Date of vaccination
Item
Date (fill in only if different from visit date) :
date
C0011008 (UMLS CUI [1,1])
C0042196 (UMLS CUI [1,2])
temperature
Item
Pre-Vaccination temperature:
float
C0005903 (UMLS CUI [1,1])
C0042196 (UMLS CUI [1,2])
C0332152 (UMLS CUI [1,3])
Item
Pre-Vaccination temperature: Route:
text
C0005903 (UMLS CUI [1,1])
C0042196 (UMLS CUI [1,2])
C0449687 (UMLS CUI [1,3])
Code List
Pre-Vaccination temperature: Route:
Item
Vaccine Administration (only one box must be ticked by vaccine)
text
C2368628 (UMLS CUI [1])
Code List
Vaccine Administration (only one box must be ticked by vaccine)
CL Item
MENCEVAX™ ACWY (1/5) Vaccine (S)
CL Item
Replacement vial (R)
CL Item
Wrong vial number (W)
CL Item
Not administered, please complete below (*) (N)
Item
(*) Why not administered ? Please tick the ONE most appropriate category for non administration :
text
C2368628 (UMLS CUI [1,1])
C0392360 (UMLS CUI [1,2])
C1272696 (UMLS CUI [1,3])
Code List
(*) Why not administered ? Please tick the ONE most appropriate category for non administration :
CL Item
Serious adverse event (complete the Serious Adverse Event form) Please specify SAE N° (SAE)
CL Item
Non-Serious adverse event (complete the Non-serious Adverse Event section) Please specify unsolicited AE N° or Solicited AE code (AEX)
CL Item
Other, please specify (OTH)
Item
Please tick who made the decision
text
C0679006 (UMLS CUI [1])
Code List
Please tick who made the decision
CL Item
Parents/Guardians (P)
undefined item
Item
Side / Site Route: Left Deltoid I.M.
text
Vaccine administration
Item
Has the study vaccine been administered according to the Protocol?
boolean
C2368628 (UMLS CUI [1])
Item
Side
text
C0441987 (UMLS CUI [1,1])
C0013153 (UMLS CUI [1,2])
C0042210 (UMLS CUI [1,3])
Item
Site
integer
C1515974 (UMLS CUI [1,1])
C0013153 (UMLS CUI [1,2])
C0042210 (UMLS CUI [1,3])
Item
Route
text
C0013153 (UMLS CUI [1,1])
C0042210 (UMLS CUI [1,2])
Post vaccination observation
Item
IMMEDIATE POST-VACCINATION OBSERVATION 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 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
C1443955 (UMLS CUI [1,1])
C0700325 (UMLS CUI [1,2])
Item
Has the subject experienced any serious or non-serious unsolicited adverse events within one month (minimum 30 days) post-vaccination ?
text
C1519255 (UMLS CUI [1,1])
C0231291 (UMLS CUI [1,2])
C1518404 (UMLS CUI [2,1])
C0231291 (UMLS CUI [2,2])
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 (U)
CL Item
No Vaccine administered (NA)
CL Item
Yes, fill in the Non-Serious Adverse Event pages or Serious Adverse Event form (Y)
Redness
Item
Redness
boolean
C0332575 (UMLS CUI [1,1])
C2700396 (UMLS CUI [1,2])
Size of redness
Item
Redness, size (mm) Day 0
float
C0456389 (UMLS CUI [1,1])
C0332575 (UMLS CUI [1,2])
C2700396 (UMLS CUI [1,3])
Size of Redness
Item
Redness, size (mm) Day 1
float
C0456389 (UMLS CUI [1,1])
C0332575 (UMLS CUI [1,2])
C2700396 (UMLS CUI [1,3])
Size of Redness
Item
Redness, size (mm) Day 2
float
C0456389 (UMLS CUI [1,1])
C0332575 (UMLS CUI [1,2])
C2700396 (UMLS CUI [1,3])
Size of Redness
Item
Redness, size (mm) Day 3
float
C0456389 (UMLS CUI [1,1])
C0332575 (UMLS CUI [1,2])
C2700396 (UMLS CUI [1,3])
Size of Redness
Item
Redness, size (mm) Day 4
float
C0456389 (UMLS CUI [1,1])
C0332575 (UMLS CUI [1,2])
C2700396 (UMLS CUI [1,3])
Size of Redness
Item
Redness, size (mm) Day 5
float
C0456389 (UMLS CUI [1,1])
C0332575 (UMLS CUI [1,2])
C2700396 (UMLS CUI [1,3])
Size of Redness
Item
Redness, size (mm) Day 6
float
C0456389 (UMLS CUI [1,1])
C0332575 (UMLS CUI [1,2])
C2700396 (UMLS CUI [1,3])
Size of Redness
Item
Redness, size (mm) Day 7
float
C0456389 (UMLS CUI [1,1])
C0332575 (UMLS CUI [1,2])
C2700396 (UMLS CUI [1,3])
Ongoing symptom
Item
Ongoing redness after day 7?
boolean
C1457887 (UMLS CUI [1,1])
C3174772 (UMLS CUI [1,2])
C0332575 (UMLS CUI [1,3])
C2700396 (UMLS CUI [1,4])
Date
Item
Date of last day of symptoms
date
C0011008 (UMLS CUI [1,1])
C1457887 (UMLS CUI [1,2])
C0332575 (UMLS CUI [1,3])
C2700396 (UMLS CUI [1,4])
Medically attended visit
Item
Medically attended visit
boolean
C0545082 (UMLS CUI [1,1])
C1386497 (UMLS CUI [1,2])
Item
Medicall attended visit
text
C0545082 (UMLS CUI [1,1])
C1386497 (UMLS CUI [1,2])
Code List
Medicall attended visit
CL Item
Hospitalisation (HO)
CL Item
Emergency Room (ER)
CL Item
Medical personell (MD)
Swelling
Item
Swelling (SW)
boolean
C0038999 (UMLS CUI [1,1])
C2700396 (UMLS CUI [1,2])
Swelling
Item
Swelling, size (mm) Day 0
float
C0038999 (UMLS CUI [1,1])
C0456389 (UMLS CUI [1,2])
C2700396 (UMLS CUI [1,3])
Swelling
Item
Swelling, size (mm) Day 1
float
C0038999 (UMLS CUI [1,1])
C0456389 (UMLS CUI [1,2])
C2700396 (UMLS CUI [1,3])
Swelling
Item
Swelling, size (mm) Day 2
float
C0038999 (UMLS CUI [1,1])
C0456389 (UMLS CUI [1,2])
C2700396 (UMLS CUI [1,3])
Swelling
Item
Swelling, size (mm) Day 3
float
C0038999 (UMLS CUI [1,1])
C0456389 (UMLS CUI [1,2])
C2700396 (UMLS CUI [1,3])
Swelling
Item
Swelling, size (mm) Day 4
float
C0038999 (UMLS CUI [1,1])
C0456389 (UMLS CUI [1,2])
C2700396 (UMLS CUI [1,3])
Swelling
Item
Swelling, size (mm) Day 5
float
C0038999 (UMLS CUI [1,1])
C0456389 (UMLS CUI [1,2])
C2700396 (UMLS CUI [1,3])
Swelling
Item
Swelling, size (mm) Day 6
float
C0038999 (UMLS CUI [1,1])
C0456389 (UMLS CUI [1,2])
C2700396 (UMLS CUI [1,3])
Swelling
Item
Swelling, size (mm) Day 7
float
C0038999 (UMLS CUI [1,1])
C0456389 (UMLS CUI [1,2])
C2700396 (UMLS CUI [1,3])
Ongoing symptom
Item
Ongoing swelling after day 7?
boolean
C1457887 (UMLS CUI [1,1])
C0549178 (UMLS CUI [1,2])
C0038999 (UMLS CUI [1,3])
C2700396 (UMLS CUI [1,4])
Date
Item
Date of last day of symptoms
date
C0011008 (UMLS CUI [1,1])
C0038999 (UMLS CUI [1,2])
C2700396 (UMLS CUI [1,3])
C0806020 (UMLS CUI [1,4])
Medically attended visit
Item
Medically attended visit
boolean
C0545082 (UMLS CUI [1,1])
C1386497 (UMLS CUI [1,2])
C0038999 (UMLS CUI [1,3])
Item
Medically attended visit
text
C0545082 (UMLS CUI [1,1])
C1386497 (UMLS CUI [1,2])
C0038999 (UMLS CUI [1,3])
Code List
Medically attended visit
CL Item
Hospitalization (HO)
CL Item
Emergency Room (ER)
CL Item
Medical Personnel (MD)
undefined item
Item
If any of these adverse events are serious according to Protocol definition, please report event to GSK monitor by telephone or fax within 24 hours (see Protocol) and complete the Serious Adverse Event form.
text
Pain
Item
Pain
boolean
C0030193 (UMLS CUI [1,1])
C2700396 (UMLS CUI [1,2])
Item
Pain, intensity Day 0
integer
C0030193 (UMLS CUI [1,1])
C0522510 (UMLS CUI [1,2])
C2700396 (UMLS CUI [1,3])
Code List
Pain, intensity Day 0
Item
Pain, intensity Day 1
integer
C0030193 (UMLS CUI [1,1])
C0522510 (UMLS CUI [1,2])
C2700396 (UMLS CUI [1,3])
Code List
Pain, intensity Day 1
Item
Pain, intensity Day 2
integer
C0030193 (UMLS CUI [1,1])
C0522510 (UMLS CUI [1,2])
C2700396 (UMLS CUI [1,3])
Code List
Pain, intensity Day 2
Item
Pain, intensity Day 3
integer
C0030193 (UMLS CUI [1,1])
C0522510 (UMLS CUI [1,2])
C2700396 (UMLS CUI [1,3])
Code List
Pain, intensity Day 3
Item
Pain, intensity Day 4
integer
C0030193 (UMLS CUI [1,1])
C0522510 (UMLS CUI [1,2])
C2700396 (UMLS CUI [1,3])
Code List
Pain, intensity Day 4
Item
Pain, intensity Day 5
integer
C0030193 (UMLS CUI [1,1])
C0522510 (UMLS CUI [1,2])
C2700396 (UMLS CUI [1,3])
Code List
Pain, intensity Day 5
Item
Pain, intensity Day 6
integer
C0030193 (UMLS CUI [1,1])
C0522510 (UMLS CUI [1,2])
C2700396 (UMLS CUI [1,3])
Code List
Pain, intensity Day 6
Item
Pain, intensity Day 7
integer
C0030193 (UMLS CUI [1,1])
C0522510 (UMLS CUI [1,2])
C2700396 (UMLS CUI [1,3])
Code List
Pain, intensity Day 7
Ongoing symptom
Item
Ongoing after day 7?
boolean
C0521491 (UMLS CUI [1,1])
C0549178 (UMLS CUI [1,2])
Date
Item
Date of last day of symptoms
date
C0011008 (UMLS CUI [1,1])
C0030193 (UMLS CUI [1,2])
C2700396 (UMLS CUI [1,3])
Medically attended visit
Item
Medically attended visit
boolean
C0545082 (UMLS CUI [1,1])
C1386497 (UMLS CUI [1,2])
C0332575 (UMLS CUI [1,3])
Item
Medically attended visit
text
C0545082 (UMLS CUI [1,1])
C1386497 (UMLS CUI [1,2])
C0332575 (UMLS CUI [1,3])
Code List
Medically attended visit
CL Item
Hospitalization (HO)
CL Item
Emergency Room (ER)
CL Item
Medical Personnel (MD)