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])
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])
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])
Informed Consent, Date in time
Item
Informed Consent Date
date
C0021430 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
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])
Item
Race
text
C0034510 (UMLS CUI [1])
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)
Eligibility Determination
Item
Did the subject meet all the entry criteria?
boolean
C0013893 (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])
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])
Randomization, Numbers
Item
Record treatment number
integer
C0034656 (UMLS CUI [1,1])
C0237753 (UMLS CUI [1,2])
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])
Code List
MedDRA System Organ Class
CL Item
Skin and subcutaneous tissue (1)
CL Item
Musculoskeletal and connective tissue (2)
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
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
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])
Code List
Past or Current?
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])
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])
CL Item
Oral (protocol case - using an oral digital thermometer) (2)
Item
Vaccine Administration (only one box must be ticked by vaccine)
text
C0042196 (UMLS CUI [1,1])
C2368628 (UMLS CUI [1,2])
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])
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])
Item
If No, Site
text
C0042196 (UMLS CUI [1,1])
C2368628 (UMLS CUI [1,2])
C1515974 (UMLS CUI [1,3])
Item
If No, Route
text
C0042196 (UMLS CUI [1,1])
C2368628 (UMLS CUI [1,2])
C0013153 (UMLS CUI [1,3])
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])
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])
Code List
Please tick who made the decision
CL Item
Parents/Guardians (2)
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])
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)
Item
Local Symptoms
text
C0877248 (UMLS CUI [1,1])
C1457887 (UMLS CUI [1,2])
C0205276 (UMLS CUI [1,3])
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])
Code List
Medically attended visit - Type
CL Item
Hospitalization (1)
CL Item
Emergency Room (2)
CL Item
Medical Personnel (3)
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])
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)
Item
General Symptoms
text
C0877248 (UMLS CUI [1,1])
C0159028 (UMLS CUI [1,2])
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])
Code List
Medically attended visit - Type
CL Item
Hospitalization (1)
CL Item
Emergency Room (2)
CL Item
Medical Personnel (3)
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])
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)