivning
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
Nyckelord
Versioner (3)
- 2017-06-23 2017-06-23 -
- 2017-06-23 2017-06-23 -
- 2017-09-25 2017-09-25 -
Rättsinnehavare
GlaxoSmithKline
Uppladdad den
23 juni 2017
DOI
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Licens
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
Typ
Description | Question | Decode (Coded Value)
Datatyp
Alias
Subject number
Item
Subject number
integer
Item
Did the subject return for follow-up concerning the additional vaccination visit?
text
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
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)
Specification of other reason
Item
If Other reason, please specify
text
CL Item
Investigator (1)
CL Item
Subject (2)
Date of visit
Item
Date of visit
date
Subject number
Item
Subject number
integer
CL Item
Yes -> Please complete next item if different from visit date. (1)
CL Item
No. (2)
Date blood sample was taken
Item
Date blood sample was taken
date
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)
Trade / (Generic) Name
Item
Trade / (Generic) Name
text
Route
Item
Route
text
Administration date
Item
Administration date
date
Subject Number
Item
Subject Number
integer
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
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
Trade / Generic name
Item
Trade / Generic name
text
Medical Indication
Item
Medical Indication
text
Prophylactic
Item
Prophylactic
boolean
Total daily dose
Item
Total daily dose
float
Route
Item
Route
text
Start date
Item
Start date
date
End date
Item
End date
date
Continuing at the end of study?
Item
Continuing at the end of study?
boolean
Item Group
Additional Vaccination / Non-Serious Adverse Events
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)
AE No.
Item
AE No.
integer
Description
Item
Description
text
CL Item
Administration site (1)
CL Item
Non-administration site (2)
Date started
Item
Date started
date
Started during immediate post-vaccination period (30 minutes)
Item
Started during immediate post-vaccination period (30 minutes)
boolean
Date stopped
Item
Date stopped
date
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
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
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)
Item
Reason not willing to be contacted in the future
text
Code List
Reason not willing to be contacted in the future
CL Item
Adverse Events, or Serious Adverse Events (1)
CL Item
Other (2)
Specification of Adverse Events, or Serious Adverse Events
Item
If Adverse Events, or Serious Adverse Events, please specify
text
Specification of Other reason
Item
If other reason not willing to be contacted in the future, please specify
text
Item
Did the subject experience any Serious Adverse Event during the study period as specified in the protocol?
text
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)
Specification of number of SAE´s
Item
Please specify total number of AE´s
integer
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)
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)
Specification of protocol violation
Item
If protocol violation, please specify
text
Specification of Other reason for withdrawal
Item
If Other reason for withdrawal, please specify
text
CL Item
Investigator (1)
CL Item
Subject (2)
Date of last contact
Item
Date of last contact
date
CL Item
No -> Please give details in Adverse Events section. (1)
CL Item
Yes. (2)
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
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)
Specification of eligibility criteria that are not fullfilled
Item
If subject not eligible, please specify criteria that are not fullfilled.
text
Specification of adverse event, serious adverse event
Item
If subject eligible but not willing to participate due to adverse event or serious adverse event, please specify
text
Specification of other reason not willing to participate
Item
If subject is eligible but not willing to participate due to other, please specify other
text
Specification of death
Item
If subject died, please specificate date of death
date
Investigator name
Item
Investigator name
text
Signature
Item
Signature
text
Date
Item
Date
date