ID

36926

Beschrijving

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

Trefwoorden

Versies (1)
  1. 21-06-19 21-06-19 -
Houder van rechten

GlaxoSmithKline

Geüploaded op

21 juni 2019

DOI

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Licentie

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

Engels

Visit 1

1 Formulieren  
  1. StudyEvent: ODM
    1. Visit 1
Administrative Data
Beschrijving

Administrative Data

Date of Visit
Beschrijving

Date of visit

Datatype

date

Alias
UMLS CUI [1]
C1320303
Subject Number
Beschrijving

Clinical Trial Subject Unique Identifier

Datatype

integer

Alias
UMLS CUI [1]
C2348585
Demographics
Beschrijving

Demographics

Alias
UMLS CUI-1
C0011298
Center number
Beschrijving

Institution name, Identifier

Datatype

integer

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

Patient date of birth

Datatype

date

Alias
UMLS CUI [1]
C0421451
Gender
Beschrijving

Gender

Datatype

text

Alias
UMLS CUI [1]
C0079399
Has the subject had any SAEs since the end of the primary phase and before the start of this booster study ?
Beschrijving

Serious Adverse Event, During, Clinical Trials

Datatype

boolean

Alias
UMLS CUI [1,1]
C1519255
UMLS CUI [1,2]
C0347984
UMLS CUI [1,3]
C0008976
If Yes, Specify number of SAEs
Beschrijving

Serious Adverse Event, During, Clinical Trials, Numbers

Datatype

integer

Maateenheden
  • cm
Alias
UMLS CUI [1,1]
C1519255
UMLS CUI [1,2]
C0347984
UMLS CUI [1,3]
C0008976
UMLS CUI [1,4]
C0237753
cm
Has the subject had any specific AEs include onset of chronic illness(es) (e.g. autoimmune disorders, asthma, type I diabetes and allergies), rash (hives, idiopathic thrombocytopenic purpura, petechiae), since the end of the primary phase and before the start of this booster study ?
Beschrijving

Adverse Event, During, Clinical Trials

Datatype

boolean

Alias
UMLS CUI [1,1]
C0877248
UMLS CUI [1,2]
C0347984
UMLS CUI [1,3]
C0008976
If Yes, Specify number of specific AEs
Beschrijving

Adverse Event, During, Clinical Trials, Numbers

Datatype

boolean

Alias
UMLS CUI [1,1]
C0877248
UMLS CUI [1,2]
C0347984
UMLS CUI [1,3]
C0008976
UMLS CUI [1,4]
C0237753
Eligibility Check
Beschrijving

Eligibility Check

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

Eligibility Determination

Datatype

boolean

Alias
UMLS CUI [1]
C0013893
Exclusion Criteria
Beschrijving

Exclusion Criteria

Alias
UMLS CUI-1
C0680251
History of measles, mumps, rubella or varicella.
Beschrijving

Measles, Medical History; Mumps, Medical History; Rubella, Medical History; Varicella zoster, Medical History

Datatype

boolean

Alias
UMLS CUI [1,1]
C0025007
UMLS CUI [1,2]
C0262926
UMLS CUI [2,1]
C0026780
UMLS CUI [2,2]
C0262926
UMLS CUI [3,1]
C0035920
UMLS CUI [3,2]
C0262926
UMLS CUI [4,1]
C0740380
UMLS CUI [4,2]
C0262926
Previous vaccination against measles, mumps, rubella or varicella.
Beschrijving

Measles, Vaccination, Previous; Mumps, Vaccination, Previous; Rubella, Vaccination, Previous; Varicella zoster, Vaccination, Previous

Datatype

boolean

Alias
UMLS CUI [1,1]
C0025007
UMLS CUI [1,2]
C0042196
UMLS CUI [1,3]
C0205156
UMLS CUI [2,1]
C0026780
UMLS CUI [2,2]
C0042196
UMLS CUI [2,3]
C0205156
UMLS CUI [3,1]
C0035920
UMLS CUI [3,2]
C0042196
UMLS CUI [3,3]
C0205156
UMLS CUI [4,1]
C0740380
UMLS CUI [4,2]
C0042196
UMLS CUI [4,3]
C0205156
Previous booster vaccination with Hib or meningococcal serogroup C vaccine since the last visit of the primary phase.
Beschrijving

Haemophilus influenzae type b polysaccharide vaccine, Previous; Meningococcal group C vaccine, Previous

Datatype

boolean

Alias
UMLS CUI [1,1]
C0062086
UMLS CUI [1,2]
C0205156
UMLS CUI [2,1]
C1720015
UMLS CUI [2,2]
C0205156
Randomisation / Treatment Allocation
Beschrijving

Randomisation / Treatment Allocation

Alias
UMLS CUI-1
C0034656
Record treatment number
Beschrijving

Randomization, Identifier

Datatype

integer

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

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 ?
Beschrijving

Medical History

Datatype

boolean

Alias
UMLS CUI [1]
C0262926
Cutaneous - Diagnosis
Beschrijving

Physical Examination, Skin, Diagnosis

Datatype

text

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

Physical Examination, Skin, Current or Past

Datatype

text

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

Physical Examination, Eye, Diagnosis

Datatype

text

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

Physical Examination, Eye, Current or Past

Datatype

text

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

Physical Examination, ENT examination, Diagnosis

Datatype

text

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

Physical Examination, ENT examination, Current or Past

Datatype

text

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

Physical Examination, Cardiovascular system, Diagnosis

Datatype

text

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

Physical Examination,Cardiovascular system, Current or Past

Datatype

text

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

Physical Examination, Respiratory system, Diagnosis

Datatype

text

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

Physical Examination, Respiratory system, Current or Past

Datatype

text

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

Physical Examination, Gastrointestinal system, Diagnosis

Datatype

text

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

Physical Examination, Gastrointestinal system, Current or Past

Datatype

text

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

Physical Examination, Muskuloskeletal system, Diagnosis

Datatype

text

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

Physical Examination, Muskuloskeletal system, Current or Past

Datatype

text

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

Physical Examination, Neurologic Examination, Diagnosis

Datatype

text

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

Physical Examination, Neurologic Examination, Current or Past

Datatype

text

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

Physical Examination, Genitourinary assessment, Diagnosis

Datatype

text

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

Physical Examination, Genitourinary assessment, Current or Past

Datatype

text

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

Physical Examination, Hematology finding, Diagnosis

Datatype

text

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

Physical Examination, Hematology finding, Current or Past

Datatype

text

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

Physical Examination, Hypersensitivity, Diagnosis

Datatype

text

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

Physical Examination, Hypersensitivity, Current or Past

Datatype

text

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

Physical Examination,Endocrine system, Diagnosis

Datatype

text

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

Physical Examination, Endocrine system, Current or Past

Datatype

text

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

Physical Examination, Other, Diagnosis

Datatype

text

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

Physical Examination, Other, Current or Past

Datatype

text

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

Vaccine History

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

Vaccines, Medical History

Datatype

text

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

Vaccine, Medication name

Datatype

text

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

Vaccine, Dose Number

Datatype

integer

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

Administration of vaccine, Date in tine

Datatype

date

Alias
UMLS CUI [1,1]
C2368628
UMLS CUI [1,2]
C0011008
Medication History
Beschrijving

Medication History

Alias
UMLS CUI-1
C0013227
UMLS CUI-2
C0262926
Has any relevant medication been administered since the last visit of the primary phase of the study ?
Beschrijving

Pharmaceutical Preparations, Medical History

Datatype

text

Alias
UMLS CUI [1,1]
C0013227
UMLS CUI [1,2]
C0262926
Trade / Generic Name
Beschrijving

Pharmaceutical Preparations, Medication name

Datatype

text

Alias
UMLS CUI [1,1]
C0013227
UMLS CUI [1,2]
C2360065
Medical Indication
Beschrijving

Pharmaceutical Preparations, Indication

Datatype

text

Alias
UMLS CUI [1,1]
C0013227
UMLS CUI [1,2]
C3146298
Total daily dose
Beschrijving

Pharmaceutical Preparations, Daily Dose, Total

Datatype

text

Alias
UMLS CUI [1,1]
C0013227
UMLS CUI [1,2]
C2348070
UMLS CUI [1,3]
C0439810
Route
Beschrijving

Pharmaceutical Preparations, Drug Administration Routes

Datatype

text

Alias
UMLS CUI [1,1]
C0013227
UMLS CUI [1,2]
C0013153
Start Date
Beschrijving

Pharmaceutical Preparations, Start Date

Datatype

date

Alias
UMLS CUI [1,1]
C0013227
UMLS CUI [1,2]
C0808070
End Date
Beschrijving

Pharmaceutical Preparations, End Date

Datatype

date

Alias
UMLS CUI [1,1]
C0013227
UMLS CUI [1,2]
C0806020
Tick box if continuing at end of study
Beschrijving

Pharmaceutical Preparations, Continuous

Datatype

boolean

Alias
UMLS CUI [1,1]
C0013227
UMLS CUI [1,2]
C0549178
Laboratory Tests - Blood Sample
Beschrijving

Laboratory Tests - Blood Sample

Alias
UMLS CUI-1
C0022885
UMLS CUI-2
C0005834
Has a blood sample been taken ?
Beschrijving

Collection of blood specimen for laboratory procedure

Datatype

boolean

Alias
UMLS CUI [1]
C0005834
Please complete only if different from visit date
Beschrijving

Collection of blood specimen for laboratory procedure, Date in time

Datatype

date

Alias
UMLS CUI [1,1]
C0005834
UMLS CUI [1,2]
C0011008
Vaccine Administration - Hib-MenCY-TT Group/Lic MenC group
Beschrijving

Vaccine Administration - Hib-MenCY-TT Group/Lic MenC group

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

Administration of vaccine, Date in time

Datatype

date

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

Body Temperature, Vaccination, Before

Datatype

float

Maateenheden
  • °C
Alias
UMLS CUI [1,1]
C0005903
UMLS CUI [1,2]
C0042196
UMLS CUI [1,3]
C0332152
°C
Route
Beschrijving

Body Temperature, Vaccination, Before, Route

Datatype

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)
Beschrijving

Administration of vaccine

Datatype

text

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

Administration of vaccine, Vial Device, Replacement, Identifier

Datatype

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
Beschrijving

Administration of vaccine, Vial Device, Wrong, Identifier

Datatype

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
Beschrijving

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

Datatype

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 ?
Beschrijving

Administration of vaccine, Protocol Compliance

Datatype

boolean

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

Administration of vaccine, Side

Datatype

text

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

Administration of vaccine, Anatomic site

Datatype

text

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

Administration of vaccine, Drug Administration Routes

Datatype

text

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

Administration of vaccine, Comment

Datatype

text

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

Administration of Vaccine - ActHIB group

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

Administration of vaccine, Date in time

Datatype

date

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

Body Temperature, Vaccination, Before

Datatype

float

Maateenheden
  • °C
Alias
UMLS CUI [1,1]
C0005903
UMLS CUI [1,2]
C0042196
UMLS CUI [1,3]
C0332152
°C
Route
Beschrijving

Body Temperature, Vaccination, Before, Route

Datatype

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)
Beschrijving

Administration of vaccine

Datatype

text

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

Administration of vaccine, Vial Device, Replacement, Identifier

Datatype

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
Beschrijving

Administration of vaccine, Vial Device, Wrong, Identifier

Datatype

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
Beschrijving

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

Datatype

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 ?
Beschrijving

Administration of vaccine, Protocol Compliance

Datatype

boolean

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

Administration of vaccine, Side

Datatype

text

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

Administration of vaccine, Anatomic site

Datatype

text

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

Administration of vaccine, Drug Administration Routes

Datatype

text

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

Administration of vaccine, Comment

Datatype

text

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

Vaccine Administration (continued)

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

Administration of Vaccine, Not-Done Reason

Datatype

text

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

Administration of Vaccine, Not-Done Reason

Datatype

text

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

Administration of Vaccine, Not done, Decision

Datatype

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 Formulieren
  1. StudyEvent: ODM
    1. Visit 1
Name
Type
Description | Question | Decode (Coded Value)
Datatype
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
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)
Serious Adverse Event, During, Clinical Trials
Item
Has the subject had any SAEs since the end of the primary phase and before the start of this booster study ?
boolean
C1519255 (UMLS CUI [1,1])
C0347984 (UMLS CUI [1,2])
C0008976 (UMLS CUI [1,3])
Serious Adverse Event, During, Clinical Trials, Numbers
Item
If Yes, Specify number of SAEs
integer
C1519255 (UMLS CUI [1,1])
C0347984 (UMLS CUI [1,2])
C0008976 (UMLS CUI [1,3])
C0237753 (UMLS CUI [1,4])
Adverse Event, During, Clinical Trials
Item
Has the subject had any specific AEs include onset of chronic illness(es) (e.g. autoimmune disorders, asthma, type I diabetes and allergies), rash (hives, idiopathic thrombocytopenic purpura, petechiae), since the end of the primary phase and before the start of this booster study ?
boolean
C0877248 (UMLS CUI [1,1])
C0347984 (UMLS CUI [1,2])
C0008976 (UMLS CUI [1,3])
Adverse Event, During, Clinical Trials, Numbers
Item
If Yes, Specify number of specific AEs
boolean
C0877248 (UMLS CUI [1,1])
C0347984 (UMLS CUI [1,2])
C0008976 (UMLS CUI [1,3])
C0237753 (UMLS CUI [1,4])
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
Exclusion Criteria
C0680251 (UMLS CUI-1)
Measles, Medical History; Mumps, Medical History; Rubella, Medical History; Varicella zoster, Medical History
Item
History of measles, mumps, rubella or varicella.
boolean
C0025007 (UMLS CUI [1,1])
C0262926 (UMLS CUI [1,2])
C0026780 (UMLS CUI [2,1])
C0262926 (UMLS CUI [2,2])
C0035920 (UMLS CUI [3,1])
C0262926 (UMLS CUI [3,2])
C0740380 (UMLS CUI [4,1])
C0262926 (UMLS CUI [4,2])
Measles, Vaccination, Previous; Mumps, Vaccination, Previous; Rubella, Vaccination, Previous; Varicella zoster, Vaccination, Previous
Item
Previous vaccination against measles, mumps, rubella or varicella.
boolean
C0025007 (UMLS CUI [1,1])
C0042196 (UMLS CUI [1,2])
C0205156 (UMLS CUI [1,3])
C0026780 (UMLS CUI [2,1])
C0042196 (UMLS CUI [2,2])
C0205156 (UMLS CUI [2,3])
C0035920 (UMLS CUI [3,1])
C0042196 (UMLS CUI [3,2])
C0205156 (UMLS CUI [3,3])
C0740380 (UMLS CUI [4,1])
C0042196 (UMLS CUI [4,2])
C0205156 (UMLS CUI [4,3])
Haemophilus influenzae type b polysaccharide vaccine, Previous; Meningococcal group C vaccine, Previous
Item
Previous booster vaccination with Hib or meningococcal serogroup C vaccine since the last visit of the primary phase.
boolean
C0062086 (UMLS CUI [1,1])
C0205156 (UMLS CUI [1,2])
C1720015 (UMLS CUI [2,1])
C0205156 (UMLS CUI [2,2])
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
Medication History
C0013227 (UMLS CUI-1)
C0262926 (UMLS CUI-2)
Item
Has any relevant medication been administered since the last visit of the primary phase of the study ?
text
C0013227 (UMLS CUI [1,1])
C0262926 (UMLS CUI [1,2])
Pharmaceutical Preparations, Medical History
Code List
Has any relevant medication been administered since the last visit of the primary phase of the study ?
CL Item
No (1)
CL Item
Unknown (2)
CL Item
Yes (3)
Pharmaceutical Preparations, Medication name
Item
Trade / Generic Name
text
C0013227 (UMLS CUI [1,1])
C2360065 (UMLS CUI [1,2])
Pharmaceutical Preparations, Indication
Item
Medical Indication
text
C0013227 (UMLS CUI [1,1])
C3146298 (UMLS CUI [1,2])
Pharmaceutical Preparations, Daily Dose, Total
Item
Total daily dose
text
C0013227 (UMLS CUI [1,1])
C2348070 (UMLS CUI [1,2])
C0439810 (UMLS CUI [1,3])
Pharmaceutical Preparations, Drug Administration Routes
Item
Route
text
C0013227 (UMLS CUI [1,1])
C0013153 (UMLS CUI [1,2])
Pharmaceutical Preparations, Start Date
Item
Start Date
date
C0013227 (UMLS CUI [1,1])
C0808070 (UMLS CUI [1,2])
Pharmaceutical Preparations, End Date
Item
End Date
date
C0013227 (UMLS CUI [1,1])
C0806020 (UMLS CUI [1,2])
Pharmaceutical Preparations, Continuous
Item
Tick box if continuing at end of study
boolean
C0013227 (UMLS CUI [1,1])
C0549178 (UMLS CUI [1,2])
Item Group
Laboratory Tests - Blood Sample
C0022885 (UMLS CUI-1)
C0005834 (UMLS CUI-2)
Collection of blood specimen for laboratory procedure
Item
Has a blood sample been taken ?
boolean
C0005834 (UMLS CUI [1])
Collection of blood specimen for laboratory procedure, Date in time
Item
Please complete only if different from visit date
date
C0005834 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
Item Group
Vaccine Administration - Hib-MenCY-TT Group/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
Hib-MenCY-TT Vaccine (1)
CL Item
Replacement vial (2)
CL Item
Wrong vial  (3)
CL Item
Not administered (4)
CL Item
M-M-R® II Vaccine (5)
CL Item
Replacement vial (6)
CL Item
Wrong vial  (7)
CL Item
Not administered (8)
CL Item
Varivax® 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 Right Arm, S.C. (2)
CL Item
Upper Left Arm, S.C. (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
Left (1)
CL Item
Right (2)
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
Buttock (2)
CL Item
Upper thigh (3)
CL Item
Lower thigh (4)
CL Item
Upper arm (5)
CL Item
Lower arm (6)
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 - 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
PedvaxHIB® Vaccine (1)
CL Item
Replacement vial (2)
CL Item
Wrong vial  (3)
CL Item
Not administered (4)
CL Item
M-M-R® II Vaccine (5)
CL Item
Replacement vial (6)
CL Item
Wrong vial  (7)
CL Item
Not administered (8)
CL Item
Varivax® 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 Right Arm, S.C. (2)
CL Item
Upper Left Arm, S.C. (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
Left (1)
CL Item
Right (2)
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
Buttock (2)
CL Item
Upper thigh (3)
CL Item
Lower thigh (4)
CL Item
Upper arm (5)
CL Item
Lower arm (6)
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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