ID

36923

Descrição

Study ID: 102370 (primary study) Clinical Study ID: 102370 Study Title: A multicentre when given according to the 2-4-6 month schedule to healthy infants with booster dose at 12 to 15 months Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00134719 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 2 Study Recruitment Status: Completed Generic Name: Haemophilus influenzae Type b, Meningococcal C and Y-Tetanus Toxoid Conjugate Vaccine Trade Name: BIO HIB-MENCY-TT; MenHibrix Study Indication: Haemophilus influenzae type b; Neisseria Meningitidis

Palavras-chave

  1. 21/06/2019 21/06/2019 -
Titular dos direitos

GlaxoSmithKline

Transferido a

21 de junho de 2019

DOI

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Licença

Creative Commons BY-NC 3.0

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GSK Biologicals' Hib-MenCY-TT Conjugate Vaccine vs ActHIB® & MenC Conjugate Licensed Vaccine (NCT00134719)

  1. StudyEvent: ODM
    1. Visit 2
Administrative Data
Descrição

Administrative Data

Date of Visit
Descrição

Date of visit

Tipo de dados

date

Alias
UMLS CUI [1]
C1320303
Subject Number
Descrição

Clinical Trial Subject Unique Identifier

Tipo de dados

integer

Alias
UMLS CUI [1]
C2348585
Check for Study Continuation
Descrição

Check for Study Continuation

Alias
UMLS CUI-1
C0805733
UMLS CUI-2
C0008976
Did the subject return for visit 2?
Descrição

Continuation Status, Clinical Trials

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0805733
UMLS CUI [1,2]
C0008976
Please tick the ONE most appropriate reason and skip the following pages of this visit.
Descrição

Continuation Status, Clinical Trials, Reason

Tipo de dados

text

Alias
UMLS CUI [1,1]
C0805733
UMLS CUI [1,2]
C0008976
UMLS CUI [1,3]
C0566251
Specify
Descrição

Continuation Status, Clinical Trials, Reason

Tipo de dados

text

Alias
UMLS CUI [1,1]
C0805733
UMLS CUI [1,2]
C0008976
UMLS CUI [1,3]
C0566251
Please tick who took the decision
Descrição

Continuation Status, Clinical Trials, Decision

Tipo de dados

text

Alias
UMLS CUI [1,1]
C0805733
UMLS CUI [1,2]
C0008976
UMLS CUI [1,3]
C0679006
Vaccine Administration - Hib-MenCY-TT Group
Descrição

Vaccine Administration - Hib-MenCY-TT Group

Alias
UMLS CUI-1
C2368628
Date (fill in only if different from visit date)
Descrição

Administration of vaccine, Date in time

Tipo de dados

date

Alias
UMLS CUI [1,1]
C2368628
UMLS CUI [1,2]
C0011008
Pre-Vaccination temperature
Descrição

Body Temperature, Vaccination, Before

Tipo de dados

float

Unidades de medida
  • °C
Alias
UMLS CUI [1,1]
C0005903
UMLS CUI [1,2]
C0042196
UMLS CUI [1,3]
C0332152
°C
Route
Descrição

Body Temperature, Vaccination, Before, Route

Tipo de dados

text

Alias
UMLS CUI [1,1]
C0005903
UMLS CUI [1,2]
C0042196
UMLS CUI [1,3]
C0332152
UMLS CUI [1,4]
C0449444
Vaccine Administration (only one box must be ticked by vaccine)
Descrição

Administration of vaccine

Tipo de dados

text

Alias
UMLS CUI [1]
C2368628
Vaccine Administration - Replacement vial number
Descrição

Administration of vaccine, Vial Device, Replacement, Identifier

Tipo de dados

integer

Alias
UMLS CUI [1,1]
C2368628
UMLS CUI [1,2]
C0184301
UMLS CUI [1,3]
C0559956
UMLS CUI [1,4]
C0600091
Vaccine Administration - Wrong vial number
Descrição

Administration of vaccine, Vial Device, Wrong, Identifier

Tipo de dados

integer

Alias
UMLS CUI [1,1]
C2368628
UMLS CUI [1,2]
C0184301
UMLS CUI [1,3]
C3827420
UMLS CUI [1,4]
C0600091
Side / site route
Descrição

Administration of vaccine, Drug Administration Routes, Side, Anatomic site

Tipo de dados

text

Alias
UMLS CUI [1,1]
C2368628
UMLS CUI [1,2]
C0013153
UMLS CUI [1,3]
C0441987
UMLS CUI [1,4]
C1515974
Has the study vaccine been administered according to the Protocol ?
Descrição

Administration of vaccine, Protocol Compliance

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C2368628
UMLS CUI [1,2]
C0525058
If No, Side
Descrição

Administration of vaccine, Side

Tipo de dados

text

Alias
UMLS CUI [1,1]
C2368628
UMLS CUI [1,2]
C0441987
If No, Site
Descrição

Administration of vaccine, Anatomic site

Tipo de dados

text

Alias
UMLS CUI [1,1]
C2368628
UMLS CUI [1,2]
C1515974
If No, Route
Descrição

Administration of vaccine, Drug Administration Routes

Tipo de dados

text

Alias
UMLS CUI [1,1]
C2368628
UMLS CUI [1,2]
C0013153
Comments
Descrição

Administration of vaccine, Comment

Tipo de dados

text

Alias
UMLS CUI [1,1]
C2368628
UMLS CUI [1,2]
C0947611
Administration of Vaccine - Lic MenC group
Descrição

Administration of Vaccine - Lic MenC group

Alias
UMLS CUI-1
C2368628
Date (fill in only if different from visit date)
Descrição

Administration of vaccine, Date in time

Tipo de dados

date

Alias
UMLS CUI [1,1]
C2368628
UMLS CUI [1,2]
C0011008
Pre-Vaccination temperature
Descrição

Body Temperature, Vaccination, Before

Tipo de dados

float

Unidades de medida
  • °C
Alias
UMLS CUI [1,1]
C0005903
UMLS CUI [1,2]
C0042196
UMLS CUI [1,3]
C0332152
°C
Route
Descrição

Body Temperature, Vaccination, Before, Route

Tipo de dados

text

Alias
UMLS CUI [1,1]
C0005903
UMLS CUI [1,2]
C0042196
UMLS CUI [1,3]
C0332152
UMLS CUI [1,4]
C0449444
Vaccine Administration (only one box must be ticked by vaccine)
Descrição

Administration of vaccine

Tipo de dados

text

Alias
UMLS CUI [1]
C2368628
Vaccine Administration - Replacement vial number
Descrição

Administration of vaccine, Vial Device, Replacement, Identifier

Tipo de dados

integer

Alias
UMLS CUI [1,1]
C2368628
UMLS CUI [1,2]
C0184301
UMLS CUI [1,3]
C0559956
UMLS CUI [1,4]
C0600091
Vaccine Administration - Wrong vial number
Descrição

Administration of vaccine, Vial Device, Wrong, Identifier

Tipo de dados

integer

Alias
UMLS CUI [1,1]
C2368628
UMLS CUI [1,2]
C0184301
UMLS CUI [1,3]
C3827420
UMLS CUI [1,4]
C0600091
Side / site route
Descrição

Administration of vaccine, Drug Administration Routes, Side, Anatomic site

Tipo de dados

text

Alias
UMLS CUI [1,1]
C2368628
UMLS CUI [1,2]
C0013153
UMLS CUI [1,3]
C0441987
UMLS CUI [1,4]
C1515974
Has the study vaccine been administered according to the Protocol ?
Descrição

Administration of vaccine, Protocol Compliance

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C2368628
UMLS CUI [1,2]
C0525058
If No, Side
Descrição

Administration of vaccine, Side

Tipo de dados

text

Alias
UMLS CUI [1,1]
C2368628
UMLS CUI [1,2]
C0441987
If No, Site
Descrição

Administration of vaccine, Anatomic site

Tipo de dados

text

Alias
UMLS CUI [1,1]
C2368628
UMLS CUI [1,2]
C1515974
If No, Route
Descrição

Administration of vaccine, Drug Administration Routes

Tipo de dados

text

Alias
UMLS CUI [1,1]
C2368628
UMLS CUI [1,2]
C0013153
Comments
Descrição

Administration of vaccine, Comment

Tipo de dados

text

Alias
UMLS CUI [1,1]
C2368628
UMLS CUI [1,2]
C0947611
Administration of Vaccine - ActHIB group
Descrição

Administration of Vaccine - ActHIB group

Alias
UMLS CUI-1
C2368628
Date (fill in only if different from visit date)
Descrição

Administration of vaccine, Date in time

Tipo de dados

date

Alias
UMLS CUI [1,1]
C2368628
UMLS CUI [1,2]
C0011008
Pre-Vaccination temperature
Descrição

Body Temperature, Vaccination, Before

Tipo de dados

float

Unidades de medida
  • °C
Alias
UMLS CUI [1,1]
C0005903
UMLS CUI [1,2]
C0042196
UMLS CUI [1,3]
C0332152
°C
Route
Descrição

Body Temperature, Vaccination, Before, Route

Tipo de dados

text

Alias
UMLS CUI [1,1]
C0005903
UMLS CUI [1,2]
C0042196
UMLS CUI [1,3]
C0332152
UMLS CUI [1,4]
C0449444
Vaccine Administration (only one box must be ticked by vaccine)
Descrição

Administration of vaccine

Tipo de dados

text

Alias
UMLS CUI [1]
C2368628
Vaccine Administration - Replacement vial number
Descrição

Administration of vaccine, Vial Device, Replacement, Identifier

Tipo de dados

integer

Alias
UMLS CUI [1,1]
C2368628
UMLS CUI [1,2]
C0184301
UMLS CUI [1,3]
C0559956
UMLS CUI [1,4]
C0600091
Vaccine Administration - Wrong vial number
Descrição

Administration of vaccine, Vial Device, Wrong, Identifier

Tipo de dados

integer

Alias
UMLS CUI [1,1]
C2368628
UMLS CUI [1,2]
C0184301
UMLS CUI [1,3]
C3827420
UMLS CUI [1,4]
C0600091
Side / site route
Descrição

Administration of vaccine, Drug Administration Routes, Side, Anatomic site

Tipo de dados

text

Alias
UMLS CUI [1,1]
C2368628
UMLS CUI [1,2]
C0013153
UMLS CUI [1,3]
C0441987
UMLS CUI [1,4]
C1515974
Has the study vaccine been administered according to the Protocol ?
Descrição

Administration of vaccine, Protocol Compliance

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C2368628
UMLS CUI [1,2]
C0525058
If No, Side
Descrição

Administration of vaccine, Side

Tipo de dados

text

Alias
UMLS CUI [1,1]
C2368628
UMLS CUI [1,2]
C0441987
If No, Site
Descrição

Administration of vaccine, Anatomic site

Tipo de dados

text

Alias
UMLS CUI [1,1]
C2368628
UMLS CUI [1,2]
C1515974
If No, Route
Descrição

Administration of vaccine, Drug Administration Routes

Tipo de dados

text

Alias
UMLS CUI [1,1]
C2368628
UMLS CUI [1,2]
C0013153
Comments
Descrição

Administration of vaccine, Comment

Tipo de dados

text

Alias
UMLS CUI [1,1]
C2368628
UMLS CUI [1,2]
C0947611
Vaccine Administration (continued)
Descrição

Vaccine Administration (continued)

Alias
UMLS CUI-1
C2368628
Why not administered? Please tick the ONE most appropriate category for non administration
Descrição

Administration of Vaccine, Not-Done Reason

Tipo de dados

text

Alias
UMLS CUI [1,1]
C2368628
UMLS CUI [1,2]
C2826287
Why not administered? - Specifications
Descrição

Administration of Vaccine, Not-Done Reason

Tipo de dados

text

Alias
UMLS CUI [1,1]
C2368628
UMLS CUI [1,2]
C2826287
Please tick who took the decision
Descrição

Administration of Vaccine, Not done, Decision

Tipo de dados

text

Alias
UMLS CUI [1,1]
C2368628
UMLS CUI [1,2]
C1272696
UMLS CUI [1,3]
C0679006

Similar models

  1. StudyEvent: ODM
    1. Visit 2
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de dados
Alias
Item Group
Administrative Data
Date of visit
Item
Date of Visit
date
C1320303 (UMLS CUI [1])
Clinical Trial Subject Unique Identifier
Item
Subject Number
integer
C2348585 (UMLS CUI [1])
Item Group
Check for Study Continuation
C0805733 (UMLS CUI-1)
C0008976 (UMLS CUI-2)
Continuation Status, Clinical Trials
Item
Did the subject return for visit 2?
boolean
C0805733 (UMLS CUI [1,1])
C0008976 (UMLS CUI [1,2])
Item
Please tick the ONE most appropriate reason and skip the following pages of this visit.
text
C0805733 (UMLS CUI [1,1])
C0008976 (UMLS CUI [1,2])
C0566251 (UMLS CUI [1,3])
Code List
Please tick the ONE most appropriate reason and skip the following pages of this visit.
CL Item
Serious adverse event (Please specify SAE N°) (1)
CL Item
Non-Serious adverse event (Please specify unsolicited AE N° or solicited AE code) (2)
CL Item
Other, please specify (3)
Continuation Status, Clinical Trials, Reason
Item
Specify
text
C0805733 (UMLS CUI [1,1])
C0008976 (UMLS CUI [1,2])
C0566251 (UMLS CUI [1,3])
Item
Please tick who took the decision
text
C0805733 (UMLS CUI [1,1])
C0008976 (UMLS CUI [1,2])
C0679006 (UMLS CUI [1,3])
Code List
Please tick who took the decision
CL Item
Investigator (1)
CL Item
Parents/Guardians (2)
Item Group
Vaccine Administration - Hib-MenCY-TT Group
C2368628 (UMLS CUI-1)
Administration of vaccine, Date in time
Item
Date (fill in only if different from visit date)
date
C2368628 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
Body Temperature, Vaccination, Before
Item
Pre-Vaccination temperature
float
C0005903 (UMLS CUI [1,1])
C0042196 (UMLS CUI [1,2])
C0332152 (UMLS CUI [1,3])
Item
Route
text
C0005903 (UMLS CUI [1,1])
C0042196 (UMLS CUI [1,2])
C0332152 (UMLS CUI [1,3])
C0449444 (UMLS CUI [1,4])
CL Item
Axillary (preferably) (1)
CL Item
Oral (2)
CL Item
Tympanic (oral conversion)  (3)
CL Item
Tympanic (rectal conversion)  (4)
CL Item
Rectal (5)
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
Hib-MenCY-TT Vaccine (1)
CL Item
Replacement vial (2)
CL Item
Wrong vial  (3)
CL Item
Not administered (4)
CL Item
Infanrix® penta Vaccine (5)
CL Item
Replacement vial (6)
CL Item
Wrong vial  (7)
CL Item
Not administered (8)
CL Item
Prevenar® Vaccine (9)
CL Item
Replacement vial (10)
CL Item
Wrong vial  (11)
CL Item
Not administered (12)
Administration of vaccine, Vial Device, Replacement, Identifier
Item
Vaccine Administration - Replacement vial number
integer
C2368628 (UMLS CUI [1,1])
C0184301 (UMLS CUI [1,2])
C0559956 (UMLS CUI [1,3])
C0600091 (UMLS CUI [1,4])
Administration of vaccine, Vial Device, Wrong, Identifier
Item
Vaccine Administration - Wrong vial number
integer
C2368628 (UMLS CUI [1,1])
C0184301 (UMLS CUI [1,2])
C3827420 (UMLS CUI [1,3])
C0600091 (UMLS CUI [1,4])
Item
Side / site route
text
C2368628 (UMLS CUI [1,1])
C0013153 (UMLS CUI [1,2])
C0441987 (UMLS CUI [1,3])
C1515974 (UMLS CUI [1,4])
CL Item
Upper Right Thigh, I.M. (1)
CL Item
Upper Left Thigh, I.M. (2)
CL Item
Lower Left Thigh, I.M. (3)
Administration of vaccine, Protocol Compliance
Item
Has the study vaccine been administered according to the Protocol ?
boolean
C2368628 (UMLS CUI [1,1])
C0525058 (UMLS CUI [1,2])
Item
If No, Side
text
C2368628 (UMLS CUI [1,1])
C0441987 (UMLS CUI [1,2])
Code List
If No, Side
CL Item
Upper left (1)
CL Item
Lower left (2)
CL Item
Upper right (3)
CL Item
Lower right (4)
Item
If No, Site
text
C2368628 (UMLS CUI [1,1])
C1515974 (UMLS CUI [1,2])
CL Item
Deltoid (1)
CL Item
Thigh (2)
CL Item
Buttock (3)
Item
If No, Route
text
C2368628 (UMLS CUI [1,1])
C0013153 (UMLS CUI [1,2])
CL Item
I.M. (1)
CL Item
S.C. (2)
Administration of vaccine, Comment
Item
Comments
text
C2368628 (UMLS CUI [1,1])
C0947611 (UMLS CUI [1,2])
Item Group
Administration of Vaccine - Lic MenC group
C2368628 (UMLS CUI-1)
Administration of vaccine, Date in time
Item
Date (fill in only if different from visit date)
date
C2368628 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
Body Temperature, Vaccination, Before
Item
Pre-Vaccination temperature
float
C0005903 (UMLS CUI [1,1])
C0042196 (UMLS CUI [1,2])
C0332152 (UMLS CUI [1,3])
Item
Route
text
C0005903 (UMLS CUI [1,1])
C0042196 (UMLS CUI [1,2])
C0332152 (UMLS CUI [1,3])
C0449444 (UMLS CUI [1,4])
CL Item
Axillary (preferably) (1)
CL Item
Oral (2)
CL Item
Tympanic (oral conversion)  (3)
CL Item
Tympanic (rectal conversion)  (4)
CL Item
Rectal (5)
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
ActHIB® Vaccine (1)
CL Item
Replacement vial (2)
CL Item
Wrong vial  (3)
CL Item
Not administered (4)
CL Item
Infanrix® penta Vaccine (5)
CL Item
Replacement vial (6)
CL Item
Wrong vial  (7)
CL Item
Not administered (8)
CL Item
Prevenar® Vaccine (9)
CL Item
Replacement vial (10)
CL Item
Wrong vial  (11)
CL Item
Not administered (12)
CL Item
Meningitec® Vaccine (13)
CL Item
Replacement vial (14)
CL Item
Wrong vial  (15)
CL Item
Not administered (16)
Administration of vaccine, Vial Device, Replacement, Identifier
Item
Vaccine Administration - Replacement vial number
integer
C2368628 (UMLS CUI [1,1])
C0184301 (UMLS CUI [1,2])
C0559956 (UMLS CUI [1,3])
C0600091 (UMLS CUI [1,4])
Administration of vaccine, Vial Device, Wrong, Identifier
Item
Vaccine Administration - Wrong vial number
integer
C2368628 (UMLS CUI [1,1])
C0184301 (UMLS CUI [1,2])
C3827420 (UMLS CUI [1,3])
C0600091 (UMLS CUI [1,4])
Item
Side / site route
text
C2368628 (UMLS CUI [1,1])
C0013153 (UMLS CUI [1,2])
C0441987 (UMLS CUI [1,3])
C1515974 (UMLS CUI [1,4])
CL Item
Upper Right Thigh, I.M. (1)
CL Item
Upper Left Thigh, I.M. (2)
CL Item
Lower Right Thigh, I.M. (3)
CL Item
Lower Left Thigh, I.M. (4)
Administration of vaccine, Protocol Compliance
Item
Has the study vaccine been administered according to the Protocol ?
boolean
C2368628 (UMLS CUI [1,1])
C0525058 (UMLS CUI [1,2])
Item
If No, Side
text
C2368628 (UMLS CUI [1,1])
C0441987 (UMLS CUI [1,2])
Code List
If No, Side
CL Item
Upper left (1)
CL Item
Lower left (2)
CL Item
Upper right (3)
CL Item
Lower right (4)
Item
If No, Site
text
C2368628 (UMLS CUI [1,1])
C1515974 (UMLS CUI [1,2])
Code List
If No, Site
CL Item
Deltoid (1)
CL Item
Thigh (2)
CL Item
Buttock (3)
Item
If No, Route
text
C2368628 (UMLS CUI [1,1])
C0013153 (UMLS CUI [1,2])
Code List
If No, Route
CL Item
I.M. (1)
CL Item
S.C. (2)
Administration of vaccine, Comment
Item
Comments
text
C2368628 (UMLS CUI [1,1])
C0947611 (UMLS CUI [1,2])
Item Group
Administration of Vaccine - ActHIB group
C2368628 (UMLS CUI-1)
Administration of vaccine, Date in time
Item
Date (fill in only if different from visit date)
date
C2368628 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
Body Temperature, Vaccination, Before
Item
Pre-Vaccination temperature
float
C0005903 (UMLS CUI [1,1])
C0042196 (UMLS CUI [1,2])
C0332152 (UMLS CUI [1,3])
Item
Route
text
C0005903 (UMLS CUI [1,1])
C0042196 (UMLS CUI [1,2])
C0332152 (UMLS CUI [1,3])
C0449444 (UMLS CUI [1,4])
CL Item
Axillary (preferably) (1)
CL Item
Oral (2)
CL Item
Tympanic (oral conversion)  (3)
CL Item
Tympanic (rectal conversion)  (4)
CL Item
Rectal (5)
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
ActHIB® Vaccine (1)
CL Item
Replacement vial (2)
CL Item
Wrong vial  (3)
CL Item
Not administered (4)
CL Item
Infanrix® penta Vaccine (5)
CL Item
Replacement vial (6)
CL Item
Wrong vial  (7)
CL Item
Not administered (8)
CL Item
Prevenar® Vaccine (9)
CL Item
Replacement vial (10)
CL Item
Wrong vial  (11)
CL Item
Not administered (12)
Administration of vaccine, Vial Device, Replacement, Identifier
Item
Vaccine Administration - Replacement vial number
integer
C2368628 (UMLS CUI [1,1])
C0184301 (UMLS CUI [1,2])
C0559956 (UMLS CUI [1,3])
C0600091 (UMLS CUI [1,4])
Administration of vaccine, Vial Device, Wrong, Identifier
Item
Vaccine Administration - Wrong vial number
integer
C2368628 (UMLS CUI [1,1])
C0184301 (UMLS CUI [1,2])
C3827420 (UMLS CUI [1,3])
C0600091 (UMLS CUI [1,4])
Item
Side / site route
text
C2368628 (UMLS CUI [1,1])
C0013153 (UMLS CUI [1,2])
C0441987 (UMLS CUI [1,3])
C1515974 (UMLS CUI [1,4])
CL Item
Upper Right Thigh, I.M. (1)
CL Item
Upper Left Thigh, I.M. (2)
CL Item
Lower Left Thigh, I.M. (3)
Administration of vaccine, Protocol Compliance
Item
Has the study vaccine been administered according to the Protocol ?
boolean
C2368628 (UMLS CUI [1,1])
C0525058 (UMLS CUI [1,2])
Item
If No, Side
text
C2368628 (UMLS CUI [1,1])
C0441987 (UMLS CUI [1,2])
Code List
If No, Side
CL Item
Upper left (1)
CL Item
Lower left (2)
CL Item
Upper right (3)
CL Item
Lower right (4)
Item
If No, Site
text
C2368628 (UMLS CUI [1,1])
C1515974 (UMLS CUI [1,2])
Code List
If No, Site
CL Item
Deltoid (1)
CL Item
Thigh (2)
CL Item
Buttock (3)
Item
If No, Route
text
C2368628 (UMLS CUI [1,1])
C0013153 (UMLS CUI [1,2])
Code List
If No, Route
CL Item
I.M. (1)
CL Item
S.C. (2)
Administration of vaccine, Comment
Item
Comments
text
C2368628 (UMLS CUI [1,1])
C0947611 (UMLS CUI [1,2])
Item Group
Vaccine Administration (continued)
C2368628 (UMLS CUI-1)
Item
Why not administered? Please tick the ONE most appropriate category for non administration
text
C2368628 (UMLS CUI [1,1])
C2826287 (UMLS CUI [1,2])
Code List
Why not administered? Please tick the ONE most appropriate category for non administration
CL Item
Serious adverse event (Please specify SAE N°) (1)
CL Item
Non-Serious adverse event (Please specify unsolicited AE N° or solicited AE code) (2)
CL Item
Other, please specify (e.g. consent withdrawal, recoil violation, ...) (3)
Item
Why not administered? - Specifications
text
C2368628 (UMLS CUI [1,1])
C2826287 (UMLS CUI [1,2])
Code List
Why not administered? - Specifications
Item
Please tick who took the decision
text
C2368628 (UMLS CUI [1,1])
C1272696 (UMLS CUI [1,2])
C0679006 (UMLS CUI [1,3])
Code List
Please tick who took the decision
CL Item
Investigator  (1)
CL Item
Parents/Guardians (2)

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