Check for Study Continuation
Item
Did the subject return for visit 1?
boolean
If No, please record ONE most appropriate reason and skip the following forms of this visit.
Item
If No, please record ONE most appropriate reason and skip the following forms of this visit.
text
Item
Has a blood sample been taken for haematology/ biochemistry testing?
text
Code List
Has a blood sample been taken for haematology/ biochemistry testing?
CL Item
N/A (Only if Visit 1 occurred within 48 hours from blood sample taken at screening visit) (3)
Laboratory Name
Item
Laboratory Name
text
Laboratory Code
Item
Laboratory Code
integer
Creatinine
Item
[CREA] Creatinine
float
AST/SGOT
Item
[AST] AST/SGOT
float
ALT/SGPT
Item
[ALT] ALT/SGPT
float
Cholesterol
Item
[CHOL] Cholesterol
float
Creatine phosphokinase
Item
[CPK] Creatine phosphokinase
float
Serum Haptoglobin
Item
[HAP] Serum Haptoglobin
float
Lactate Dehydrogenase
Item
[LDH] Lactate Dehydrogenase
text
Blood Sample for Immunogenicity Assays
Item
Has a blood sample been taken for immunogenicity assays?
boolean
Urine Sample Question
Item
Has a urine sample been taken for dipstick?
boolean
pH (via dipstick)
Item
pH (via dipstick)
integer
Item
Proteins (via dipstick)
text
Code List
Proteins (via dipstick)
Item
Glucose (via dipstick)
text
Code List
Glucose (via dipstick)
Item
Ketones (via dipstick)
text
Code List
Ketones (via dipstick)
Item
Blood and myoglobin (via dipstick)
text
Code List
Blood and myoglobin (via dipstick)
Item
Bilirubin (via dipstick)
text
Code List
Bilirubin (via dipstick)
Item
Urobilinogen (via dipstick)
text
Code List
Urobilinogen (via dipstick)
Item
Nitrites (via dipstick)
text
Code List
Nitrites (via dipstick)
Item
Leukocyte esterase (via dipstick)
text
Code List
Leukocyte esterase (via dipstick)
Urina Sample for Diagnostic Sssay?
Item
Has a urine sample been taken for development of diagnostic assay?
boolean
Pre-Vaccination temperature
Item
Pre-Vaccination temperature:
float
Item
Administration data
text
Code List
Administration data
CL Item
Study Vaccine (1)
CL Item
Replacement vial (2)
CL Item
Not administered (3)
Replacement vial Number
Item
Replacement vial Number
integer
Comment
Item
Comment
text
Has the study vaccine been administered according to the Protocol?
Item
Has the study vaccine been administered according to the Protocol?
boolean
Comment
Item
Comment
text
Item
Please tick the major reason for non administration.
text
Code List
Please tick the major reason for non administration.
CL Item
Serious adverse event (1)
CL Item
Non-Serious adverse event (2)
SAE number
Item
In case of SAE, record SAE number
integer
AE number
Item
In case of AE, record AE number
integer
Specify Other
Item
In Other cases, specify
text
Item
Please record who made the decision
text
Code List
Please record who made the decision
Reminder AE
Item
If any adverse events occurred during the immediate post-vaccination time (30 minutes) please fill in the Solicited Adverse Events section, the Non-Serious Adverse Event section or a Serious Adverse Event report.
text
Reminder Concomitant Medication
Item
If any prophylactic medication has been administered in anticipation of study vaccine reaction, please complete the Medication section and tick prophylactic box.
text
Reminder Concomitant Vaccination
Item
Any other vaccines administered during the study period must be recorded in the Concomitant Vaccination section.
text
Item
Has the subject experienced any of the following signs/symptoms at the administration site during the solicited period?
text
Code List
Has the subject experienced any of the following signs/symptoms at the administration site during the solicited period?
CL Item
Information not available (1)
CL Item
No vaccine administered (2)
CL Item
Yes, please record information for all symptoms (4)
Redness
Item
Redness
boolean
Ongoing after day 6?
Item
Ongoing after day 6?
boolean
Date of last day of symptoms
Item
Date of last day of symptoms
date
Medically attended visit
Item
Medically attended visit?
boolean
Item
Medically attended visit
text
Code List
Medically attended visit
CL Item
Hospitalization (1)
CL Item
Emergency Room (2)
CL Item
Medical Personnel (3)
Swelling
Item
Swelling
boolean
Ongoing after day 6?
Item
Ongoing after day 6?
boolean
Date of last day of symptoms
Item
Date of last day of symptoms
date
Medically attended visit
Item
Medically attended visit
boolean
Item
Medically attended visit
text
Code List
Medically attended visit
CL Item
Hospitalization (1)
CL Item
Emergency Room (2)
CL Item
Medical Personnel (3)
CL Item
Painful on touch (2)
CL Item
Painful when limb is moved (3)
CL Item
Pain that prevents normal activity (4)
Ongoing after day 6?
Item
Ongoing after day 6?
boolean
Date of last day of symptoms
Item
Date of last day of symptoms
date
Medically attended visit
Item
Medically attended visit
boolean
Item
Medically attended visit
text
Code List
Medically attended visit
CL Item
Hospitalization (1)
CL Item
Emergency Room (2)
CL Item
Medical Personnel (3)
Item
Has the subject experienced any of the following signs/symptoms during the solicited period?
text
Code List
Has the subject experienced any of the following signs/symptoms during the solicited period?
CL Item
Information not available (1)
CL Item
No vaccine administered (2)
CL Item
Yes, please record information for each symptom (4)
Temperature
Item
Temperature
boolean
Ongoing after day 6?
Item
Ongoing after day 6?
boolean
Date of last day of symptoms
Item
Date of last day of symptoms
date
Causality?
Item
Causality?
boolean
Medically attended visit
Item
Medically attended visit?
boolean
Item
Medically attended visit
text
Code List
Medically attended visit
CL Item
Hospitalization (1)
CL Item
Emergency Room (2)
CL Item
Medical Personnel (3)
Fatigue
Item
Fatigue
boolean
CL Item
Fatigue that is easily tolerated (2)
CL Item
Fatigue that interferes with normal activity (3)
CL Item
Fatigue that prevents normal activity (4)
Ongoing after day 6?
Item
Ongoing after day 6?
boolean
Date of last day of symptoms
Item
Date of last day of symptoms
date
Causality?
Item
Causality?
boolean
Medically attended visit
Item
Medically attended visit?
boolean
Item
Medically attended visit
text
Code List
Medically attended visit
CL Item
Hospitalization (1)
CL Item
Emergency Room (2)
CL Item
Medical Personnel (3)
Headache
Item
Headache
boolean
CL Item
Headache that is easily tolerated (2)
CL Item
Headache that interferes with normal activity (3)
CL Item
Headache that prevents normal activity (4)
Ongoing after day 6?
Item
Ongoing after day 6?
boolean
Date of last day of symptoms
Item
Date of last day of symptoms
date
Causality?
Item
Causality?
boolean
Medically attended visit
Item
Medically attended visit
boolean
Item
Medically attended visit
text
Code List
Medically attended visit
CL Item
Hospitalization (1)
CL Item
Emergency Room (2)
CL Item
Medical Personnel (3)
Gastrointestinal symptoms
Item
Gastrointestinal symptoms
boolean
CL Item
Gastrointestinal symptoms that are easily tolerated (2)
CL Item
Gastrointestinal symptoms that interfere with normal activity (3)
CL Item
Gastrointestinal symptoms that prevent normal activity (4)
Ongoing after day 6?
Item
Ongoing after day 6?
boolean
Date of last day of symptoms
Item
Date of last day of symptoms
date
Causality?
Item
Causality?
boolean
Medically attended visit
Item
Medically attended visit
boolean
Item
Medically attended visit
text
Code List
Medically attended visit
CL Item
Hospitalization (1)
CL Item
Emergency Room (2)
CL Item
Medical Personnel (3)
Malaise
Item
Malaise
boolean
CL Item
Malaise that is easily tolerated (2)
CL Item
Malaise that interferes with normal activity (3)
CL Item
Malaise that prevents normal activity (4)
Ongoing after day 6?
Item
Ongoing after day 6?
boolean
Date of last day of symptoms
Item
Date of last day of symptoms
date
Medically attended visit
Item
Medically attended visit
boolean
Item
Medically attended visit
text
Code List
Medically attended visit
CL Item
Hospitalization (1)
CL Item
Emergency Room (2)
CL Item
Medical Personnel (3)
Myalgia
Item
Myalgia
boolean
CL Item
Myalgia that is easily tolerated (2)
CL Item
Myalgia that interferes with normal activity (3)
CL Item
Myalgia that prevents normal activity (4)
Ongoing after day 6?
Item
Ongoing after day 6?
boolean
Date of last day of symptoms
Item
Date of last day of symptoms
date
Causality
Item
Causality
boolean
Medically attended visit
Item
Medically attended visit
boolean
Item
Medically attended visit
text
Code List
Medically attended visit
CL Item
Hospitalization (1)
CL Item
Emergency Room (2)
CL Item
Medical Personnel (3)
Item
Has the subject experienced any non-serious unsolicited adverse events within one month (minimum 30 days) post-vaccination or any serious adverse events or medically significant condition between dose 1 and dose 2 (Day 60)?
text
Code List
Has the subject experienced any non-serious unsolicited adverse events within one month (minimum 30 days) post-vaccination or any serious adverse events or medically significant condition between dose 1 and dose 2 (Day 60)?
CL Item
Information not available (1)
CL Item
No vaccine administered (2)