Item
Did the subject return for visit 5?
integer
C0545082 (UMLS CUI [1,1])
C0805733 (UMLS CUI [1,2])
C0008976 (UMLS CUI [1,3])
Code List
Did the subject return for visit 5?
CL Item
Yes → Please complete the next pages. (1)
CL Item
No → Please complete below. (2)
Item
Withdrawal reason: Please tick the ONE most appropriate reason and skip the following pages of this visit.
integer
C2349954 (UMLS CUI [1,1])
C0392360 (UMLS CUI [1,2])
C0008976 (UMLS CUI [1,3])
Code List
Withdrawal reason: Please tick the ONE most appropriate reason and skip the following pages of this visit.
CL Item
Same reason and decision as previous visit. (1)
CL Item
[SAE] Serious adverse event (complete the Serious Adverse Event form) Please specify SAE N°: |__|__| (2)
CL Item
[AEX] Non-Serious adverse event (complete the Non-serious Adverse Event section) Please specify unsolicited AE N°: |__|__| or solicited AE code: |__|__| (3)
CL Item
[OTH] Other, please specify: ____________________________________________________ (e.g.: consent withdrawal, Protocol violation, …) (4)
Item
Please tick who took the decision:
integer
C0422727 (UMLS CUI [1,1])
C0679006 (UMLS CUI [1,2])
Code List
Please tick who took the decision:
CL Item
[I] Investigator (1)
CL Item
[P] Parents/Guardians (2)
Item
Please tick who took the decision:
integer
C0422727 (UMLS CUI [1,1])
C0679006 (UMLS CUI [1,2])
Code List
Please tick who took the decision:
CL Item
[I] Investigator (1)
CL Item
[P] Parents/Guardians (2)
Item
Please tick who took the decision:
integer
C0422727 (UMLS CUI [1,1])
C0679006 (UMLS CUI [1,2])
Code List
Please tick who took the decision:
CL Item
[I] Investigator (1)
CL Item
[P] Parents/Guardians (2)
Date of vaccination
Item
Date (fill in only if different from visit date):
date
C0011008 (UMLS CUI [1,1])
C0042196 (UMLS CUI [1,2])
Pre-Vaccination temperature
Item
Pre-Vaccination temperature:
float
C0005903 (UMLS CUI [1,1])
C0042196 (UMLS CUI [1,2])
C0332152 (UMLS CUI [1,3])
Item
Vaccine name
integer
C0042210 (UMLS CUI [1])
CL Item
[S] TETRActHib Vaccine (1)
CL Item
[R] Replacement vial →|__|__|__|__|__| (2)
CL Item
[W] Wrong vial number→|__|__|__|__|__| (3)
CL Item
[N] Not administered → Please complete below (*) (4)
Side / Site Route
Item
Side / Site Route
boolean
C2368628 (UMLS CUI [1,1])
C1515974 (UMLS CUI [1,2])
C0013153 (UMLS CUI [1,3])
C0441987 (UMLS CUI [1,4])
Vaccine administration protocol
Item
Has the study vaccine been administered according to the Protocol?
boolean
C2368628 (UMLS CUI [1,1])
C2348563 (UMLS CUI [1,2])
Item
If you answered the previous question with No → Please tick all items that apply: Side
integer
C0441987 (UMLS CUI [1,1])
C0013153 (UMLS CUI [1,2])
C0042210 (UMLS CUI [1,3])
Code List
If you answered the previous question with No → Please tick all items that apply: Side
Item
If you answered the previous question with No → Please tick all items that apply: Site
text
C1515974 (UMLS CUI [1,1])
C0013153 (UMLS CUI [1,2])
C0042210 (UMLS CUI [1,3])
Code List
If you answered the previous question with No → Please tick all items that apply: Site
Item
If you answered the previous question with No Please tick all items that apply: Route
integer
C0013153 (UMLS CUI [1,1])
C0042210 (UMLS CUI [1,2])
Code List
If you answered the previous question with No Please tick all items that apply: Route
Comments on vaccination
Item
Comments:
text
C0947611 (UMLS CUI [1])
Item
If the vaccine was not administered (*) Why not administered?
text
C2368628 (UMLS CUI [1,1])
C0566251 (UMLS CUI [1,2])
Code List
If the vaccine was not administered (*) Why not administered?
CL Item
SAE] Serious adverse event (complete the Serious Adverse Event form) Please specify SAE N°: |__|__| (SAE] Serious adverse event (complete the Serious Adverse Event form) Please specify SAE N°: |__|__|)
CL Item
[AEX] Non-Serious adverse event (complete the Non-serious Adverse Event section) Please specify unsolicited AE N°: |__|__| or solicited AE code: |__|__| ([AEX] Non-Serious adverse event (complete the Non-serious Adverse Event section) Please specify unsolicited AE N°: |__|__| or solicited AE code: |__|__|)
CL Item
[OTH] Other, please specify: ___________________________________________________ (e.g.: consent withdrawal, protocol violation, …) ([OTH] Other, please specify: ___________________________________________________ (e.g.: consent withdrawal, protocol violation, …))
Item
Please tick who took the decision:
integer
C0679006 (UMLS CUI [1])
C1709536 (UMLS CUI [2])
Code List
Please tick who took the decision:
CL Item
[I] Investigator (1)
CL Item
[P] Parents/Guardians (2)
Item
Has the subject experienced any serious or non-serious unsolicited adverse events within two weeks postvaccination?
integer
C0877248 (UMLS CUI [1,1])
C0042196 (UMLS CUI [1,2])
Code List
Has the subject experienced any serious or non-serious unsolicited adverse events within two weeks postvaccination?
CL Item
[U] Information not available (1)
CL Item
[NA] No Vaccine administered (2)
CL Item
[Y] Yes, fill in the Non-Serious Adverse Event pages or Serious Adverse Event form. (4)
Item
Has the subject experienced any of the following signs/symptoms at the administration site during the solicited period?
integer
C0877248 (UMLS CUI [1,1])
C0042196 (UMLS CUI [1,2])
Code List
Has the subject experienced any of the following signs/symptoms at the administration site during the solicited period?
CL Item
[U] Information not available (1)
CL Item
[NA] No Vaccine administered (2)
CL Item
[Y] Yes, please tick No/Yes for each symptom. If Yes is ticked, please complete all items. (4)
Item
Swelling day
integer
C0038999 (UMLS CUI [1,1])
C2700396 (UMLS CUI [1,2])
Swelling size
Item
Swelling size
integer
C0038999 (UMLS CUI [1,1])
C0456389 (UMLS CUI [1,2])
C2700396 (UMLS CUI [1,3])
Swelling ongoing
Item
Ongoing after Day 6?
boolean
C0038999 (UMLS CUI [1,1])
C0549178 (UMLS CUI [1,2])
C2700396 (UMLS CUI [1,3])
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])
Item
Pain day
integer
C0030193 (UMLS CUI [1,1])
C2700396 (UMLS CUI [1,2])
Item
Pain intensity
integer
C0030193 (UMLS CUI [1,1])
C0522510 (UMLS CUI [1,2])
C2700396 (UMLS CUI [1,3])
Pain ongoing
Item
Ongoing after Day 6?
boolean
C0030193 (UMLS CUI [1,1])
C0549178 (UMLS CUI [1,2])
C2700396 (UMLS CUI [1,3])
Date of last Day of Symptoms
Item
Date of last Day of Symptoms
date
C0011008 (UMLS CUI [1,1])
C0030193 (UMLS CUI [1,2])
C2700396 (UMLS CUI [1,3])
Item
Has the subject experienced any of the following signs/symptoms during the solicited period?
integer
C0877248 (UMLS CUI [1])
Code List
Has the subject experienced any of the following signs/symptoms during the solicited period?
CL Item
[U] Information not available (1)
CL Item
[NA] No Vaccine administered (2)
CL Item
[Y] Yes, please tick No/Yes for each symptom. If Yes is ticked, please complete all items. (4)
Item
Fever day
integer
C0015967 (UMLS CUI [1])
Fever not taken
Item
Fever not taken?
boolean
C0015967 (UMLS CUI [1])
Fever temperature
Item
Fever temperature
float
C0039476 (UMLS CUI [1,1])
C0015967 (UMLS CUI [1,2])
Ongoing fever
Item
Ongoing after Day 6?
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])
Irritability/ Fussiness day
Item
Irritability/ Fussiness day
boolean
C0022107 (UMLS CUI [1])
Item
Irritability/ Fussiness intensity
integer
C0022107 (UMLS CUI [1,1])
C0522510 (UMLS CUI [1,2])
Code List
Irritability/ Fussiness intensity
CL Item
3: Severe (*) (4)
Irritability/ Fussiness ongoing
Item
Ongoing after day 6?
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
C0011008 (UMLS CUI [1,1])
C0022107 (UMLS CUI [1,2])
Causality
Item
Causality?
boolean
C0015127 (UMLS CUI [1,1])
C0022107 (UMLS CUI [1,2])
Item
Drowsiness day
integer
C0013144 (UMLS CUI [1])
Item
Drowsiness intensity
integer
C0013144 (UMLS CUI [1,1])
C0522510 (UMLS CUI [1,2])
Code List
Drowsiness intensity
CL Item
3: Severe (*) (4)
Drowsiness ongoing
Item
Ongoing after day 6?
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
C0011008 (UMLS CUI [1,1])
C0013144 (UMLS CUI [1,2])
Causality
Item
Causality?
boolean
C0015127 (UMLS CUI [1,1])
C0013144 (UMLS CUI [1,2])
Item
Loss of appetite day
integer
C1971624 (UMLS CUI [1])
Code List
Loss of appetite day
Item
Loss of appetite intensity
integer
C1971624 (UMLS CUI [1,1])
C0522510 (UMLS CUI [1,2])
Code List
Loss of appetite intensity
CL Item
3: Severe (*) (4)
Loss of appetite ongoing
Item
Ongoing after Day 6?
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
C0011008 (UMLS CUI [1,1])
C1971624 (UMLS CUI [1,2])
Causality
Item
Causality?
boolean
C0015127 (UMLS CUI [1,1])
C1971624 (UMLS CUI [1,2])
Temperature not related to vaccination
Item
For any Grade 3 temperature not related to vaccination (temperature > 39°C) (Causality “NO”), please describe alternative reason:
text
C0005903 (UMLS CUI [1])