Did the subject return for Visit 3?
Item
Did the subject return for Visit 3?
boolean
Item
If No, please tick ONE most appropriate reason
text
Code List
If No, please tick ONE most appropriate reason
CL Item
Serious Adverse Event (SAE) (1)
CL Item
Non-Serious Adverse Event (Non-SAE) (2)
CL Item
Other (e.g.withdrawal,protocol violation) (3)
If Other, please specify
Item
If Other, please specify
text
If SAE, record the SAE number
Item
If SAE, record the SAE number
integer
If non-SAE, please record the AE number
Item
If non-SAE, please record the AE number
integer
Item
Please tick who took the decision
text
Code List
Please tick who took the decision
CL Item
Parents / Guardians (2)
Item
The following criteria should be checked at each visit subsequent to the first visit.
text
Code List
The following criteria should be checked at each visit subsequent to the first visit.
CL Item
Use of any investigational or non-registered product (drug or vaccine) other than the study vaccine(s) during the study period (1)
CL Item
Chronic administration (defined as more than 14 days) or immunodepressants or other imminodefying drugs during the study period. (For corticosteroids, this will mean prednisone, or equivalent, ≥0.5 mg/kg/day. Inhaled and topical steroids are allowed.) (2)
Item
1. Use of any investigational or non-registered product (drug or vaccine) other than the study vaccine(s) during the study period
text
Code List
1. Use of any investigational or non-registered product (drug or vaccine) other than the study vaccine(s) during the study period
CL Item
Not applicable (2)
Item
2. Chronic administration (defined as more than 14 days) or immunodepressants or other imminodefying drugs during the study period.
text
Code List
2. Chronic administration (defined as more than 14 days) or immunodepressants or other imminodefying drugs during the study period.
CL Item
Not applicable (2)
Item
3. Administration of a vaccine not foreseen by the study protocol during the period starting from 30 days before each dose of vaccine(s) and ending 30 days after
text
Code List
3. Administration of a vaccine not foreseen by the study protocol during the period starting from 30 days before each dose of vaccine(s) and ending 30 days after
CL Item
Not applicable (2)
Item
4. Administration of immunoglobulins and/or any blood products during the study period
text
Code List
4. Administration of immunoglobulins and/or any blood products during the study period
CL Item
Not applicable (2)
Pre-Vaccination temperature
Item
Pre-Vaccination temperature
float
Item
Tick ONLY one box by vaccine
text
Code List
Tick ONLY one box by vaccine
CL Item
Hib-MenC Vaccine (1)
CL Item
MeningitecTM Vaccine (2)
CL Item
Replacement vial (3)
CL Item
Wrong vial number (4)
CL Item
Not administered -> please complete following section (5)
If replacement vial, please record the number
Item
If replacement vial, please record the number
integer
If wrong vial, please record the number
Item
If wrong vial, please record the number
integer
Has the study vaccine been administered according to the Protocol?
Item
Has the study vaccine been administered according to the Protocol?
boolean
Item
Tick ONLY one box by vaccine
text
Code List
Tick ONLY one box by vaccine
CL Item
InfanrixTM-IPV Vaccine (1)
CL Item
PediacelTM Vaccine (2)
CL Item
Replacement vial (3)
CL Item
Wrong vial number (4)
CL Item
Not administered -> please complete following section (5)
If Replacement vial, please record the number
Item
If Replacement vial, please record the number
integer
If Wrong vial number, please record the number
Item
If Wrong vial number, please record the number
integer
Has the study vaccine been administered according to protocol?
Item
Has the study vaccine been administered according to protocol?
boolean
Item
If vaccine not administered, choose ONE most appropriate reason
text
Code List
If vaccine not administered, choose ONE most appropriate reason
CL Item
Serious Adverse Event (SAE) (1)
CL Item
Non-Serious Adverse Event (Non-SAE) (2)
CL Item
Other (e.g.withdrawal,protocol violation) (3)
If Other, please specify
Item
If Other, please specify
text
If SAE, record the SAE number
Item
If SAE, record the SAE number
integer
If non-SAE, please record the AE number
Item
If non-SAE, please record the AE number
integer
Item
Has the subject experienced any serious or non-serious unsolicited adverse events within one month (minimum 30 days) post-vaccination?
text
Code List
Has the subject experienced any serious or non-serious unsolicited adverse events within one month (minimum 30 days) post-vaccination?
CL Item
Information not available (1)
CL Item
No Vaccine administered (2)
CL Item
Yes, fill in the Non-Serious Adverse Event pages or Serious Adverse Event form (4)
Item
Local Symptom
integer
If Redness, record size
Item
If Redness, record size
float
If Swelling, record size
Item
If Swelling, record size
float
Item
If Pain, record Intensity
text
Code List
If Pain, record Intensity
Ongoing after day 3?
Item
Ongoing after day 3?
boolean
Date of last day of symptoms
Item
Date of last day of symptoms
date
Medically attended visit?
Item
Was the visit medically attended?
boolean
Item
If Yes, please record type
text
Code List
If Yes, please record type
CL Item
Hospitalization (1)
CL Item
Emergency Room (2)
CL Item
Medical Personnel (3)
If Redness, record size
Item
If Redness, record size
float
If Swelling, record size
Item
If Swelling, record size
float
Item
If Pain, record Intensity
text
Code List
If Pain, record Intensity
Ongoing after day 3?
Item
Ongoing after day 3?
boolean
Date of last day of symptoms
Item
Date of last day of symptoms
boolean
medically attended visit?
Item
Was the visit medically attended?
boolean
Item
If Yes, please record type
text
Code List
If Yes, please record type
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
Irritability/Fussiness (2)
CL Item
Loss of appetite (4)
If Fever, record t°
Item
If Fever, record t°
float
Item
If Irritability / Fussiness, record intens
text
Code List
If Irritability / Fussiness, record intens
Item
If Irritability / Fussiness, record intensity
text
Code List
If Irritability / Fussiness, record intensity
Item
If Drowsiness, record intensity
text
Code List
If Drowsiness, record intensity
Item
If Loss of appetite, record intensity
text
Code List
If Loss of appetite, record intensity
Ongoing after day 3?
Item
Ongoing after day 3?
boolean
Date of last day of symptoms
Item
Date of last day of symptoms
date
Causality
Item
Causality
boolean
Medically attended visit?
Item
Was the visit medically attended?
boolean
Item
If Yes, record the type
text
Code List
If Yes, record the type
CL Item
Hospitalization (1)
CL Item
Emergency Room (2)
CL Item
Medical Personnel (3)