ID

23056

Description

Study ID: 100480 Clinical Study ID: 100480 Study Title: Study to show lot-to-lot consistency of Hib-MenAC mixed with Tritanrix™-HBV, its non-inferiority to Tritanrix™-HBV/Hiberix™ with or without Meningitec™, and MenA response in 2, 4, 6 month infants with hepatitis B birth dose Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00317161 https://clinicaltrials.gov/ct2/show/NCT00317161 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: phase 3 Study Recruitment Status: Completed Generic Name: Combined Diphtheria, Tetanus, Whole Cell Pertussis, Hepatitis B, Haemophilus influenzae Type b Vaccine Trade Name: Tritanrix HepB/Hiberix Study Indication: Diphtheria; Haemophilus influenzae type b; Hepatitis B; Tetanus; Whole Cell Pertussis Visit 1: 15-24 months of age

Link

https://clinicaltrials.gov/ct2/show/NCT00317161

Keywords

Versions (1)
  1. 6/21/17 6/21/17 -
Uploaded on

June 21, 2017

DOI

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License

Creative Commons BY-NC 3.0
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Non-inferiority Hib-MenAC mixed with Tritanrix-HBV Visit 1 NCT00317161

English

Visit 1 Non-inferiority Hib-MenAC mixed with Tritanrix-HBV NCT00317161

1 forms  
Informed Consent
Description

Informed Consent

Alias
UMLS CUI-1
C0021430
Subject Number
Description

Subject Number

Data type

text

Alias
UMLS CUI [1]
C2348585
Date of Visit
Description

Date of Visit

Data type

date

Alias
UMLS CUI [1]
C1320303
Informed Consent Date
Description

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

Data type

time

Alias
UMLS CUI [1,1]
C0021430
UMLS CUI [1,2]
C0011008
Demographics
Description

Demographics

Alias
UMLS CUI-1
C0011298
Center number
Description

Center number

Data type

integer

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

Date of birth

Data type

date

Alias
UMLS CUI [1]
C0421451
Gender
Description

Gender

Data type

text

Alias
UMLS CUI [1]
C0079399
Eligibility Question
Description

Eligibility Question

Alias
UMLS CUI-1
C1516637
Did the subject meet all the entry criteria?
Description

If No, tick all boxes corresponding to violations of any inclusion/exclusion criteria. Do not enter the subject into the study if he/she failed any inclusion or exclusion criteria below.

Data type

boolean

Alias
UMLS CUI [1]
C1516637
Inclusion Criteria
Description

Tick the boxes corresponding to any of the inclusion criteria the subject failed

Data type

integer

Alias
UMLS CUI [1]
C1512693
Exclusion Criteria
Description

Tick the box corresponding to any of the exclusion criteria that disqualified the subject from entry.

Data type

integer

Alias
UMLS CUI [1]
C0680251
Randomisation
Description

Randomisation

Alias
UMLS CUI-1
C0034656
Record treatment number
Description

Treatment number

Data type

integer

Alias
UMLS CUI [1,1]
C1522541
UMLS CUI [1,2]
C0600091
General Medical History / Physical Examination
Description

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 prior to the start of the study?
Description

Please give diagnosis and tick appropriate Past/Current box(es).

Data type

boolean

Alias
UMLS CUI [1,1]
C0262926
UMLS CUI [1,2]
C1457887
Skin and subcutaneous tissue: Diagnosis
Description

Skin and subcutaneous tissue

Data type

text

Alias
UMLS CUI [1,1]
C0178301
UMLS CUI [1,2]
C0011900
Skin and subcutaneous tissue
Description

Skin and subcutaneous tissue

Data type

integer

Alias
UMLS CUI [1]
C0178301
Musculoskeletal and connective tissue: Diagnosis
Description

Musculoskeletal and connective tissue

Data type

text

Alias
UMLS CUI [1,1]
C0026857
UMLS CUI [1,2]
C0011900
Musculoskeletal and connective tissue
Description

Musculoskeletal and connective tissue

Data type

integer

Alias
UMLS CUI [1]
C0026857
Cardiac: Diagnosis
Description

Cardiac

Data type

text

Alias
UMLS CUI [1,1]
C0018799
UMLS CUI [1,2]
C0011900
Cardiac
Description

Cardiac

Data type

integer

Alias
UMLS CUI [1]
C0018799
Vascular: Diagnosis
Description

undefined item

Data type

text

Alias
UMLS CUI [1,1]
C0042373
UMLS CUI [1,2]
C0011900
Vascular
Description

Vascular

Data type

integer

Alias
UMLS CUI [1]
C0042373
Respiratory, thoracic and mediastinal: Diagnosis
Description

Respiratory, thoracic and mediastinal

Data type

text

Alias
UMLS CUI [1,1]
C0851355
UMLS CUI [1,2]
C0011900
Respiratory, thoracic and mediastinal
Description

Respiratory, thoracic and mediastinal

Data type

integer

Alias
UMLS CUI [1]
C0851355
Gastrointestinal: Diagnosis
Description

Gastrointestinal

Data type

text

Alias
UMLS CUI [1,1]
C0017178
UMLS CUI [1,2]
C0011900
Gastrointestinal
Description

Gastrointestinal

Data type

integer

Alias
UMLS CUI [1]
C0017178
Hepatobiliary: Diagnosis
Description

Hepatobiliary

Data type

text

Alias
UMLS CUI [1,1]
C0267792
UMLS CUI [1,2]
C0011900
Hepatobiliary
Description

Hepatobiliary

Data type

integer

Alias
UMLS CUI [1]
C0267792
Renal and urinary: Diagnosis
Description

Renal and urinary

Data type

text

Alias
UMLS CUI [1,1]
C0042075
UMLS CUI [1,2]
C0011900
Renal and urinary
Description

Renal and urinary

Data type

integer

Alias
UMLS CUI [1]
C0042075
Nervous system: Diagnosis
Description

Nervous system

Data type

text

Alias
UMLS CUI [1,1]
C0027765
UMLS CUI [1,2]
C0011900
Nervous system
Description

Nervous system

Data type

integer

Alias
UMLS CUI [1]
C0027765
Eye: Diagnosis
Description

Eye

Data type

text

Alias
UMLS CUI [1,1]
C0015397
UMLS CUI [1,2]
C0011900
Eye
Description

Eye

Data type

integer

Alias
UMLS CUI [1]
C0015397
Ear and labyrinth: Diagnosis
Description

Ear and labyrinth

Data type

text

Alias
UMLS CUI [1,1]
C0851354
UMLS CUI [1,2]
C0011900
Ear and labyrinth
Description

Ear and labyrinth

Data type

integer

Alias
UMLS CUI [1]
C0851354
Endocrine: Diagnosis
Description

Endocrine

Data type

text

Alias
UMLS CUI [1,1]
C0014130
UMLS CUI [1,2]
C0011900
Endocrine
Description

Endocrine

Data type

integer

Alias
UMLS CUI [1]
C0014130
Metabolism and nutrition: Diagnosis
Description

Metabolism and nutrition

Data type

text

Alias
UMLS CUI [1,1]
C0851358
UMLS CUI [1,2]
C0011900
Metabolism and nutrition
Description

Metabolism and nutrition

Data type

integer

Alias
UMLS CUI [1]
C0851358
Blood and lymphatic system: Diagnosis
Description

Blood and lymphatic system

Data type

text

Alias
UMLS CUI [1,1]
C0851353
UMLS CUI [1,2]
C0011900
Blood and lymphatic system
Description

Blood and lymphatic system

Data type

integer

Alias
UMLS CUI [1]
C0851353
Immune system (incl allergies, autoimmune disorders): Diagnosis
Description

Immune system

Data type

text

Alias
UMLS CUI [1,1]
C0021053
UMLS CUI [1,2]
C0011900
Immune system
Description

Immune system

Data type

integer

Alias
UMLS CUI [1]
C0021053
Infections and infestations: Diagnosis
Description

Infections and infestations

Data type

text

Alias
UMLS CUI [1,1]
C0009450
UMLS CUI [1,2]
C0851341
UMLS CUI [1,3]
C0011900
Infections and infestations
Description

Infections and infestations

Data type

integer

Alias
UMLS CUI [1,1]
C0009450
UMLS CUI [1,2]
C0851341
Neoplasms benign, malignant and unspecified (incl cysts, polyps): Diagnosis
Description

Neoplasms benign, malignant and unspecified

Data type

text

Alias
UMLS CUI [1,1]
C1882062
UMLS CUI [1,2]
C0011900
Neoplasms benign, malignant and unspecified
Description

Neoplasms benign, malignant and unspecified

Data type

integer

Alias
UMLS CUI [1]
C1882062
Surgical and medical procedures: Diagnosis
Description

Surgical and medical procedures

Data type

text

Alias
UMLS CUI [1,1]
C1948041
UMLS CUI [1,2]
C0011900
Surgical and medical procedures
Description

Surgical and medical procedures

Data type

integer

Alias
UMLS CUI [1]
C1948041
Persistent Crying (crying continuous and unaltered for over 3 hours): Diagnosis
Description

Persistent Crying

Data type

text

Alias
UMLS CUI [1,1]
C2721683
UMLS CUI [1,2]
C0011900
Persistent Crying
Description

Persistent Crying

Data type

integer

Alias
UMLS CUI [1]
C2721683
Other disorder, please specify
Description

Other disorder

Data type

text

Alias
UMLS CUI [1,1]
C0012634
UMLS CUI [1,2]
C0011900
Other disorder
Description

Other disorder

Data type

integer

Alias
UMLS CUI [1]
C0012634
Laboratory Tests
Description

Laboratory Tests

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

blood sample

Data type

boolean

Alias
UMLS CUI [1]
C0005834
blood sample date
Description

Has a blood sample been taken? If Yes, Please complete only if different from visit date:

Data type

date

Alias
UMLS CUI [1,1]
C0011008
UMLS CUI [1,2]
C0005834
Protocol required Concomitant Vaccination
Description

Protocol required Concomitant Vaccination

Alias
UMLS CUI-1
C0042196
UMLS CUI-2
C2347852
UMLS CUI-3
C0032375
OPV
Description

Has the following protocol required concomitant vaccine been administered?

Data type

boolean

Alias
UMLS CUI [1]
C0032375
OPV Date
Description

If Yes, please complete only if different from visit date. If Yes is ticked, the above vaccine is not to be reported again in the Concomitant Vaccination section at the end of the CRF. Any other vaccines administered during the study period are to be recorded in the Concomitant Vaccination section at the end of the CRF.

Data type

text

Alias
UMLS CUI [1,1]
C0032375
UMLS CUI [1,2]
C0011008
Vaccine Administration, Single Injection
Description

Vaccine Administration, Single Injection

Alias
UMLS CUI-1
C2368628
UMLS CUI-2
C0042196
Date of Vaccine Administration
Description

Please complete only if different from visit date

Data type

date

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

Pre-Vaccination temperature

Data type

float

Measurement units
  • C
Alias
UMLS CUI [1]
C0005903
C
Pre-Vaccination temperature Route:
Description

Pre-Vaccination temperature Route

Data type

text

Alias
UMLS CUI [1,1]
C0005903
UMLS CUI [1,2]
C0449687
Vaccine Administration
Description

Vaccine Administration

Data type

integer

Alias
UMLS CUI [1]
C2368628
Wrong vial number
Description

If Wrong vial number, please specify number

Data type

integer

Alias
UMLS CUI [1]
C0184301
Please tick the major reason for non administration
Description

If not administered

Data type

integer

Alias
UMLS CUI [1,1]
C1533734
UMLS CUI [1,2]
C0392360
UMLS CUI [1,3]
C1272696
Serious adverse event Number
Description

If reason for non administration = Serious adverse event

Data type

integer

Alias
UMLS CUI [1,1]
C1519255
UMLS CUI [1,2]
C0237753
Non-serious adverse event Number
Description

If reason for non administration = Non-serious adverse event

Data type

integer

Alias
UMLS CUI [1,1]
C1518404
UMLS CUI [1,2]
C0237753
reason for non administration, if other please specify
Description

reason for non administration

Data type

text

Alias
UMLS CUI [1,1]
C1533734
UMLS CUI [1,2]
C0392360
UMLS CUI [1,3]
C1272696
Please tick who made the decision
Description

non administration

Data type

integer

Alias
UMLS CUI [1,1]
C1533734
UMLS CUI [1,2]
C0392360
UMLS CUI [1,3]
C1272696
Administration Side
Description

Administration Side

Data type

text

Alias
UMLS CUI [1,1]
C0441987
UMLS CUI [1,2]
C0013153
UMLS CUI [1,3]
C0042210
Administration Site
Description

Administration Site

Data type

text

Alias
UMLS CUI [1,1]
C1515974
UMLS CUI [1,2]
C0013153
UMLS CUI [1,3]
C0042210
Administration Route
Description

Administration Route

Data type

text

Alias
UMLS CUI [1,1]
C0013153
UMLS CUI [1,2]
C0042210
Has the study vaccine been administered according to the Protocol ?
Description

Study vaccine Administration

Data type

boolean

Alias
UMLS CUI [1]
C2368628
Study vaccine Administration: Side
Description

Has the study vaccine been administered according to the Protocol? If No, please tick all items that apply

Data type

integer

Alias
UMLS CUI [1,1]
C0441987
UMLS CUI [1,2]
C0013153
UMLS CUI [1,3]
C0042210
Study vaccine Administration: Site
Description

Has the study vaccine been administered according to the Protocol? If No, please tick all items that apply

Data type

integer

Alias
UMLS CUI [1,1]
C1515974
UMLS CUI [1,2]
C0013153
UMLS CUI [1,3]
C0042210
Study vaccine Administration: Route
Description

Has the study vaccine been administered according to the Protocol? If No, please tick all items that apply

Data type

integer

Alias
UMLS CUI [1,1]
C0013153
UMLS CUI [1,2]
C0042210
Vaccine Administration, Multi Injections
Description

Vaccine Administration, Multi Injections

Alias
UMLS CUI-1
C2368628
Date of Vaccine Administration
Description

Please complete only if different from visit date

Data type

date

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

Pre-Vaccination temperature

Data type

float

Measurement units
  • C
Alias
UMLS CUI [1]
C0005903
C
Pre-Vaccination temperature Route:
Description

Pre-Vaccination temperature Route

Data type

text

Alias
UMLS CUI [1,1]
C0005903
UMLS CUI [1,2]
C0449687
Vaccine Administration
Description

Vaccine Administration

Data type

integer

Alias
UMLS CUI [1]
C2368628
Vaccine Administration
Description

Vaccine Administration

Data type

integer

Alias
UMLS CUI [1]
C2368628
Wrong vial number
Description

If Wrong vial number, please specify number

Data type

integer

Alias
UMLS CUI [1]
C0184301
Please tick the major reason for non administration
Description

If not administered

Data type

integer

Alias
UMLS CUI [1,1]
C1533734
UMLS CUI [1,2]
C0392360
UMLS CUI [1,3]
C1272696
Serious adverse event Number
Description

If reason for non administration = Serious adverse event

Data type

integer

Alias
UMLS CUI [1,1]
C1519255
UMLS CUI [1,2]
C0237753
Non-serious adverse event Number
Description

If reason for non administration = Non-serious adverse event

Data type

integer

Alias
UMLS CUI [1,1]
C1518404
UMLS CUI [1,2]
C0237753
reason for non administration, if other please specify
Description

reason for non administration

Data type

text

Alias
UMLS CUI [1,1]
C1533734
UMLS CUI [1,2]
C0392360
UMLS CUI [1,3]
C1272696
Please tick who made the decision
Description

non administration

Data type

integer

Alias
UMLS CUI [1,1]
C1533734
UMLS CUI [1,2]
C0392360
UMLS CUI [1,3]
C1272696
Administration Side
Description

Administration Side

Data type

text

Alias
UMLS CUI [1,1]
C0441987
UMLS CUI [1,2]
C0013153
UMLS CUI [1,3]
C0042210
Administration Site
Description

Administration Site

Data type

text

Alias
UMLS CUI [1,1]
C1515974
UMLS CUI [1,2]
C0013153
UMLS CUI [1,3]
C0042210
Administration Route
Description

Administration Route

Data type

text

Alias
UMLS CUI [1,1]
C0013153
UMLS CUI [1,2]
C0042210
Has the study vaccine been administered according to the Protocol ?
Description

Study vaccine Administration

Data type

boolean

Alias
UMLS CUI [1]
C2368628
Study vaccine Administration: Side
Description

Has the study vaccine been administered according to the Protocol? If No, please tick all items that apply

Data type

integer

Alias
UMLS CUI [1,1]
C0441987
UMLS CUI [1,2]
C0013153
UMLS CUI [1,3]
C0042210
Study vaccine Administration: Site
Description

Has the study vaccine been administered according to the Protocol? If No, please tick all items that apply

Data type

integer

Alias
UMLS CUI [1,1]
C1515974
UMLS CUI [1,2]
C0013153
UMLS CUI [1,3]
C0042210
Study vaccine Administration: Route
Description

Has the study vaccine been administered according to the Protocol? If No, please tick all items that apply

Data type

integer

Alias
UMLS CUI [1,1]
C0013153
UMLS CUI [1,2]
C0042210
Solicited Adverse Events - Local Symptoms - Booster Dose
Description

Solicited Adverse Events - Local Symptoms - Booster Dose

Alias
UMLS CUI-1
C0877248
UMLS CUI-2
C1457887
UMLS CUI-3
C0042196
Has the subject experienced any of the following signs/symptoms at the administration site during the solicited period? Booster Dose
Description

Booster Dose

Data type

text

Alias
UMLS CUI [1]
C1457887
Redness
Description

Redness

Data type

boolean

Alias
UMLS CUI [1,1]
C0332575
UMLS CUI [1,2]
C2700396
Redness, size (mm)
Description

If Yes, please specify

Data type

float

Measurement units
  • mm
Alias
UMLS CUI [1,1]
C0332575
UMLS CUI [1,2]
C0456389
UMLS CUI [1,3]
C2700396
mm
Redness on Day 0
Description

Redness on Day 0

Data type

float

Measurement units
  • mm
Alias
UMLS CUI [1,1]
C0332575
UMLS CUI [1,2]
C0456389
UMLS CUI [1,3]
C2700396
mm
Redness on Day 1
Description

Redness on Day 1

Data type

float

Measurement units
  • mm
Alias
UMLS CUI [1,1]
C0332575
UMLS CUI [1,2]
C0456389
UMLS CUI [1,3]
C2700396
mm
Redness on Day 2
Description

Redness on Day 2

Data type

float

Measurement units
  • mm
Alias
UMLS CUI [1,1]
C0332575
UMLS CUI [1,2]
C0456389
UMLS CUI [1,3]
C2700396
mm
Redness on Day 3
Description

Redness on Day 3

Data type

float

Measurement units
  • mm
Alias
UMLS CUI [1,1]
C0332575
UMLS CUI [1,2]
C0456389
UMLS CUI [1,3]
C2700396
mm
Redness ongoing after day 3?
Description

Redness ongoing after day 3

Data type

boolean

Alias
UMLS CUI [1,1]
C0332575
UMLS CUI [1,2]
C2700396
Date of last day of symptoms
Description

Redness ongoing after day 3? If Yes, please specify

Data type

date

Alias
UMLS CUI [1,1]
C0011008
UMLS CUI [1,2]
C0332575
UMLS CUI [1,3]
C2700396
Medically attended visit
Description

Medically attended visit

Data type

boolean

Alias
UMLS CUI [1,1]
C0545082
UMLS CUI [1,2]
C1386497
UMLS CUI [2]
C0332575
Medically attended visit Type
Description

Medically attended visit Type

Data type

text

Alias
UMLS CUI [1,1]
C0545082
UMLS CUI [1,2]
C0332307
UMLS CUI [1,3]
C1386497
UMLS CUI [2]
C0332575
Swelling
Description

Swelling

Data type

boolean

Alias
UMLS CUI [1,1]
C0038999
UMLS CUI [1,2]
C2700396
Swelling, size (mm)
Description

If Yes, please specify

Data type

float

Measurement units
  • mm
Alias
UMLS CUI [1,1]
C0038999
UMLS CUI [1,2]
C0456389
UMLS CUI [1,3]
C2700396
mm
Swelling on Day 0
Description

Swelling on Day 0

Data type

float

Measurement units
  • mm
Alias
UMLS CUI [1,1]
C0038999
UMLS CUI [1,2]
C0456389
UMLS CUI [1,3]
C2700396
mm
Swelling on Day 1
Description

Swelling on Day 1

Data type

float

Measurement units
  • mm
Alias
UMLS CUI [1,1]
C0038999
UMLS CUI [1,2]
C0456389
UMLS CUI [1,3]
C2700396
mm
Swelling on Day 2
Description

Swelling on Day 2

Data type

float

Measurement units
  • mm
Alias
UMLS CUI [1,1]
C0038999
UMLS CUI [1,2]
C0456389
UMLS CUI [1,3]
C2700396
mm
Swelling on Day 3
Description

Swelling on Day 3

Data type

float

Measurement units
  • mm
Alias
UMLS CUI [1,1]
C0038999
UMLS CUI [1,2]
C0456389
UMLS CUI [1,3]
C2700396
mm
Swelling ongoing after day 3?
Description

Swelling ongoing after day 3

Data type

boolean

Alias
UMLS CUI [1,1]
C0038999
UMLS CUI [1,2]
C2700396
Date of last day of symptoms
Description

Swelling ongoing after day 3? If Yes, please specify

Data type

date

Alias
UMLS CUI [1,1]
C0011008
UMLS CUI [1,2]
C0038999
UMLS CUI [1,3]
C2700396
Medically attended visit
Description

Medically attended visit

Data type

boolean

Alias
UMLS CUI [1,1]
C0545082
UMLS CUI [1,2]
C1386497
UMLS CUI [2]
C0038999
Medically attended visit Type
Description

Medically attended visit Type

Data type

text

Alias
UMLS CUI [1,1]
C0545082
UMLS CUI [1,2]
C0332307
UMLS CUI [1,3]
C1386497
UMLS CUI [2]
C0038999
Pain
Description

Pain

Data type

boolean

Alias
UMLS CUI [1,1]
C0030193
UMLS CUI [1,2]
C2700396
Pain, intensity
Description

If Yes, please specify

Data type

integer

Alias
UMLS CUI [1,1]
C0030193
UMLS CUI [1,2]
C0522510
UMLS CUI [1,3]
C2700396
Pain on Day 0
Description

Pain on Day 0

Data type

integer

Alias
UMLS CUI [1,1]
C0030193
UMLS CUI [1,2]
C0522510
UMLS CUI [1,3]
C2700396
Pain on Day 1
Description

Pain on Day 1

Data type

integer

Alias
UMLS CUI [1,1]
C0030193
UMLS CUI [1,2]
C0522510
UMLS CUI [1,3]
C2700396
Pain on Day 2
Description

Pain on Day 2

Data type

integer

Alias
UMLS CUI [1,1]
C0030193
UMLS CUI [1,2]
C0522510
UMLS CUI [1,3]
C2700396
Pain on Day 3
Description

Pain on Day 3

Data type

integer

Alias
UMLS CUI [1,1]
C0030193
UMLS CUI [1,2]
C0522510
UMLS CUI [1,3]
C2700396
Pain ongoing after day 3?
Description

Pain ongoing after day 3

Data type

boolean

Alias
UMLS CUI [1,1]
C0030193
UMLS CUI [1,2]
C2700396
Date of last day of symptoms
Description

Pain ongoing after day 3? If Yes, please specify

Data type

date

Alias
UMLS CUI [1,1]
C0011008
UMLS CUI [1,2]
C0030193
UMLS CUI [1,3]
C2700396
Medically attended visit
Description

Medically attended visit

Data type

boolean

Alias
UMLS CUI [1,1]
C0545082
UMLS CUI [1,2]
C1386497
UMLS CUI [2]
C0030193
Medically attended visit Type
Description

Medically attended visit Type

Data type

text

Alias
UMLS CUI [1,1]
C0545082
UMLS CUI [1,2]
C0332307
UMLS CUI [1,3]
C1386497
UMLS CUI [2]
C0030193
Solicited Adverse Events - Local Symptoms - DTPw-HBV/Hib vaccine
Description

Solicited Adverse Events - Local Symptoms - DTPw-HBV/Hib vaccine

Alias
UMLS CUI-1
C0877248
UMLS CUI-2
C1457887
UMLS CUI-3
C0520241
For each vaccine, has the subject experienced any of the following signs/symptoms at the administration site during the solicited period? DTPw-HBV/Hib vaccine
Description

DTPw-HBV/Hib vaccine

Data type

boolean

Alias
UMLS CUI [1]
C1457887
Redness
Description

Redness

Data type

boolean

Alias
UMLS CUI [1,1]
C0332575
UMLS CUI [1,2]
C2700396
Redness, size (mm)
Description

If Yes, please specify

Data type

float

Measurement units
  • mm
Alias
UMLS CUI [1,1]
C0332575
UMLS CUI [1,2]
C0456389
UMLS CUI [1,3]
C2700396
mm
Redness on Day 0
Description

Redness on Day 0

Data type

float

Measurement units
  • mm
Alias
UMLS CUI [1,1]
C0332575
UMLS CUI [1,2]
C0456389
UMLS CUI [1,3]
C2700396
mm
Redness on Day 1
Description

Redness on Day 1

Data type

float

Measurement units
  • mm
Alias
UMLS CUI [1,1]
C0332575
UMLS CUI [1,2]
C0456389
UMLS CUI [1,3]
C2700396
mm
Redness on Day 2
Description

Redness on Day 2

Data type

float

Measurement units
  • mm
Alias
UMLS CUI [1,1]
C0332575
UMLS CUI [1,2]
C0456389
UMLS CUI [1,3]
C2700396
mm
Redness on Day 3
Description

Redness on Day 3

Data type

float

Measurement units
  • mm
Alias
UMLS CUI [1,1]
C0332575
UMLS CUI [1,2]
C0456389
UMLS CUI [1,3]
C2700396
mm
Redness ongoing after day 3?
Description

Redness ongoing after day 3

Data type

boolean

Alias
UMLS CUI [1,1]
C0332575
UMLS CUI [1,2]
C2700396
Date of last day of symptoms
Description

Redness ongoing after day 3? If Yes, please specify

Data type

date

Alias
UMLS CUI [1,1]
C0011008
UMLS CUI [1,2]
C0332575
UMLS CUI [1,3]
C2700396
Medically attended visit
Description

Medically attended visit

Data type

boolean

Alias
UMLS CUI [1,1]
C0545082
UMLS CUI [1,2]
C1386497
UMLS CUI [2]
C0332575
Medically attended visit Type
Description

Medically attended visit Type

Data type

text

Alias
UMLS CUI [1,1]
C0545082
UMLS CUI [1,2]
C0332307
UMLS CUI [1,3]
C1386497
UMLS CUI [2]
C0332575
Swelling
Description

Swelling

Data type

boolean

Alias
UMLS CUI [1,1]
C0038999
UMLS CUI [1,2]
C2700396
Swelling, size (mm)
Description

If Yes, please specify

Data type

float

Measurement units
  • mm
Alias
UMLS CUI [1,1]
C0038999
UMLS CUI [1,2]
C0456389
UMLS CUI [1,3]
C2700396
mm
Swelling on Day 0
Description

Swelling on Day 0

Data type

float

Measurement units
  • mm
Alias
UMLS CUI [1,1]
C0038999
UMLS CUI [1,2]
C0456389
UMLS CUI [1,3]
C2700396
mm
Swelling on Day 1
Description

Swelling on Day 1

Data type

float

Measurement units
  • mm
Alias
UMLS CUI [1,1]
C0038999
UMLS CUI [1,2]
C0456389
UMLS CUI [1,3]
C2700396
mm
Swelling on Day 2
Description

Swelling on Day 2

Data type

float

Measurement units
  • mm
Alias
UMLS CUI [1,1]
C0038999
UMLS CUI [1,2]
C0456389
UMLS CUI [1,3]
C2700396
mm
Swelling on Day 3
Description

Swelling on Day 3

Data type

float

Measurement units
  • mm
Alias
UMLS CUI [1,1]
C0038999
UMLS CUI [1,2]
C0456389
UMLS CUI [1,3]
C2700396
mm
Swelling ongoing after day 3?
Description

Swelling ongoing after day 3

Data type

boolean

Alias
UMLS CUI [1,1]
C0038999
UMLS CUI [1,2]
C2700396
Date of last day of symptoms
Description

Swelling ongoing after day 3? If Yes, please specify

Data type

date

Alias
UMLS CUI [1,1]
C0011008
UMLS CUI [1,2]
C0038999
UMLS CUI [1,3]
C2700396
Medically attended visit
Description

Medically attended visit

Data type

boolean

Alias
UMLS CUI [1,1]
C0545082
UMLS CUI [1,2]
C1386497
UMLS CUI [2]
C0038999
Medically attended visit Type
Description

Medically attended visit Type

Data type

text

Alias
UMLS CUI [1,1]
C0545082
UMLS CUI [1,2]
C0332307
UMLS CUI [1,3]
C1386497
UMLS CUI [2]
C0038999
Pain
Description

Pain

Data type

boolean

Alias
UMLS CUI [1,1]
C0030193
UMLS CUI [1,2]
C2700396
Pain, intensity
Description

If Yes, please specify

Data type

integer

Alias
UMLS CUI [1,1]
C0030193
UMLS CUI [1,2]
C0522510
UMLS CUI [1,3]
C2700396
Pain on Day 0
Description

Pain on Day 0

Data type

integer

Alias
UMLS CUI [1,1]
C0030193
UMLS CUI [1,2]
C0522510
UMLS CUI [1,3]
C2700396
Pain on Day 1
Description

Pain on Day 1

Data type

integer

Alias
UMLS CUI [1,1]
C0030193
UMLS CUI [1,2]
C0522510
UMLS CUI [1,3]
C2700396
Pain on Day 2
Description

Pain on Day 2

Data type

integer

Alias
UMLS CUI [1,1]
C0030193
UMLS CUI [1,2]
C0522510
UMLS CUI [1,3]
C2700396
Pain on Day 3
Description

Pain on Day 3

Data type

integer

Alias
UMLS CUI [1,1]
C0030193
UMLS CUI [1,2]
C0522510
UMLS CUI [1,3]
C2700396
Pain ongoing after day 3?
Description

Pain ongoing after day 3

Data type

boolean

Alias
UMLS CUI [1,1]
C0030193
UMLS CUI [1,2]
C2700396
Date of last day of symptoms
Description

Pain ongoing after day 3? If Yes, please specify

Data type

date

Alias
UMLS CUI [1,1]
C0011008
UMLS CUI [1,2]
C0030193
UMLS CUI [1,3]
C2700396
Medically attended visit
Description

Medically attended visit

Data type

boolean

Alias
UMLS CUI [1,1]
C0545082
UMLS CUI [1,2]
C1386497
UMLS CUI [2]
C0030193
Medically attended visit Type
Description

Medically attended visit Type

Data type

text

Alias
UMLS CUI [1,1]
C0545082
UMLS CUI [1,2]
C0332307
UMLS CUI [1,3]
C1386497
UMLS CUI [2]
C0030193
Solicited Adverse Events - Local Symptoms - Meningitec vaccine
Description

Solicited Adverse Events - Local Symptoms - Meningitec vaccine

Alias
UMLS CUI-1
C0877248
UMLS CUI-2
C1457887
UMLS CUI-3
C0700144
For each vaccine, has the subject experienced any of the following signs/symptoms at the administration site during the solicited period? Meningitec™ vaccine
Description

Meningitec™ vaccine

Data type

boolean

Alias
UMLS CUI [1]
C1457887
Redness
Description

Redness

Data type

boolean

Alias
UMLS CUI [1,1]
C0332575
UMLS CUI [1,2]
C2700396
Redness, size (mm)
Description

If Yes, please specify

Data type

float

Measurement units
  • mm
Alias
UMLS CUI [1,1]
C0332575
UMLS CUI [1,2]
C0456389
UMLS CUI [1,3]
C2700396
mm
Redness on Day 0
Description

Redness on Day 0

Data type

float

Measurement units
  • mm
Alias
UMLS CUI [1,1]
C0332575
UMLS CUI [1,2]
C0456389
UMLS CUI [1,3]
C2700396
mm
Redness on Day 1
Description

Redness on Day 1

Data type

float

Measurement units
  • mm
Alias
UMLS CUI [1,1]
C0332575
UMLS CUI [1,2]
C0456389
UMLS CUI [1,3]
C2700396
mm
Redness on Day 2
Description

Redness on Day 2

Data type

float

Measurement units
  • mm
Alias
UMLS CUI [1,1]
C0332575
UMLS CUI [1,2]
C0456389
UMLS CUI [1,3]
C2700396
mm
Redness on Day 3
Description

Redness on Day 3

Data type

float

Measurement units
  • mm
Alias
UMLS CUI [1,1]
C0332575
UMLS CUI [1,2]
C0456389
UMLS CUI [1,3]
C2700396
mm
Redness ongoing after day 3?
Description

Redness ongoing after day 3

Data type

boolean

Alias
UMLS CUI [1,1]
C0332575
UMLS CUI [1,2]
C2700396
Date of last day of symptoms
Description

Redness ongoing after day 3? If Yes, please specify

Data type

date

Alias
UMLS CUI [1,1]
C0011008
UMLS CUI [1,2]
C0332575
UMLS CUI [1,3]
C2700396
Medically attended visit
Description

Medically attended visit

Data type

boolean

Alias
UMLS CUI [1,1]
C0545082
UMLS CUI [1,2]
C1386497
UMLS CUI [2]
C0332575
Medically attended visit Type
Description

Medically attended visit Type

Data type

text

Alias
UMLS CUI [1,1]
C0545082
UMLS CUI [1,2]
C0332307
UMLS CUI [1,3]
C1386497
UMLS CUI [2]
C0332575
Swelling
Description

Swelling

Data type

boolean

Alias
UMLS CUI [1,1]
C0038999
UMLS CUI [1,2]
C2700396
Swelling, size (mm)
Description

If Yes, please specify

Data type

float

Measurement units
  • mm
Alias
UMLS CUI [1,1]
C0038999
UMLS CUI [1,2]
C0456389
UMLS CUI [1,3]
C2700396
mm
Swelling on Day 0
Description

Swelling on Day 0

Data type

float

Measurement units
  • mm
Alias
UMLS CUI [1,1]
C0038999
UMLS CUI [1,2]
C0456389
UMLS CUI [1,3]
C2700396
mm
Swelling on Day 1
Description

Swelling on Day 1

Data type

float

Measurement units
  • mm
Alias
UMLS CUI [1,1]
C0038999
UMLS CUI [1,2]
C0456389
UMLS CUI [1,3]
C2700396
mm
Swelling on Day 2
Description

Swelling on Day 2

Data type

float

Measurement units
  • mm
Alias
UMLS CUI [1,1]
C0038999
UMLS CUI [1,2]
C0456389
UMLS CUI [1,3]
C2700396
mm
Swelling on Day 3
Description

Swelling on Day 3

Data type

float

Measurement units
  • mm
Alias
UMLS CUI [1,1]
C0038999
UMLS CUI [1,2]
C0456389
UMLS CUI [1,3]
C2700396
mm
Swelling ongoing after day 3?
Description

Swelling ongoing after day 3

Data type

boolean

Alias
UMLS CUI [1,1]
C0038999
UMLS CUI [1,2]
C2700396
Date of last day of symptoms
Description

Swelling ongoing after day 3? If Yes, please specify

Data type

date

Alias
UMLS CUI [1,1]
C0011008
UMLS CUI [1,2]
C0038999
UMLS CUI [1,3]
C2700396
Medically attended visit
Description

Medically attended visit

Data type

boolean

Alias
UMLS CUI [1,1]
C0545082
UMLS CUI [1,2]
C1386497
UMLS CUI [2]
C0038999
Medically attended visit Type
Description

Medically attended visit Type

Data type

text

Alias
UMLS CUI [1,1]
C0545082
UMLS CUI [1,2]
C0332307
UMLS CUI [1,3]
C1386497
UMLS CUI [2]
C0038999
Pain
Description

Pain

Data type

boolean

Alias
UMLS CUI [1,1]
C0030193
UMLS CUI [1,2]
C2700396
Pain, intensity
Description

If Yes, please specify

Data type

integer

Alias
UMLS CUI [1,1]
C0030193
UMLS CUI [1,2]
C0522510
UMLS CUI [1,3]
C2700396
Pain on Day 0
Description

Pain on Day 0

Data type

integer

Alias
UMLS CUI [1,1]
C0030193
UMLS CUI [1,2]
C0522510
UMLS CUI [1,3]
C2700396
Pain on Day 1
Description

Pain on Day 1

Data type

integer

Alias
UMLS CUI [1,1]
C0030193
UMLS CUI [1,2]
C0522510
UMLS CUI [1,3]
C2700396
Pain on Day 2
Description

Pain on Day 2

Data type

integer

Alias
UMLS CUI [1,1]
C0030193
UMLS CUI [1,2]
C0522510
UMLS CUI [1,3]
C2700396
Pain on Day 3
Description

Pain on Day 3

Data type

integer

Alias
UMLS CUI [1,1]
C0030193
UMLS CUI [1,2]
C0522510
UMLS CUI [1,3]
C2700396
Pain ongoing after day 3?
Description

Pain ongoing after day 3

Data type

boolean

Alias
UMLS CUI [1,1]
C0030193
UMLS CUI [1,2]
C2700396
Date of last day of symptoms
Description

Pain ongoing after day 3? If Yes, please specify

Data type

date

Alias
UMLS CUI [1,1]
C0011008
UMLS CUI [1,2]
C0030193
UMLS CUI [1,3]
C2700396
Medically attended visit
Description

Medically attended visit

Data type

boolean

Alias
UMLS CUI [1,1]
C0545082
UMLS CUI [1,2]
C1386497
UMLS CUI [2]
C0030193
Medically attended visit Type
Description

Medically attended visit Type

Data type

text

Alias
UMLS CUI [1,1]
C0545082
UMLS CUI [1,2]
C0332307
UMLS CUI [1,3]
C1386497
UMLS CUI [2]
C0030193
Solicited Adverse Events - General Symptoms
Description

Solicited Adverse Events - General Symptoms

Alias
UMLS CUI-1
C0877248
UMLS CUI-2
C1457887
UMLS CUI-3
C0042196
Fever
Description

Axillary ≥ 37.5°C Oral ≥ 37.5°C Tympanic (oral conversion) ≥ 37.5°C Tympanic (rectal conversion) ≥ 38°C Rectal ≥ 38°C

Data type

boolean

Alias
UMLS CUI [1]
C0015967
Fever
Description

If Yes, please specify

Data type

float

Measurement units
  • C
Alias
UMLS CUI [1]
C0015967
C
Fever, Site of measurement
Description

Site of measurement

Data type

text

Alias
UMLS CUI [1,1]
C0449687
UMLS CUI [1,2]
C0015967
Fever on Day 0
Description

Fever on Day 0

Data type

integer

Alias
UMLS CUI [1]
C0015967
Fever on Day 0
Description

if taken, please specify

Data type

float

Measurement units
  • C
Alias
UMLS CUI [1,1]
C0005903
UMLS CUI [1,2]
C0015967
C
Fever on Day 1
Description

Fever on Day 1

Data type

integer

Alias
UMLS CUI [1]
C0015967
Fever on Day 1
Description

if taken, please specify

Data type

float

Measurement units
  • C
Alias
UMLS CUI [1,1]
C0005903
UMLS CUI [1,2]
C0015967
C
Fever on Day 2
Description

Fever on Day 2

Data type

integer

Alias
UMLS CUI [1]
C0015967
Fever on Day 2
Description

if taken, please specify

Data type

float

Measurement units
  • C
Alias
UMLS CUI [1,1]
C0005903
UMLS CUI [1,2]
C0015967
C
Fever on Day 3
Description

Fever on Day 3

Data type

integer

Alias
UMLS CUI [1]
C0015967
Fever on Day 3
Description

if taken, please specify

Data type

float

Measurement units
  • C
Alias
UMLS CUI [1,1]
C0005903
UMLS CUI [1,2]
C0015967
C
Fever ongoing after day 3?
Description

Fever ongoing after day 3

Data type

boolean

Alias
UMLS CUI [1]
C0015967
Date of last day of symptoms
Description

Fever ongoing after day 3? If Yes, please specify

Data type

date

Alias
UMLS CUI [1,1]
C0011008
UMLS CUI [1,2]
C0015967
Causality?
Description

Causality

Data type

boolean

Alias
UMLS CUI [1]
C0015127
UMLS CUI [2]
C0015967
Medically attended visit
Description

Medically attended visit

Data type

boolean

Alias
UMLS CUI [1,1]
C0545082
UMLS CUI [1,2]
C1386497
UMLS CUI [2]
C0015967
Medically attended visit Type
Description

Medically attended visit Type

Data type

text

Alias
UMLS CUI [1,1]
C0545082
UMLS CUI [1,2]
C0332307
UMLS CUI [1,3]
C1386497
UMLS CUI [2]
C0015967
Drowsiness
Description

Drowsiness

Data type

boolean

Alias
UMLS CUI [1]
C0013144
Drowsiness, Intensity
Description

If Yes, please specify

Data type

integer

Alias
UMLS CUI [1,1]
C0013144
UMLS CUI [1,2]
C0522510
Drowsiness on Day 0
Description

Drowsiness on Day 0

Data type

integer

Alias
UMLS CUI [1]
C0013144
Drowsiness on Day 1
Description

Drowsiness on Day 1

Data type

integer

Alias
UMLS CUI [1]
C0013144
Drowsiness on Day 2
Description

Drowsiness on Day 2

Data type

integer

Alias
UMLS CUI [1]
C0013144
Drowsiness on Day 3
Description

Drowsiness on Day 3

Data type

integer

Alias
UMLS CUI [1]
C0013144
Drowsiness ongoing after day 3?
Description

Drowsiness ongoing after day 3

Data type

boolean

Alias
UMLS CUI [1]
C0013144
Date of last day of symptoms
Description

Drowsiness ongoing after day 3? If Yes, please specify

Data type

date

Alias
UMLS CUI [1,1]
C0013144
UMLS CUI [1,2]
C0011008
Causality?
Description

Causality

Data type

boolean

Alias
UMLS CUI [1]
C0015127
UMLS CUI [2]
C0013144
Medically attended visit
Description

Medically attended visit

Data type

boolean

Alias
UMLS CUI [1,1]
C0545082
UMLS CUI [1,2]
C1386497
UMLS CUI [2]
C0013144
Medically attended visit Type
Description

Medically attended visit Type

Data type

text

Alias
UMLS CUI [1,1]
C0545082
UMLS CUI [1,2]
C0332307
UMLS CUI [1,3]
C1386497
UMLS CUI [2]
C0013144
Irritability/Fussiness
Description

Irritability/Fussiness

Data type

boolean

Alias
UMLS CUI [1]
C0022107
Irritability/Fussiness, Intensity
Description

If Yes, please specify

Data type

integer

Alias
UMLS CUI [1,1]
C0022107
UMLS CUI [1,2]
C0522510
Irritability/Fussiness on Day 0
Description

Irritability/Fussiness on Day 0

Data type

integer

Alias
UMLS CUI [1]
C0022107
Irritability/Fussiness on Day 1
Description

Irritability/Fussiness on Day 1

Data type

integer

Alias
UMLS CUI [1]
C0022107
Irritability/Fussiness on Day 2
Description

Irritability/Fussiness on Day 2

Data type

integer

Alias
UMLS CUI [1]
C0022107
Irritability/Fussiness on Day 3
Description

Irritability/Fussiness on Day 3

Data type

integer

Alias
UMLS CUI [1]
C0022107
Irritability/Fussiness ongoing after day 3?
Description

Irritability/Fussiness ongoing after day 3

Data type

boolean

Alias
UMLS CUI [1]
C0022107
Date of last day of symptoms
Description

Irritability/Fussiness ongoing after day 3? If Yes, please specify

Data type

date

Alias
UMLS CUI [1,1]
C0022107
UMLS CUI [1,2]
C0011008
Causality
Description

Causality

Data type

boolean

Alias
UMLS CUI [1]
C0015127
UMLS CUI [2]
C0022107
Medically attended visit
Description

Medically attended visit

Data type

boolean

Alias
UMLS CUI [1,1]
C0545082
UMLS CUI [1,2]
C1386497
UMLS CUI [2]
C0022107
Medically attended visit Type
Description

Medically attended visit Type

Data type

text

Alias
UMLS CUI [1,1]
C0545082
UMLS CUI [1,2]
C0332307
UMLS CUI [1,3]
C1386497
UMLS CUI [2]
C0022107
Loss of appetite
Description

Loss of appetite

Data type

boolean

Alias
UMLS CUI [1]
C1971624
Loss of appetite, Intensity
Description

If Yes, please specify

Data type

integer

Alias
UMLS CUI [1,1]
C1971624
UMLS CUI [1,2]
C0522510
Loss of appetite on Day 0
Description

Loss of appetite on Day 0

Data type

integer

Alias
UMLS CUI [1]
C1971624
Loss of appetite on Day 1
Description

Loss of appetite on Day 1

Data type

integer

Alias
UMLS CUI [1]
C1971624
Loss of appetite on Day 2
Description

Loss of appetite on Day 2

Data type

integer

Alias
UMLS CUI [1]
C1971624
Loss of appetite on Day 3
Description

Loss of appetite on Day 3

Data type

integer

Alias
UMLS CUI [1]
C1971624
Loss of appetite ongoing after day 3?
Description

Loss of appetite ongoing after day 3

Data type

boolean

Alias
UMLS CUI [1]
C1971624
Date of last day of symptoms
Description

Loss of appetite ongoing after day 3? If Yes, please specify

Data type

date

Alias
UMLS CUI [1,1]
C1971624
UMLS CUI [1,2]
C0011008
Causality?
Description

Causality

Data type

boolean

Alias
UMLS CUI [1]
C0015127
UMLS CUI [2]
C1971624
Medically attended visit
Description

Medically attended visit

Data type

boolean

Alias
UMLS CUI [1,1]
C0545082
UMLS CUI [1,2]
C1386497
UMLS CUI [2]
C1971624
Medically attended visit Type
Description

Medically attended visit Type

Data type

text

Alias
UMLS CUI [1,1]
C0545082
UMLS CUI [1,2]
C0332307
UMLS CUI [1,3]
C1386497
UMLS CUI [2]
C1971624
Unsolicited Adverse Events
Description

Unsolicited Adverse Events

Alias
UMLS CUI-1
C0877248
UMLS CUI-2
C0042196
Has the subject experienced any serious or non-serious unsolicited adverse events within one month (minimum 30 days) post-vaccination?
Description

Unsolicited Adverse Events

Data type

text

Alias
UMLS CUI [1]
C0877248
UMLS CUI [2]
C0042196
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Similar models

Visit 1 Non-inferiority Hib-MenAC mixed with Tritanrix-HBV NCT00317161

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
Informed Consent
C0021430 (UMLS CUI-1)
Subject Number
Item
Subject Number
text
C2348585 (UMLS CUI [1])
Date of Visit
Item
Date of Visit
date
C1320303 (UMLS CUI [1])
Informed Consent Date
Item
Informed Consent Date
time
C0021430 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
Item Group
Demographics
C0011298 (UMLS CUI-1)
Center number
Item
Center number
integer
C1301943 (UMLS CUI [1,1])
C0600091 (UMLS CUI [1,2])
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 (M)
CL Item
female (F)
Item Group
Eligibility Question
C1516637 (UMLS CUI-1)
Did the subject meet all the entry criteria?
Item
Did the subject meet all the entry criteria?
boolean
C1516637 (UMLS CUI [1])
Item
Inclusion Criteria
integer
C1512693 (UMLS CUI [1])
Inclusion Criteria
Code List
Inclusion Criteria
CL Item
Subjects who 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.  (1)
CL Item
A male or female between, and including, 15 and 24 months of age (i.e. as of 14 months +1 day until 25 months –1 day of age or 427 to 730 days old) at the time of vaccination. Note: The largest interval will be used in case the different definitions lead to time intervals that do not coincide.  (2)
CL Item
Written informed consent obtained from the parent or guardian of the subject (3)
CL Item
Healthy subjects as established by medical history and clinical examination before entering into the study.  (4)
CL Item
Having participated in the primary vaccination study DTPW-HBV=HIB-MENAC-TT-003 (eTrack No. 100480). (5)
Item
Exclusion Criteria
integer
C0680251 (UMLS CUI [1])
Exclusion Criteria
Code List
Exclusion Criteria
CL Item
Use of any investigational or non-registered product (drug or vaccine) other than the study vaccine within 30 days preceding the vaccination, or planned use during the study period.  (6)
CL Item
Chronic administration (defined as more than 14 days) of immunosuppressants or other immune-modifying drugs within six months prior to vaccination. (For corticosteroids, this will mean prednisone, or equivalent, ≥ 0.5 mg/kg/day. Inhaled and topical steroids are allowed).  (7)
CL Item
Planned administration/ administration of a vaccine not foreseen by the study protocol within 30 days of vaccination. Note: Oral Poliovirus vaccine will be given concomitantly.  (8)
CL Item
Booster vaccination against diphtheria, tetanus, pertussis, hepatitis B, Haemophilus influenzae type b (Hib) and/or meningococcal serogroups A and/or C disease not foreseen in the protocol, after the date of the study conclusion visit of the primary vaccination study DTPW-HBV=HIB-MENAC-TT-003 (eTrack No. 100480).  (9)
CL Item
History of diphtheria, tetanus, pertussis, hepatitis B, Hib and/or meningococcal serogroup A or C disease.  (10)
CL Item
Known exposure to diphtheria, tetanus, pertussis, hepatitis B, Hib and/or meningococcal serogroup A or C disease.  (11)
CL Item
Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination (no laboratory testing required).  (12)
CL Item
A family history of congenital or hereditary immunodeficiency.  (13)
CL Item
History of allergic disease or reactions likely to be exacerbated by any component of the vaccine.  (14)
CL Item
Major congenital defects or serious chronic illness.  (15)
CL Item
History of any neurologic disorders or seizures including febrile seizures (at least two events) in infancy. Note: In case of one event, the investigator will take into account the special warnings and special precautions for use.  (16)
CL 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 lowgrade febrile illness, i.e. axillary temperature <37.5°C).  (17)
CL Item
Administration of immunoglobulins and/or any blood products within the three months preceding the vaccination or planned administration during the study period. (18)
Item Group
Randomisation
C0034656 (UMLS CUI-1)
Treatment number
Item
Record treatment number
integer
C1522541 (UMLS CUI [1,1])
C0600091 (UMLS CUI [1,2])
Item Group
General Medical History / Physical Examination
C0262926 (UMLS CUI-1)
C0031809 (UMLS CUI-2)
pre-existing conditions or signs and/or symptoms
Item
Are you aware of any pre-existing conditions or signs and/or symptoms present prior to the start of the study?
boolean
C0262926 (UMLS CUI [1,1])
C1457887 (UMLS CUI [1,2])
Skin and subcutaneous tissue
Item
Skin and subcutaneous tissue: Diagnosis
text
C0178301 (UMLS CUI [1,1])
C0011900 (UMLS CUI [1,2])
Item
Skin and subcutaneous tissue
integer
C0178301 (UMLS CUI [1])
Cutaneous disease
Code List
Skin and subcutaneous tissue
CL Item
Past (1)
CL Item
Current (2)
Musculoskeletal and connective tissue
Item
Musculoskeletal and connective tissue: Diagnosis
text
C0026857 (UMLS CUI [1,1])
C0011900 (UMLS CUI [1,2])
Item
Musculoskeletal and connective tissue
integer
C0026857 (UMLS CUI [1])
Cutaneous disease
Code List
Musculoskeletal and connective tissue
CL Item
Past (1)
CL Item
Current (2)
Cardiac
Item
Cardiac: Diagnosis
text
C0018799 (UMLS CUI [1,1])
C0011900 (UMLS CUI [1,2])
Item
Cardiac
integer
C0018799 (UMLS CUI [1])
Cutaneous disease
Code List
Cardiac
CL Item
Past (1)
CL Item
Current (2)
undefined item
Item
Vascular: Diagnosis
text
C0042373 (UMLS CUI [1,1])
C0011900 (UMLS CUI [1,2])
Item
Vascular
integer
C0042373 (UMLS CUI [1])
Cutaneous disease
Code List
Vascular
CL Item
Past (1)
CL Item
Current (2)
Respiratory, thoracic and mediastinal
Item
Respiratory, thoracic and mediastinal: Diagnosis
text
C0851355 (UMLS CUI [1,1])
C0011900 (UMLS CUI [1,2])
Item
Respiratory, thoracic and mediastinal
integer
C0851355 (UMLS CUI [1])
Cutaneous disease
Code List
Respiratory, thoracic and mediastinal
CL Item
Past (1)
CL Item
Current (2)
Gastrointestinal
Item
Gastrointestinal: Diagnosis
text
C0017178 (UMLS CUI [1,1])
C0011900 (UMLS CUI [1,2])
Item
Gastrointestinal
integer
C0017178 (UMLS CUI [1])
Cutaneous disease
Code List
Gastrointestinal
CL Item
Past (1)
CL Item
Current (2)
Hepatobiliary
Item
Hepatobiliary: Diagnosis
text
C0267792 (UMLS CUI [1,1])
C0011900 (UMLS CUI [1,2])
Item
Hepatobiliary
integer
C0267792 (UMLS CUI [1])
Cutaneous disease
Code List
Hepatobiliary
CL Item
Past (1)
CL Item
Current (2)
Renal and urinary
Item
Renal and urinary: Diagnosis
text
C0042075 (UMLS CUI [1,1])
C0011900 (UMLS CUI [1,2])
Item
Renal and urinary
integer
C0042075 (UMLS CUI [1])
Cutaneous disease
Code List
Renal and urinary
CL Item
Past (1)
CL Item
Current (2)
Nervous system
Item
Nervous system: Diagnosis
text
C0027765 (UMLS CUI [1,1])
C0011900 (UMLS CUI [1,2])
Item
Nervous system
integer
C0027765 (UMLS CUI [1])
Cutaneous disease
Code List
Nervous system
CL Item
Past (1)
CL Item
Current (2)
Eye
Item
Eye: Diagnosis
text
C0015397 (UMLS CUI [1,1])
C0011900 (UMLS CUI [1,2])
Item
Eye
integer
C0015397 (UMLS CUI [1])
Cutaneous disease
Code List
Eye
CL Item
Past (1)
CL Item
Current (2)
Ear and labyrinth
Item
Ear and labyrinth: Diagnosis
text
C0851354 (UMLS CUI [1,1])
C0011900 (UMLS CUI [1,2])
Item
Ear and labyrinth
integer
C0851354 (UMLS CUI [1])
Cutaneous disease
Code List
Ear and labyrinth
CL Item
Past (1)
CL Item
Current (2)
Endocrine
Item
Endocrine: Diagnosis
text
C0014130 (UMLS CUI [1,1])
C0011900 (UMLS CUI [1,2])
Item
Endocrine
integer
C0014130 (UMLS CUI [1])
Cutaneous disease
Code List
Endocrine
CL Item
Past (1)
CL Item
Current (2)
Metabolism and nutrition
Item
Metabolism and nutrition: Diagnosis
text
C0851358 (UMLS CUI [1,1])
C0011900 (UMLS CUI [1,2])
Item
Metabolism and nutrition
integer
C0851358 (UMLS CUI [1])
Cutaneous disease
Code List
Metabolism and nutrition
CL Item
Past (1)
CL Item
Current (2)
Blood and lymphatic system
Item
Blood and lymphatic system: Diagnosis
text
C0851353 (UMLS CUI [1,1])
C0011900 (UMLS CUI [1,2])
Item
Blood and lymphatic system
integer
C0851353 (UMLS CUI [1])
Cutaneous disease
Code List
Blood and lymphatic system
CL Item
Past (1)
CL Item
Current (2)
Immune system
Item
Immune system (incl allergies, autoimmune disorders): Diagnosis
text
C0021053 (UMLS CUI [1,1])
C0011900 (UMLS CUI [1,2])
Item
Immune system
integer
C0021053 (UMLS CUI [1])
Cutaneous disease
Code List
Immune system
CL Item
Past (1)
CL Item
Current (2)
Infections and infestations
Item
Infections and infestations: Diagnosis
text
C0009450 (UMLS CUI [1,1])
C0851341 (UMLS CUI [1,2])
C0011900 (UMLS CUI [1,3])
Item
Infections and infestations
integer
C0009450 (UMLS CUI [1,1])
C0851341 (UMLS CUI [1,2])
Cutaneous disease
Code List
Infections and infestations
CL Item
Past (1)
CL Item
Current (2)
Neoplasms benign, malignant and unspecified
Item
Neoplasms benign, malignant and unspecified (incl cysts, polyps): Diagnosis
text
C1882062 (UMLS CUI [1,1])
C0011900 (UMLS CUI [1,2])
Item
Neoplasms benign, malignant and unspecified
integer
C1882062 (UMLS CUI [1])
Cutaneous disease
Code List
Neoplasms benign, malignant and unspecified
CL Item
Past (1)
CL Item
Current (2)
Surgical and medical procedures
Item
Surgical and medical procedures: Diagnosis
text
C1948041 (UMLS CUI [1,1])
C0011900 (UMLS CUI [1,2])
Item
Surgical and medical procedures
integer
C1948041 (UMLS CUI [1])
Cutaneous disease
Code List
Surgical and medical procedures
CL Item
Past (1)
CL Item
Current (2)
Persistent Crying
Item
Persistent Crying (crying continuous and unaltered for over 3 hours): Diagnosis
text
C2721683 (UMLS CUI [1,1])
C0011900 (UMLS CUI [1,2])
Item
Persistent Crying
integer
C2721683 (UMLS CUI [1])
Cutaneous disease
Code List
Persistent Crying
CL Item
Past (1)
CL Item
Current (2)
Other disorder
Item
Other disorder, please specify
text
C0012634 (UMLS CUI [1,1])
C0011900 (UMLS CUI [1,2])
Item
Other disorder
integer
C0012634 (UMLS CUI [1])
Cutaneous disease
Code List
Other disorder
CL Item
Past (1)
CL Item
Current (2)
Item Group
Laboratory Tests
C0022885 (UMLS CUI-1)
C0005834 (UMLS CUI-2)
blood sample
Item
Has a blood sample been taken?
boolean
C0005834 (UMLS CUI [1])
blood sample date
Item
blood sample date
date
C0011008 (UMLS CUI [1,1])
C0005834 (UMLS CUI [1,2])
Item Group
Protocol required Concomitant Vaccination
C0042196 (UMLS CUI-1)
C2347852 (UMLS CUI-2)
C0032375 (UMLS CUI-3)
OPV
Item
OPV
boolean
C0032375 (UMLS CUI [1])
OPV Date
Item
OPV Date
text
C0032375 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
Item Group
Vaccine Administration, Single Injection
C2368628 (UMLS CUI-1)
C0042196 (UMLS CUI-2)
Date of Vaccine Administration
Item
Date of Vaccine Administration
date
C0011008 (UMLS CUI [1,1])
C2368628 (UMLS CUI [1,2])
Pre-Vaccination temperature
Item
Pre-Vaccination temperature:
float
C0005903 (UMLS CUI [1])
Item
Pre-Vaccination temperature Route:
text
C0005903 (UMLS CUI [1,1])
C0449687 (UMLS CUI [1,2])
Pre-Vaccination temperature Route
Code List
Pre-Vaccination temperature Route:
CL Item
Axillary (A)
CL Item
Oral (O)
CL Item
Rectal (R)
Item
Vaccine Administration
integer
C2368628 (UMLS CUI [1])
Vaccine Administration
Code List
Vaccine Administration
CL Item
DTPw-HBV/Hib-MenAC Vaccine  (1)
CL Item
DTPw-HBV/Hib Vaccine  (2)
CL Item
Replacement vial  (3)
CL Item
Wrong vial number (4)
CL Item
Not administered (Please complete below) (5)
Wrong vial number
Item
Wrong vial number
integer
C0184301 (UMLS CUI [1])
Item
Please tick the major reason for non administration
integer
C1533734 (UMLS CUI [1,1])
C0392360 (UMLS CUI [1,2])
C1272696 (UMLS CUI [1,3])
reason for non administration
Code List
Please tick the major reason for non administration
CL Item
Serious adverse event (1)
CL Item
Non-Serious adverse event (2)
CL Item
Other (3)
Serious adverse event Number
Item
Serious adverse event Number
integer
C1519255 (UMLS CUI [1,1])
C0237753 (UMLS CUI [1,2])
Non-serious adverse event Number
Item
Non-serious adverse event Number
integer
C1518404 (UMLS CUI [1,1])
C0237753 (UMLS CUI [1,2])
reason for non administration
Item
reason for non administration, if other please specify
text
C1533734 (UMLS CUI [1,1])
C0392360 (UMLS CUI [1,2])
C1272696 (UMLS CUI [1,3])
Item
Please tick who made the decision
integer
C1533734 (UMLS CUI [1,1])
C0392360 (UMLS CUI [1,2])
C1272696 (UMLS CUI [1,3])
non administration
Code List
Please tick who made the decision
CL Item
Investigator (1)
CL Item
Parents/Guardians (2)
Administration Side
Item
Administration Side
text
C0441987 (UMLS CUI [1,1])
C0013153 (UMLS CUI [1,2])
C0042210 (UMLS CUI [1,3])
Administration Site
Item
Administration Site
text
C1515974 (UMLS CUI [1,1])
C0013153 (UMLS CUI [1,2])
C0042210 (UMLS CUI [1,3])
Administration Route
Item
Administration Route
text
C0013153 (UMLS CUI [1,1])
C0042210 (UMLS CUI [1,2])
Study vaccine Administration
Item
Has the study vaccine been administered according to the Protocol ?
boolean
C2368628 (UMLS CUI [1])
Item
Study vaccine Administration: Side
integer
C0441987 (UMLS CUI [1,1])
C0013153 (UMLS CUI [1,2])
C0042210 (UMLS CUI [1,3])
Study vaccine Administration
Code List
Study vaccine Administration: Side
CL Item
Left (1)
CL Item
Right (2)
Item
Study vaccine Administration: Site
integer
C1515974 (UMLS CUI [1,1])
C0013153 (UMLS CUI [1,2])
C0042210 (UMLS CUI [1,3])
Study vaccine Administration Site
Code List
Study vaccine Administration: Site
CL Item
Deltoid (1)
CL Item
Thigh (2)
CL Item
Buttock (3)
Item
Study vaccine Administration: Route
integer
C0013153 (UMLS CUI [1,1])
C0042210 (UMLS CUI [1,2])
Study vaccine Administration Route
Code List
Study vaccine Administration: Route
CL Item
I.M. (1)
CL Item
S.C. (2)
Item Group
Vaccine Administration, Multi Injections
C2368628 (UMLS CUI-1)
Date of Vaccine Administration
Item
Date of Vaccine Administration
date
C0011008 (UMLS CUI [1,1])
C2368628 (UMLS CUI [1,2])
Pre-Vaccination temperature
Item
Pre-Vaccination temperature:
float
C0005903 (UMLS CUI [1])
Item
Pre-Vaccination temperature Route:
text
C0005903 (UMLS CUI [1,1])
C0449687 (UMLS CUI [1,2])
Pre-Vaccination temperature Route
Code List
Pre-Vaccination temperature Route:
CL Item
Axillary (A)
CL Item
Oral (O)
CL Item
Rectal (R)
Item
Vaccine Administration
integer
C2368628 (UMLS CUI [1])
Vaccine Administration
Code List
Vaccine Administration
Item
Vaccine Administration
integer
C2368628 (UMLS CUI [1])
Vaccine Administration
Code List
Vaccine Administration
CL Item
Meningitec™ Vaccine (1)
CL Item
Replacement vial  (2)
CL Item
Wrong vial number  (3)
CL Item
Not administered (4)
Wrong vial number
Item
Wrong vial number
integer
C0184301 (UMLS CUI [1])
Item
Please tick the major reason for non administration
integer
C1533734 (UMLS CUI [1,1])
C0392360 (UMLS CUI [1,2])
C1272696 (UMLS CUI [1,3])
reason for non administration
Code List
Please tick the major reason for non administration
CL Item
Serious adverse event (1)
CL Item
Non-Serious adverse event (2)
CL Item
Other (3)
Serious adverse event Number
Item
Serious adverse event Number
integer
C1519255 (UMLS CUI [1,1])
C0237753 (UMLS CUI [1,2])
Non-serious adverse event Number
Item
Non-serious adverse event Number
integer
C1518404 (UMLS CUI [1,1])
C0237753 (UMLS CUI [1,2])
reason for non administration
Item
reason for non administration, if other please specify
text
C1533734 (UMLS CUI [1,1])
C0392360 (UMLS CUI [1,2])
C1272696 (UMLS CUI [1,3])
Item
Please tick who made the decision
integer
C1533734 (UMLS CUI [1,1])
C0392360 (UMLS CUI [1,2])
C1272696 (UMLS CUI [1,3])
non administration
Code List
Please tick who made the decision
CL Item
Investigator (1)
CL Item
Parents/Guardians (2)
Administration Side
Item
Administration Side
text
C0441987 (UMLS CUI [1,1])
C0013153 (UMLS CUI [1,2])
C0042210 (UMLS CUI [1,3])
Administration Site
Item
Administration Site
text
C1515974 (UMLS CUI [1,1])
C0013153 (UMLS CUI [1,2])
C0042210 (UMLS CUI [1,3])
Administration Route
Item
Administration Route
text
C0013153 (UMLS CUI [1,1])
C0042210 (UMLS CUI [1,2])
Study vaccine Administration
Item
Has the study vaccine been administered according to the Protocol ?
boolean
C2368628 (UMLS CUI [1])
Item
Study vaccine Administration: Side
integer
C0441987 (UMLS CUI [1,1])
C0013153 (UMLS CUI [1,2])
C0042210 (UMLS CUI [1,3])
Study vaccine Administration
Code List
Study vaccine Administration: Side
CL Item
Left (1)
CL Item
Right (2)
Item
Study vaccine Administration: Site
integer
C1515974 (UMLS CUI [1,1])
C0013153 (UMLS CUI [1,2])
C0042210 (UMLS CUI [1,3])
Study vaccine Administration Site
Code List
Study vaccine Administration: Site
CL Item
Deltoid (1)
CL Item
Thigh (2)
CL Item
Buttock (3)
Item
Study vaccine Administration: Route
integer
C0013153 (UMLS CUI [1,1])
C0042210 (UMLS CUI [1,2])
Study vaccine Administration Route
Code List
Study vaccine Administration: Route
CL Item
I.M. (1)
CL Item
S.C. (2)
Item Group
Solicited Adverse Events - Local Symptoms - Booster Dose
C0877248 (UMLS CUI-1)
C1457887 (UMLS CUI-2)
C0042196 (UMLS CUI-3)
Item
Has the subject experienced any of the following signs/symptoms at the administration site during the solicited period? Booster Dose
text
C1457887 (UMLS CUI [1])
symptoms
Code List
Has the subject experienced any of the following signs/symptoms at the administration site during the solicited period? Booster Dose
CL Item
Information not available (U)
CL Item
No vaccine administered  (NA)
CL Item
No (N)
CL Item
Yes, please tick No/Yes for each symptom. If Yes is ticked, please complete all items. (Y)
Redness
Item
Redness
boolean
C0332575 (UMLS CUI [1,1])
C2700396 (UMLS CUI [1,2])
Redness
Item
Redness, size (mm)
float
C0332575 (UMLS CUI [1,1])
C0456389 (UMLS CUI [1,2])
C2700396 (UMLS CUI [1,3])
Redness on Day 0
Item
Redness on Day 0
float
C0332575 (UMLS CUI [1,1])
C0456389 (UMLS CUI [1,2])
C2700396 (UMLS CUI [1,3])
Redness on Day 1
Item
Redness on Day 1
float
C0332575 (UMLS CUI [1,1])
C0456389 (UMLS CUI [1,2])
C2700396 (UMLS CUI [1,3])
Redness on Day 2
Item
Redness on Day 2
float
C0332575 (UMLS CUI [1,1])
C0456389 (UMLS CUI [1,2])
C2700396 (UMLS CUI [1,3])
Redness on Day 3
Item
Redness on Day 3
float
C0332575 (UMLS CUI [1,1])
C0456389 (UMLS CUI [1,2])
C2700396 (UMLS CUI [1,3])
Redness ongoing after day 3
Item
Redness ongoing after day 3?
boolean
C0332575 (UMLS CUI [1,1])
C2700396 (UMLS CUI [1,2])
Date of last day of symptoms
Item
Date of last day of symptoms
date
C0011008 (UMLS CUI [1,1])
C0332575 (UMLS CUI [1,2])
C2700396 (UMLS CUI [1,3])
Medically attended visit
Item
Medically attended visit
boolean
C0545082 (UMLS CUI [1,1])
C1386497 (UMLS CUI [1,2])
C0332575 (UMLS CUI [2])
Item
Medically attended visit Type
text
C0545082 (UMLS CUI [1,1])
C0332307 (UMLS CUI [1,2])
C1386497 (UMLS CUI [1,3])
C0332575 (UMLS CUI [2])
Medical advice Type
Code List
Medically attended visit Type
CL Item
Hospitalization (HO)
CL Item
Emergency room (ER)
CL Item
Medical doctor (MD)
Swelling
Item
Swelling
boolean
C0038999 (UMLS CUI [1,1])
C2700396 (UMLS CUI [1,2])
Swelling
Item
Swelling, size (mm)
float
C0038999 (UMLS CUI [1,1])
C0456389 (UMLS CUI [1,2])
C2700396 (UMLS CUI [1,3])
Swelling on Day 0
Item
Swelling on Day 0
float
C0038999 (UMLS CUI [1,1])
C0456389 (UMLS CUI [1,2])
C2700396 (UMLS CUI [1,3])
Swelling on Day 1
Item
Swelling on Day 1
float
C0038999 (UMLS CUI [1,1])
C0456389 (UMLS CUI [1,2])
C2700396 (UMLS CUI [1,3])
Swelling on Day 2
Item
Swelling on Day 2
float
C0038999 (UMLS CUI [1,1])
C0456389 (UMLS CUI [1,2])
C2700396 (UMLS CUI [1,3])
Swelling on Day 3
Item
Swelling on Day 3
float
C0038999 (UMLS CUI [1,1])
C0456389 (UMLS CUI [1,2])
C2700396 (UMLS CUI [1,3])
Swelling ongoing after day 3
Item
Swelling ongoing after day 3?
boolean
C0038999 (UMLS CUI [1,1])
C2700396 (UMLS CUI [1,2])
Date of last day of symptoms
Item
Date of last day of symptoms
date
C0011008 (UMLS CUI [1,1])
C0038999 (UMLS CUI [1,2])
C2700396 (UMLS CUI [1,3])
Medically attended visit
Item
Medically attended visit
boolean
C0545082 (UMLS CUI [1,1])
C1386497 (UMLS CUI [1,2])
C0038999 (UMLS CUI [2])
Item
Medically attended visit Type
text
C0545082 (UMLS CUI [1,1])
C0332307 (UMLS CUI [1,2])
C1386497 (UMLS CUI [1,3])
C0038999 (UMLS CUI [2])
Medical advice Type
Code List
Medically attended visit Type
CL Item
Hospitalization (HO)
CL Item
Emergency room (ER)
CL Item
Medical doctor (MD)
Pain
Item
Pain
boolean
C0030193 (UMLS CUI [1,1])
C2700396 (UMLS CUI [1,2])
Item
Pain, intensity
integer
C0030193 (UMLS CUI [1,1])
C0522510 (UMLS CUI [1,2])
C2700396 (UMLS CUI [1,3])
Pain
Code List
Pain, intensity
CL Item
None (0)
CL Item
Mild (1)
CL Item
Moderate (2)
CL Item
Severe (3)
Item
Pain on Day 0
integer
C0030193 (UMLS CUI [1,1])
C0522510 (UMLS CUI [1,2])
C2700396 (UMLS CUI [1,3])
Pain
Code List
Pain on Day 0
CL Item
None (0)
CL Item
Mild (1)
CL Item
Moderate (2)
CL Item
Severe (3)
Item
Pain on Day 1
integer
C0030193 (UMLS CUI [1,1])
C0522510 (UMLS CUI [1,2])
C2700396 (UMLS CUI [1,3])
Pain
Code List
Pain on Day 1
CL Item
None (0)
CL Item
Mild (1)
CL Item
Moderate (2)
CL Item
Severe (3)
Item
Pain on Day 2
integer
C0030193 (UMLS CUI [1,1])
C0522510 (UMLS CUI [1,2])
C2700396 (UMLS CUI [1,3])
Pain
Code List
Pain on Day 2
CL Item
None (0)
CL Item
Mild (1)
CL Item
Moderate (2)
CL Item
Severe (3)
Item
Pain on Day 3
integer
C0030193 (UMLS CUI [1,1])
C0522510 (UMLS CUI [1,2])
C2700396 (UMLS CUI [1,3])
Pain
Code List
Pain on Day 3
CL Item
None (0)
CL Item
Mild (1)
CL Item
Moderate (2)
CL Item
Severe (3)
Pain ongoing after day 3
Item
Pain ongoing after day 3?
boolean
C0030193 (UMLS CUI [1,1])
C2700396 (UMLS CUI [1,2])
Date of last day of symptoms
Item
Date of last day of symptoms
date
C0011008 (UMLS CUI [1,1])
C0030193 (UMLS CUI [1,2])
C2700396 (UMLS CUI [1,3])
Medically attended visit
Item
Medically attended visit
boolean
C0545082 (UMLS CUI [1,1])
C1386497 (UMLS CUI [1,2])
C0030193 (UMLS CUI [2])
Item
Medically attended visit Type
text
C0545082 (UMLS CUI [1,1])
C0332307 (UMLS CUI [1,2])
C1386497 (UMLS CUI [1,3])
C0030193 (UMLS CUI [2])
Medical advice Type
Code List
Medically attended visit Type
CL Item
Hospitalization (HO)
CL Item
Emergency room (ER)
CL Item
Medical doctor (MD)
Item Group
Solicited Adverse Events - Local Symptoms - DTPw-HBV/Hib vaccine
C0877248 (UMLS CUI-1)
C1457887 (UMLS CUI-2)
C0520241 (UMLS CUI-3)
symptoms
Item
For each vaccine, has the subject experienced any of the following signs/symptoms at the administration site during the solicited period? DTPw-HBV/Hib vaccine
boolean
C1457887 (UMLS CUI [1])
Redness
Item
Redness
boolean
C0332575 (UMLS CUI [1,1])
C2700396 (UMLS CUI [1,2])
Redness
Item
Redness, size (mm)
float
C0332575 (UMLS CUI [1,1])
C0456389 (UMLS CUI [1,2])
C2700396 (UMLS CUI [1,3])
Redness on Day 0
Item
Redness on Day 0
float
C0332575 (UMLS CUI [1,1])
C0456389 (UMLS CUI [1,2])
C2700396 (UMLS CUI [1,3])
Redness on Day 1
Item
Redness on Day 1
float
C0332575 (UMLS CUI [1,1])
C0456389 (UMLS CUI [1,2])
C2700396 (UMLS CUI [1,3])
Redness on Day 2
Item
Redness on Day 2
float
C0332575 (UMLS CUI [1,1])
C0456389 (UMLS CUI [1,2])
C2700396 (UMLS CUI [1,3])
Redness on Day 3
Item
Redness on Day 3
float
C0332575 (UMLS CUI [1,1])
C0456389 (UMLS CUI [1,2])
C2700396 (UMLS CUI [1,3])
Redness ongoing after day 3
Item
Redness ongoing after day 3?
boolean
C0332575 (UMLS CUI [1,1])
C2700396 (UMLS CUI [1,2])
Date of last day of symptoms
Item
Date of last day of symptoms
date
C0011008 (UMLS CUI [1,1])
C0332575 (UMLS CUI [1,2])
C2700396 (UMLS CUI [1,3])
Medically attended visit
Item
Medically attended visit
boolean
C0545082 (UMLS CUI [1,1])
C1386497 (UMLS CUI [1,2])
C0332575 (UMLS CUI [2])
Item
Medically attended visit Type
text
C0545082 (UMLS CUI [1,1])
C0332307 (UMLS CUI [1,2])
C1386497 (UMLS CUI [1,3])
C0332575 (UMLS CUI [2])
Medical advice Type
Code List
Medically attended visit Type
CL Item
Hospitalization (HO)
CL Item
Emergency room (ER)
CL Item
Medical doctor (MD)
Swelling
Item
Swelling
boolean
C0038999 (UMLS CUI [1,1])
C2700396 (UMLS CUI [1,2])
Swelling
Item
Swelling, size (mm)
float
C0038999 (UMLS CUI [1,1])
C0456389 (UMLS CUI [1,2])
C2700396 (UMLS CUI [1,3])
Swelling on Day 0
Item
Swelling on Day 0
float
C0038999 (UMLS CUI [1,1])
C0456389 (UMLS CUI [1,2])
C2700396 (UMLS CUI [1,3])
Swelling on Day 1
Item
Swelling on Day 1
float
C0038999 (UMLS CUI [1,1])
C0456389 (UMLS CUI [1,2])
C2700396 (UMLS CUI [1,3])
Swelling on Day 2
Item
Swelling on Day 2
float
C0038999 (UMLS CUI [1,1])
C0456389 (UMLS CUI [1,2])
C2700396 (UMLS CUI [1,3])
Swelling on Day 3
Item
Swelling on Day 3
float
C0038999 (UMLS CUI [1,1])
C0456389 (UMLS CUI [1,2])
C2700396 (UMLS CUI [1,3])
Swelling ongoing after day 3
Item
Swelling ongoing after day 3?
boolean
C0038999 (UMLS CUI [1,1])
C2700396 (UMLS CUI [1,2])
Date of last day of symptoms
Item
Date of last day of symptoms
date
C0011008 (UMLS CUI [1,1])
C0038999 (UMLS CUI [1,2])
C2700396 (UMLS CUI [1,3])
Medically attended visit
Item
Medically attended visit
boolean
C0545082 (UMLS CUI [1,1])
C1386497 (UMLS CUI [1,2])
C0038999 (UMLS CUI [2])
Item
Medically attended visit Type
text
C0545082 (UMLS CUI [1,1])
C0332307 (UMLS CUI [1,2])
C1386497 (UMLS CUI [1,3])
C0038999 (UMLS CUI [2])
Medical advice Type
Code List
Medically attended visit Type
CL Item
Hospitalization (HO)
CL Item
Emergency room (ER)
CL Item
Medical doctor (MD)
Pain
Item
Pain
boolean
C0030193 (UMLS CUI [1,1])
C2700396 (UMLS CUI [1,2])
Item
Pain, intensity
integer
C0030193 (UMLS CUI [1,1])
C0522510 (UMLS CUI [1,2])
C2700396 (UMLS CUI [1,3])
Pain
Code List
Pain, intensity
CL Item
None (0)
CL Item
Mild (1)
CL Item
Moderate (2)
CL Item
Severe (3)
Item
Pain on Day 0
integer
C0030193 (UMLS CUI [1,1])
C0522510 (UMLS CUI [1,2])
C2700396 (UMLS CUI [1,3])
Pain
Code List
Pain on Day 0
CL Item
None (0)
CL Item
Mild (1)
CL Item
Moderate (2)
CL Item
Severe (3)
Item
Pain on Day 1
integer
C0030193 (UMLS CUI [1,1])
C0522510 (UMLS CUI [1,2])
C2700396 (UMLS CUI [1,3])
Pain
Code List
Pain on Day 1
CL Item
None (0)
CL Item
Mild (1)
CL Item
Moderate (2)
CL Item
Severe (3)
Item
Pain on Day 2
integer
C0030193 (UMLS CUI [1,1])
C0522510 (UMLS CUI [1,2])
C2700396 (UMLS CUI [1,3])
Pain
Code List
Pain on Day 2
CL Item
None (0)
CL Item
Mild (1)
CL Item
Moderate (2)
CL Item
Severe (3)
Item
Pain on Day 3
integer
C0030193 (UMLS CUI [1,1])
C0522510 (UMLS CUI [1,2])
C2700396 (UMLS CUI [1,3])
Pain
Code List
Pain on Day 3
CL Item
None (0)
CL Item
Mild (1)
CL Item
Moderate (2)
CL Item
Severe (3)
Pain ongoing after day 3
Item
Pain ongoing after day 3?
boolean
C0030193 (UMLS CUI [1,1])
C2700396 (UMLS CUI [1,2])
Date of last day of symptoms
Item
Date of last day of symptoms
date
C0011008 (UMLS CUI [1,1])
C0030193 (UMLS CUI [1,2])
C2700396 (UMLS CUI [1,3])
Medically attended visit
Item
Medically attended visit
boolean
C0545082 (UMLS CUI [1,1])
C1386497 (UMLS CUI [1,2])
C0030193 (UMLS CUI [2])
Item
Medically attended visit Type
text
C0545082 (UMLS CUI [1,1])
C0332307 (UMLS CUI [1,2])
C1386497 (UMLS CUI [1,3])
C0030193 (UMLS CUI [2])
Medical advice Type
Code List
Medically attended visit Type
CL Item
Hospitalization (HO)
CL Item
Emergency room (ER)
CL Item
Medical doctor (MD)
Item Group
Solicited Adverse Events - Local Symptoms - Meningitec vaccine
C0877248 (UMLS CUI-1)
C1457887 (UMLS CUI-2)
C0700144 (UMLS CUI-3)
symptoms
Item
For each vaccine, has the subject experienced any of the following signs/symptoms at the administration site during the solicited period? Meningitec™ vaccine
boolean
C1457887 (UMLS CUI [1])
Redness
Item
Redness
boolean
C0332575 (UMLS CUI [1,1])
C2700396 (UMLS CUI [1,2])
Redness
Item
Redness, size (mm)
float
C0332575 (UMLS CUI [1,1])
C0456389 (UMLS CUI [1,2])
C2700396 (UMLS CUI [1,3])
Redness on Day 0
Item
Redness on Day 0
float
C0332575 (UMLS CUI [1,1])
C0456389 (UMLS CUI [1,2])
C2700396 (UMLS CUI [1,3])
Redness on Day 1
Item
Redness on Day 1
float
C0332575 (UMLS CUI [1,1])
C0456389 (UMLS CUI [1,2])
C2700396 (UMLS CUI [1,3])
Redness on Day 2
Item
Redness on Day 2
float
C0332575 (UMLS CUI [1,1])
C0456389 (UMLS CUI [1,2])
C2700396 (UMLS CUI [1,3])
Redness on Day 3
Item
Redness on Day 3
float
C0332575 (UMLS CUI [1,1])
C0456389 (UMLS CUI [1,2])
C2700396 (UMLS CUI [1,3])
Redness ongoing after day 3
Item
Redness ongoing after day 3?
boolean
C0332575 (UMLS CUI [1,1])
C2700396 (UMLS CUI [1,2])
Date of last day of symptoms
Item
Date of last day of symptoms
date
C0011008 (UMLS CUI [1,1])
C0332575 (UMLS CUI [1,2])
C2700396 (UMLS CUI [1,3])
Medically attended visit
Item
Medically attended visit
boolean
C0545082 (UMLS CUI [1,1])
C1386497 (UMLS CUI [1,2])
C0332575 (UMLS CUI [2])
Item
Medically attended visit Type
text
C0545082 (UMLS CUI [1,1])
C0332307 (UMLS CUI [1,2])
C1386497 (UMLS CUI [1,3])
C0332575 (UMLS CUI [2])
Medical advice Type
Code List
Medically attended visit Type
CL Item
Hospitalization (HO)
CL Item
Emergency room (ER)
CL Item
Medical doctor (MD)
Swelling
Item
Swelling
boolean
C0038999 (UMLS CUI [1,1])
C2700396 (UMLS CUI [1,2])
Swelling
Item
Swelling, size (mm)
float
C0038999 (UMLS CUI [1,1])
C0456389 (UMLS CUI [1,2])
C2700396 (UMLS CUI [1,3])
Swelling on Day 0
Item
Swelling on Day 0
float
C0038999 (UMLS CUI [1,1])
C0456389 (UMLS CUI [1,2])
C2700396 (UMLS CUI [1,3])
Swelling on Day 1
Item
Swelling on Day 1
float
C0038999 (UMLS CUI [1,1])
C0456389 (UMLS CUI [1,2])
C2700396 (UMLS CUI [1,3])
Swelling on Day 2
Item
Swelling on Day 2
float
C0038999 (UMLS CUI [1,1])
C0456389 (UMLS CUI [1,2])
C2700396 (UMLS CUI [1,3])
Swelling on Day 3
Item
Swelling on Day 3
float
C0038999 (UMLS CUI [1,1])
C0456389 (UMLS CUI [1,2])
C2700396 (UMLS CUI [1,3])
Swelling ongoing after day 3
Item
Swelling ongoing after day 3?
boolean
C0038999 (UMLS CUI [1,1])
C2700396 (UMLS CUI [1,2])
Date of last day of symptoms
Item
Date of last day of symptoms
date
C0011008 (UMLS CUI [1,1])
C0038999 (UMLS CUI [1,2])
C2700396 (UMLS CUI [1,3])
Medically attended visit
Item
Medically attended visit
boolean
C0545082 (UMLS CUI [1,1])
C1386497 (UMLS CUI [1,2])
C0038999 (UMLS CUI [2])
Item
Medically attended visit Type
text
C0545082 (UMLS CUI [1,1])
C0332307 (UMLS CUI [1,2])
C1386497 (UMLS CUI [1,3])
C0038999 (UMLS CUI [2])
Medical advice Type
Code List
Medically attended visit Type
CL Item
Hospitalization (HO)
CL Item
Emergency room (ER)
CL Item
Medical doctor (MD)
Pain
Item
Pain
boolean
C0030193 (UMLS CUI [1,1])
C2700396 (UMLS CUI [1,2])
Item
Pain, intensity
integer
C0030193 (UMLS CUI [1,1])
C0522510 (UMLS CUI [1,2])
C2700396 (UMLS CUI [1,3])
Pain
Code List
Pain, intensity
CL Item
None (0)
CL Item
Mild (1)
CL Item
Moderate (2)
CL Item
Severe (3)
Item
Pain on Day 0
integer
C0030193 (UMLS CUI [1,1])
C0522510 (UMLS CUI [1,2])
C2700396 (UMLS CUI [1,3])
Pain
Code List
Pain on Day 0
CL Item
None (0)
CL Item
Mild (1)
CL Item
Moderate (2)
CL Item
Severe (3)
Item
Pain on Day 1
integer
C0030193 (UMLS CUI [1,1])
C0522510 (UMLS CUI [1,2])
C2700396 (UMLS CUI [1,3])
Pain
Code List
Pain on Day 1
CL Item
None (0)
CL Item
Mild (1)
CL Item
Moderate (2)
CL Item
Severe (3)
Item
Pain on Day 2
integer
C0030193 (UMLS CUI [1,1])
C0522510 (UMLS CUI [1,2])
C2700396 (UMLS CUI [1,3])
Pain
Code List
Pain on Day 2
CL Item
None (0)
CL Item
Mild (1)
CL Item
Moderate (2)
CL Item
Severe (3)
Item
Pain on Day 3
integer
C0030193 (UMLS CUI [1,1])
C0522510 (UMLS CUI [1,2])
C2700396 (UMLS CUI [1,3])
Pain
Code List
Pain on Day 3
CL Item
None (0)
CL Item
Mild (1)
CL Item
Moderate (2)
CL Item
Severe (3)
Pain ongoing after day 3
Item
Pain ongoing after day 3?
boolean
C0030193 (UMLS CUI [1,1])
C2700396 (UMLS CUI [1,2])
Date of last day of symptoms
Item
Date of last day of symptoms
date
C0011008 (UMLS CUI [1,1])
C0030193 (UMLS CUI [1,2])
C2700396 (UMLS CUI [1,3])
Medically attended visit
Item
Medically attended visit
boolean
C0545082 (UMLS CUI [1,1])
C1386497 (UMLS CUI [1,2])
C0030193 (UMLS CUI [2])
Item
Medically attended visit Type
text
C0545082 (UMLS CUI [1,1])
C0332307 (UMLS CUI [1,2])
C1386497 (UMLS CUI [1,3])
C0030193 (UMLS CUI [2])
Medical advice Type
Code List
Medically attended visit Type
CL Item
Hospitalization (HO)
CL Item
Emergency room (ER)
CL Item
Medical doctor (MD)
Item Group
Solicited Adverse Events - General Symptoms
C0877248 (UMLS CUI-1)
C1457887 (UMLS CUI-2)
C0042196 (UMLS CUI-3)
Fever
Item
Fever
boolean
C0015967 (UMLS CUI [1])
Fever
Item
Fever
float
C0015967 (UMLS CUI [1])
Item
Fever, Site of measurement
text
C0449687 (UMLS CUI [1,1])
C0015967 (UMLS CUI [1,2])
Site of measurement
Code List
Fever, Site of measurement
CL Item
Axillary (A)
CL Item
Oral (O)
CL Item
Rectal (R)
Item
Fever on Day 0
integer
C0015967 (UMLS CUI [1])
Fever on Day 0
Code List
Fever on Day 0
CL Item
taken (1)
CL Item
not taken (2)
Fever on Day 0
Item
Fever on Day 0
float
C0005903 (UMLS CUI [1,1])
C0015967 (UMLS CUI [1,2])
Item
Fever on Day 1
integer
C0015967 (UMLS CUI [1])
Fever on Day 0
Code List
Fever on Day 1
CL Item
taken (1)
CL Item
not taken (2)
Fever on Day 1
Item
Fever on Day 1
float
C0005903 (UMLS CUI [1,1])
C0015967 (UMLS CUI [1,2])
Item
Fever on Day 2
integer
C0015967 (UMLS CUI [1])
Fever on Day 0
Code List
Fever on Day 2
CL Item
taken (1)
CL Item
not taken (2)
Fever on Day 2
Item
Fever on Day 2
float
C0005903 (UMLS CUI [1,1])
C0015967 (UMLS CUI [1,2])
Item
Fever on Day 3
integer
C0015967 (UMLS CUI [1])
Fever on Day 0
Code List
Fever on Day 3
CL Item
taken (1)
CL Item
not taken (2)
Fever on Day 3
Item
Fever on Day 3
float
C0005903 (UMLS CUI [1,1])
C0015967 (UMLS CUI [1,2])
Fever ongoing after day 3
Item
Fever ongoing after day 3?
boolean
C0015967 (UMLS CUI [1])
Date of last day of symptoms
Item
Date of last day of symptoms
date
C0011008 (UMLS CUI [1,1])
C0015967 (UMLS CUI [1,2])
Causality
Item
Causality?
boolean
C0015127 (UMLS CUI [1])
C0015967 (UMLS CUI [2])
Medically attended visit
Item
Medically attended visit
boolean
C0545082 (UMLS CUI [1,1])
C1386497 (UMLS CUI [1,2])
C0015967 (UMLS CUI [2])
Item
Medically attended visit Type
text
C0545082 (UMLS CUI [1,1])
C0332307 (UMLS CUI [1,2])
C1386497 (UMLS CUI [1,3])
C0015967 (UMLS CUI [2])
Medical advice Type
Code List
Medically attended visit Type
CL Item
Hospitalization (HO)
CL Item
Emergency room (ER)
CL Item
Medical doctor (MD)
Drowsiness
Item
Drowsiness
boolean
C0013144 (UMLS CUI [1])
Item
Drowsiness, Intensity
integer
C0013144 (UMLS CUI [1,1])
C0522510 (UMLS CUI [1,2])
Pain
Code List
Drowsiness, Intensity
CL Item
None (0)
CL Item
Mild (1)
CL Item
Moderate (2)
CL Item
Severe (3)
Item
Drowsiness on Day 0
integer
C0013144 (UMLS CUI [1])
Pain
Code List
Drowsiness on Day 0
CL Item
None (0)
CL Item
Mild (1)
CL Item
Moderate (2)
CL Item
Severe (3)
Item
Drowsiness on Day 1
integer
C0013144 (UMLS CUI [1])
Pain
Code List
Drowsiness on Day 1
CL Item
None (0)
CL Item
Mild (1)
CL Item
Moderate (2)
CL Item
Severe (3)
Item
Drowsiness on Day 2
integer
C0013144 (UMLS CUI [1])
Pain
Code List
Drowsiness on Day 2
CL Item
None (0)
CL Item
Mild (1)
CL Item
Moderate (2)
CL Item
Severe (3)
Item
Drowsiness on Day 3
integer
C0013144 (UMLS CUI [1])
Pain
Code List
Drowsiness on Day 3
CL Item
None (0)
CL Item
Mild (1)
CL Item
Moderate (2)
CL Item
Severe (3)
Drowsiness ongoing after day 3
Item
Drowsiness ongoing after day 3?
boolean
C0013144 (UMLS CUI [1])
Date of last day of symptoms
Item
Date of last day of symptoms
date
C0013144 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
Causality
Item
Causality?
boolean
C0015127 (UMLS CUI [1])
C0013144 (UMLS CUI [2])
Medically attended visit
Item
Medically attended visit
boolean
C0545082 (UMLS CUI [1,1])
C1386497 (UMLS CUI [1,2])
C0013144 (UMLS CUI [2])
Item
Medically attended visit Type
text
C0545082 (UMLS CUI [1,1])
C0332307 (UMLS CUI [1,2])
C1386497 (UMLS CUI [1,3])
C0013144 (UMLS CUI [2])
Medical advice Type
Code List
Medically attended visit Type
CL Item
Hospitalization (HO)
CL Item
Emergency room (ER)
CL Item
Medical doctor (MD)
Irritability/Fussiness
Item
Irritability/Fussiness
boolean
C0022107 (UMLS CUI [1])
Item
Irritability/Fussiness, Intensity
integer
C0022107 (UMLS CUI [1,1])
C0522510 (UMLS CUI [1,2])
Pain
Code List
Irritability/Fussiness, Intensity
CL Item
None (0)
CL Item
Mild (1)
CL Item
Moderate (2)
CL Item
Severe (3)
Item
Irritability/Fussiness on Day 0
integer
C0022107 (UMLS CUI [1])
Pain
Code List
Irritability/Fussiness on Day 0
CL Item
None (0)
CL Item
Mild (1)
CL Item
Moderate (2)
CL Item
Severe (3)
Item
Irritability/Fussiness on Day 1
integer
C0022107 (UMLS CUI [1])
Pain
Code List
Irritability/Fussiness on Day 1
CL Item
None (0)
CL Item
Mild (1)
CL Item
Moderate (2)
CL Item
Severe (3)
Item
Irritability/Fussiness on Day 2
integer
C0022107 (UMLS CUI [1])
Pain
Code List
Irritability/Fussiness on Day 2
CL Item
None (0)
CL Item
Mild (1)
CL Item
Moderate (2)
CL Item
Severe (3)
Item
Irritability/Fussiness on Day 3
integer
C0022107 (UMLS CUI [1])
Pain
Code List
Irritability/Fussiness on Day 3
CL Item
None (0)
CL Item
Mild (1)
CL Item
Moderate (2)
CL Item
Severe (3)
Irritability/Fussiness ongoing after day 3
Item
Irritability/Fussiness ongoing after day 3?
boolean
C0022107 (UMLS CUI [1])
Date of last day of symptoms
Item
Date of last day of symptoms
date
C0022107 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
Causality
Item
Causality
boolean
C0015127 (UMLS CUI [1])
C0022107 (UMLS CUI [2])
Medically attended visit
Item
Medically attended visit
boolean
C0545082 (UMLS CUI [1,1])
C1386497 (UMLS CUI [1,2])
C0022107 (UMLS CUI [2])
Item
Medically attended visit Type
text
C0545082 (UMLS CUI [1,1])
C0332307 (UMLS CUI [1,2])
C1386497 (UMLS CUI [1,3])
C0022107 (UMLS CUI [2])
Medical advice Type
Code List
Medically attended visit Type
CL Item
Hospitalization (HO)
CL Item
Emergency room (ER)
CL Item
Medical doctor (MD)
Loss of appetite
Item
Loss of appetite
boolean
C1971624 (UMLS CUI [1])
Item
Loss of appetite, Intensity
integer
C1971624 (UMLS CUI [1,1])
C0522510 (UMLS CUI [1,2])
Pain
Code List
Loss of appetite, Intensity
CL Item
None (0)
CL Item
Mild (1)
CL Item
Moderate (2)
CL Item
Severe (3)
Item
Loss of appetite on Day 0
integer
C1971624 (UMLS CUI [1])
Pain
Code List
Loss of appetite on Day 0
CL Item
None (0)
CL Item
Mild (1)
CL Item
Moderate (2)
CL Item
Severe (3)
Item
Loss of appetite on Day 1
integer
C1971624 (UMLS CUI [1])
Pain
Code List
Loss of appetite on Day 1
CL Item
None (0)
CL Item
Mild (1)
CL Item
Moderate (2)
CL Item
Severe (3)
Item
Loss of appetite on Day 2
integer
C1971624 (UMLS CUI [1])
Pain
Code List
Loss of appetite on Day 2
CL Item
None (0)
CL Item
Mild (1)
CL Item
Moderate (2)
CL Item
Severe (3)
Item
Loss of appetite on Day 3
integer
C1971624 (UMLS CUI [1])
Pain
Code List
Loss of appetite on Day 3
CL Item
None (0)
CL Item
Mild (1)
CL Item
Moderate (2)
CL Item
Severe (3)
Loss of appetite ongoing after day 3
Item
Loss of appetite ongoing after day 3?
boolean
C1971624 (UMLS CUI [1])
Date of last day of symptoms
Item
Date of last day of symptoms
date
C1971624 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
Causality
Item
Causality?
boolean
C0015127 (UMLS CUI [1])
C1971624 (UMLS CUI [2])
Medically attended visit
Item
Medically attended visit
boolean
C0545082 (UMLS CUI [1,1])
C1386497 (UMLS CUI [1,2])
C1971624 (UMLS CUI [2])
Item
Medically attended visit Type
text
C0545082 (UMLS CUI [1,1])
C0332307 (UMLS CUI [1,2])
C1386497 (UMLS CUI [1,3])
C1971624 (UMLS CUI [2])
Medical advice Type
Code List
Medically attended visit Type
CL Item
Hospitalization (HO)
CL Item
Emergency room (ER)
CL Item
Medical doctor (MD)
Item Group
Unsolicited Adverse Events
C0877248 (UMLS CUI-1)
C0042196 (UMLS CUI-2)
Item
Has the subject experienced any serious or non-serious unsolicited adverse events within one month (minimum 30 days) post-vaccination?
text
C0877248 (UMLS CUI [1])
C0042196 (UMLS CUI [2])
Unsolicited Adverse Events
Code List
Has the subject experienced any serious or non-serious unsolicited adverse events within one month (minimum 30 days) post-vaccination?
CL Item
Information not available (U)
CL Item
No vaccine administered  (NA)
CL Item
No (N)
CL Item
Yes, Fill in the Non-Serious Adverse Event section or Serious Adverse Event report as necessary. (Y)
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