Pre-Vaccination temperature
Item
Pre-Vaccination temperature
float
Item
Only one box must be ticked by vaccine
text
Code List
Only one box must be ticked by vaccine
CL Item
TritanrixTM-HepB Vaccine (1)
CL Item
ZilbrixTM Vaccine (2)
CL Item
Replacement vial (3)
CL Item
Wrong vial number (4)
CL Item
Not administered (5)
if Replacement vial, record number
Item
if Replacement vial, record number
integer
If Wrong vial number, please record the correct one
Item
If Wrong vial number, please record the correct one
integer
Has the study vaccine been administered according to protocol?
Item
Has the study vaccine been administered according to protocol?
boolean
Item
If No, please tick all items that apply: Side
integer
Code List
If No, please tick all items that apply: Side
Comment
Item
Comment
text
Code List
Only one box must be ticked by vaccine 2
CL Item
RotarixTM Vaccine or Placebo (1)
CL Item
Replacement vial (2)
CL Item
Wrong vial number (3)
CL Item
Not administered (4)
if Replacement vial, record number
Item
if Replacement vial, record number
integer
If Wrong vial number, please record the correct one
Item
If Wrong vial number, please record the correct one
integer
Has the study vaccine been administered according to protocol?
Item
Has the study vaccine been administered according to protocol?
boolean
Item
If No, please tick all items that apply: Side
integer
Code List
If No, please tick all items that apply: Side
Comment
Item
Comment
text
Item
Please tick the ONE most appropriate category for non-administration
text
Code List
Please tick the ONE most appropriate category for non-administration
CL Item
[SAE] Serious adverse event (complete the SAE form) (1)
CL Item
[AEX] Non-Serious adverse event (complete the Non-serious AE section) (2)
Code List
Only one box must be ticked by vaccine 2
CL Item
RotarixTM Vaccine or Placebo (1)
CL Item
Replacement vial (2)
CL Item
Wrong vial number (3)
CL Item
Not administered (4)
If Non-SAE, record the event number
Item
If Non-SAE, record the event number
integer
If Other, please specify
Item
If Other, please specify
text
Item
Please tick who took the decision
text
Code List
Please tick who took the decision
CL Item
Parents/Guardians (P)
If any adverse events occurred during the immediate post-vaccination time (30 min), fill in the SAE or Non-SAE form.
Item
If any adverse events occurred during the immediate post-vaccination time (30 min), fill in the SAE or Non-SAE form.
text
If any prophylactic medications has been administered, please complete the Medication Form and tick prophylactic box.
Item
If any prophylactic medications has been administered, please complete the Medication Form and tick prophylactic box.
text
Item
Only one box must be ticked by vaccine 3
text
Code List
Only one box must be ticked by vaccine 3
CL Item
Triple AntigenTM Vaccine (1)
CL Item
Replacement vial (2)
CL Item
Wrong vial number (3)
CL Item
Not administered (4)
if Replacement vial, record number
Item
if Replacement vial, record number
integer
If Wrong vial number, please record the correct one
Item
If Wrong vial number, please record the correct one
integer
Has the study vaccine been administered according to protocol?
Item
Has the study vaccine been administered according to protocol?
boolean
Item
If No, please tick all items that apply: Side
integer
Code List
If No, please tick all items that apply: Side
Comment
Item
Comment
text
Item
Only one box must be ticked by vaccine 4
text
Code List
Only one box must be ticked by vaccine 4
CL Item
EngerixTM-B Vaccine (1)
CL Item
Replacement vial (2)
CL Item
Wrong vial number (3)
CL Item
Not administered (4)
if Replacement vial, record number
Item
if Replacement vial, record number
integer
If Wrong vial number, please record the correct one
Item
If Wrong vial number, please record the correct one
integer
Has the study vaccine been administered according to protocol?
Item
Has the study vaccine been administered according to protocol?
boolean
Item
If No, please tick all items that apply: Side
integer
Code List
If No, please tick all items that apply: Side
Comment
Item
Comment
text
Record here any necessary comments
Item
Record here any necessary comments
text