Visit 5 ( Month 7.5)

  1. StudyEvent: ODM
    1. Visit 5 ( Month 7.5)
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
Administrative data
C1320722 (UMLS CUI-1)
Center
Item
Center
integer
C1301943 (UMLS CUI [1,1])
C0600091 (UMLS CUI [1,2])
Visit Date
Item
Visit Date
date
C1320303 (UMLS CUI [1])
Subject number
Item
Subject number
integer
C2348585 (UMLS CUI [1])
Item Group
ELIMINATION CRITERIA DURING THE STUDY
C0680251 (UMLS CUI-1)
C0347984 (UMLS CUI-2)
C0008976 (UMLS CUI-3)
Use of any investigational or non-registered drug or vaccine other than the study vaccine(s) during the study period.
Item
Use of any investigational or non-registered drug or vaccine other than the study vaccine(s) during the study period.
boolean
C0013230 (UMLS CUI [1,1])
C4723751 (UMLS CUI [1,2])
C0304229 (UMLS CUI [1,3])
C0347984 (UMLS CUI [1,4])
C2347804 (UMLS CUI [1,5])
C0013230 (UMLS CUI [2,1])
C4723751 (UMLS CUI [2,2])
C0304229 (UMLS CUI [2,3])
C0042196 (UMLS CUI [2,4])
C0347984 (UMLS CUI [2,5])
C2347804 (UMLS CUI [2,6])
Chronic immunosuppressants or other immunemodifying drugs during the study period
Item
Chronic administration (defined as more than 14 days) of immunosuppressants or other immunemodifying drugs during the study period.
boolean
C0021081 (UMLS CUI [1,1])
C0205191 (UMLS CUI [1,2])
C0347984 (UMLS CUI [1,3])
C2347804 (UMLS CUI [1,4])
C0005525 (UMLS CUI [2,1])
C0205191 (UMLS CUI [2,2])
C0347984 (UMLS CUI [2,3])
C2347804 (UMLS CUI [2,4])
C0332300 (UMLS CUI [3,1])
C2065041 (UMLS CUI [3,2])
C0332300 (UMLS CUI [4,1])
C2064827 (UMLS CUI [4,2])
Unplanned vaccination
Item
Administration of a vaccine not foreseen by the study protocol during the period starting from 30 days before the first dose of vaccine(s) and ending 30 days after the last dose of vaccine(s) with the exception of OPV.
boolean
C0042196 (UMLS CUI [1,1])
C2347852 (UMLS CUI [1,2])
C4511973 (UMLS CUI [1,3])
C2347804 (UMLS CUI [1,4])
C2348563 (UMLS CUI [1,5])
C4698437 (UMLS CUI [1,6])
C0332300 (UMLS CUI [2,1])
C0032375 (UMLS CUI [2,2])
Administration of a meningococcal vaccine
Item
Administration of a meningococcal vaccine not foreseen by the study protocol during the entire study period.
boolean
C2368628 (UMLS CUI [1,1])
C0700144 (UMLS CUI [1,2])
C0347984 (UMLS CUI [1,3])
C2347804 (UMLS CUI [1,4])
C2348563 (UMLS CUI [1,5])
C4698437 (UMLS CUI [1,6])
Administration of immunoglobulins and/or any blood products during the study period.
Item
Administration of immunoglobulins and/or any blood products during the study period.
boolean
C1533734 (UMLS CUI [1,1])
C0021027 (UMLS CUI [1,2])
C2347804 (UMLS CUI [1,3])
C1533734 (UMLS CUI [2,1])
C0456388 (UMLS CUI [2,2])
C2347804 (UMLS CUI [2,3])
C1533734 (UMLS CUI [3,1])
C0456388 (UMLS CUI [3,2])
C0021027 (UMLS CUI [3,3])
C0205430 (UMLS CUI [3,4])
C2347804 (UMLS CUI [3,5])
Item Group
Contraindications and precautions for further doses
C1301624 (UMLS CUI-1)
C1517331 (UMLS CUI-2)
C0178602 (UMLS CUI-3)
C1517331 (UMLS CUI-4)
C1882442 (UMLS CUI-5)
C0178602 (UMLS CUI-6)
Anaphylactic reaction following the administration of vaccine(s).
Item
Anaphylactic reaction following the administration of vaccine(s).
boolean
C0002792 (UMLS CUI [1,1])
C0332282 (UMLS CUI [1,2])
C0042196 (UMLS CUI [1,3])
Hypersensitivity
Item
Known hypersensitivity to any component of the vaccine, or subjects having shown signs of hypersensitivity after previous administration of diphtheria, tetanus, pertussis, HB, Hib or meningococcal vaccines.
boolean
C0020517 (UMLS CUI [1,1])
C0304229 (UMLS CUI [1,2])
C0042210 (UMLS CUI [1,3])
C0262926 (UMLS CUI [2,1])
C0020517 (UMLS CUI [2,2])
C0012546 (UMLS CUI [2,3])
C0042210 (UMLS CUI [2,4])
C0262926 (UMLS CUI [3,1])
C0020517 (UMLS CUI [3,2])
C0305062 (UMLS CUI [3,3])
C0262926 (UMLS CUI [4,1])
C0020517 (UMLS CUI [4,2])
C0058773 (UMLS CUI [4,3])
C0262926 (UMLS CUI [5,1])
C0020517 (UMLS CUI [5,2])
C0031237 (UMLS CUI [5,3])
C0262926 (UMLS CUI [6,1])
C0020517 (UMLS CUI [6,2])
C0012559 (UMLS CUI [6,3])
C0262926 (UMLS CUI [7,1])
C0020517 (UMLS CUI [7,2])
C2240392 (UMLS CUI [7,3])
C0262926 (UMLS CUI [8,1])
C0020517 (UMLS CUI [8,2])
C2352428 (UMLS CUI [8,3])
C0262926 (UMLS CUI [9,1])
C0020517 (UMLS CUI [9,2])
C0700144 (UMLS CUI [9,3])
Immunosuppressive or immunodeficient condition
Item
Any confirmed or suspected immunosuppressive or immunodeficient condition, including human immunodeficiency virus (HIV) infection.
boolean
C0011900 (UMLS CUI [1,1])
C0020962 (UMLS CUI [1,2])
C0221099 (UMLS CUI [1,3])
C0011900 (UMLS CUI [2,1])
C0019693 (UMLS CUI [2,2])
C0332147 (UMLS CUI [3,1])
C0020962 (UMLS CUI [3,2])
C0221099 (UMLS CUI [3,3])
C0332147 (UMLS CUI [4,1])
C0019693 (UMLS CUI [4,2])
Acute disease at the time of vaccination
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 or oral temperature < 37.5°C/rectal temperature < 38°C).
boolean
C0001314 (UMLS CUI [1,1])
C0205081 (UMLS CUI [1,2])
C0205420 (UMLS CUI [1,3])
C2368628 (UMLS CUI [1,4])
C0001314 (UMLS CUI [2,1])
C0205420 (UMLS CUI [2,2])
C2368628 (UMLS CUI [2,3])
C0205082 (UMLS CUI [2,4])
Axillary or oral temperature ≥ 37.5°C/rectal temperature ≥ 38°C at the time of vaccination.
Item
Axillary or oral temperature ≥ 37.5°C/rectal temperature ≥ 38°C at the time of vaccination.
boolean
C0437737 (UMLS CUI [1,1])
C1531924 (UMLS CUI [1,2])
C0347984 (UMLS CUI [1,3])
C0042196 (UMLS CUI [1,4])
C0437737 (UMLS CUI [2,1])
C0489749 (UMLS CUI [2,2])
C0347984 (UMLS CUI [2,3])
C0042196 (UMLS CUI [2,4])
C1532216 (UMLS CUI [3,1])
C0437737 (UMLS CUI [3,2])
C0347984 (UMLS CUI [3,3])
C0042196 (UMLS CUI [3,4])
C0015967 (UMLS CUI [4,1])
C0347984 (UMLS CUI [4,2])
C0042196 (UMLS CUI [4,3])
Item Group
DEMOGRAPHICS
C1698647 (UMLS CUI-1)
Subject number
Item
Subject number
integer
C2348585 (UMLS CUI [1])
Birth date
Item
Date of birth
date
C0421451 (UMLS CUI [1])
Item
Gender
text
C0079399 (UMLS CUI [1])
Code List
Gender
CL Item
Male (1)
CL Item
Female (2)
Item
Race
text
C0034510 (UMLS CUI [1])
Code List
Race
CL Item
Black (1)
CL Item
Arabic/North African (2)
CL Item
White/Caucasian (3)
CL Item
East & South East Asian (4)
CL Item
South Asian (5)
CL Item
Other (6)
Specify Other
Item
If Other, please specify
text
C0034510 (UMLS CUI [1,1])
C0205394 (UMLS CUI [1,2])
C2348235 (UMLS CUI [1,3])
Serious adverse event
Item
Has the subject had any serious adverse event since the end of the primary phase and before the start of this booster vaccination ?
boolean
C1519255 (UMLS CUI [1,1])
C4511973 (UMLS CUI [1,2])
C2347804 (UMLS CUI [1,3])
C1519255 (UMLS CUI [2,1])
C0332185 (UMLS CUI [2,2])
Item Group
PRE-VACCINATION ASSESSMENT
C0042196 (UMLS CUI-1)
C0220825 (UMLS CUI-2)
C0332152 (UMLS CUI-3)
Temperature
Item
Temperature
float
C0005903 (UMLS CUI [1])
Item
Route
text
C0886414 (UMLS CUI [1,1])
C0449444 (UMLS CUI [1,2])
Code List
Route
CL Item
Axillary (1)
CL Item
Rectal (2)
Item Group
THROAT SWAB (for subject’s parents/guardians)
C0439056 (UMLS CUI-1)
C0030551 (UMLS CUI-3)
C0023226 (UMLS CUI-4)
Will the throat swab be taken from the same person as at Visit 1, 2 or 4 ?
Item
Will the throat swab be taken from the same person as at Visit 1, 2 or 4?
boolean
C0730255 (UMLS CUI [1,1])
C1552089 (UMLS CUI [1,2])
C0445247 (UMLS CUI [1,3])
C4727054 (UMLS CUI [1,4])
Informed Consent
Item
I certify that Informed Consent has been obtained prior to any study procedure :
boolean
C0021430 (UMLS CUI [1,1])
C0150312 (UMLS CUI [1,2])
Informed Consent Date
Item
Informed Consent Date:
date
C2985782 (UMLS CUI [1])
Has a throat swab been taken ?
Item
Has a throat swab been taken ?
boolean
C0730255 (UMLS CUI [1,1])
C1272695 (UMLS CUI [1,2])
Date
Item
Please complete only if different from visit date:
date
C0011008 (UMLS CUI [1])
Item Group
THROAT SWAB (for subject)
C0439056 (UMLS CUI-1)
C0681850 (UMLS CUI-3)
throat swab
Item
Has a throat swab been taken ?
boolean
C0730255 (UMLS CUI [1,1])
C1272695 (UMLS CUI [1,2])
Date
Item
Please complete only if different from visit date:
date
C0011008 (UMLS CUI [1])
Item Group
VACCINE ADMINISTRATION
C2368628 (UMLS CUI-1)
measles vaccine
Item
Has the commercial measles vaccine been administered ?
boolean
C0025010 (UMLS CUI [1,1])
C2368628 (UMLS CUI [1,2])
C1272695 (UMLS CUI [1,3])
yellow fever vaccine
Item
Has the commercial yellow fever vaccine been administered ?
boolean
C0301508 (UMLS CUI [1,1])
C1272695 (UMLS CUI [1,2])
C2368628 (UMLS CUI [1,3])

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