Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
Administrative data
Date of visit
Item
Date of visit
date
Subject Number
Item
Subject Number
integer
Item Group
ELIMINATION CRITERIA
Check Elimination Criteria
Item
The following criteria should be checked at each visit subsequent to the first visit.
text
Concomitant Medication
Item
Use of any investigational or non-registered product (drug or vaccine) other than the study vaccine(s) during the study period
boolean
immunosuppressants or immunemodifying drugs
Item
Chronic administration (defined as more than 14 days) of immunosuppressants or other immunemodifying drugs during the study period.
boolean
mmunoglobulins
Item
Administration of immunoglobulins and/or any blood products during the study.
boolean
Concomitant Vaccination
Item
Administration of any vaccine other than the study vaccine during the study.
boolean
Item Group
CHECK FOR STUDY CONTINUATION
check for study continuation
Item
Did the subject return for Visit "Day 21"?
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 (1)
CL Item
Non-Serious adverse event (2)
SAE No.
Item
Please specify SAE No.
integer
AE No.
Item
Please specify AE No.
integer
Specify Other
Item
Specify Other
text
Item
Please tick who made the decision
text
Code List
Please tick who made the decision
Item Group
LABORATORY TESTS
ANTIBODY DETERMINATION (HI)
Item
Has a blood sample been taken for antibody determination (7.5 mL)?
boolean
Item Group
SOLICITED ADVERSE EVENTS - LOCAL SYMPTOMS
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 tick No/Yes for each symptom. If Yes is ticked, please complete all items. (4)
Item Group
Local Symptoms - Redness
Redness
Item
Redness
boolean
Redness Size
Item
Size
integer
Ongoing after Day 3?
Item
Ongoing after Day 3?
boolean
Date
Item
Date of last Day of Symptoms
date
Medically attended visit
Item
Was the visit medically attended?
boolean
Item
Type of medical help:
text
Code List
Type of medical help:
CL Item
Hospitalization (1)
CL Item
Emergency Room (2)
CL Item
Medical Personnel (3)
Item Group
Local Symptoms - Swelling
Swelling
Item
Swelling
boolean
If Yes, record the size
Item
If Yes, record the size
integer
Ongoing after day 3?
Item
Ongoing after day 3?
boolean
If Yes, record date of last day of symptoms
Item
If Yes, record date of last day of symptoms
date
Medically attended visit
Item
Medically attended visit
boolean
Item
If Yes, record the visit type
text
Code List
If Yes, record the visit type
CL Item
Hospitalisation (1)
CL Item
Emergency room (2)
CL Item
Medical personnel (3)
Item Group
Local Symptoms - Induration
Induration
Item
Induration
boolean
Induration Size
Item
Size
integer
Ongoing after day 3?
Item
Ongoing after day 3?
boolean
Date
Item
Date of last Day of Symptoms
date
Medically attended visit
Item
Was the visit medically attended?
boolean
Item
Type of medical help:
text
Code List
Type of medical help:
CL Item
Hospitalization (1)
CL Item
Emergency Room (2)
CL Item
Medical Personnel (3)
Item Group
Local Symptoms - Ecchymosis
Ecchymosis
Item
Ecchymosis
boolean
Ecchymosis Size
Item
Size
integer
Ongoing after Day 3?
Item
Ongoing after Day 3?
boolean
Date
Item
Date of last Day of Symptoms
date
Medically attended visit
Item
Was the visit medically attended?
boolean
Item
Type of medical help:
text
Code List
Type of medical help:
CL Item
Hospitalization (1)
CL Item
Emergency Room (2)
CL Item
Medical Personnel (3)
Item Group
Local Symptoms - Pain
Ongoing after day 3?
Item
Ongoing after day 3?
boolean
Date
Item
Date of last Day of Symptoms
date
Medically attended visit
Item
Was the visit medically attended?
boolean
Item
Type of medical help:
text
Code List
Type of medical help:
CL Item
Hospitalization (1)
CL Item
Emergency Room (2)
CL Item
Medical Personnel (3)
Item Group
SOLICITED ADVERSE EVENTS - GENERAL SYMPTOMS
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 tick No/Yes for each symptom. If Yes is ticked, please complete all items (4)
Item Group
General Symptoms - Temperature
Temperature
Item
Temperature
boolean
CL Item
Axillary (preferable) (1)
Temperature not taken
Item
Not taken (temperature)
boolean
Ongoing after day 3?
Item
Ongoing after day 3?
boolean
Date
Item
Date of last Day of Symptoms
date
Causality
Item
Causality?
boolean
Medically attended visit
Item
Was the visit medically attended?
boolean
Item
Type of medical help:
text
Code List
Type of medical help:
CL Item
Hospitalization (1)
CL Item
Emergency Room (2)
CL Item
Medical Personnel (3)
Item Group
General Symptoms - Fatigue
Fatigue
Item
Fatigue
boolean
CL Item
that is easily tolerated (2)
CL Item
that interferes with normal activity (3)
CL Item
that prevents normal activity (4)
Ongoing after day 3?
Item
Ongoing after day 3?
boolean
Date
Item
Date of last Day of Symptoms
boolean
Causality
Item
Causality?
boolean
Medically attended visit
Item
Was the visit medically attended?
boolean
Item
Type of medical help:
text
Code List
Type of medical help:
CL Item
Hospitalization (1)
CL Item
Emergency Room (2)
CL Item
Medical Personnel (3)
Item Group
General Symptoms - Headache
Headache
Item
Headache
boolean
CL Item
that is easily tolerated (2)
CL Item
that interferes with normal activity (3)
CL Item
that prevents normal activity (4)
Ongoing after day 3?
Item
Ongoing after day 3?
boolean
Date
Item
Date of last Day of Symptoms
date
Causality
Item
Causality?
boolean
Medically attended visit
Item
Was the visit medically attended?
boolean
Item
Type of medical help:
text
Code List
Type of medical help:
CL Item
Hospitalization (1)
CL Item
Emergency Room (2)
CL Item
Medical Personnel (3)
Item Group
General Symptoms - Myalgia
Myalgia
Item
Myalgia
boolean
CL Item
easily tolerated (2)
CL Item
interferes with normal activity (3)
CL Item
that prevents normal activity (4)
Ongoing after day 3?
Item
Ongoing after day 3?
boolean
Date
Item
Date of last Day of Symptoms
date
Causality
Item
Causality?
boolean
Medically attended visit
Item
Was the visit medically attended?
boolean
Item
Type of medical help:
text
Code List
Type of medical help:
CL Item
Hospitalization (1)
CL Item
Emergency Room (2)
CL Item
Medical Personnel (3)
Item Group
General Symptoms - Shivering
Shivering
Item
Shivering
boolean
CL Item
easily tolerated (2)
CL Item
interferes with normal activity (3)
CL Item
that prevents normal activity (4)
Ongoing after day 3?
Item
Ongoing after day 3?
boolean
Date
Item
Date of last Day of Symptoms
date
Causality
Item
Causality?
boolean
Medically attended visit
Item
Was the visit medically attended?
boolean
Item
Type of medical help:
text
Code List
Type of medical help:
CL Item
Hospitalization (1)
CL Item
Emergency Room (2)
CL Item
Medical Personnel (3)
Item Group
General Symptoms - Arthralgia
Arthralgia
Item
Arthralgia
boolean
CL Item
easily tolerated (2)
CL Item
interferes with normal activity (3)
CL Item
that prevents normal activity (4)
Ongoing after day 3?
Item
Ongoing after day 3?
boolean
Date
Item
Date of last Day of Symptoms
date
Causality
Item
Causality?
boolean
Medically attended visit
Item
Was the visit medically attended?
boolean
Item
Type of medical help:
text
Code List
Type of medical help:
CL Item
Hospitalization (1)
CL Item
Emergency Room (2)
CL Item
Medical Personnel (3)
Item Group
General Symptoms - Sweating increase
Sweating increase
Item
Sweating increase
boolean
CL Item
easily tolerated (2)
CL Item
interferes with normal activity (3)
CL Item
that prevents normal activity (4)
Ongoing after day 3?
Item
Ongoing after day 3?
boolean
Date
Item
Date of last Day of Symptoms
date
Causality
Item
Causality?
boolean
Medically attended visit
Item
Was the visit medically attended?
boolean
Item
Type of medical help:
text
Code List
Type of medical help:
CL Item
Hospitalization (1)
CL Item
Emergency Room (2)
CL Item
Medical Personnel (3)
Item Group
UNSOLICITED ADVERSE EVENTS
Item
Has the subject experienced any serious or non-serious unsolicited adverse events between Visit "Day 0" and Visit "Day 21"?
text
Code List
Has the subject experienced any serious or non-serious unsolicited adverse events between Visit "Day 0" and Visit "Day 21"?
CL Item
Information not available (1)
CL Item
No vaccine administered (2)
CL Item
Yes -> Fill in the Non-Serious Adverse Event section or Serious Adverse Event report as (4)
CL Item
necessary. (necessary.)