Informed consent
Item
I certify that Informed Consent has been obtained prior to any study procedure. Informed Consent Date:
date
C0021430 (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])
Item
Race
text
C0034510 (UMLS CUI [1])
CL Item
White Caucasian (2)
CL Item
Arabic/North African (4)
CL Item
East & South East Asian (5)
CL Item
American Hispanic (7)
CL Item
Other, please specify (9)
Eligibility Check
Item
Did the subject meet all the entry criteria ? 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.
boolean
C0013893 (UMLS CUI [1])
Patient Compliance
Item
[ 1 ] 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
C1321605 (UMLS CUI [1,1])
C0023226 (UMLS CUI [1,2])
Age at first vaccination
Item
[ 2 ] A male or female between, and including, 12 and 14 months or 3 and 5 years (36 to 60 months) of age at the time of the first vaccination
boolean
C0001779 (UMLS CUI [1,1])
C0042196 (UMLS CUI [1,2])
Written informed consent
Item
[ 3 ] Written informed consent obtained from the the parent or guardian of the subject.
boolean
C0021430 (UMLS CUI [1,1])
C0023226 (UMLS CUI [1,2])
Health Problems
Item
[ 4 ] Free of obvious health problems as established by medical history and clinical examination before entering into the study.
boolean
C1446390 (UMLS CUI [1,1])
C0332296 (UMLS CUI [1,2])
childhood vaccination
Item
[ 5 ] Previously completed routine childhood vaccinations to the best of his/her parents’/guardians’ knowledge. For pertussis vaccination, the children aged 12-14 months should have been vaccinated with an acellular pertussis vaccine.
boolean
C0205156 (UMLS CUI [1,1])
C0231335 (UMLS CUI [1,2])
C0042196 (UMLS CUI [1,3])
C0205197 (UMLS CUI [1,4])
Use of investigational new drug
Item
[ 6 ] 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
C0013230 (UMLS CUI [1,1])
C1524063 (UMLS CUI [1,2])
Immunosuppressants | Immune-modifying drugs
Item
[ 7 ] 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, x 0.5 mg/kg/day. Inhaled and topical steroids are allowed.)
boolean
C0021081 (UMLS CUI [1,1])
C0205191 (UMLS CUI [1,2])
C0005525 (UMLS CUI [2,1])
C0205191 (UMLS CUI [2,2])
Other vaccine
Item
[ 8 ] Planned administration/ administration of a vaccine not foreseen by the study protocol within one month of the first dose of vaccine and up to one month after administration of each study vaccine dose with the exception of oral polio vaccine (OPV)
boolean
C2368628 (UMLS CUI [1,1])
C1444655 (UMLS CUI [1,2])
C2348563 (UMLS CUI [1,3])
Meningococcal vaccination
Item
[ 9 ] Previous vaccination against meningococcal serogroup A, C, W-135 or Y disease.
boolean
C2368628 (UMLS CUI [1,1])
C0700144 (UMLS CUI [1,2])
C0776552 (UMLS CUI [1,3])
C1444655 (UMLS CUI [1,4])
H. influenza type B Vaccine | Diphteria vaccine | Tetanus vaccine
Item
[ 10 ] Administration of a H. influenzae type b, diphtheria or tetanus vaccine within 3 months before the first dose of vaccine.
boolean
C0062082 (UMLS CUI [1])
C0012546 (UMLS CUI [2,1])
C0042210 (UMLS CUI [2,2])
C0305062 (UMLS CUI [3])
Booster vaccination
Item
[ 11 ] For subjects aged 12-14 months at enrolment: - For Austria: DTPa-HBV-IPV/Hib booster vaccination in the second year of life: these booster vaccines will be given at Visit 2. - For Greece: DTPa-IPV/Hib booster vaccination in the second year of life: these booster vaccines will be given at Visit 2.
boolean
C0020975 (UMLS CUI [1,1])
C0545082 (UMLS CUI [1,2])
C0205448 (UMLS CUI [1,3])
Disease history
Item
[ 12 ] History of meningococcal serogroup A, C, W-135 or Y disease.
boolean
C0683519 (UMLS CUI [1,1])
C1135745 (UMLS CUI [1,2])
C0683519 (UMLS CUI [2,1])
C1135746 (UMLS CUI [2,2])
C0683519 (UMLS CUI [3,1])
C1135747 (UMLS CUI [3,2])
C0683519 (UMLS CUI [4,1])
C1136209 (UMLS CUI [4,2])
C0683519 (UMLS CUI [5,1])
C1136210 (UMLS CUI [5,2])
Disease exposure
Item
[ 13 ] Known exposure to meningococcal serogroup A, C, W-135 or Y disease within the previous year.
boolean
C0332157 (UMLS CUI [1,1])
C1135745 (UMLS CUI [1,2])
C0332157 (UMLS CUI [2,1])
C1135746 (UMLS CUI [2,2])
C0332157 (UMLS CUI [3,1])
C1135747 (UMLS CUI [3,2])
C0332157 (UMLS CUI [4,1])
C1136209 (UMLS CUI [4,2])
C0332157 (UMLS CUI [5,1])
C1136210 (UMLS CUI [5,2])
Immunosuppresive condition | immunodeficient condition
Item
[ 14 ] Any confirmed or suspected immunosuppressive or immunodeficient condition, including human immunodeficiency virus (HIV) infection.
boolean
C3829792 (UMLS CUI [1,1])
C0021051 (UMLS CUI [1,2])
C0019693 (UMLS CUI [1,3])
Immunodeficiency
Item
[ 15 ] A family history of congenital or hereditary immunodeficiency.
boolean
C0021051 (UMLS CUI [1,1])
C0853602 (UMLS CUI [1,2])
C0021051 (UMLS CUI [2,1])
C0439660 (UMLS CUI [2,2])
allergic reactions
Item
[ 16 ] History of allergic disease or reactions likely to be exacerbated by any component of the vaccine.
boolean
C0020517 (UMLS CUI [1,1])
C2106654 (UMLS CUI [1,2])
C0042210 (UMLS CUI [1,3])
C1705248 (UMLS CUI [1,4])
Congenital defects | Serious chronic illness
Item
[ 17 ] Major congenital defects or serious chronic illness.
boolean
C0008679 (UMLS CUI [1])
C0220810 (UMLS CUI [2,1])
C0205164 (UMLS CUI [2,2])
C0008679 (UMLS CUI [2,3])
C0205404 (UMLS CUI [2,4])
Neurological disorders
Item
[ 18 ] History of any neurologic disorders or seizures.
boolean
C0027765 (UMLS CUI [1,1])
C0036572 (UMLS CUI [1,2])
Acute disease
Item
[ 19 ] > 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. Axillary temperature <37.5°C / Rectal temperature <38°C)
boolean
C0001314 (UMLS CUI [1])
Immunoglobulins | Blood products
Item
[ 20 ] Administration of immunoglobulins and/or any blood products within the three months preceding the first dose of study vaccine or planned administration during the study period.
boolean
C0021027 (UMLS CUI [1])
C0371802 (UMLS CUI [2])