Concomitant Vaccination Question
Item
Have any other than the study vaccine(s) been administered during the timeframe as specified in the Protocol?
boolean
concomitant medications / treatments
Item
Have any medications/treatments been administered during the time frame as specified in the Protocol?
boolean
Trade/Genereic Name
Item
Trade/Genereic Name
text
Prophylactic Administration
Item
Was the administration prophylactic?
boolean
Medical Indication
Item
Medical Indication
text
Total daily dose
Item
Total daily dose
text
CL Item
Intramuscular (3)
Specify Other
Item
If Other, please specify
text
Start Date
Item
Start Date
date
End Date
Item
End Date
date
Ongoing?
Item
Is the event continuing?
boolean
Non-Serious AE
Item
Has any non-serious adverse events occurred within minimum 30 days post-vaccination, excluding those recorded on the Solicited Adverse Events forms?
boolean
Episode Number
Item
Episode Number
integer
Description
Item
Description
text
Item
Was the Adverse Event at the administration site?
text
Code List
Was the Adverse Event at the administration site?
CL Item
administrationsite (1)
CL Item
non-administration site (2)
Item
Please record the vaccine
text
Code List
Please record the vaccine
CL Item
Hib-MenC vaccine (1)
CL Item
Priorix vaccine (2)
Date started
Item
Date started
date
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)
Medically attended visit
Item
Medically attended visit
boolean
Item
If Yes, please specify type
text
Code List
If Yes, please specify type
CL Item
Hospitalization (1)
CL Item
Emergency Room (2)
CL Item
Medical Personnel (3)
Potential Follow-up Study Participation
Item
If a booster study or a follow-up study is offered in the future, would the subject be willing to be contacted and learn more about it?
boolean
Item
Reason for Non-participation:
text
Code List
Reason for Non-participation:
CL Item
Adverse Events, or Serious Adverse Events (1)
Comment
Item
Comment
text
Occurrence of SAE
Item
Did the subject experience any Serious Adverse Event during the study?
boolean
Specify Number of SAE
Item
If Yes, Specify total number of SAE's:
integer
Status of the Treatment Blind
Item
Was the treatment blind broken during the study?
boolean
Treatment Blind Broken
Item
If Yes, complete date and tick one reason below.
date
Item
Reason for the treatment line break
text
Code List
Reason for the treatment line break
CL Item
Medical emergency requiring identification of investigational product for further treatments. (1)
Specify Other
Item
if Other, please specify
text
Elimination Criteria
Item
Did any elimination criteria become applicable during the study?
boolean
Specify Elimination Criteria
Item
If Yes, please specify
text
Subject Withdrawn
Item
Was the subject withdrawn from the study?
boolean
Item
Major reason for withdrawal
text
Code List
Major 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)
Specify Number of SAE
Item
Specify Number of SAE
integer
Specify Number of AE
Item
Specify Number of AE
integer
Protocol Violation Specify
Item
Please specify the typo of protocol violation
text
Specify Other
Item
If Other, please specify below
text
Item
Who made the decision:
text
Code List
Who made the decision:
Date of last contact
Item
Date of last contact:
date
Subject Status
Item
Was the subject in good condition at date of last contact?
boolean
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