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
Item
Please tick who took the decision
text
Code List
Please tick who took the decision
Date of visit
Item
Date of visit
date
Subject number
Item
Subject number
integer
Item
Has a blood sample been taken?
text
Code List
Has a blood sample been taken?
CL Item
Yes -> Please complete next item if different from visit date. (1)
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
Yes, please record concomitant vaccination with trade name and/or generic name, route and vaccine administration date (fill in items below). (2)
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
Yes, please complete the following table. (2)
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
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
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
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
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
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)
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
Yes, Specify number of AE´s below. (2)
Specification of number of SAE´s
Item
Please specify total number of AE´s
integer
Item
Did the subject become pregnant during the study period?
text
Code List
Did the subject become pregnant during the study period?
CL Item
Yes (complete the Pregnancy Notification form) (2)
CL Item
Not Applicable (not of child bearing potential or male) (3)
Item
Was the subject withdrawn from the study?
text
Code List
Was the subject withdrawn from the study?
CL Item
Yes, please fill in following items (2)
Item
Major reason for withdrawal (tick one box)
text
Code List
Major reason for withdrawal (tick one box)
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
Item
Who made the decision?
text
Code List
Who made the decision?
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 in Adverse Events section. (1)
Investigator´s signature
Item
Investigator´s signature
text
Printed Investigator´s name
Item
Printed Investigator´s name
text
Previous subject number
Item
Previous subject number
integer
Date of birth
Item
Date of birth
date
Item
Reason for non-participation
text
Code List
Reason for non-participation
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