ID

39362

Beskrivning

Study ID: 104430 Clinical Study ID: 104430 Study Title: A phase II, double blind, randomized, controlled study to evaluate the immunogenicity, reactogenicity and safety of GlaxoSmithKline (GSK) Biologicals’ Hib-MenAC vaccine, extemporaneously mixed with GSK Biologicals’ Tritanrix-HepB, as compared to GSK Biologicals’ Hiberix vaccine, extemporaneously mixed with GSK Biologicals’ Tritanrix-HepB, when administered intramuscularly in infants at 6, 10 and 14 weeks of age. Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: N/A Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 1/2 Study Recruitment Status: Completed Generic Name: Hib-MenAC vaccine Trade Name: Tritanrix-HepB, Hiberix Study Indication: Immune, Inflammatory & Infections - Other

Nyckelord

Versioner (3)
  1. 2019-03-25 2019-03-25 -
  2. 2019-12-31 2019-12-31 -
  3. 2021-03-15 2021-03-15 - Dr. rer. medic Philipp Neuhaus
Rättsinnehavare

GSK group of companies

Uppladdad den

31 december 2019

DOI

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Licens

Creative Commons BY-NC 3.0
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Hib-MenAC vaccine administered intramuscularly in infants at 6 10 and 14 weeks of age - 104430

Engelsk

Visit 5 ( Month 7.5)

1 Formulär  
  1. StudyEvent: ODM
    1. Visit 5 ( Month 7.5)
Administrative data
Beskrivning

Administrative data

Alias
UMLS CUI-1
C1320722
Center
Beskrivning

Center

Datatyp

integer

Alias
UMLS CUI [1,1]
C1301943
UMLS CUI [1,2]
C0600091
Visit Date
Beskrivning

Visit Date

Datatyp

date

Alias
UMLS CUI [1]
C1320303
Subject number
Beskrivning

Subject number

Datatyp

integer

Alias
UMLS CUI [1]
C2348585
ELIMINATION CRITERIA DURING THE STUDY
Beskrivning

ELIMINATION CRITERIA DURING THE STUDY

Alias
UMLS CUI-1
C0680251
UMLS CUI-2
C0347984
UMLS CUI-3
C0008976
Use of any investigational or non-registered drug or vaccine other than the study vaccine(s) during the study period.
Beskrivning

Use of any investigational or non-registered drug or vaccine other than the study vaccine(s) during the study period.

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0013230
UMLS CUI [1,2]
C4723751
UMLS CUI [1,3]
C0304229
UMLS CUI [1,4]
C0347984
UMLS CUI [1,5]
C2347804
UMLS CUI [2,1]
C0013230
UMLS CUI [2,2]
C4723751
UMLS CUI [2,3]
C0304229
UMLS CUI [2,4]
C0042196
UMLS CUI [2,5]
C0347984
UMLS CUI [2,6]
C2347804
Chronic administration (defined as more than 14 days) of immunosuppressants or other immunemodifying drugs during the study period.
Beskrivning

(For corticosteroids, this will mean prednisone, or equivalent, ≥ 0.5 mg/kg/day. Inhaled and topical steroids are allowed).

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0021081
UMLS CUI [1,2]
C0205191
UMLS CUI [1,3]
C0347984
UMLS CUI [1,4]
C2347804
UMLS CUI [2,1]
C0005525
UMLS CUI [2,2]
C0205191
UMLS CUI [2,3]
C0347984
UMLS CUI [2,4]
C2347804
UMLS CUI [3,1]
C0332300
UMLS CUI [3,2]
C2065041
UMLS CUI [4,1]
C0332300
UMLS CUI [4,2]
C2064827
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.
Beskrivning

Unplanned vaccination

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0042196
UMLS CUI [1,2]
C2347852
UMLS CUI [1,3]
C4511973
UMLS CUI [1,4]
C2347804
UMLS CUI [1,5]
C2348563
UMLS CUI [1,6]
C4698437
UMLS CUI [2,1]
C0332300
UMLS CUI [2,2]
C0032375
Administration of a meningococcal vaccine not foreseen by the study protocol during the entire study period.
Beskrivning

Administration of a meningococcal vaccine

Datatyp

boolean

Alias
UMLS CUI [1,1]
C2368628
UMLS CUI [1,2]
C0700144
UMLS CUI [1,3]
C0347984
UMLS CUI [1,4]
C2347804
UMLS CUI [1,5]
C2348563
UMLS CUI [1,6]
C4698437
Administration of immunoglobulins and/or any blood products during the study period.
Beskrivning

Administration of immunoglobulins and/or any blood products during the study period.

Datatyp

boolean

Alias
UMLS CUI [1,1]
C1533734
UMLS CUI [1,2]
C0021027
UMLS CUI [1,3]
C2347804
UMLS CUI [2,1]
C1533734
UMLS CUI [2,2]
C0456388
UMLS CUI [2,3]
C2347804
UMLS CUI [3,1]
C1533734
UMLS CUI [3,2]
C0456388
UMLS CUI [3,3]
C0021027
UMLS CUI [3,4]
C0205430
UMLS CUI [3,5]
C2347804
Contraindications and precautions for further doses
Beskrivning

Contraindications and precautions for further doses

Alias
UMLS CUI-1
C1301624
UMLS CUI-2
C1517331
UMLS CUI-3
C0178602
UMLS CUI-4
C1517331
UMLS CUI-5
C1882442
UMLS CUI-6
C0178602
Anaphylactic reaction following the administration of vaccine(s).
Beskrivning

Anaphylactic reaction following the administration of vaccine(s).

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0002792
UMLS CUI [1,2]
C0332282
UMLS CUI [1,3]
C0042196
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.
Beskrivning

Hypersensitivity

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0020517
UMLS CUI [1,2]
C0304229
UMLS CUI [1,3]
C0042210
UMLS CUI [2,1]
C0262926
UMLS CUI [2,2]
C0020517
UMLS CUI [2,3]
C0012546
UMLS CUI [2,4]
C0042210
UMLS CUI [3,1]
C0262926
UMLS CUI [3,2]
C0020517
UMLS CUI [3,3]
C0305062
UMLS CUI [4,1]
C0262926
UMLS CUI [4,2]
C0020517
UMLS CUI [4,3]
C0058773
UMLS CUI [5,1]
C0262926
UMLS CUI [5,2]
C0020517
UMLS CUI [5,3]
C0031237
UMLS CUI [6,1]
C0262926
UMLS CUI [6,2]
C0020517
UMLS CUI [6,3]
C0012559
UMLS CUI [7,1]
C0262926
UMLS CUI [7,2]
C0020517
UMLS CUI [7,3]
C2240392
UMLS CUI [8,1]
C0262926
UMLS CUI [8,2]
C0020517
UMLS CUI [8,3]
C2352428
UMLS CUI [9,1]
C0262926
UMLS CUI [9,2]
C0020517
UMLS CUI [9,3]
C0700144
Any confirmed or suspected immunosuppressive or immunodeficient condition, including human immunodeficiency virus (HIV) infection.
Beskrivning

Immunosuppressive or immunodeficient condition

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0011900
UMLS CUI [1,2]
C0020962
UMLS CUI [1,3]
C0221099
UMLS CUI [2,1]
C0011900
UMLS CUI [2,2]
C0019693
UMLS CUI [3,1]
C0332147
UMLS CUI [3,2]
C0020962
UMLS CUI [3,3]
C0221099
UMLS CUI [4,1]
C0332147
UMLS CUI [4,2]
C0019693
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).
Beskrivning

The following AEs constitute contraindications to administration of the study vaccines at that point in time; if any one of these AEs occurs at the time scheduled for vaccination, the subject may be vaccinated at a later date, within the time window specified in the protocol or withdrawn at the discretion of the investigator. The subject must be followed until resolution of the event, as with any adverse event

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0001314
UMLS CUI [1,2]
C0205081
UMLS CUI [1,3]
C0205420
UMLS CUI [1,4]
C2368628
UMLS CUI [2,1]
C0001314
UMLS CUI [2,2]
C0205420
UMLS CUI [2,3]
C2368628
UMLS CUI [2,4]
C0205082
Axillary or oral temperature ≥ 37.5°C/rectal temperature ≥ 38°C at the time of vaccination.
Beskrivning

The following AEs constitute contraindications to administration of the study vaccines at that point in time; if any one of these AEs occurs at the time scheduled for vaccination, the subject may be vaccinated at a later date, within the time window specified in the protocol or withdrawn at the discretion of the investigator. The subject must be followed until resolution of the event, as with any adverse event

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0437737
UMLS CUI [1,2]
C1531924
UMLS CUI [1,3]
C0347984
UMLS CUI [1,4]
C0042196
UMLS CUI [2,1]
C0437737
UMLS CUI [2,2]
C0489749
UMLS CUI [2,3]
C0347984
UMLS CUI [2,4]
C0042196
UMLS CUI [3,1]
C1532216
UMLS CUI [3,2]
C0437737
UMLS CUI [3,3]
C0347984
UMLS CUI [3,4]
C0042196
UMLS CUI [4,1]
C0015967
UMLS CUI [4,2]
C0347984
UMLS CUI [4,3]
C0042196
DEMOGRAPHICS
Beskrivning

DEMOGRAPHICS

Alias
UMLS CUI-1
C1698647
Subject number
Beskrivning

Previous study : 759346/009 (DTPwHB/HIBMenACTT009)

Datatyp

integer

Alias
UMLS CUI [1]
C2348585
Date of birth
Beskrivning

Birth date

Datatyp

date

Alias
UMLS CUI [1]
C0421451
Gender
Beskrivning

Gender

Datatyp

text

Alias
UMLS CUI [1]
C0079399
Race
Beskrivning

Race

Datatyp

text

Alias
UMLS CUI [1]
C0034510
If Other, please specify
Beskrivning

Specify Other

Datatyp

text

Alias
UMLS CUI [1,1]
C0034510
UMLS CUI [1,2]
C0205394
UMLS CUI [1,3]
C2348235
Has the subject had any serious adverse event since the end of the primary phase and before the start of this booster vaccination ?
Beskrivning

If Yes → Specify number of SAE’s : |__|__| and → Check SAE form(s) have been submitted to GSK Biologicals

Datatyp

boolean

Alias
UMLS CUI [1,1]
C1519255
UMLS CUI [1,2]
C4511973
UMLS CUI [1,3]
C2347804
UMLS CUI [2,1]
C1519255
UMLS CUI [2,2]
C0332185
PRE-VACCINATION ASSESSMENT
Beskrivning

PRE-VACCINATION ASSESSMENT

Alias
UMLS CUI-1
C0042196
UMLS CUI-2
C0220825
UMLS CUI-3
C0332152
Temperature
Beskrivning

Temperature

Datatyp

float

Måttenheter
  • °C
Alias
UMLS CUI [1]
C0005903
°C
Route
Beskrivning

preferrably axillary

Datatyp

text

Alias
UMLS CUI [1,1]
C0886414
UMLS CUI [1,2]
C0449444
THROAT SWAB (for subject’s parents/guardians)
Beskrivning

THROAT SWAB (for subject’s parents/guardians)

Alias
UMLS CUI-1
C0439056
UMLS CUI-3
C0030551
UMLS CUI-4
C0023226
Will the throat swab be taken from the same person as at Visit 1, 2 or 4?
Beskrivning

Will the throat swab be taken from the same person as at Visit 1, 2 or 4 ?

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0730255
UMLS CUI [1,2]
C1552089
UMLS CUI [1,3]
C0445247
UMLS CUI [1,4]
C4727054
I certify that Informed Consent has been obtained prior to any study procedure :
Beskrivning

Informed Consent

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0021430
UMLS CUI [1,2]
C0150312
Informed Consent Date:
Beskrivning

Informed Consent Date

Datatyp

date

Alias
UMLS CUI [1]
C2985782
Has a throat swab been taken ?
Beskrivning

Has a throat swab been taken ?

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0730255
UMLS CUI [1,2]
C1272695
Please complete only if different from visit date:
Beskrivning

Date

Datatyp

date

Alias
UMLS CUI [1]
C0011008
THROAT SWAB (for subject)
Beskrivning

THROAT SWAB (for subject)

Alias
UMLS CUI-1
C0439056
UMLS CUI-3
C0681850
Has a throat swab been taken ?
Beskrivning

throat swab

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0730255
UMLS CUI [1,2]
C1272695
Please complete only if different from visit date:
Beskrivning

Date

Datatyp

date

Alias
UMLS CUI [1]
C0011008
VACCINE ADMINISTRATION
Beskrivning

VACCINE ADMINISTRATION

Alias
UMLS CUI-1
C2368628
Has the commercial measles vaccine been administered ?
Beskrivning

measles vaccine

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0025010
UMLS CUI [1,2]
C2368628
UMLS CUI [1,3]
C1272695
Has the commercial yellow fever vaccine been administered ?
Beskrivning

yellow fever vaccine

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0301508
UMLS CUI [1,2]
C1272695
UMLS CUI [1,3]
C2368628
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Similar models

Visit 5 ( Month 7.5)

1 Formulär
  1. StudyEvent: ODM
    1. Visit 5 ( Month 7.5)
Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
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])
Gender
Code List
Gender
CL Item
Male (1)
CL Item
Female (2)
Item
Race
text
C0034510 (UMLS CUI [1])
Race
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])
Route
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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