Did the subject return for visit 4 ?
Item
Did the subject return for visit 4 ?
boolean
C0545082 (UMLS CUI [1])
Item
If no return because:
integer
C0545082 (UMLS CUI [1,1])
C1548100 (UMLS CUI [1,2])
Code List
If no return because:
CL Item
Serious adverse event (1)
CL Item
Non-Serious adverse event (2)
CL Item
Other, please specify (3)
no return other
Item
If no return because:
text
C0545082 (UMLS CUI [1,1])
C1548100 (UMLS CUI [1,2])
C0392360 (UMLS CUI [1,3])
Serious adverse event
Item
Please specify SAE No.
integer
C1519255 (UMLS CUI [1])
Non-Serious adverse event
Item
Please specify AE No
text
C1518404 (UMLS CUI [1])
Item
Please tick who made the decision
integer
C0679006 (UMLS CUI [1])
Code List
Please tick who made the decision
CL Item
Parents/Guardians (2)
investigational or non-registered product
Item
Use of any investigational or non-registered product (drug or vaccine) other than the study vaccine(s) during the study period.
boolean
C0013227 (UMLS CUI [1,1])
C0042210 (UMLS CUI [1,2])
immunosuppressants
Item
Chronic administration (defined as more than 14 days) of immunosuppressants or other immunemodifying drugs during the study period. (For corticosteroids, this will mean prednisone, or equivalent, ³ 0.5 mg/kg/day. Inhaled and topical steroids are allowed).
boolean
C0021081 (UMLS CUI [1])
vaccine
Item
Administration of a vaccine not foreseen by the study protocol during the period starting from 30 days before vaccination and ending 30 days after.
boolean
C0042210 (UMLS CUI [1,1])
C1444655 (UMLS CUI [1,2])
meningococcal vaccine
Item
Administration of a meningococcal vaccine not foreseen in the protocol throughout the study period.
boolean
C0700144 (UMLS CUI [1,1])
C1444655 (UMLS CUI [1,2])
immunoglobulins blood products
Item
Administration of immunoglobulins and/or any blood products during the study period.
boolean
C0021027 (UMLS CUI [1,1])
C0371802 (UMLS CUI [1,2])
hypersensitivity
Item
Known hypersensitivity to any component of the vaccine.
boolean
C0020517 (UMLS CUI [1,1])
C0042210 (UMLS CUI [1,2])
Anaphylactic reaction
Item
Anaphylactic reaction following the administration of vaccine.
boolean
C0002792 (UMLS CUI [1,1])
C0042196 (UMLS CUI [1,2])
hypersensitivity vaccine
Item
Known hypersensitivity to any component of the vaccine.
boolean
C0020517 (UMLS CUI [1,1])
C0042210 (UMLS CUI [1,2])
Acute disease
Item
Acute disease at the time of vaccination. (Acute disease is defined as the presence of a moderate or severe illness with or without fever. All vaccines can be administered to persons with a minor illness such as diarrhoea, mild upper respiratory infection with or without low-grade febrile illness, i.e. Axillary temperature < 37.5°C).
boolean
C0001314 (UMLS CUI [1])
Axillary temperature
Item
Axillary temperature > 37.5°C at the time of vaccination.
boolean
C1531924 (UMLS CUI [1,1])
C0042196 (UMLS CUI [1,2])
blood sample
Item
Has a blood sample been taken?
boolean
C0005834 (UMLS CUI [1,1])
C1277698 (UMLS CUI [1,2])
blood sample date
Item
blood sample date
date
C0011008 (UMLS CUI [1,1])
C0005834 (UMLS CUI [1,2])
Vaccination Date
Item
Date of vaccination
date
C1115436 (UMLS CUI [1,1])
C4310469 (UMLS CUI [1,2])
Pre-Vaccination temperature
Item
Pre-Vaccination temperature
integer
C0005903 (UMLS CUI [1,1])
C0042196 (UMLS CUI [1,2])
Item
Pre-Vaccination temperature Route
integer
C0005903 (UMLS CUI [1,1])
C0042196 (UMLS CUI [1,2])
C0449687 (UMLS CUI [1,3])
Code List
Pre-Vaccination temperature Route
Item
Vaccine administration
integer
C2368628 (UMLS CUI [1,1])
C4310469 (UMLS CUI [1,2])
Code List
Vaccine administration
CL Item
Mencevax ACWY (1/5 th dose) (1)
CL Item
Replacement vial (3)
CL Item
Wrong vial number (4)
CL Item
Not administered (5)
Side / Site Route
Item
Side / Site Route: Left Upper arm I.M.
boolean
C0441987 (UMLS CUI [1,1])
C0678813 (UMLS CUI [1,2])
Has the study vaccine been administered according to the Protocol?
Item
Has the study vaccine been administered according to the Protocol?
boolean
C0042196 (UMLS CUI [1,1])
C2368628 (UMLS CUI [1,2])
Item
Has the study vaccine been administered according to the Protocol? Side
integer
C0042196 (UMLS CUI [1,1])
C2368628 (UMLS CUI [1,2])
C0441987 (UMLS CUI [1,3])
Code List
Has the study vaccine been administered according to the Protocol? Side
Item
Has the study vaccine been administered according to the Protocol? Site
integer
C0042196 (UMLS CUI [1,1])
C2368628 (UMLS CUI [1,2])
C0205145 (UMLS CUI [1,3])
Code List
Has the study vaccine been administered according to the Protocol? Site
Item
Has the study vaccine been administered according to the Protocol? Route
integer
C0042196 (UMLS CUI [1,1])
C2368628 (UMLS CUI [1,2])
C0013153 (UMLS CUI [1,3])
Code List
Has the study vaccine been administered according to the Protocol? Route
Item
Why not administered?
integer
C0042196 (UMLS CUI [1,1])
C2368628 (UMLS CUI [1,2])
Code List
Why not administered?
CL Item
Serious adverse event (1)
CL Item
Non-Serious adverse event (2)
CL Item
Other, please specify (3)
Why not administered? Other
Item
Why not administered? Other, please specify
text
C0042196 (UMLS CUI [1,1])
C2368628 (UMLS CUI [1,2])
Item
Has the subject experienced any of the following signs/symptoms at the administration site during the solicited period?
integer
C1457887 (UMLS CUI [1])
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)
Redness
Item
Redness
boolean
C0332575 (UMLS CUI [1,1])
C2700396 (UMLS CUI [1,2])
Redness
Item
Redness, size
integer
C0332575 (UMLS CUI [1,1])
C0456389 (UMLS CUI [1,2])
C2700396 (UMLS CUI [1,3])
Item
Redness intensity day 0
integer
C0332575 (UMLS CUI [1,1])
C0518690 (UMLS CUI [1,2])
Code List
Redness intensity day 0
Item
Redness intensity day 1
integer
C0332575 (UMLS CUI [1,1])
C0518690 (UMLS CUI [1,2])
Code List
Redness intensity day 1
Item
Redness intensity day 2
integer
C0332575 (UMLS CUI [1,1])
C0518690 (UMLS CUI [1,2])
Code List
Redness intensity day 2
Item
Redness intensity day 3
integer
C0332575 (UMLS CUI [1,1])
C0518690 (UMLS CUI [1,2])
Code List
Redness intensity day 3
Ongoing after day 3?
Item
Ongoing after day 3?
boolean
C0332575 (UMLS CUI [1,1])
C0518690 (UMLS CUI [1,2])
C0549178 (UMLS CUI [1,3])
Date of last day of symptoms
Item
Date of last day of symptoms
date
C0011008 (UMLS CUI [1,1])
C0332575 (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
integer
C0545082 (UMLS CUI [1,1])
C1386497 (UMLS CUI [1,2])
C0332575 (UMLS CUI [1,3])
Code List
Medically attended visit
Swelling
Item
Swelling
boolean
C0038999 (UMLS CUI [1,1])
C2700396 (UMLS CUI [1,2])
Size Swelling
Item
Size Swelling
integer
C0456389 (UMLS CUI [1,1])
C0038999 (UMLS CUI [1,2])
C2700396 (UMLS CUI [1,3])
Item
Swelling intensity day 0
integer
C0038999 (UMLS CUI [1,1])
C0518690 (UMLS CUI [1,2])
Code List
Swelling intensity day 0
Item
Swelling intensity day 1
integer
C0038999 (UMLS CUI [1,1])
C0518690 (UMLS CUI [1,2])
Code List
Swelling intensity day 1
Item
Swelling intensity day 2
integer
C0038999 (UMLS CUI [1,1])
C0518690 (UMLS CUI [1,2])
Code List
Swelling intensity day 2
Item
Swelling intensity day 3
integer
C0038999 (UMLS CUI [1,1])
C0518690 (UMLS CUI [1,2])
Code List
Swelling intensity day 3
Ongoing after day 3?
Item
Ongoing after day 3?
boolean
C0038999 (UMLS CUI [1,1])
C0549178 (UMLS CUI [1,2])
Date of last day of symptoms
Item
Date of last day of symptoms
date
C0011008 (UMLS CUI [1,1])
C0038999 (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])
C1518404 (UMLS CUI [1,3])
Item
Medically attended visit
integer
C0545082 (UMLS CUI [1,1])
C1386497 (UMLS CUI [1,2])
C1518404 (UMLS CUI [1,3])
Code List
Medically attended visit
Pain
Item
Pain
boolean
C0030193 (UMLS CUI [1,1])
C2700396 (UMLS CUI [1,2])
Pain intensity
Item
Pain intensity
integer
C3840282 (UMLS CUI [1,1])
C2700396 (UMLS CUI [1,2])
Item
Pain intensity day 0
integer
C3840282 (UMLS CUI [1])
Code List
Pain intensity day 0
Item
Pain intensity day 1
integer
C3840282 (UMLS CUI [1])
Code List
Pain intensity day 1
Item
Pain intensity day 2
integer
C3840282 (UMLS CUI [1])
Code List
Pain intensity day 2
Item
Pain intensity day 3
integer
C3840282 (UMLS CUI [1])
Code List
Pain intensity day 3
Ongoing after day 3?
Item
Ongoing after day 3?
boolean
C0549178 (UMLS CUI [1,1])
C0030193 (UMLS CUI [1,2])
Date of last day of symptoms
Item
Date of last day of symptoms
date
C0011008 (UMLS CUI [1,1])
C0030193 (UMLS CUI [1,2])
Medically attended visit
Item
Medically attended visit
boolean
C0545082 (UMLS CUI [1,1])
C1386497 (UMLS CUI [1,2])
C1518404 (UMLS CUI [1,3])
Item
Medically attended visit
integer
C0545082 (UMLS CUI [1,1])
C1386497 (UMLS CUI [1,2])
C1518404 (UMLS CUI [1,3])
Code List
Medically attended visit
Item
Has the subject experienced any of the following signs/symptoms during the solicited period?
integer
C1457887 (UMLS CUI [1])
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)
Fever
Item
Fever
boolean
C0015967 (UMLS CUI [1])
Fever C
Item
Fever C°
integer
C0015967 (UMLS CUI [1,1])
Item
Fever intensity day 0
integer
C0015967 (UMLS CUI [1,1])
C0522510 (UMLS CUI [1,2])
Code List
Fever intensity day 0
Item
Fever intensity day 1
integer
C0015967 (UMLS CUI [1,1])
C0522510 (UMLS CUI [1,2])
Code List
Fever intensity day 1
Item
Fever intensity day 2
integer
C0015967 (UMLS CUI [1,1])
C0522510 (UMLS CUI [1,2])
Code List
Fever intensity day 2
Item
Fever intensity day 3
integer
C0015967 (UMLS CUI [1,1])
C0522510 (UMLS CUI [1,2])
Code List
Fever intensity day 3
Ongoing after day 3?
Item
Ongoing after day 3?
boolean
C0015967 (UMLS CUI [1,1])
C0549178 (UMLS CUI [1,2])
Date of last day of symptoms
Item
Date of last day of symptoms
date
C0011008 (UMLS CUI [1,1])
C0015967 (UMLS CUI [1,2])
Causality?
Item
Causality?
boolean
C0015127 (UMLS CUI [1,1])
C0015967 (UMLS CUI [1,2])
Medically attended visit
Item
Medically attended visit
boolean
C0545082 (UMLS CUI [1,1])
C1386497 (UMLS CUI [1,2])
C1518404 (UMLS CUI [1,3])
Item
Medically attended visit
integer
C0545082 (UMLS CUI [1,1])
C1386497 (UMLS CUI [1,2])
C1518404 (UMLS CUI [1,3])
Code List
Medically attended visit
Item
Site
integer
C0015967 (UMLS CUI [1,1])
C1515974 (UMLS CUI [1,2])
Irritability/ Fussiness
Item
Irritability/ Fussiness
boolean
C0022107 (UMLS CUI [1])
Item
Irritability / Fussiness intensity day 0
integer
C0022107 (UMLS CUI [1,1])
C0522510 (UMLS CUI [1,2])
Code List
Irritability / Fussiness intensity day 0
Item
Irritability / Fussiness intensity day 1
integer
C0022107 (UMLS CUI [1,1])
C0522510 (UMLS CUI [1,2])
Code List
Irritability / Fussiness intensity day 1
Item
Irritability / Fussiness intensity day 2
integer
C0022107 (UMLS CUI [1,1])
C0522510 (UMLS CUI [1,2])
Code List
Irritability / Fussiness intensity day 2
Item
Irritability / Fussiness intensity day 3
integer
C0022107 (UMLS CUI [1,1])
C0522510 (UMLS CUI [1,2])
Code List
Irritability / Fussiness intensity day 3
Ongoing after day 3?
Item
Ongoing after day 3?
boolean
C0022107 (UMLS CUI [1,1])
C0549178 (UMLS CUI [1,2])
Date of last day of symptoms
Item
Date of last day of symptoms
date
C0022107 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
Causality?
Item
Causality?
boolean
C0015127 (UMLS CUI [1,1])
C0022107 (UMLS CUI [1,2])
Medically attended visit
Item
Medically attended visit
boolean
C0545082 (UMLS CUI [1,1])
C1386497 (UMLS CUI [1,2])
C1518404 (UMLS CUI [1,3])
Item
Medically attended visit
integer
C0545082 (UMLS CUI [1,1])
C1386497 (UMLS CUI [1,2])
C1518404 (UMLS CUI [1,3])
Code List
Medically attended visit
Drowsiness
Item
Drowsiness
boolean
C0013144 (UMLS CUI [1])
Item
Drowsiness intensity day 0
integer
C0013144 (UMLS CUI [1,1])
C0522510 (UMLS CUI [1,2])
Code List
Drowsiness intensity day 0
Item
Drowsiness intensity day 1
integer
C0013144 (UMLS CUI [1,1])
C0522510 (UMLS CUI [1,2])
Code List
Drowsiness intensity day 1
Item
Drowsiness intensity day 2
integer
C0013144 (UMLS CUI [1,1])
C0522510 (UMLS CUI [1,2])
Code List
Drowsiness intensity day 2
Item
Drowsiness intensity day 3
integer
C0013144 (UMLS CUI [1,1])
C0522510 (UMLS CUI [1,2])
Code List
Drowsiness intensity day 3
Ongoing after day 3?
Item
Ongoing after day 3?
boolean
C0013144 (UMLS CUI [1,1])
C0549178 (UMLS CUI [1,2])
Date of last day of symptoms
Item
Date of last day of symptoms
date
C0013144 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
Causality?
Item
Causality?
boolean
C0015127 (UMLS CUI [1,1])
C0013144 (UMLS CUI [1,2])
Medically attended visit
Item
Medically attended visit
boolean
C0545082 (UMLS CUI [1,1])
C1386497 (UMLS CUI [1,2])
C1518404 (UMLS CUI [1,3])
Item
Medically attended visit
integer
C0545082 (UMLS CUI [1,1])
C1386497 (UMLS CUI [1,2])
C1518404 (UMLS CUI [1,3])
Code List
Medically attended visit
Loss of appetite
Item
Loss of appetite
boolean
C1971624 (UMLS CUI [1])
Item
Loss of appetite intensity day 0
integer
C1971624 (UMLS CUI [1,1])
C0522510 (UMLS CUI [1,2])
Code List
Loss of appetite intensity day 0
Item
Loss of appetite intensity day 1
integer
C1971624 (UMLS CUI [1,1])
C0522510 (UMLS CUI [1,2])
Code List
Loss of appetite intensity day 1
Item
Loss of appetite intensity day 2
integer
C1971624 (UMLS CUI [1,1])
C0522510 (UMLS CUI [1,2])
Code List
Loss of appetite intensity day 2
Item
Loss of appetite intensity day 3
integer
C1971624 (UMLS CUI [1,1])
C0522510 (UMLS CUI [1,2])
Code List
Loss of appetite intensity day 3
Ongoing after day 3?
Item
Ongoing after day 3?
boolean
C1971624 (UMLS CUI [1,1])
C0549178 (UMLS CUI [1,2])
Date of last day of symptoms
Item
Date of last day of symptoms
date
C1971624 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
Causality?
Item
Causality?
boolean
C0015127 (UMLS CUI [1,1])
C1971624 (UMLS CUI [1,2])
Medically attended visit
Item
Medically attended visit
boolean
C0545082 (UMLS CUI [1,1])
C1386497 (UMLS CUI [1,2])
C1518404 (UMLS CUI [1,3])
Item
Medically attended visit
integer
C0545082 (UMLS CUI [1,1])
C1386497 (UMLS CUI [1,2])
C1518404 (UMLS CUI [1,3])
Code List
Medically attended visit
Item
Has the subject experienced any serious or non-serious unsolicited adverse events within one month post-vaccination?
text
Code List
Has the subject experienced any serious or non-serious unsolicited adverse events within one month 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)