Study Continuation Question
Item
Did the subject come at visit 4?
boolean
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)
Other Specify
Item
If Other, please specify
text
Item
Please tick who took the decision
text
Code List
Please tick who took the decision
CL Item
Parents/Guardians (2)
Item
Has a blood sample been taken ?
text
Code List
Has a blood sample been taken ?
CL Item
NA - > Only for 100 subjects without BS (3)
BLOOD SAMPLE
Item
Has a blood sample been taken ?
boolean
Concomitant vaccinations
Item
Has any vaccine other than the study vaccine(s) been administered during the timeframe as specified in the Protocol?
boolean
Trade / (Generic) Name
Item
Trade / (Generic) Name
text
CL Item
Intramuscular (3)
Administration date
Item
Administration date
date
Concomitant Medication
Item
Have any medications/treatments been administered during study period?
boolean
Trade / Generic Name
Item
Trade / Generic Name
text
Medical Indication
Item
Medical Indication
text
Medical Indication Prophylactic
Item
Was the medical indication prophylactic?
boolean
Total daily dose
Item
Total daily dose
text
Start date
Item
Start date
date
End date
Item
End date
date
Ongoing
Item
Ongoing?
boolean
Non-SAE Question
Item
Has any non-serious adverse events occurred within one month (minimum 30 days) post-vaccination, excluding those recorded on the Solicited Adverse Events pages?
boolean
AE Number
Item
AE Number
integer
Description
Item
Description
text
Administration sites Reaction
Item
Did the AE occur on administration site?
boolean
Item
If administration site:
text
Code List
If administration site:
CL Item
DTPw-HBV/Hib Kft. vaccine (1)
CL Item
DTPw-HBV Kft. vaccine (2)
CL Item
Hiberix™ vaccine (3)
CL Item
Tritanrix™-HepB/Hiberix™ vaccine (4)
Start date
Item
Start date
date
End date
Item
End date
date
Relationship to investigational products:
Item
Relationship to investigational products:
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)
Medically attended visit
Item
Medically attended visit
boolean
Item
Type of Medically attended visit
text
Code List
Type of Medically attended visit
CL Item
Hospitalisation (1)
CL Item
Emergency Room (2)
CL Item
Medical Personnel (3)
FOLLOW-UP STUDIES
Item
Would the subject be willing to participate in a follow-up study?
boolean
Item
reason for non-participation
text
Code List
reason for non-participation
CL Item
Adverse Events, or Serious Adverse Events (1)
Specify
Item
Specify
text
SAE Occurrence
Item
Did the subject experience any Serious Adverse Event during the study period ?
boolean
total SAE number
Item
if Yes -> specify total number of SAE's below
integer
Elimination criteria applied?
Item
Did any elimination criteria become applicable during the study ?
boolean
Specify
Item
Specify
text
subject withdrawn from study?
Item
Was the subject withdrawn from study?
boolean
Item
Reason for withdrawal
text
Code List
Reason for withdrawal
CL Item
Serious adverse event (1)
CL Item
Non-Serious adverse event (2)
CL Item
Protocol violation (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)
Date of last contact:
Item
Date of last contact:
date
Item
Was the subject in good condition at date of last contact?
text
Code List
Was the subject in good condition at date of last contact?
CL Item
No, please give details within the Adverse Events section. (1)
Item
Please tick who took decision
text
Code List
Please tick who took decision
CL Item
Parents/Guardians (2)
Investigator's confirmation
Item
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.
date
Investigator's signature
Item
Investigator's signature:
text
Printed Investigator's name
Item
Printed Investigator's name:
text