ID

36618

Description

Study ID: 105910 Clinical Study ID: 105910 Study Title: Compare Immunogenicity & Reactogenicity of 2 Formulations of GSK Biologicals' DTPa-HBV-IPV/Hib Vaccine (New vs Current) Given in Healthy Infants. The DTPa-HBV-IPV Vaccine (New Formulation) Will Also be Assessed in a 3rd Group of Subjects Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00320463 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 3 Study Recruitment Status: Completed Generic Name: DTPa-HBV-IPV/Hib vaccine Trade Name: N/A Study Indication: Diphtheria, Hepatitis B, Poliomyelitis, Tetanus, Whooping Cough

Keywords

Versions (1)
  1. 5/26/19 5/26/19 -
Copyright Holder

GlaxoSmithKline

Uploaded on

May 26, 2019

DOI

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License

Creative Commons BY-NC 3.0
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DTPa-HBV-IPV/Hib Vaccine Given in Healthy Infants; NCT00320463

English

Visit 1 - Day 0 - Dose 1

1 forms  
Administrative Data
Description

Administrative Data

Alias
UMLS CUI-1
C1320722
Date of visit
Description

Date of visit

Data type

date

Alias
UMLS CUI [1]
C1320303
Subject Number
Description

Clinical Trial Subject Unique Identifier

Data type

integer

Alias
UMLS CUI [1]
C2348585
Elimination Criteria During the Study
Description

Elimination Criteria During the Study

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

Pharmaceutical Preparations, Vaccination

Data type

boolean

Alias
UMLS CUI [1]
C0013227
UMLS CUI [2]
C0042196
Chronic administration (defined as more than 14 days) of immunosuppressants or other immune- modifying drugs during the study period. (For corticosteroids, this will mean prednisone, or equivalent, ≥ 0.5 mg/kg/day. Inhaled and topical steroids are allowed.)
Description

Immunosuppressive Agents, Chronic

Data type

boolean

Alias
UMLS CUI [1,1]
C0021081
UMLS CUI [1,2]
C0205191
Administration of a vaccine not foreseen by the study protocol during the period starting 30 days before the administration of the first dose and ending 30 days after the last dose.
Description

Vaccination, Concomitant Agent

Data type

boolean

Alias
UMLS CUI [1,1]
C0042196
UMLS CUI [1,2]
C2347852
Administration of immunoglobulins and/or any blood products during the study period.
Description

Immunoglobulins, Blood Product

Data type

boolean

Alias
UMLS CUI [1,1]
C0021027
UMLS CUI [1,2]
C0456388
Contradictions to Subsequent Vaccination
Description

Contradictions to Subsequent Vaccination

Alias
UMLS CUI-1
C0042196
UMLS CUI-2
C1301624
Hypersensitivity reaction due to the vaccine.
Description

Vaccination, Hypersensitivity

Data type

boolean

Alias
UMLS CUI [1,1]
C0042196
UMLS CUI [1,2]
C0020517
Encephalopathy defined as an acute, severe central nervous system disorder occurring within 7 days following vaccination and generally consisting of major alterations in consciousness, unresponsiveness, generalised or focal seizures that persist more than a few hours, with failure to recover within 24 hours.
Description

Encephalopathies, Administration of vaccines, Post

Data type

boolean

Alias
UMLS CUI [1,1]
C0085584
UMLS CUI [1,2]
C2368628
UMLS CUI [1,3]
C0687676
Temperature of ≥ 40.5 oC (rectal temperature) within 48 hours of vaccination, not due to another identifiable cause.
Description

Body Temperature, Administration of vaccine, Post

Data type

boolean

Alias
UMLS CUI [1,1]
C0005903
UMLS CUI [1,2]
C2368628
UMLS CUI [1,3]
C0687676
Collapse or shock-like state (hypotonic-hyporesponsive episode) within 48 hours of vaccination.
Description

Collapse, Administration of vaccine, Post

Data type

boolean

Alias
UMLS CUI [1,1]
C0344329
UMLS CUI [1,2]
C2368628
UMLS CUI [1,3]
C0687676
Persistent, inconsolable crying occurring within 48 hours of vaccination and lasting ≥ 3 hours.
Description

Persistent Crying, Administration of vaccine, Post

Data type

boolean

Alias
UMLS CUI [1,1]
C2721683
UMLS CUI [1,2]
C2368628
UMLS CUI [1,3]
C0687676
Seizures with or without fever occurring within 3 days of vaccination.
Description

Seizures, Administration of vaccine, Post

Data type

boolean

Alias
UMLS CUI [1,1]
C0036572
UMLS CUI [1,2]
C2368628
UMLS CUI [1,3]
C0687676
Acute disease at the time of vaccination. (Acute disease is defined as the presence of a moderate or severe illness with or without fever. All vaccines can be administered to persons with a minor illness such as diarrhoea, mild upper respiratory infection with or without low-grade febrile illness, i.e. Rectal temperature <38 °C
Description

Acute disease, During, Administration of vaccine

Data type

boolean

Alias
UMLS CUI [1,1]
C0001314
UMLS CUI [1,2]
C0347984
UMLS CUI [1,3]
C2368628
Rectal temperature ≥ 38°C.
Description

Rectal temperature

Data type

boolean

Alias
UMLS CUI [1]
C0489749
Informed Consent
Description

Informed Consent

Alias
UMLS CUI-1
C0021430
Informed Consent Date
Description

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

Data type

date

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

Demographics

Alias
UMLS CUI-1
C1704791
Center number
Description

Institution name, Identifier

Data type

integer

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

Patient date of birth

Data type

date

Alias
UMLS CUI [1]
C0421451
Gender
Description

Gender

Data type

text

Alias
UMLS CUI [1]
C0079399
Race
Description

Racial group

Data type

text

Alias
UMLS CUI [1]
C0034510
Eligibility Check
Description

Eligibility Check

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

Eligibility Determination

Data type

boolean

Alias
UMLS CUI [1]
C0013893
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI-1
C1512693
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.
Description

Protocol Compliance

Data type

boolean

Alias
UMLS CUI [1]
C0525058
A male or female between, and including, 11 and 17 weeks of age at the time of the first vaccination.
Description

Gender, Age

Data type

boolean

Alias
UMLS CUI [1,1]
C0079399
UMLS CUI [1,2]
C0001779
Infant born to known hepatitis B surface antigen (HBsAg) seronegative mother (documented laboratory result of HBsAg assay from the maternal blood sample is available).
Description

Mother, Hepatitis B surface antigen negative

Data type

boolean

Alias
UMLS CUI [1,1]
C0026591
UMLS CUI [1,2]
C0919711
Born after a normal gestation period (between 36 and 42 weeks)
Description

Full Term Birth

Data type

boolean

Alias
UMLS CUI [1]
C3814420
Written informed consent obtained from the parent or guardian of the subject
Description

Informed Consent

Data type

boolean

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

Healthy

Data type

boolean

Alias
UMLS CUI [1]
C3898900
Exclusion Criteria
Description

Exclusion Criteria

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

Pharmaceutical Preparations

Data type

boolean

Alias
UMLS CUI [1]
C0013227
Chronic administration (defined as more than 14 days) of immunosuppressants or other immune-modifying drugs within six months prior to the first vaccine dose. (For corticosteroids, this will mean prednisone, or equivalent, ≥ 0.5 mg/kg/day. Inhaled and topical steroids are allowed).
Description

Immunosuppressive Agents

Data type

boolean

Alias
UMLS CUI [1]
C0021081
Any chronic drug therapy to be continued during the study period.
Description

Pharmaceutical Preparations, Chronic

Data type

boolean

Alias
UMLS CUI [1,1]
C0013227
UMLS CUI [1,2]
C0205191
Planned administration/ administration of a vaccine not foreseen by the study protocol during the period starting from 30 days before each dose of study vaccine and ending 30 days after the last vaccine dose.
Description

Concomitant Agent, Vaccination, Planned

Data type

boolean

Alias
UMLS CUI [1,1]
C2347852
UMLS CUI [1,2]
C0042196
UMLS CUI [1,3]
C1301732
Previous vaccination against diphtheria, tetanus, pertussis, poliomyelitis, hepatitis B and/or Haemophilus influenzae diseases.
Description

Diphtheria-Tetanus-Pertussis Vaccine, Previous; Poliomyelitis, Vaccination, Previous; Hepatitis B vaccination, Previous; Haemophilus influenzae, Vaccination, Previous

Data type

boolean

Alias
UMLS CUI [1,1]
C0012559
UMLS CUI [1,2]
C0205156
UMLS CUI [2,1]
C0032371
UMLS CUI [2,2]
C0042196
UMLS CUI [2,3]
C0205156
UMLS CUI [3,1]
C0474232
UMLS CUI [3,2]
C0205156
UMLS CUI [4,1]
C0018483
UMLS CUI [4,2]
C0042196
UMLS CUI [4,3]
C0205156
Known history of or exposure to diphtheria, tetanus, pertussis, poliomyelitis, hepatitis B and/or Haemophilus influenzae diseases since birth.
Description

Diphtheria, Exposure to; Tetanus, Exposure to; Pertussis, Exposure to; Poliomyelitis, Exposure to; Hepatitis B, Exposure to; Haemophilus influenzae, Exposure to

Data type

boolean

Alias
UMLS CUI [1,1]
C0012546
UMLS CUI [1,2]
C0332157
UMLS CUI [2,1]
C0039614
UMLS CUI [2,2]
C0332157
UMLS CUI [3,1]
C0043167
UMLS CUI [3,2]
C0332157
UMLS CUI [4,1]
C0032371
UMLS CUI [4,2]
C0332157
UMLS CUI [5,1]
C0019163
UMLS CUI [5,2]
C0332157
UMLS CUI [6,1]
C0018483
UMLS CUI [6,2]
C0332157
History of allergic disease or reactions likely to be exacerbated by any component of the vaccines.
Description

Vaccination, Hypersensitivity

Data type

boolean

Alias
UMLS CUI [1,1]
C0042196
UMLS CUI [1,2]
C0020517
Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination (no laboratory testing required).
Description

Immunologic Deficiency Syndromes

Data type

boolean

Alias
UMLS CUI [1]
C0021051
A family history of congenital or hereditary immunodeficiency.
Description

Immunodeficiency congenital, Family history; Immunologic Deficiency Syndromes, Hereditary, Family History

Data type

boolean

Alias
UMLS CUI [1,1]
C0853602
UMLS CUI [1,2]
C0241889
UMLS CUI [2,1]
C0021051
UMLS CUI [2,2]
C0439660
UMLS CUI [2,3]
C0241889
Major congenital defects or serious chronic illness.
Description

Congenital Abnormality, Major; Chronic disease, Serious

Data type

boolean

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

Nervous system disorder; Seizures

Data type

boolean

Alias
UMLS CUI [1]
C0027765
UMLS CUI [2]
C0036572
Acute or chronic, clinically significant pulmonary, cardiovascular, hepatic or renal functional abnormality, as determined by physical examination.
Description

Pulmonary function, Abnormality; Cardiovascular system function, Abnormality; Liver function, Abnormality; Renal function, Abnormality

Data type

boolean

Alias
UMLS CUI [1,1]
C0231921
UMLS CUI [1,2]
C1704258
UMLS CUI [2,1]
C0678859
UMLS CUI [2,2]
C1704258
UMLS CUI [3,1]
C0232741
UMLS CUI [3,2]
C1704258
UMLS CUI [4,1]
C0232804
UMLS CUI [4,2]
C1704258
Hepatomegaly, right upper quadrant abdominal pain or tenderness.
Description

Hepatomegaly; Right Upper Quadrant Pain; Right Upper Quadrant Abdominal Tenderness

Data type

boolean

Alias
UMLS CUI [1,1]
C0019209
UMLS CUI [1,2]
C0235299
UMLS CUI [1,3]
C0238571
Acute disease at the time of enrolment. (Acute disease is defined as the presence of a moderate or severe illness with or without fever. All vaccines can be administered to persons with a minor illness such as diarrhoea, mild upper respiratory infection with or without low- grade febrile illness, i.e. Rectal temperature < 38°C (100.4°F).
Description

Acute Disease

Data type

boolean

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

Immunoglobulins, Blood product

Data type

boolean

Alias
UMLS CUI [1,1]
C0021027
UMLS CUI [1,2]
C0456388
Other conditions which in the opinion of the investigator may potentially interfere with interpretation of study outcomes.
Description

Disease, Interferes with, Result

Data type

boolean

Alias
UMLS CUI [1,1]
C0012634
UMLS CUI [1,2]
C0521102
UMLS CUI [1,3]
C1274040
Randomisation / Treatment Allocation
Description

Randomisation / Treatment Allocation

Alias
UMLS CUI-1
C0034656
Record treatment number
Description

Randomization, Numbers

Data type

integer

Alias
UMLS CUI [1,1]
C0034656
UMLS CUI [1,2]
C0237753
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, signs or symptoms present prior to the start of the study?
Description

Disease; Symptoms

Data type

boolean

Alias
UMLS CUI [1]
C0012634
UMLS CUI [2]
C1457887
MedDRA System Organ Class
Description

MedDRA System Organ Class

Data type

text

Alias
UMLS CUI [1]
C2347091
Diagnosis
Description

Diagnosis

Data type

text

Alias
UMLS CUI [1]
C0011900
Past or Current?
Description

Diagnosis, Past, Current

Data type

text

Alias
UMLS CUI [1,1]
C0011900
UMLS CUI [1,2]
C1444637
UMLS CUI [1,3]
C0521116
Laboratory Tests - Blood Sample
Description

Laboratory Tests - Blood Sample

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

Collection of blood specimen for laboratory procedure

Data type

boolean

Alias
UMLS CUI [1]
C0005834
Date if different from visit date
Description

Collection of blood specimen for laboratory procedure, Date in time

Data type

date

Alias
UMLS CUI [1,1]
C0005834
UMLS CUI [1,2]
C0011008
Vaccine Administration
Description

Vaccine Administration

Alias
UMLS CUI-1
C0042196
UMLS CUI-2
C2368628
Date if different from visit date
Description

Vaccination, Administration of Vaccine, Date in time

Data type

date

Alias
UMLS CUI [1,1]
C0042196
UMLS CUI [1,2]
C2368628
UMLS CUI [1,3]
C0011008
Pre-Vaccination temperature
Description

Vaccination, Body Temperature, Vaccination, Before

Data type

float

Measurement units
  • °C
Alias
UMLS CUI [1,1]
C0042196
UMLS CUI [1,2]
C0005903
UMLS CUI [1,3]
C0042196
UMLS CUI [1,4]
C0332152
°C
Route
Description

Vaccination, Administration of vaccine, Body Temperature, Measurement site

Data type

text

Alias
UMLS CUI [1,1]
C0042196
UMLS CUI [1,2]
C2368628
UMLS CUI [1,3]
C0005903
UMLS CUI [1,4]
C0449687
Vaccine Administration (only one box must be ticked by vaccine)
Description

Vaccination, Administration of Vaccine

Data type

text

Alias
UMLS CUI [1,1]
C0042196
UMLS CUI [1,2]
C2368628
If Replacement vial, give number
Description

Vaccination, Administration of Vaccine, Vial Device, Replacement, Numbers

Data type

integer

Alias
UMLS CUI [1,1]
C0042196
UMLS CUI [1,2]
C2368628
UMLS CUI [1,3]
C0184301
UMLS CUI [1,4]
C0559956
UMLS CUI [1,5]
C0600091
If Wrong vial, give number
Description

Vaccination, Administration of Vaccine, Vial Device, Wrong, Numbers

Data type

integer

Alias
UMLS CUI [1,1]
C0042196
UMLS CUI [1,2]
C2368628
UMLS CUI [1,3]
C0184301
UMLS CUI [1,4]
C3827420
UMLS CUI [1,5]
C0600091
Side / Site, Route
Description

Vaccination, Administration of Vaccine, Anatomic Site, Drug Administration Routes

Data type

text

Alias
UMLS CUI [1,1]
C0042196
UMLS CUI [1,2]
C2368628
UMLS CUI [1,3]
C1515974
UMLS CUI [1,4]
C0013153
Has the study vaccine been administered according to the Protocol?
Description

Vaccination, Administration of Vaccine, Protocol Compliance

Data type

boolean

Alias
UMLS CUI [1,1]
C0042196
UMLS CUI [1,2]
C2368628
UMLS CUI [1,3]
C0525058
If No, Side
Description

Vaccination, Administration of Vaccine, Side

Data type

text

Alias
UMLS CUI [1,1]
C0042196
UMLS CUI [1,2]
C2368628
UMLS CUI [1,3]
C0441987
If No, Site
Description

Vaccination, Administration of Vaccine, Anatomic site

Data type

text

Alias
UMLS CUI [1,1]
C0042196
UMLS CUI [1,2]
C2368628
UMLS CUI [1,3]
C1515974
If No, Route
Description

Vaccination, Administration of Vaccine, Drug Administration Routes

Data type

text

Alias
UMLS CUI [1,1]
C0042196
UMLS CUI [1,2]
C2368628
UMLS CUI [1,3]
C0013153
Why not administered? Please tick the major reason for non administration.
Description

Vaccination, Administration of Vaccine, Not done

Data type

text

Alias
UMLS CUI [1,1]
C0042196
UMLS CUI [1,2]
C2368628
UMLS CUI [1,3]
C1272696
Please tick who made the decision
Description

Vaccination, Administration of Vaccine, Decision

Data type

text

Alias
UMLS CUI [1,1]
C0042196
UMLS CUI [1,2]
C2368628
UMLS CUI [1,3]
C0679006
Solicited Adverse Events - Local Symptoms
Description

Solicited Adverse Events - Local Symptoms

Alias
UMLS CUI-1
C0877248
UMLS CUI-2
C1457887
UMLS CUI-3
C0205276
UMLS CUI-4
C0545082
UMLS CUI-5
C0332307
Has the subject experienced any of the following signs/symptoms at the administration site during the solicited period?
Description

Adverse Event, Symptoms, Local

Data type

text

Alias
UMLS CUI [1,1]
C0877248
UMLS CUI [1,2]
C1457887
UMLS CUI [1,3]
C0205276
Local Symptoms
Description

Adverse Event, Symptoms, Local

Data type

text

Alias
UMLS CUI [1,1]
C0877248
UMLS CUI [1,2]
C1457887
UMLS CUI [1,3]
C0205276
Day 0
Description

Adverse Event, Symptoms, Local

Data type

text

Alias
UMLS CUI [1,1]
C0877248
UMLS CUI [1,2]
C1457887
UMLS CUI [1,3]
C0205276
Day 1
Description

Adverse Event, Symptoms, Local

Data type

text

Alias
UMLS CUI [1,1]
C0877248
UMLS CUI [1,2]
C1457887
UMLS CUI [1,3]
C0205276
Day 2
Description

Adverse Event, Symptoms, Local

Data type

text

Alias
UMLS CUI [1,1]
C0877248
UMLS CUI [1,2]
C1457887
UMLS CUI [1,3]
C0205276
Day 3
Description

Adverse Event, Symptoms, Local

Data type

text

Alias
UMLS CUI [1,1]
C0877248
UMLS CUI [1,2]
C1457887
UMLS CUI [1,3]
C0205276
Ongoing after Day 3
Description

Adverse Event, Symptoms, Local, Continuous

Data type

boolean

Alias
UMLS CUI [1,1]
C0877248
UMLS CUI [1,2]
C1457887
UMLS CUI [1,3]
C0205276
UMLS CUI [1,4]
C0549178
Date of last Day of Symptoms
Description

Adverse Event, Symptoms, Local, End Date

Data type

date

Alias
UMLS CUI [1,1]
C0877248
UMLS CUI [1,2]
C1457887
UMLS CUI [1,3]
C0205276
UMLS CUI [1,4]
C0806020
Medically attended visit
Description

Adverse Event, Symptoms, Local, Visit/Advice

Data type

boolean

Alias
UMLS CUI [1,1]
C0877248
UMLS CUI [1,2]
C1457887
UMLS CUI [1,3]
C0205276
UMLS CUI [1,4]
C0545082
Medically attended visit - Type
Description

Adverse Event, Symptoms, Local, Visit/Advice, Type

Data type

text

Alias
UMLS CUI [1,1]
C0877248
UMLS CUI [1,2]
C1457887
UMLS CUI [1,3]
C0205276
UMLS CUI [1,4]
C0545082
UMLS CUI [1,5]
C0332307
Solicited Adverse Events - General Symptoms
Description

Solicited Adverse Events - General Symptoms

Alias
UMLS CUI-1
C0877248
UMLS CUI-2
C0159028
Has the subject experienced any of the following signs/symptoms during the solicited period?
Description

Adverse Event, General symptom

Data type

text

Alias
UMLS CUI [1,1]
C0877248
UMLS CUI [1,2]
C0159028
General Symptoms
Description

Adverse Event, General symptom

Data type

text

Alias
UMLS CUI [1,1]
C0877248
UMLS CUI [1,2]
C0159028
Day 0
Description

Adverse Event, General symptom

Data type

text

Alias
UMLS CUI [1,1]
C0877248
UMLS CUI [1,2]
C0159028
Day 1
Description

Adverse Event, General symptom

Data type

text

Alias
UMLS CUI [1,1]
C0877248
UMLS CUI [1,2]
C0159028
Day 2
Description

Adverse Event, General symptom

Data type

text

Alias
UMLS CUI [1,1]
C0877248
UMLS CUI [1,2]
C0159028
Day 3
Description

Adverse Event, General symptom

Data type

text

Alias
UMLS CUI [1,1]
C0877248
UMLS CUI [1,2]
C0159028
Ongoing after Day 3
Description

Adverse Event, General symptom, Continuous

Data type

boolean

Alias
UMLS CUI [1,1]
C0877248
UMLS CUI [1,2]
C0159028
UMLS CUI [1,3]
C0549178
Date of last Day of Symptoms
Description

Adverse Event, General symptom, End Date

Data type

date

Alias
UMLS CUI [1,1]
C0877248
UMLS CUI [1,2]
C0159028
UMLS CUI [1,3]
C0806020
Causality
Description

Adverse Event, General symptom, Etiology aspects

Data type

boolean

Alias
UMLS CUI [1,1]
C0877248
UMLS CUI [1,2]
C0159028
UMLS CUI [1,3]
C0015127
Medically attended visit
Description

Adverse Event, General symptom, Visit/Advice

Data type

boolean

Alias
UMLS CUI [1,1]
C0877248
UMLS CUI [1,2]
C0159028
UMLS CUI [1,3]
C0545082
Medically attended visit - Type
Description

Adverse Event, General symptom, Visit/Advice, Type

Data type

text

Alias
UMLS CUI [1,1]
C0877248
UMLS CUI [1,2]
C0159028
UMLS CUI [1,3]
C0545082
UMLS CUI [1,4]
C0332307
Unsolicited Adverse Event
Description

Unsolicited Adverse Event

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

Adverse Event, Vaccination

Data type

text

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

Visit 1 - Day 0 - Dose 1

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
Administrative Data
C1320722 (UMLS CUI-1)
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
Elimination Criteria During the Study
C0680251 (UMLS CUI-1)
C0347984 (UMLS CUI-2)
C0008976 (UMLS CUI-3)
Pharmaceutical Preparations, Vaccination
Item
Use of any investigational or non-registered drug or vaccine other than the study vaccine(s) during the study period.
boolean
C0013227 (UMLS CUI [1])
C0042196 (UMLS CUI [2])
Immunosuppressive Agents, Chronic
Item
Chronic administration (defined as more than 14 days) of immunosuppressants or other immune- modifying drugs during the study period. (For corticosteroids, this will mean prednisone, or equivalent, ≥ 0.5 mg/kg/day. Inhaled and topical steroids are allowed.)
boolean
C0021081 (UMLS CUI [1,1])
C0205191 (UMLS CUI [1,2])
Vaccination, Concomitant Agent
Item
Administration of a vaccine not foreseen by the study protocol during the period starting 30 days before the administration of the first dose and ending 30 days after the last dose.
boolean
C0042196 (UMLS CUI [1,1])
C2347852 (UMLS CUI [1,2])
Immunoglobulins, Blood Product
Item
Administration of immunoglobulins and/or any blood products during the study period.
boolean
C0021027 (UMLS CUI [1,1])
C0456388 (UMLS CUI [1,2])
Item Group
Contradictions to Subsequent Vaccination
C0042196 (UMLS CUI-1)
C1301624 (UMLS CUI-2)
Vaccination, Hypersensitivity
Item
Hypersensitivity reaction due to the vaccine.
boolean
C0042196 (UMLS CUI [1,1])
C0020517 (UMLS CUI [1,2])
Encephalopathies, Administration of vaccines, Post
Item
Encephalopathy defined as an acute, severe central nervous system disorder occurring within 7 days following vaccination and generally consisting of major alterations in consciousness, unresponsiveness, generalised or focal seizures that persist more than a few hours, with failure to recover within 24 hours.
boolean
C0085584 (UMLS CUI [1,1])
C2368628 (UMLS CUI [1,2])
C0687676 (UMLS CUI [1,3])
Body Temperature, Administration of vaccine, Post
Item
Temperature of ≥ 40.5 oC (rectal temperature) within 48 hours of vaccination, not due to another identifiable cause.
boolean
C0005903 (UMLS CUI [1,1])
C2368628 (UMLS CUI [1,2])
C0687676 (UMLS CUI [1,3])
Collapse, Administration of vaccine, Post
Item
Collapse or shock-like state (hypotonic-hyporesponsive episode) within 48 hours of vaccination.
boolean
C0344329 (UMLS CUI [1,1])
C2368628 (UMLS CUI [1,2])
C0687676 (UMLS CUI [1,3])
Persistent Crying, Administration of vaccine, Post
Item
Persistent, inconsolable crying occurring within 48 hours of vaccination and lasting ≥ 3 hours.
boolean
C2721683 (UMLS CUI [1,1])
C2368628 (UMLS CUI [1,2])
C0687676 (UMLS CUI [1,3])
Seizures, Administration of vaccine, Post
Item
Seizures with or without fever occurring within 3 days of vaccination.
boolean
C0036572 (UMLS CUI [1,1])
C2368628 (UMLS CUI [1,2])
C0687676 (UMLS CUI [1,3])
Acute disease, During, Administration of vaccine
Item
Acute disease at the time of vaccination. (Acute disease is defined as the presence of a moderate or severe illness with or without fever. All vaccines can be administered to persons with a minor illness such as diarrhoea, mild upper respiratory infection with or without low-grade febrile illness, i.e. Rectal temperature <38 °C
boolean
C0001314 (UMLS CUI [1,1])
C0347984 (UMLS CUI [1,2])
C2368628 (UMLS CUI [1,3])
Rectal temperature
Item
Rectal temperature ≥ 38°C.
boolean
C0489749 (UMLS CUI [1])
Item Group
Informed Consent
C0021430 (UMLS CUI-1)
Informed Consent, Date in time
Item
Informed Consent Date
date
C0021430 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
Item Group
Demographics
C1704791 (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])
undefined item
Code List
Gender
CL Item
Male (1)
CL Item
Female (2)
Item
Race
text
C0034510 (UMLS CUI [1])
Racial group
Code List
Race
CL Item
African Heritage / African American  (1)
CL Item
American Indian or Alaskan Native  (2)
CL Item
Asian - Central/South Asian Heritage (3)
CL Item
Asian - East Asian Heritage (4)
CL Item
Asian - Japanese Heritage (5)
CL Item
Asian - South East Asian Heritage (6)
CL Item
Native Hawaiian or Other Pacific Islander (7)
CL Item
White - Arabic / North African Heritage (8)
CL Item
White - Caucasian / European Heritage (9)
CL Item
Other, specify (10)
Item Group
Eligibility Check
C0013893 (UMLS CUI-1)
Eligibility Determination
Item
Did the subject meet all the entry criteria?
boolean
C0013893 (UMLS CUI [1])
Item Group
Inclusion Criteria
C1512693 (UMLS CUI-1)
Protocol Compliance
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.
boolean
C0525058 (UMLS CUI [1])
Gender, Age
Item
A male or female between, and including, 11 and 17 weeks of age at the time of the first vaccination.
boolean
C0079399 (UMLS CUI [1,1])
C0001779 (UMLS CUI [1,2])
Mother, Hepatitis B surface antigen negative
Item
Infant born to known hepatitis B surface antigen (HBsAg) seronegative mother (documented laboratory result of HBsAg assay from the maternal blood sample is available).
boolean
C0026591 (UMLS CUI [1,1])
C0919711 (UMLS CUI [1,2])
Full Term Birth
Item
Born after a normal gestation period (between 36 and 42 weeks)
boolean
C3814420 (UMLS CUI [1])
Informed Consent
Item
Written informed consent obtained from the parent or guardian of the subject
boolean
C0021430 (UMLS CUI [1])
Healthy
Item
Free of obvious health problems as established by medical history and clinical examination before entering into the study.
boolean
C3898900 (UMLS CUI [1])
Item Group
Exclusion Criteria
C0680251 (UMLS CUI-1)
Pharmaceutical Preparations
Item
Use of any investigational or non-registered product (drug or vaccine) other than the study vaccine(s) within 30 days preceding the first dose of study vaccine, or planned use during the study period.
boolean
C0013227 (UMLS CUI [1])
Immunosuppressive Agents
Item
Chronic administration (defined as more than 14 days) of immunosuppressants or other immune-modifying drugs within six months prior to the first vaccine dose. (For corticosteroids, this will mean prednisone, or equivalent, ≥ 0.5 mg/kg/day. Inhaled and topical steroids are allowed).
boolean
C0021081 (UMLS CUI [1])
Pharmaceutical Preparations, Chronic
Item
Any chronic drug therapy to be continued during the study period.
boolean
C0013227 (UMLS CUI [1,1])
C0205191 (UMLS CUI [1,2])
Concomitant Agent, Vaccination, Planned
Item
Planned administration/ administration of a vaccine not foreseen by the study protocol during the period starting from 30 days before each dose of study vaccine and ending 30 days after the last vaccine dose.
boolean
C2347852 (UMLS CUI [1,1])
C0042196 (UMLS CUI [1,2])
C1301732 (UMLS CUI [1,3])
Diphtheria-Tetanus-Pertussis Vaccine, Previous; Poliomyelitis, Vaccination, Previous; Hepatitis B vaccination, Previous; Haemophilus influenzae, Vaccination, Previous
Item
Previous vaccination against diphtheria, tetanus, pertussis, poliomyelitis, hepatitis B and/or Haemophilus influenzae diseases.
boolean
C0012559 (UMLS CUI [1,1])
C0205156 (UMLS CUI [1,2])
C0032371 (UMLS CUI [2,1])
C0042196 (UMLS CUI [2,2])
C0205156 (UMLS CUI [2,3])
C0474232 (UMLS CUI [3,1])
C0205156 (UMLS CUI [3,2])
C0018483 (UMLS CUI [4,1])
C0042196 (UMLS CUI [4,2])
C0205156 (UMLS CUI [4,3])
Diphtheria, Exposure to; Tetanus, Exposure to; Pertussis, Exposure to; Poliomyelitis, Exposure to; Hepatitis B, Exposure to; Haemophilus influenzae, Exposure to
Item
Known history of or exposure to diphtheria, tetanus, pertussis, poliomyelitis, hepatitis B and/or Haemophilus influenzae diseases since birth.
boolean
C0012546 (UMLS CUI [1,1])
C0332157 (UMLS CUI [1,2])
C0039614 (UMLS CUI [2,1])
C0332157 (UMLS CUI [2,2])
C0043167 (UMLS CUI [3,1])
C0332157 (UMLS CUI [3,2])
C0032371 (UMLS CUI [4,1])
C0332157 (UMLS CUI [4,2])
C0019163 (UMLS CUI [5,1])
C0332157 (UMLS CUI [5,2])
C0018483 (UMLS CUI [6,1])
C0332157 (UMLS CUI [6,2])
Vaccination, Hypersensitivity
Item
History of allergic disease or reactions likely to be exacerbated by any component of the vaccines.
boolean
C0042196 (UMLS CUI [1,1])
C0020517 (UMLS CUI [1,2])
Immunologic Deficiency Syndromes
Item
Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination (no laboratory testing required).
boolean
C0021051 (UMLS CUI [1])
Immunodeficiency congenital, Family history; Immunologic Deficiency Syndromes, Hereditary, Family History
Item
A family history of congenital or hereditary immunodeficiency.
boolean
C0853602 (UMLS CUI [1,1])
C0241889 (UMLS CUI [1,2])
C0021051 (UMLS CUI [2,1])
C0439660 (UMLS CUI [2,2])
C0241889 (UMLS CUI [2,3])
Congenital Abnormality, Major; Chronic disease, Serious
Item
Major congenital defects or serious chronic illness.
boolean
C0000768 (UMLS CUI [1,1])
C0205164 (UMLS CUI [1,2])
C0008679 (UMLS CUI [2,1])
C0205404 (UMLS CUI [2,2])
Nervous system disorder; Seizures
Item
History of any neurologic disorders or seizures.
boolean
C0027765 (UMLS CUI [1])
C0036572 (UMLS CUI [2])
Pulmonary function, Abnormality; Cardiovascular system function, Abnormality; Liver function, Abnormality; Renal function, Abnormality
Item
Acute or chronic, clinically significant pulmonary, cardiovascular, hepatic or renal functional abnormality, as determined by physical examination.
boolean
C0231921 (UMLS CUI [1,1])
C1704258 (UMLS CUI [1,2])
C0678859 (UMLS CUI [2,1])
C1704258 (UMLS CUI [2,2])
C0232741 (UMLS CUI [3,1])
C1704258 (UMLS CUI [3,2])
C0232804 (UMLS CUI [4,1])
C1704258 (UMLS CUI [4,2])
Hepatomegaly; Right Upper Quadrant Pain; Right Upper Quadrant Abdominal Tenderness
Item
Hepatomegaly, right upper quadrant abdominal pain or tenderness.
boolean
C0019209 (UMLS CUI [1,1])
C0235299 (UMLS CUI [1,2])
C0238571 (UMLS CUI [1,3])
Acute Disease
Item
Acute disease at the time of enrolment. (Acute disease is defined as the presence of a moderate or severe illness with or without fever. All vaccines can be administered to persons with a minor illness such as diarrhoea, mild upper respiratory infection with or without low- grade febrile illness, i.e. Rectal temperature < 38°C (100.4°F).
boolean
C0001314 (UMLS CUI [1])
Immunoglobulins, Blood product
Item
Administration of immunoglobulins and/or any blood products since birth or planned administration during the study period.
boolean
C0021027 (UMLS CUI [1,1])
C0456388 (UMLS CUI [1,2])
Disease, Interferes with, Result
Item
Other conditions which in the opinion of the investigator may potentially interfere with interpretation of study outcomes.
boolean
C0012634 (UMLS CUI [1,1])
C0521102 (UMLS CUI [1,2])
C1274040 (UMLS CUI [1,3])
Item Group
Randomisation / Treatment Allocation
C0034656 (UMLS CUI-1)
Randomization, Numbers
Item
Record treatment number
integer
C0034656 (UMLS CUI [1,1])
C0237753 (UMLS CUI [1,2])
Item Group
General Medical History / Physical Examination
C0262926 (UMLS CUI-1)
C0031809 (UMLS CUI-2)
Disease; Symptoms
Item
Are you aware of any pre-existing conditions, signs or symptoms present prior to the start of the study?
boolean
C0012634 (UMLS CUI [1])
C1457887 (UMLS CUI [2])
Item
MedDRA System Organ Class
text
C2347091 (UMLS CUI [1])
MedDRA System Organ Class
Code List
MedDRA System Organ Class
CL Item
Skin and subcutaneous tissue (1)
CL Item
Musculoskeletal and connective tissue (2)
CL Item
Cardiac (3)
CL Item
Vascular (4)
CL Item
Respiratory, thoracic and mediastinal (5)
CL Item
Gastrointestinal (6)
CL Item
Hepatobiliary (7)
CL Item
Renal and urinary (8)
CL Item
Nervous system (9)
CL Item
Eye (10)
CL Item
Endocrine (12)
CL Item
Metabolism and nutrition (13)
CL Item
Blood and lymphatic system (14)
CL Item
Immune system (incl allergies, autoimmune disorders) (15)
CL Item
Infections and infestations (16)
CL Item
Neoplasms benign, malignant and unspecified (incl cysts, polyps) (17)
CL Item
Surgical and medical procedures (18)
CL Item
Other (19)
CL Item
Ear and labyrinth (11)
Diagnosis
Item
Diagnosis
text
C0011900 (UMLS CUI [1])
Item
Past or Current?
text
C0011900 (UMLS CUI [1,1])
C1444637 (UMLS CUI [1,2])
C0521116 (UMLS CUI [1,3])
Diagnosis, Past, Current
Code List
Past or Current?
CL Item
Past (1)
CL Item
Current (2)
Item Group
Laboratory Tests - Blood Sample
C0005834 (UMLS CUI-1)
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
Date if different from visit date
date
C0005834 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
Item Group
Vaccine Administration
C0042196 (UMLS CUI-1)
C2368628 (UMLS CUI-2)
Vaccination, Administration of Vaccine, Date in time
Item
Date if different from visit date
date
C0042196 (UMLS CUI [1,1])
C2368628 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,3])
Vaccination, Body Temperature, Vaccination, Before
Item
Pre-Vaccination temperature
float
C0042196 (UMLS CUI [1,1])
C0005903 (UMLS CUI [1,2])
C0042196 (UMLS CUI [1,3])
C0332152 (UMLS CUI [1,4])
Item
Route
text
C0042196 (UMLS CUI [1,1])
C2368628 (UMLS CUI [1,2])
C0005903 (UMLS CUI [1,3])
C0449687 (UMLS CUI [1,4])
Influenza virus vaccine, Administration of vaccine, Drug Administration Routes
Code List
Route
CL Item
Axillary (1)
CL Item
Oral (protocol case - using an oral digital thermometer) (2)
CL Item
Rectal (3)
Item
Vaccine Administration (only one box must be ticked by vaccine)
text
C0042196 (UMLS CUI [1,1])
C2368628 (UMLS CUI [1,2])
Influenza virus vaccine, Administration of Vaccine
Code List
Vaccine Administration (only one box must be ticked by vaccine)
CL Item
DTPa-HBV-IPV/Hib Vaccine  (1)
CL Item
DTPa-HBV-IPV Vaccine (2)
CL Item
Not administered (3)
Vaccination, Administration of Vaccine, Vial Device, Replacement, Numbers
Item
If Replacement vial, give number
integer
C0042196 (UMLS CUI [1,1])
C2368628 (UMLS CUI [1,2])
C0184301 (UMLS CUI [1,3])
C0559956 (UMLS CUI [1,4])
C0600091 (UMLS CUI [1,5])
Vaccination, Administration of Vaccine, Vial Device, Wrong, Numbers
Item
If Wrong vial, give number
integer
C0042196 (UMLS CUI [1,1])
C2368628 (UMLS CUI [1,2])
C0184301 (UMLS CUI [1,3])
C3827420 (UMLS CUI [1,4])
C0600091 (UMLS CUI [1,5])
Item
Side / Site, Route
text
C0042196 (UMLS CUI [1,1])
C2368628 (UMLS CUI [1,2])
C1515974 (UMLS CUI [1,3])
C0013153 (UMLS CUI [1,4])
Influenza virus vaccine, Administration of Vaccine, Anatomic Site, Drug Administration Routes
Code List
Side / Site, Route
CL Item
Right, Thigh, I.M. (Right, Thigh, I.M.)
Vaccination, Administration of Vaccine, Protocol Compliance
Item
Has the study vaccine been administered according to the Protocol?
boolean
C0042196 (UMLS CUI [1,1])
C2368628 (UMLS CUI [1,2])
C0525058 (UMLS CUI [1,3])
Item
If No, Side
text
C0042196 (UMLS CUI [1,1])
C2368628 (UMLS CUI [1,2])
C0441987 (UMLS CUI [1,3])
Influenza virus vaccine, Administration of Vaccine, Side
Code List
If No, Side
CL Item
Left (1)
CL Item
Right (2)
Item
If No, Site
text
C0042196 (UMLS CUI [1,1])
C2368628 (UMLS CUI [1,2])
C1515974 (UMLS CUI [1,3])
Influenza virus vaccine, Administration of Vaccine, Side
Code List
If No, Site
CL Item
Deltoid  (1)
CL Item
Thigh  (2)
CL Item
Buttock (3)
Item
If No, Route
text
C0042196 (UMLS CUI [1,1])
C2368628 (UMLS CUI [1,2])
C0013153 (UMLS CUI [1,3])
Influenza virus vaccine, Administration of Vaccine, Side
Code List
If No, Route
CL Item
I.M.  (1)
CL Item
S.C (2)
Item
Why not administered? Please tick the major reason for non administration.
text
C0042196 (UMLS CUI [1,1])
C2368628 (UMLS CUI [1,2])
C1272696 (UMLS CUI [1,3])
Influenza virus vaccine, Administration of Vaccine, Side
Code List
Why not administered? Please tick the major reason for non administration.
CL Item
Serious adverse event (Please specify SAE No.) (1)
CL Item
Non-Serious adverse event. (Please specify AE No.) (2)
CL Item
Other, please specify (3)
Item
Please tick who made the decision
text
C0042196 (UMLS CUI [1,1])
C2368628 (UMLS CUI [1,2])
C0679006 (UMLS CUI [1,3])
Influenza virus vaccine, Administration of Vaccine, Side
Code List
Please tick who made the decision
CL Item
Investigator (1)
CL Item
Parents/Guardians (2)
Item Group
Solicited Adverse Events - Local Symptoms
C0877248 (UMLS CUI-1)
C1457887 (UMLS CUI-2)
C0205276 (UMLS CUI-3)
C0545082 (UMLS CUI-4)
C0332307 (UMLS CUI-5)
Item
Has the subject experienced any of the following signs/symptoms at the administration site during the solicited period?
text
C0877248 (UMLS CUI [1,1])
C1457887 (UMLS CUI [1,2])
C0205276 (UMLS CUI [1,3])
Adverse Event, Symptoms, Local
Code List
Has the subject experienced any of the following signs/symptoms at the administration site during the solicited period?
CL Item
Information not available (1)
CL Item
No vaccine administered (2)
CL Item
No (3)
CL Item
Yes (4)
Item
Local Symptoms
text
C0877248 (UMLS CUI [1,1])
C1457887 (UMLS CUI [1,2])
C0205276 (UMLS CUI [1,3])
Adverse Event, Symptoms, Local
Code List
Local Symptoms
CL Item
Redness, give size (mm) (1)
CL Item
Swelling, give size (mm) (2)
CL Item
Pain, give intensity (3)
Adverse Event, Symptoms, Local
Item
Day 0
text
C0877248 (UMLS CUI [1,1])
C1457887 (UMLS CUI [1,2])
C0205276 (UMLS CUI [1,3])
Adverse Event, Symptoms, Local
Item
Day 1
text
C0877248 (UMLS CUI [1,1])
C1457887 (UMLS CUI [1,2])
C0205276 (UMLS CUI [1,3])
Adverse Event, Symptoms, Local
Item
Day 2
text
C0877248 (UMLS CUI [1,1])
C1457887 (UMLS CUI [1,2])
C0205276 (UMLS CUI [1,3])
Adverse Event, Symptoms, Local
Item
Day 3
text
C0877248 (UMLS CUI [1,1])
C1457887 (UMLS CUI [1,2])
C0205276 (UMLS CUI [1,3])
Adverse Event, Symptoms, Local, Continuous
Item
Ongoing after Day 3
boolean
C0877248 (UMLS CUI [1,1])
C1457887 (UMLS CUI [1,2])
C0205276 (UMLS CUI [1,3])
C0549178 (UMLS CUI [1,4])
Adverse Event, Symptoms, Local, End Date
Item
Date of last Day of Symptoms
date
C0877248 (UMLS CUI [1,1])
C1457887 (UMLS CUI [1,2])
C0205276 (UMLS CUI [1,3])
C0806020 (UMLS CUI [1,4])
Adverse Event, Symptoms, Local, Visit/Advice
Item
Medically attended visit
boolean
C0877248 (UMLS CUI [1,1])
C1457887 (UMLS CUI [1,2])
C0205276 (UMLS CUI [1,3])
C0545082 (UMLS CUI [1,4])
Item
Medically attended visit - Type
text
C0877248 (UMLS CUI [1,1])
C1457887 (UMLS CUI [1,2])
C0205276 (UMLS CUI [1,3])
C0545082 (UMLS CUI [1,4])
C0332307 (UMLS CUI [1,5])
Adverse Event, Symptoms, Local, Visit/Advice, Type
Code List
Medically attended visit - Type
CL Item
Hospitalization  (1)
CL Item
Emergency Room (2)
CL Item
Medical Personnel (3)
Item Group
Solicited Adverse Events - General Symptoms
C0877248 (UMLS CUI-1)
C0159028 (UMLS CUI-2)
Item
Has the subject experienced any of the following signs/symptoms during the solicited period?
text
C0877248 (UMLS CUI [1,1])
C0159028 (UMLS CUI [1,2])
Adverse Event, General symptom
Code List
Has the subject experienced any of the following signs/symptoms during the solicited period?
CL Item
Information not available (1)
CL Item
No Vaccine administered  (2)
CL Item
No (3)
CL Item
Yes (4)
Item
General Symptoms
text
C0877248 (UMLS CUI [1,1])
C0159028 (UMLS CUI [1,2])
Adverse Event, General symptom
Code List
General Symptoms
CL Item
Temperature, give °C (1)
CL Item
Temperature: Axillary, Oral or Rectal (2)
CL Item
Irritability/Fussiness, give intensity (3)
CL Item
Drowsiness, give intensity (4)
CL Item
Loss of appetite, give intensity (5)
Adverse Event, General symptom
Item
Day 0
text
C0877248 (UMLS CUI [1,1])
C0159028 (UMLS CUI [1,2])
Adverse Event, General symptom
Item
Day 1
text
C0877248 (UMLS CUI [1,1])
C0159028 (UMLS CUI [1,2])
Adverse Event, General symptom
Item
Day 2
text
C0877248 (UMLS CUI [1,1])
C0159028 (UMLS CUI [1,2])
Adverse Event, General symptom
Item
Day 3
text
C0877248 (UMLS CUI [1,1])
C0159028 (UMLS CUI [1,2])
Adverse Event, General symptom, Continuous
Item
Ongoing after Day 3
boolean
C0877248 (UMLS CUI [1,1])
C0159028 (UMLS CUI [1,2])
C0549178 (UMLS CUI [1,3])
Adverse Event, General symptom, End Date
Item
Date of last Day of Symptoms
date
C0877248 (UMLS CUI [1,1])
C0159028 (UMLS CUI [1,2])
C0806020 (UMLS CUI [1,3])
Adverse Event, General symptom, Etiology aspects
Item
Causality
boolean
C0877248 (UMLS CUI [1,1])
C0159028 (UMLS CUI [1,2])
C0015127 (UMLS CUI [1,3])
Adverse Event, General symptom, Visit/Advice
Item
Medically attended visit
boolean
C0877248 (UMLS CUI [1,1])
C0159028 (UMLS CUI [1,2])
C0545082 (UMLS CUI [1,3])
Item
Medically attended visit - Type
text
C0877248 (UMLS CUI [1,1])
C0159028 (UMLS CUI [1,2])
C0545082 (UMLS CUI [1,3])
C0332307 (UMLS CUI [1,4])
Adverse Event, General symptom, Visit/Advice, Type
Code List
Medically attended visit - Type
CL Item
Hospitalization (1)
CL Item
Emergency Room  (2)
CL Item
Medical Personnel (3)
Item Group
Unsolicited Adverse Event
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 [1,1])
C0042196 (UMLS CUI [1,2])
Adverse Event, Vaccination
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  (1)
CL Item
No vaccine administered  (2)
CL Item
No (3)
CL Item
Yes (4)
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