Check for Study Continuation
Did the subject return for Visit 3?
boolean
If No, please tick ONE most appropriate reason
text
If Other, please specify
text
If SAE, record the SAE number
integer
If non-SAE, please record the AE number
integer
Please tick who took the decision
text
Elimination Criteria During The Study
If any of the criteria become applicable during the study, it will not require withdrawal of the subject from the study but may determine a subject's evaluability in the according-to-protocol (ATP) analysis.
text
1. Use of any investigational or non-registered product (drug or vaccine) other than the study vaccine(s) during the study period
text
2. Chronic administration (defined as more than 14 days) or immunodepressants or other imminodefying drugs during the study period.
text
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
4. Administration of immunoglobulins and/or any blood products during the study period
text
Vaccine Administration - Vaccine 1
fill in only if different from visit date
date
Pre-Vaccination temperature
float
Route
text
Tick ONLY one box by vaccine
text
If replacement vial, please record the number
integer
If wrong vial, please record the number
integer
according to Protocol
text
according to Protocol
text
according to Protocol
text
If No, please tick below all items that apply
boolean
Side
text
Site
text
Route
text
Vaccine Administration - Vaccine 2
Tick ONLY one box by vaccine
text
If Replacement vial, please record the number
integer
If Wrong vial number, please record the number
integer
According to Protocol
text
According to Protocol
text
According to Protocol
text
If No, please tick below all items that apply
boolean
Side
text
Site
text
Route
text
Non-administration
If any AE occurred during the immediate post-vaccination time (30 min) please fill in the Solicited AE section, the Non-SAE section or a SAE form. If any prophylactic medication has been administered in anticipation of study vaccine reaction, please complete the Medication section and tick prophylactic box. Any other vaccines administered during the study period must be recorded in the Concomitant Vaccination section.
text
If Other, please specify
text
If SAE, record the SAE number
integer
If non-SAE, please record the AE number
integer
Unsolicited Adverse Events
Solicited Adverse Events - Local Symptoms
Hib-MenC vaccine or MeningitecTM vaccine
integer
Day
integer
If Redness, record size
float
If Swelling, record size
float
If Pain, record Intensity
text
Ongoing after day 3?
boolean
Date of last day of symptoms
date
Medically attended visit?
boolean
If Yes, please record type
text
Solicited Adverse Events - Local Symptoms - Vaccine 2
InfanrixTM-IPV vaccine or PediacelTM vaccine
text
Day
text
If Redness, record size
float
If Swelling, record size
float
If Pain, record Intensity
text
Ongoing after day 3?
boolean
Date of last day of symptoms
boolean
medically attended visit?
boolean
If Yes, please record type
text
Solicited Adverse Events
General Symptoms
Symptom
text
preferably axillary! Axillary >= 37.5°C Rectal >=38°C
float
If Irritability / Fussiness, record intens
text
If Irritability / Fussiness, record intensity
text
If Drowsiness, record intensity
text
If Loss of appetite, record intensity
text
Ongoing after day 3?
boolean
Date of last day of symptoms
date
Causality
boolean
Medically attended visit?
boolean
If Yes, record the type
text