ID

36791

Descripción

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

Palabras clave

Versiones (1)
  1. 2019-06-10 2019-06-10 -
Titular de derechos de autor

GlaxoSmithKline

Subido en

10 juni 2019

DOI

Para solicitar uno, por favor iniciar sesión.

Licencia

Creative Commons BY-NC 3.0
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GSK Biologicals' Hib-MenCY-TT Conjugate Vaccine vs ActHIB® & MenC Conjugate Licensed Vaccine (NCT00134719)

Inglés

Visit 1

1 formularios  
  1. StudyEvent: ODM
    1. Visit 1
Administrative Data
Descripción

Administrative Data

Date of Visit
Descripción

Date of visit

Tipo de datos

date

Alias
UMLS CUI [1]
C1320303
Subject Number
Descripción

Clinical Trial Subject Unique Identifier

Tipo de datos

integer

Alias
UMLS CUI [1]
C2348585
Informed Consent
Descripción

Informed Consent

Alias
UMLS CUI-1
C0021430
Informed Consent Date
Descripción

I certify that Informed Consent has been obtained prior to any study procedure.

Tipo de datos

date

Alias
UMLS CUI [1]
C2985782
Demographics
Descripción

Demographics

Alias
UMLS CUI-1
C0011298
Center number
Descripción

Institution name, Identifier

Tipo de datos

integer

Alias
UMLS CUI [1,1]
C1301943
UMLS CUI [1,2]
C0600091
Date of birth
Descripción

Patient date of birth

Tipo de datos

date

Alias
UMLS CUI [1]
C0421451
Gender
Descripción

Gender

Tipo de datos

text

Alias
UMLS CUI [1]
C0079399
Race
Descripción

Racial group

Tipo de datos

text

Alias
UMLS CUI [1]
C0034510
Height
Descripción

Body Height

Tipo de datos

integer

Unidades de medida
  • cm
Alias
UMLS CUI [1]
C0005890
cm
Weight
Descripción

Body Weight

Tipo de datos

float

Unidades de medida
  • kg
Alias
UMLS CUI [1]
C0005910
kg
Eligibility Check
Descripción

Eligibility Check

Alias
UMLS CUI-1
C0013893
Did the subject meet all the entry criteria ?
Descripción

Eligibility Determination

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0013893
Inclusion Criteria
Descripción

Inclusion Criteria

Alias
UMLS CUI-1
C1512693
Subjects for whom the investigator believes that their parents/guardians can and will comply with the requirements of the protocol (e.g., completion of the diary cards, return for follow- up visits) should be enrolled in the study.
Descripción

Compliance behavior, Study Protocol

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C1321605
UMLS CUI [1,2]
C2348563
A male or female between, and including, 6 and 12 weeks of age at the time of the first vaccination.
Descripción

Gender; Age

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0079399
UMLS CUI [2]
C0001779
Written informed consent obtained from the parent or guardian of the subject.
Descripción

Informed Consent

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0021430
Free of obvious health problems as established by medical history and clinical examination before entering into the study.
Descripción

Health Status

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0018759
Born after a gestation period between 36 and 42 weeks.
Descripción

Duration of gestation

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0460089
Exclusion Criteria
Descripción

Exclusion Criteria

Alias
UMLS CUI-1
C0680251
Use of any investigational or non-registered product (drug or vaccine) other than the study vaccine(s) within 30 days preceding the first dose of study vaccine, or planned use during the study period.
Descripción

Concomitant Agent

Tipo de datos

boolean

Alias
UMLS CUI [1]
C2347852
Chronic administration (defined as more than 14 days) of immunosuppressants or other immune-modifying drugs since birth. (For corticosteroids, this will mean prednisone, or equivalent, ≥ 0.5 mg/kg/day. Inhaled and topical steroids are allowed.)
Descripción

Immunosuppressants; non-specific immune-modulator therapy

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0021081
UMLS CUI [2]
C0279021
Planned administration/ administration of a vaccine not foreseen by the study protocol within 30 days of the first dose of vaccine(s).
Descripción

Concomitant Agent, Vaccination

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C2347852
UMLS CUI [1,2]
C0042196
Previous vaccination against Neisseria meningitidis, Haemophilus influenzae type b, diphtheria, tetanus, pertussis, poliovirus, and/or Streptococcus pneumoniae; more than one previous dose of hepatitis B vaccine. Vaccination with hepatitis B at birth is accepted (although not mandatory). Influenza (Flu) vaccination is allowed 30 days after the administration of the 3rd vaccine dose to 30 days preceding the booster dose.
Descripción

Vaccination, Previous

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0042196
UMLS CUI [1,2]
C0205156
History of Neisseria meningitidis, Haemophilus influenzae type b, diphtheria, tetanus, pertussis, hepatitis B, poliovirus, Streptococcus pneumoniae and/or varicella invasive disease.
Descripción

Neisseria meningitidis, Medical History; Haemophilus influenzae type b, Medical History; Diphtheria, Medical History; Tetanus, Medical History; Pertussis, Medical History; Hepatitis B, Medical History; Human poliovirus, Medical History; Streptococcus pneumoniae, Medical History; Varicella zoster, Medical History

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0027575
UMLS CUI [1,2]
C0262926
UMLS CUI [2,1]
C0121772
UMLS CUI [2,2]
C0262926
UMLS CUI [3,1]
C0012546
UMLS CUI [3,2]
C0262926
UMLS CUI [4,1]
C0039614
UMLS CUI [4,2]
C0262926
UMLS CUI [5,1]
C0043167
UMLS CUI [5,2]
C0262926
UMLS CUI [6,1]
C0019163
UMLS CUI [6,2]
C0262926
UMLS CUI [7,1]
C0206435
UMLS CUI [7,2]
C0262926
UMLS CUI [8,1]
C0038410
UMLS CUI [8,2]
C0262926
UMLS CUI [9,1]
C0740380
UMLS CUI [9,2]
C0262926
Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination (no laboratory testing is required).
Descripción

Immunosuppression; Immunologic Deficiency Syndromes

Tipo de datos

boolean

Alias
UMLS CUI [1]
C4048329
UMLS CUI [2]
C0021051
History of allergic disease or reactions likely to be exacerbated by any component of the vaccine(s), including dry natural latex rubber, tetanus toxoid, diphtheria toxoid, neomycin, polymyxin.
Descripción

Hypersensitivity, Medical History

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0020517
UMLS CUI [1,2]
C0262926
Major congenital defects or serious chronic illness.
Descripción

Congenital Abnormality, Major; Chronic disease, Serious

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0000768
UMLS CUI [1,2]
C0205164
UMLS CUI [2,1]
C0008679
UMLS CUI [2,2]
C0205404
History of any neurologic disorders or seizures.
Descripción

Nervous System Disorder, Medical History; Seizure, Medical History

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0027765
UMLS CUI [1,2]
C0262926
UMLS CUI [2,1]
C0036572
UMLS CUI [2,2]
C0262926
Acute disease at the time of enrolment. (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. rectal temperature <38°C, axillary <37.5°C. A temperature greater than or equal to these cut-offs warrants deferral of the vaccination pending recovery of the subject).
Descripción

Acute Disease

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0001314
Administration of immunoglobulins and/or any blood products since birth or planned administration during the study period.
Descripción

Immunoglobulins; Blood Product

Tipo de datos

text

Alias
UMLS CUI [1,1]
C0021027
UMLS CUI [1,2]
C0371802
Randomisation / Treatment Allocation
Descripción

Randomisation / Treatment Allocation

Alias
UMLS CUI-1
C0034656
Record treatment number
Descripción

Randomization, Identifier

Tipo de datos

integer

Alias
UMLS CUI [1,1]
C0034656
UMLS CUI [1,2]
C0600091
General Medical History / Physical Examination
Descripción

General Medical History / Physical Examination

Alias
UMLS CUI-1
C0262926
UMLS CUI-2
C0031809
Are you aware of any pre-existing conditions or signs and/or symptoms present in the subject prior to the start of the study ?
Descripción

Medical History

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0262926
Cutaneous - Diagnosis
Descripción

Physical Examination, Skin, Diagnosis

Tipo de datos

text

Alias
UMLS CUI [1,1]
C0031809
UMLS CUI [1,2]
C1123023
UMLS CUI [1,3]
C0011900
Cutaneous
Descripción

Physical Examination, Skin, Current or Past

Tipo de datos

text

Alias
UMLS CUI [1,1]
C0031809
UMLS CUI [1,2]
C1123023
UMLS CUI [1,3]
C1444635
Eyes - Diagnosis
Descripción

Physical Examination, Eye, Diagnosis

Tipo de datos

text

Alias
UMLS CUI [1,1]
C0031809
UMLS CUI [1,2]
C0015392
UMLS CUI [1,3]
C0011900
Eyes
Descripción

Physical Examination, Eye, Current or Past

Tipo de datos

text

Alias
UMLS CUI [1,1]
C0031809
UMLS CUI [1,2]
C0015392
UMLS CUI [1,3]
C1444635
Ears-Nose-Throat - Diagnosis
Descripción

Physical Examination, ENT examination, Diagnosis

Tipo de datos

text

Alias
UMLS CUI [1,1]
C0031809
UMLS CUI [1,2]
C0278350
UMLS CUI [1,3]
C0011900
Ears-Nose-Throat
Descripción

Physical Examination, ENT examination, Current or Past

Tipo de datos

text

Alias
UMLS CUI [1,1]
C0031809
UMLS CUI [1,2]
C0278350
UMLS CUI [1,3]
C1444635
Cardiovascular - Diagnosis
Descripción

Physical Examination, Cardiovascular system, Diagnosis

Tipo de datos

text

Alias
UMLS CUI [1,1]
C0031809
UMLS CUI [1,2]
C0007226
UMLS CUI [1,3]
C0011900
Cardiovascular
Descripción

Physical Examination,Cardiovascular system, Current or Past

Tipo de datos

text

Alias
UMLS CUI [1,1]
C0031809
UMLS CUI [1,2]
C0007226
UMLS CUI [1,3]
C1444635
Respiratory - Diagnosis
Descripción

Physical Examination, Respiratory system, Diagnosis

Tipo de datos

text

Alias
UMLS CUI [1,1]
C0031809
UMLS CUI [1,2]
C0035237
UMLS CUI [1,3]
C0011900
Respiratory
Descripción

Physical Examination, Respiratory system, Current or Past

Tipo de datos

text

Alias
UMLS CUI [1,1]
C0031809
UMLS CUI [1,2]
C0035237
UMLS CUI [1,3]
C1444635
Gastrointestinal - Diagnosis
Descripción

Physical Examination, Gastrointestinal system, Diagnosis

Tipo de datos

text

Alias
UMLS CUI [1,1]
C0031809
UMLS CUI [1,2]
C0012240
UMLS CUI [1,3]
C0011900
Gastrointestinal
Descripción

Physical Examination, Gastrointestinal system, Current or Past

Tipo de datos

text

Alias
UMLS CUI [1,1]
C0031809
UMLS CUI [1,2]
C0012240
UMLS CUI [1,3]
C1444635
Muskuloskeletal - Diagnosis
Descripción

Physical Examination, Muskuloskeletal system, Diagnosis

Tipo de datos

text

Alias
UMLS CUI [1,1]
C0031809
UMLS CUI [1,2]
C0026860
UMLS CUI [1,3]
C0011900
Muskuloskeletal
Descripción

Physical Examination, Muskuloskeletal system, Current or Past

Tipo de datos

text

Alias
UMLS CUI [1,1]
C0031809
UMLS CUI [1,2]
C0026860
UMLS CUI [1,3]
C1444635
Neurological - Diagnosis
Descripción

Physical Examination, Neurologic Examination, Diagnosis

Tipo de datos

text

Alias
UMLS CUI [1,1]
C0031809
UMLS CUI [1,2]
C0027853
UMLS CUI [1,3]
C0011900
Neurological
Descripción

Physical Examination, Neurologic Examination, Current or Past

Tipo de datos

text

Alias
UMLS CUI [1,1]
C0031809
UMLS CUI [1,2]
C0027853
UMLS CUI [1,3]
C1444635
Genitourinary - Diagnosis
Descripción

Physical Examination, Genitourinary assessment, Diagnosis

Tipo de datos

text

Alias
UMLS CUI [1,1]
C0031809
UMLS CUI [1,2]
C1828035
UMLS CUI [1,3]
C0011900
Genitourinary
Descripción

Physical Examination, Genitourinary assessment, Current or Past

Tipo de datos

text

Alias
UMLS CUI [1,1]
C0031809
UMLS CUI [1,2]
C1828035
UMLS CUI [1,3]
C1444635
Haematology - Diagnosis
Descripción

Physical Examination, Hematology finding, Diagnosis

Tipo de datos

text

Alias
UMLS CUI [1,1]
C0031809
UMLS CUI [1,2]
C0474523
UMLS CUI [1,3]
C0011900
Haematology
Descripción

Physical Examination, Hematology finding, Current or Past

Tipo de datos

text

Alias
UMLS CUI [1,1]
C0031809
UMLS CUI [1,2]
C0474523
UMLS CUI [1,3]
C1444635
Allergies - Diagnosis
Descripción

Physical Examination, Hypersensitivity, Diagnosis

Tipo de datos

text

Alias
UMLS CUI [1,1]
C0031809
UMLS CUI [1,2]
C0020517
UMLS CUI [1,3]
C0011900
Allergies
Descripción

Physical Examination, Hypersensitivity, Current or Past

Tipo de datos

text

Alias
UMLS CUI [1,1]
C0031809
UMLS CUI [1,2]
C0020517
UMLS CUI [1,3]
C1444635
Endocrine - Diagnosis
Descripción

Physical Examination,Endocrine system, Diagnosis

Tipo de datos

text

Alias
UMLS CUI [1,1]
C0031809
UMLS CUI [1,2]
C0014136
UMLS CUI [1,3]
C0011900
Endocrine
Descripción

Physical Examination, Endocrine system, Current or Past

Tipo de datos

text

Alias
UMLS CUI [1,1]
C0031809
UMLS CUI [1,2]
C0014136
UMLS CUI [1,3]
C1444635
Other (specify) - Diagnosis
Descripción

Physical Examination, Other, Diagnosis

Tipo de datos

text

Alias
UMLS CUI [1,1]
C0031809
UMLS CUI [1,2]
C0205394
UMLS CUI [1,3]
C0011900
Other (specify)
Descripción

Physical Examination, Other, Current or Past

Tipo de datos

text

Alias
UMLS CUI [1,1]
C0031809
UMLS CUI [1,2]
C0205394
UMLS CUI [1,3]
C1444635
Vaccine History
Descripción

Vaccine History

Alias
UMLS CUI-1
C0042210
UMLS CUI-2
C0262926
Has any vaccine been administered since birth ?
Descripción

Vaccines, Medical History

Tipo de datos

text

Alias
UMLS CUI [1,1]
C0042210
UMLS CUI [1,2]
C0262926
Trade / Generic Name
Descripción

Vaccine, Medication name

Tipo de datos

text

Alias
UMLS CUI [1,1]
C0042210
UMLS CUI [1,2]
C2360065
Dose Number
Descripción

Vaccine, Dose Number

Tipo de datos

integer

Alias
UMLS CUI [1,1]
C0042210
UMLS CUI [1,2]
C1115464
Estimated date of vaccine
Descripción

Administration of vaccine, Date in tine

Tipo de datos

date

Alias
UMLS CUI [1,1]
C2368628
UMLS CUI [1,2]
C0011008
Vaccine Administration - Hib-MenCY-TT Group
Descripción

Vaccine Administration - Hib-MenCY-TT Group

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

Administration of vaccine, Date in time

Tipo de datos

date

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

Body Temperature, Vaccination, Before

Tipo de datos

float

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

Body Temperature, Vaccination, Before, Route

Tipo de datos

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)
Descripción

Administration of vaccine

Tipo de datos

text

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

Administration of vaccine, Vial Device, Replacement, Identifier

Tipo de datos

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
Descripción

Administration of vaccine, Vial Device, Wrong, Identifier

Tipo de datos

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
Descripción

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

Tipo de datos

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 ?
Descripción

Administration of vaccine, Protocol Compliance

Tipo de datos

boolean

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

Administration of vaccine, Side

Tipo de datos

text

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

Administration of vaccine, Anatomic site

Tipo de datos

text

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

Administration of vaccine, Drug Administration Routes

Tipo de datos

text

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

Administration of vaccine, Comment

Tipo de datos

text

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

Administration of Vaccine - Lic MenC group

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

Administration of vaccine, Date in time

Tipo de datos

date

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

Body Temperature, Vaccination, Before

Tipo de datos

float

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

Body Temperature, Vaccination, Before, Route

Tipo de datos

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)
Descripción

Administration of vaccine

Tipo de datos

text

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

Administration of vaccine, Vial Device, Replacement, Identifier

Tipo de datos

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
Descripción

Administration of vaccine, Vial Device, Wrong, Identifier

Tipo de datos

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
Descripción

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

Tipo de datos

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 ?
Descripción

Administration of vaccine, Protocol Compliance

Tipo de datos

boolean

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

Administration of vaccine, Side

Tipo de datos

text

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

Administration of vaccine, Anatomic site

Tipo de datos

text

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

Administration of vaccine, Drug Administration Routes

Tipo de datos

text

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

Administration of vaccine, Comment

Tipo de datos

text

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

Administration of Vaccine - ActHIB group

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

Administration of vaccine, Date in time

Tipo de datos

date

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

Body Temperature, Vaccination, Before

Tipo de datos

float

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

Body Temperature, Vaccination, Before, Route

Tipo de datos

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)
Descripción

Administration of vaccine

Tipo de datos

text

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

Administration of vaccine, Vial Device, Replacement, Identifier

Tipo de datos

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
Descripción

Administration of vaccine, Vial Device, Wrong, Identifier

Tipo de datos

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
Descripción

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

Tipo de datos

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 ?
Descripción

Administration of vaccine, Protocol Compliance

Tipo de datos

boolean

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

Administration of vaccine, Side

Tipo de datos

text

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

Administration of vaccine, Anatomic site

Tipo de datos

text

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

Administration of vaccine, Drug Administration Routes

Tipo de datos

text

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

Administration of vaccine, Comment

Tipo de datos

text

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

Vaccine Administration (continued)

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

Administration of Vaccine, Not-Done Reason

Tipo de datos

text

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

Administration of Vaccine, Not-Done Reason

Tipo de datos

text

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

Administration of Vaccine, Not done, Decision

Tipo de datos

text

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

Visit 1

1 formularios
  1. StudyEvent: ODM
    1. Visit 1
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de datos
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
Informed Consent
C0021430 (UMLS CUI-1)
Informed Consent Date
Item
Informed Consent Date
date
C2985782 (UMLS CUI [1])
Item Group
Demographics
C0011298 (UMLS CUI-1)
Institution name, Identifier
Item
Center number
integer
C1301943 (UMLS CUI [1,1])
C0600091 (UMLS CUI [1,2])
Patient date of birth
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])
Racial group
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
American Hispanic (6)
CL Item
Japanese (7)
CL Item
Other, please specify (8)
Body Height
Item
Height
integer
C0005890 (UMLS CUI [1])
Body Weight
Item
Weight
float
C0005910 (UMLS CUI [1])
Item Group
Eligibility Check
C0013893 (UMLS CUI-1)
Eligibility Determination
Item
Did the subject meet all the entry criteria ?
boolean
C0013893 (UMLS CUI [1])
Item Group
Inclusion Criteria
C1512693 (UMLS CUI-1)
Compliance behavior, Study Protocol
Item
Subjects for whom the investigator believes that their parents/guardians can and will comply with the requirements of the protocol (e.g., completion of the diary cards, return for follow- up visits) should be enrolled in the study.
boolean
C1321605 (UMLS CUI [1,1])
C2348563 (UMLS CUI [1,2])
Gender; Age
Item
A male or female between, and including, 6 and 12 weeks of age at the time of the first vaccination.
boolean
C0079399 (UMLS CUI [1])
C0001779 (UMLS CUI [2])
Informed Consent
Item
Written informed consent obtained from the parent or guardian of the subject.
boolean
C0021430 (UMLS CUI [1])
Health Status
Item
Free of obvious health problems as established by medical history and clinical examination before entering into the study.
boolean
C0018759 (UMLS CUI [1])
Duration of gestation
Item
Born after a gestation period between 36 and 42 weeks.
boolean
C0460089 (UMLS CUI [1])
Item Group
Exclusion Criteria
C0680251 (UMLS CUI-1)
Concomitant Agent
Item
Use of any investigational or non-registered product (drug or vaccine) other than the study vaccine(s) within 30 days preceding the first dose of study vaccine, or planned use during the study period.
boolean
C2347852 (UMLS CUI [1])
Immunosuppressants; non-specific immune-modulator therapy
Item
Chronic administration (defined as more than 14 days) of immunosuppressants or other immune-modifying drugs since birth. (For corticosteroids, this will mean prednisone, or equivalent, ≥ 0.5 mg/kg/day. Inhaled and topical steroids are allowed.)
boolean
C0021081 (UMLS CUI [1])
C0279021 (UMLS CUI [2])
Concomitant Agent, Vaccination
Item
Planned administration/ administration of a vaccine not foreseen by the study protocol within 30 days of the first dose of vaccine(s).
boolean
C2347852 (UMLS CUI [1,1])
C0042196 (UMLS CUI [1,2])
Vaccination, Previous
Item
Previous vaccination against Neisseria meningitidis, Haemophilus influenzae type b, diphtheria, tetanus, pertussis, poliovirus, and/or Streptococcus pneumoniae; more than one previous dose of hepatitis B vaccine. Vaccination with hepatitis B at birth is accepted (although not mandatory). Influenza (Flu) vaccination is allowed 30 days after the administration of the 3rd vaccine dose to 30 days preceding the booster dose.
boolean
C0042196 (UMLS CUI [1,1])
C0205156 (UMLS CUI [1,2])
Neisseria meningitidis, Medical History; Haemophilus influenzae type b, Medical History; Diphtheria, Medical History; Tetanus, Medical History; Pertussis, Medical History; Hepatitis B, Medical History; Human poliovirus, Medical History; Streptococcus pneumoniae, Medical History; Varicella zoster, Medical History
Item
History of Neisseria meningitidis, Haemophilus influenzae type b, diphtheria, tetanus, pertussis, hepatitis B, poliovirus, Streptococcus pneumoniae and/or varicella invasive disease.
boolean
C0027575 (UMLS CUI [1,1])
C0262926 (UMLS CUI [1,2])
C0121772 (UMLS CUI [2,1])
C0262926 (UMLS CUI [2,2])
C0012546 (UMLS CUI [3,1])
C0262926 (UMLS CUI [3,2])
C0039614 (UMLS CUI [4,1])
C0262926 (UMLS CUI [4,2])
C0043167 (UMLS CUI [5,1])
C0262926 (UMLS CUI [5,2])
C0019163 (UMLS CUI [6,1])
C0262926 (UMLS CUI [6,2])
C0206435 (UMLS CUI [7,1])
C0262926 (UMLS CUI [7,2])
C0038410 (UMLS CUI [8,1])
C0262926 (UMLS CUI [8,2])
C0740380 (UMLS CUI [9,1])
C0262926 (UMLS CUI [9,2])
Immunosuppression; Immunologic Deficiency Syndromes
Item
Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination (no laboratory testing is required).
boolean
C4048329 (UMLS CUI [1])
C0021051 (UMLS CUI [2])
Hypersensitivity, Medical History
Item
History of allergic disease or reactions likely to be exacerbated by any component of the vaccine(s), including dry natural latex rubber, tetanus toxoid, diphtheria toxoid, neomycin, polymyxin.
boolean
C0020517 (UMLS CUI [1,1])
C0262926 (UMLS CUI [1,2])
Congenital Abnormality, Major; Chronic disease, Serious
Item
Major congenital defects or serious chronic illness.
boolean
C0000768 (UMLS CUI [1,1])
C0205164 (UMLS CUI [1,2])
C0008679 (UMLS CUI [2,1])
C0205404 (UMLS CUI [2,2])
Nervous System Disorder, Medical History; Seizure, Medical History
Item
History of any neurologic disorders or seizures.
boolean
C0027765 (UMLS CUI [1,1])
C0262926 (UMLS CUI [1,2])
C0036572 (UMLS CUI [2,1])
C0262926 (UMLS CUI [2,2])
Acute Disease
Item
Acute disease at the time of enrolment. (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. rectal temperature <38°C, axillary <37.5°C. A temperature greater than or equal to these cut-offs warrants deferral of the vaccination pending recovery of the subject).
boolean
C0001314 (UMLS CUI [1])
Immunoglobulins; Blood Product
Item
Administration of immunoglobulins and/or any blood products since birth or planned administration during the study period.
text
C0021027 (UMLS CUI [1,1])
C0371802 (UMLS CUI [1,2])
Item Group
Randomisation / Treatment Allocation
C0034656 (UMLS CUI-1)
Randomization, Identifier
Item
Record treatment number
integer
C0034656 (UMLS CUI [1,1])
C0600091 (UMLS CUI [1,2])
Item Group
General Medical History / Physical Examination
C0262926 (UMLS CUI-1)
C0031809 (UMLS CUI-2)
Medical History
Item
Are you aware of any pre-existing conditions or signs and/or symptoms present in the subject prior to the start of the study ?
boolean
C0262926 (UMLS CUI [1])
Physical Examination, Skin, Diagnosis
Item
Cutaneous - Diagnosis
text
C0031809 (UMLS CUI [1,1])
C1123023 (UMLS CUI [1,2])
C0011900 (UMLS CUI [1,3])
Item
Cutaneous
text
C0031809 (UMLS CUI [1,1])
C1123023 (UMLS CUI [1,2])
C1444635 (UMLS CUI [1,3])
Physical Examination, Skin, Current or Past
Code List
Cutaneous
CL Item
Past (1)
CL Item
Current (2)
Item
Eyes - Diagnosis
text
C0031809 (UMLS CUI [1,1])
C0015392 (UMLS CUI [1,2])
C0011900 (UMLS CUI [1,3])
Physical Examination, Skin, Current or Past
Code List
Eyes - Diagnosis
Item
Eyes
text
C0031809 (UMLS CUI [1,1])
C0015392 (UMLS CUI [1,2])
C1444635 (UMLS CUI [1,3])
Physical Examination, Skin, Current or Past
Code List
Eyes
CL Item
Past (1)
CL Item
Current (2)
Physical Examination, ENT examination, Diagnosis
Item
Ears-Nose-Throat - Diagnosis
text
C0031809 (UMLS CUI [1,1])
C0278350 (UMLS CUI [1,2])
C0011900 (UMLS CUI [1,3])
Item
Ears-Nose-Throat
text
C0031809 (UMLS CUI [1,1])
C0278350 (UMLS CUI [1,2])
C1444635 (UMLS CUI [1,3])
Physical Examination, Skin, Current or Past
Code List
Ears-Nose-Throat
CL Item
Past (1)
CL Item
Current (2)
Physical Examination, Cardiovascular system, Diagnosis
Item
Cardiovascular - Diagnosis
text
C0031809 (UMLS CUI [1,1])
C0007226 (UMLS CUI [1,2])
C0011900 (UMLS CUI [1,3])
Item
Cardiovascular
text
C0031809 (UMLS CUI [1,1])
C0007226 (UMLS CUI [1,2])
C1444635 (UMLS CUI [1,3])
Physical Examination, Skin, Current or Past
Code List
Cardiovascular
CL Item
Past (1)
CL Item
Current (2)
Physical Examination, Respiratory system, Diagnosis
Item
Respiratory - Diagnosis
text
C0031809 (UMLS CUI [1,1])
C0035237 (UMLS CUI [1,2])
C0011900 (UMLS CUI [1,3])
Item
Respiratory
text
C0031809 (UMLS CUI [1,1])
C0035237 (UMLS CUI [1,2])
C1444635 (UMLS CUI [1,3])
Physical Examination, Skin, Current or Past
Code List
Respiratory
CL Item
Past (1)
CL Item
Current (2)
Physical Examination, Gastrointestinal system, Diagnosis
Item
Gastrointestinal - Diagnosis
text
C0031809 (UMLS CUI [1,1])
C0012240 (UMLS CUI [1,2])
C0011900 (UMLS CUI [1,3])
Item
Gastrointestinal
text
C0031809 (UMLS CUI [1,1])
C0012240 (UMLS CUI [1,2])
C1444635 (UMLS CUI [1,3])
Physical Examination, Skin, Current or Past
Code List
Gastrointestinal
CL Item
Past (1)
CL Item
Current (2)
Physical Examination, Muskuloskeletal system, Diagnosis
Item
Muskuloskeletal - Diagnosis
text
C0031809 (UMLS CUI [1,1])
C0026860 (UMLS CUI [1,2])
C0011900 (UMLS CUI [1,3])
Item
Muskuloskeletal
text
C0031809 (UMLS CUI [1,1])
C0026860 (UMLS CUI [1,2])
C1444635 (UMLS CUI [1,3])
Physical Examination, Skin, Current or Past
Code List
Muskuloskeletal
CL Item
Past (1)
CL Item
Current (2)
Physical Examination, Neurologic Examination, Diagnosis
Item
Neurological - Diagnosis
text
C0031809 (UMLS CUI [1,1])
C0027853 (UMLS CUI [1,2])
C0011900 (UMLS CUI [1,3])
Item
Neurological
text
C0031809 (UMLS CUI [1,1])
C0027853 (UMLS CUI [1,2])
C1444635 (UMLS CUI [1,3])
Physical Examination, Skin, Current or Past
Code List
Neurological
CL Item
Past (1)
CL Item
Current (2)
Physical Examination, Genitourinary assessment, Diagnosis
Item
Genitourinary - Diagnosis
text
C0031809 (UMLS CUI [1,1])
C1828035 (UMLS CUI [1,2])
C0011900 (UMLS CUI [1,3])
Item
Genitourinary
text
C0031809 (UMLS CUI [1,1])
C1828035 (UMLS CUI [1,2])
C1444635 (UMLS CUI [1,3])
Physical Examination, Skin, Current or Past
Code List
Genitourinary
CL Item
Past (1)
CL Item
Current (2)
Physical Examination, Hematology finding, Diagnosis
Item
Haematology - Diagnosis
text
C0031809 (UMLS CUI [1,1])
C0474523 (UMLS CUI [1,2])
C0011900 (UMLS CUI [1,3])
Item
Haematology
text
C0031809 (UMLS CUI [1,1])
C0474523 (UMLS CUI [1,2])
C1444635 (UMLS CUI [1,3])
Physical Examination, Skin, Current or Past
Code List
Haematology
CL Item
Past (1)
CL Item
Current (2)
Physical Examination, Hypersensitivity, Diagnosis
Item
Allergies - Diagnosis
text
C0031809 (UMLS CUI [1,1])
C0020517 (UMLS CUI [1,2])
C0011900 (UMLS CUI [1,3])
Item
Allergies
text
C0031809 (UMLS CUI [1,1])
C0020517 (UMLS CUI [1,2])
C1444635 (UMLS CUI [1,3])
Physical Examination, Skin, Current or Past
Code List
Allergies
CL Item
Past (1)
CL Item
Current (2)
Physical Examination,Endocrine system, Diagnosis
Item
Endocrine - Diagnosis
text
C0031809 (UMLS CUI [1,1])
C0014136 (UMLS CUI [1,2])
C0011900 (UMLS CUI [1,3])
Item
Endocrine
text
C0031809 (UMLS CUI [1,1])
C0014136 (UMLS CUI [1,2])
C1444635 (UMLS CUI [1,3])
Physical Examination, Skin, Current or Past
Code List
Endocrine
CL Item
Past (1)
CL Item
Current (2)
Physical Examination, Other, Diagnosis
Item
Other (specify) - Diagnosis
text
C0031809 (UMLS CUI [1,1])
C0205394 (UMLS CUI [1,2])
C0011900 (UMLS CUI [1,3])
Item
Other (specify)
text
C0031809 (UMLS CUI [1,1])
C0205394 (UMLS CUI [1,2])
C1444635 (UMLS CUI [1,3])
Physical Examination, Skin, Current or Past
Code List
Other (specify)
CL Item
Past (1)
CL Item
Current (2)
Item Group
Vaccine History
C0042210 (UMLS CUI-1)
C0262926 (UMLS CUI-2)
Item
Has any vaccine been administered since birth ?
text
C0042210 (UMLS CUI [1,1])
C0262926 (UMLS CUI [1,2])
Vaccines, Medical History
Code List
Has any vaccine been administered since birth ?
CL Item
No (1)
CL Item
Unknown (2)
CL Item
Yes, if yes, please complete the following table (3)
Vaccine, Medication name
Item
Trade / Generic Name
text
C0042210 (UMLS CUI [1,1])
C2360065 (UMLS CUI [1,2])
Vaccine, Dose Number
Item
Dose Number
integer
C0042210 (UMLS CUI [1,1])
C1115464 (UMLS CUI [1,2])
Administration of vaccine, Date in tine
Item
Estimated date of vaccine
date
C2368628 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
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])
Body Temperature, Vaccination, Before, Route
Code List
Route
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])
Administration of vaccine
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])
Administration of vaccine, Drug Administration Routes, Side, Anatomic site
Code List
Side / site route
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])
Administration of vaccine, Side
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])
Administration of vaccine, Anatomic site
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])
Administration of vaccine, Drug Administration Routes
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 - 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])
Body Temperature, Vaccination, Before, Route
Code List
Route
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])
Administration of vaccine
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])
Administration of vaccine, Drug Administration Routes, Side, Anatomic site
Code List
Side / site route
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])
Administration of vaccine, Side
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])
Administration of vaccine, Side
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])
Administration of vaccine, Side
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])
Body Temperature, Vaccination, Before, Route
Code List
Route
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])
Administration of vaccine
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])
Administration of vaccine, Drug Administration Routes, Side, Anatomic site
Code List
Side / site route
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])
Administration of vaccine, Side
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])
Administration of vaccine, Side
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])
Administration of vaccine, Side
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])
Administration of Vaccine, Not-Done Reason
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])
Administration of Vaccine, Not-Done Reason
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])
Administration of Vaccine, Not-Done Reason
Code List
Please tick who took the decision
CL Item
Investigator  (1)
CL Item
Parents/Guardians (2)
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